A Phase 3 interventional study of DTG + 3TC and TAF based regimen (TBR) in HIV Infections, sponsored by ViiV Healthcare. Completed at 133 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-19.
Sponsored by ViiV Healthcare (part of GlaxoSmithKline) · Phase 3, Interventional, and Treatment
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Among 55 studies testing dolutegravir in HIV Infections — 7 open to participants now, 9 under way, 4 of them phase 3. Dolutegravir · HIV Infections.
Among the 55 studies testing dolutegravir in HIV Infections, this one is the 6th largest by enrollment, is one of 3 that started in 2018, is one of 21 in phase 3, and was the 29th registered.
4,736 studies on the registry are indexed under HIV Infections; 246 are open to participants now.
Browse HIV Infections studies →7 of the 55 studies testing dolutegravir in HIV Infections are open now, in 12 countries. Recruiting first, the newest first:
ViiV Healthcare · Sites in Romania, South Africa, Uganda
José Antonio Mata Marín · Sites in Mexico
Ages 18–70
Instituto Mexicano del Seguro Social · Sites in Mexico
Ages 18+
José Antonio Mata Marín · Sites in Mexico
Ages 18–70 · Men only
ViiV Healthcare · Sites in United States
Ages 6–12
By country, each count listing its studies:
Dolutegravir: first FDA approval 2013 (TIVICAY), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 15 · Phase 3 24 · Phase 4 11
First in 2009; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 743 is above the median of 80 across 3,491 interventional studies indexed under HIV Infections.
Median enrollment 126 across the 55 interventional studies. Of the 43 that completed or were terminated, 26 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
28 of 55 have an industry lead sponsor. The 10 most frequent:
This study is registered under ViiV Healthcare, one of the names counted as GlaxoSmithKline. Under that name alone:
ViiV Healthcare is the lead sponsor of 266 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 53 (75%) have results posted.
265 studies in HIV Infections by GlaxoSmithKline: 14 open now, 26 under way, 8 of them phase 3. Of 230 finished, 95 (41%) have results posted.
Among the 265 studies in HIV Infections by GlaxoSmithKline, this one is the 9th largest by enrollment of the 209 interventional ones that give a count, is one of 8 that started in 2018, is one of 65 in phase 3, and was the 185th registered.
GlaxoSmithKline’s HIV Infections studies by the year they started, since 1994.
1 of the studies testing dolutegravir in HIV Infections that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07031063Instituto Mexicano del Seguro SocialSafety, Tolerability and Effectiveness of DTG/3TC vs BIC/TAF/FTC in PWH Without Antiretroviral Experience | 2026-12-01 |
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Among the 55 studies testing dolutegravir in HIV Infections, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among GlaxoSmithKline’s 265 in HIV Infections:
This tab as a report to print or save as PDF → With an account.
The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult participants with current virologic suppression on a >=3-drug tenofovir alafenamide (TAF) based regimen (TBR) remain suppressed upon switching to a two-drug regimen of dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg. This study will also provide important information regarding the safety and participant satisfaction with this two-drug regimen. The primary objective of this trial is to demonstrate the non-inferior antiviral activity of switching to DTG + 3TC once daily compared to continuation of TBR over 48 weeks in HIV-1 infected, antiretroviral therapy (ART)-experienced, virologically suppressed participants. This study also will characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC compared to TBR through Week 144 and characterize the long-term antiviral activity, tolerability and safety of DTG + 3TC through Week 200.
This will be a 200-week, Phase III, randomized, open-label, active-controlled, multicenter, parallel- group study. The study will include a screening phase (up to 28 days), a randomized early switch phase (Day 1 up to Week 148), a randomized late switch phase (Week 148 up to Week 200), and a continuation phase (post Week 200). HIV-1 infected adults on stable TBR will be randomized 1:1 to switch to DTG + 3TC once daily for up to 200 weeks, or to continue their TBR for 148 weeks, at which time and if HIV-1 ribonucleic acid (RNA) \<50 copies per milliliter (c/mL) at Week 144, these participants will switch to DTG + 3TC up to Week 200.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must be on uninterrupted ART for at least 6 months prior to screening. Only the following regimens are allowed:
A female participant is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin [hCG] test at screen and a negative urine hCG test at randomization [a local serum hCG test at Randomization is allowed if it can be done, and results obtained, within 24 hours prior to randomization]), not lactating, and at least one of the following conditions applies:
a. Non- defined as:
Pre-menopausal females with one of the following:
defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause [refer to laboratory reference ranges for confirmatory levels]). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
b. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication and for at least 2 weeks after the last dose of study medication.
Participants enrolled in France must be affiliated to, or a beneficiary of, a social security category.
Exclusion Criteria:
Participants enrolled in France (or in other countries as required by local regulations or Ethics Committee/Institutional Review Board [IRB]) who:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single tablet of a two-drug regimen of DTG 50 mg + 3TC 300 mg once daily from Day 1 through Week 200 (Early and Late Switch Phase).
Drug: DTG + 3TC
Participants will continue their TBR from Day 1 to Week 148 (Early Switch Phase), and eligible participants will switch to DTG + 3TC once daily from Week 148 to 200 (Late Switch Phase).
Drug: TAF based regimen (TBR)
Drug pages: Dolutegravir · Lamivudine
DTG+3TC is supplied as white, oval, film-coated, fixed dose combination tablet. The tablets will be available in packed high density polyethylene (HDPE) bottles with induction seals and child-resistant closures.
Participants will continue to receive their TBR.
Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48
Percentage of participants with virologic failure (plasma HIV-1 RNA \>=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who received at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized.
Time frame: Week 48
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48
Percentage of participants with plasma HIV-1 RNA \<50 c/mL (virologic success) was evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
Time frame: Week 48
Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24
Percentage of participants with plasma HIV-1 RNA \>=50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
Time frame: Week 24
Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144
Percentage of participants with plasma HIV-1 RNA \>=50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144.
Time frame: Weeks 96 and 144
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Percentage values are rounded off.
Time frame: Week 24
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144.
Time frame: Weeks 96 and 144
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in CD4+ Cell Count at Weeks 96 and 144
CD4+ cells are a type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+and evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48
Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over 48 Weeks. Baseline (Day 1) values were the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable .
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144
Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio and were evaluated by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over Weeks 96 and 144. Baseline (Day 1) values are the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Number of Participants With Disease Progression at Weeks 24 and 48
HIV-associated conditions were recorded during the study and were assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV were: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: \>=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3:Documented AIDS defining condition or CD4+ T-lymphocye count \<200 cells/mcL. Disease progression summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death.
Time frame: At Weeks 24 and 48
Number of Participants With Disease Progression at Weeks 96 and 144
HIV-associated conditions were recorded during the study and assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV is: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: \>=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: Documented AIDS-defining condition or CD4+ T-lymphocye count \<200 cells/mcL. Indicators of clinical disease progression is defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death.
Time frame: At Weeks 96 and 144
Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Safety Population included all participants who received at least one dose of study treatment either DTG + 3TC or TBR. This population was based on the treatment the participant actually received. Number of participants with any SAE and common (\>=2%) non-SAEs are presented.
Time frame: Up to Week 48
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Number of TDF-based regimen participants with any SAE and common (\>=2%) non-SAEs are presented.
Time frame: Up to Week 48
Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment
Time frame: Up to Week 148
Number of Participants With AEs by Their Severity Grades: Up to Week 48
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time frame: Up to Week 48
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of TDF-based regimen participants with adverse events by maximum grade have been presented.
Time frame: Up to Week 48
Number of Participants With AEs by Their Severity Grades: Up to Week 144
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time frame: Up to Week 144
Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.
Time frame: Up to Week 48
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.
Time frame: Up to Week 48
Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
Time frame: Up to Week 144
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48
Blood samples were collected up to Week 48 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.
Time frame: Up to Week 48
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36
Blood samples were collected up to the Week 36 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those TDF-based regimen participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.
Time frame: Up to Week 36
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144
Blood samples were collected up to Week 144 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters are were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time frame: Up to Week 144
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48
Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time frame: Up to Week 48
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36
samples were collected up to the Week 36 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time frame: Up to Week 36
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144
Blood samples were collected up to Week 144 for the analysis of clinical chemistry parameters: ALT, albumin, ALP, AST, bilirubin, CO2, cholesterol, CK, creatinine, direct bilirubin, GFR from creatinine adjusted for BSA, GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, LDL cholesterol, phosphate triglycerides and lactate dehydrogenase. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
Time frame: Up to Week 144
Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48
Urine samples were collected at Baseline, Week 24 and Week 48. Baseline is defined as Day 1. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. Change from Baseline in UP/C and UA/C was calculated as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio calculated at Baseline, respectively. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at weeks 24 and 48
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen
Urine samples were collected at Baseline, Week 24 and Week 48 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline was defined as the latest pre-dose assessment value with a non-missing value. (Day 1). Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Change from Baseline in UP/C was calculated as UP/C ratio at post-Baseline visit minus UP/C ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at weeks 24 and 48
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144
Urine samples were collected at Baseline, Weeks 96 and 144. Baseline is defined as Day 1. Change from Baseline in UA/C is defined as UA/C ratio at post-Baseline visit minus UA/C ratio at Baseline. Change from Baseline in UP/C and UA/C is defined as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio at Baseline, respectively. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48
Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine beta-2 microglobulin/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at weeks 24 and 48
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Urine biomarker samples were collected to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at weeks 24 and 48
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144
Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine is defined as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48
Urine biomarker samples were collected at Baseline and at Weeks 24 and 48 to assess urine phosphate. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at weeks 24 and 48
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Urine biomarker samples were collected to assess urine phosphate. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at weeks 24 and 48
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144
Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine phosphate. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate is defined as urine phosphate at post-Baseline visit minus urine phosphate at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48
Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine retinol binding protein 4/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio was calculated as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at weeks 24 and 48
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Urine biomarker samples were collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine was calculated as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at weeks 24 and 48
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144
Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio is defined as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Change From Baseline in Fasting Lipids at Weeks 24 and 48
Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma high density lipoprotein (HDL) cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at weeks 24 and 48
Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Blood samples were collected at Baseline (Day 1), weeks 24 and 48 visit (participant withdrew from the study at Week 36) to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for fasting lipids in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at weeks 24 and 48
Change From Baseline in Fasting Lipids at Weeks 96 and 144
Blood samples were collected at Baseline (Day 1), Weeks 96 and 144 to assess fasting lipids which includes plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value is the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen.
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Number of Participants With Genotypic Resistance: Up to Week 48
Plasma samples were collected for drug resistance testing. Number of participants, who met confirmed virologic withdrawal (CVW) criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with genotypic resistance to INSTI, nucleoside reverse transcriptase inhibitor (NRTI), NNRTI and PI was summarized.
Time frame: Up to Week 48
Number of Participants With Genotypic Resistance: Up to Week 144
Plasma samples were collected for drug resistance testing. Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with genotypic resistance to INSTI, NRTI, NNRTI and PI are summarized.
Time frame: Up to Week 144
Number of Participants With Phenotypic Resistance: Up to Week 48
Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with phenotypic resistance to INSTI, NNRTI,NRTI and PI were summarized. Assessment of antiviral activity of ART using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented.
Time frame: Up to Week 48
Number of Participants With Phenotypic Resistance: Up to Week 144
Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with phenotypic resistance to INSTI,NNRT,NRTI and PI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented.
Time frame: Up to Week 144
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48
Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, body mass index (BMI) (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48
Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1) . Change from Baseline is post-dose visit value minus Baseline value. Change from Baseline in bone biomarkers-serum bone-specific ALP (Bone-ALP), osteocalcin, serum P1NP and serum CTX-1 in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144
Serum samples were collected for analysis of bone biomarkers. Baseline is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48
Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value was latest pre-dose assessment (Day 1) with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Serum samples were collected for the analysis of 25-hydroxyvitamin D. Baseline value was the value from latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum 25-hydroxyvitamin D in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144
Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48
Serum samples were collected to assess renal biomarker. Baseline was latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for following:treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - cystatin C. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum cystatin -C biomarker in TDF based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144
Serum samples were collected to assess renal biomarker. Baseline is latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48
Serum samples assessed:serum GFR from cystatin C and from creatinine adjusted using CKD-EPI Baseline(Day 1) was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value.Adjusted mean and standard error is presented.Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class,CD4+ cell count(continuous),age(continuous), sex, race, BMI(continuous),presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarkers - serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144
Serum samples were collected to assess serum GFR from cystatin C and from creatinine adjusted for BSA. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48
Serum samples assessed: renal inflammation biomarker serum creatinine.Baseline(Day 1)was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen
Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - serum creatinine. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum creatinine in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144
Serum samples were collected to assess renal inflammation biomarker - serum creatinine. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144
EQ-5D-5L questionnaire provides profile of participant function and global health state rating. Five-item measure has 1question assessing each of 5dimensions:mobility,self-care,usual activities,pain/discomfort,anxiety/depression and 5 levels for each dimension including 1=no problems,2=slight problems,3=moderate problems,4=severe problems,5=extreme problems. Health state is defined by combining levels of answers from each of 5 questions. Each health state is referred to in terms of a 5 digit code.Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state.EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.Baseline is latest pre-dose assessment value with a non-missing value (Day 1).Change from Baseline is post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 96 and 144
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset. Baseline was the latest pre-dose assessment value with a non-missing value (Day 1) and change from Baseline is defined as post-dose value minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 96 and 144
This non-inferiority study evaluated antiviral activity of switching to dolutegravir (DTG) + lamivudine (3TC) fixed dose combination (FDC) once daily compared to continuation of a Tenofovir alafenamide (TAF)-based regimen (TBR) over 148 weeks in virologically suppressed participants with human immunodeficiency type 1 infection. At week 148 all participants received DTG + 3TC FDC until week 196.
| Milestone | DTG+3TC FDC | TAF-based Regimen |
|---|---|---|
| Started | 371 | 372 |
| Itt-e population | 369 | 372 |
| Completed | 319 | 299 |
| Not completed | 52 | 73 |
| Withdrew: Adverse event | 23 | 7 |
| Withdrew: Lack of efficacy | 0 | 6 |
| Withdrew: Protocol violation | 5 | 6 |
| Withdrew: Lost to follow-up | 4 | 10 |
| Withdrew: Physician decision | 2 | 11 |
| Withdrew: Withdrawal by subject | 16 | 33 |
| Withdrew: Randomized, but did not receive treatment | 2 | 0 |
| Milestone | DTG+3TC FDC | TAF-based Regimen |
|---|---|---|
| Started | 319 | 298 |
| Completed | 307 | 274 |
| Not completed | 12 | 24 |
| Withdrew: Adverse event | 2 | 9 |
| Withdrew: Lack of efficacy | 1 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Lost to follow-up | 5 | 6 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Withdrawal by subject | 4 | 6 |
Percentage of participants with virologic failure (plasma HIV-1 RNA \>=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who received at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized.
| Percentage of participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48 | 0.3 | 0.5 |
Percentage of participants with plasma HIV-1 RNA \<50 c/mL (virologic success) was evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
| Percentage of participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48 | 93.2 | 93.0 |
Percentage of participants with plasma HIV-1 RNA \>=50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.
| Percentage of participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24 | 0.3 | 0.8 |
Percentage of participants with plasma HIV-1 RNA \>=50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144.
| Percentage of participants | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| Week 96 | 0.3 | 1.1 |
| Week 144 | 0.3 | 1.3 |
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Percentage values are rounded off.
| Percentage of participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24 | 95 | 96 |
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144.
| Percentage of participants | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| Week 96 | 85.9 | 79.0 |
| Week 144 | 85.9 | 81.7 |
CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.
| Cells per cubic millimeter | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 24, n=351, 359 | 21.0 (-68.0 to 115.0) | 6.0 (-87.0 to 99.0) |
| Week 48, n=344, 345 | 22.5 (-71.0 to 121.5) | 11.0 (-98.0 to 90.0) |
CD4+ cells are a type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+and evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable
| Cells per cubic millimeter | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| Week 96, n=315, 295 | 61.0 (-61.0 to 179.0) | 45.0 (-80.0 to 154.0) |
| Week 144, n=309, 301 | 36.0 (-64.0 to 154.0) | 35.0 (-60.0 to 134.0) |
Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over 48 Weeks. Baseline (Day 1) values were the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable .
| Ratio | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 24, n=346, 358 | 0.010 (-0.070 to 0.110) | 0.040 (-0.060 to 0.120) |
| Week 48, n=342, 343 | 0.030 (-0.050 to 0.110) | 0.050 (-0.050 to 0.160) |
Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio and were evaluated by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over Weeks 96 and 144. Baseline (Day 1) values are the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable
| Ratio | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| Week 96, n=312, 292 | 0.035 (-0.085 to 0.140) | 0.080 (-0.050 to 0.170) |
| Week 144, n=307, 300 | 0.060 (-0.060 to 0.200) | 0.100 (-0.020 to 0.240) |
HIV-associated conditions were recorded during the study and were assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV were: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: \>=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3:Documented AIDS defining condition or CD4+ T-lymphocye count \<200 cells/mcL. Disease progression summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| From CDC Stage 1 to CDC Stage 3 Event | 1 | 0 |
| From CDC Stage 2 to CDC Stage 3 Event | 0 | 0 |
| From CDC Stage 3 to new CDC Stage 3 Event | 0 | 0 |
| From CDC Stage 1, 2 or 3 to Death | 1 | 0 |
| No HIV-1 disease progression | 367 | 372 |
HIV-associated conditions were recorded during the study and assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV is: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: \>=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: Documented AIDS-defining condition or CD4+ T-lymphocye count \<200 cells/mcL. Indicators of clinical disease progression is defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death.
| Participants | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| Week 96, From CDC Stage 1 to CDC Stage 3 Event | 2 | 0 |
| Week 96, From CDC Stage 2 to CDC Stage 3 Event | 0 | 0 |
| Week 96, From CDC Stage 3 to new CDC Stage 3 Event | 0 | 0 |
| Week 96, From CDC Stage 1, 2 or 3 to Death | 2 | 0 |
| Week 96, No HIV-1 disease progression | 365 | 372 |
| Week 144, From CDC Stage 1 to CDC Stage 3 Event | 2 | 0 |
| Week 144, From CDC Stage 2 to CDC Stage 3 Event | 0 | 1 |
| Week 144,From CDC Stage 3 to new CDC Stage 3 Event | 0 | 0 |
| Week 144, From CDC Stage 1, 2 or 3 to Death | 3 | 0 |
| Week 144, No HIV-1 disease progression | 364 | 371 |
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Safety Population included all participants who received at least one dose of study treatment either DTG + 3TC or TBR. This population was based on the treatment the participant actually received. Number of participants with any SAE and common (\>=2%) non-SAEs are presented.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Any non-SAE (>=2%) | 222 | 204 |
| Any SAE | 21 | 16 |
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Number of TDF-based regimen participants with any SAE and common (\>=2%) non-SAEs are presented.
| Participants | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| Any non-SAE (>=2%) | 1 |
| Any SAE | 0 |
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment
| Participants | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| Any non-SAE (>=2%) | 307 | 304 |
| Any SAE | 57 | 44 |
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Grade 1 | 102 | 94 |
| Grade 2 | 170 | 177 |
| Grade 3 | 19 | 15 |
| Grade 4 | 3 | 6 |
| Grade 5 | 1 | 0 |
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of TDF-based regimen participants with adverse events by maximum grade have been presented.
| Participants | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| Grade 1 | 0 |
| Grade 2 | 1 |
| Grade 3 | 0 |
| Grade 4 | 0 |
| Grade 5 | 0 |
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Grade 1 | 57 | 65 |
| Grade 2 | 217 | 208 |
| Grade 3 | 50 | 54 |
| Grade 4 | 9 | 8 |
| Grade 5 | 3 | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48 | 13 | 2 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.
| Participants | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48 | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.
| Participants | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144 | 23 | 7 |
Blood samples were collected up to Week 48 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Hemoglobin, Grade 1 | 3 | 0 |
| Hemoglobin, Grade 2 | 0 | 0 |
| Hemoglobin, Grade 3 | 0 | 0 |
| Hemoglobin, Grade 4 | 0 | 0 |
| Leukocytes, Grade 1 | 1 | 1 |
| Leukocytes, Grade 2 | 1 | 0 |
| Leukocytes, Grade 3 | 0 | 0 |
| Leukocytes, Grade 4 | 0 | 0 |
| Neutrophils, Grade 1 | 3 | 4 |
| Neutrophils, Grade 2 | 2 | 4 |
| Neutrophils, Grade 3 | 0 | 0 |
| Neutrophils, Grade 4 | 1 | 0 |
| Platelets, Grade 1 | 6 | 5 |
| Platelets, Grade 2 | 1 | 1 |
| Platelets, Grade 3 | 0 | 0 |
| Platelets, Grade 4 | 0 | 0 |
Blood samples were collected up to the Week 36 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those TDF-based regimen participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.
| Participants | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| Hemoglobin, Grade 1 | 0 |
| Hemoglobin, Grade 2 | 0 |
| Hemoglobin, Grade 3 | 0 |
| Hemoglobin, Grade 4 | 0 |
| Leukocytes, Grade 1 | 0 |
| Leukocytes, Grade 2 | 0 |
| Leukocytes, Grade 3 | 0 |
| Leukocytes, Grade 4 | 0 |
| Neutrophils, Grade 1 | 0 |
| Neutrophils, Grade 2 | 0 |
| Neutrophils, Grade 3 | 0 |
| Neutrophils, Grade 4 | 0 |
| Platelets, Grade 1 | 0 |
| Platelets, Grade 2 | 0 |
| Platelets, Grade 3 | 0 |
| Platelets, Grade 4 | 0 |
Blood samples were collected up to Week 144 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters are were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Hemoglobin, Grade 1 | 7 | 2 |
| Hemoglobin, Grade 2 | 1 | 2 |
| Hemoglobin, Grade 3 | 0 | 0 |
| Hemoglobin, Grade 4 | 0 | 0 |
| Leukocytes, Grade 1 | 2 | 4 |
| Leukocytes, Grade 2 | 1 | 0 |
| Leukocytes, Grade 3 | 1 | 0 |
| Leukocytes, Grade 4 | 0 | 0 |
| Neutrophils, Grade 1 | 5 | 5 |
| Neutrophils, Grade 2 | 3 | 8 |
| Neutrophils, Grade 3 | 0 | 0 |
| Neutrophils, Grade 4 | 2 | 2 |
| Platelets, Grade 1 | 8 | 7 |
| Platelets, Grade 2 | 2 | 1 |
| Platelets, Grade 3 | 0 | 0 |
| Platelets, Grade 4 | 0 | 0 |
Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| ALT, Grade 1 | 24 | 18 |
| ALT, Grade 2 | 6 | 4 |
| ALT, Grade 3 | 1 | 1 |
| ALT, Grade 4 | 0 | 0 |
| Albumin, Grade 1 | 1 | 0 |
| Albumin, Grade 2 | 0 | 0 |
| Albumin, Grade 3 | 0 | 0 |
| Albumin, Grade 4 | 0 | 0 |
| ALP, Grade 1 | 2 | 0 |
| ALP, Grade 2 | 0 | 0 |
| ALP, Grade 3 | 0 | 0 |
| ALP, Grade 4 | 0 | 0 |
| AST, Grade 1 | 21 | 29 |
| AST, Grade 2 | 7 | 4 |
| AST, Grade 3 | 1 | 0 |
| AST, Grade 4 | 1 | 0 |
| Bilirubin, Grade 1 | 17 | 7 |
| Bilirubin, Grade 2 | 5 | 2 |
| Bilirubin, Grade 3 | 1 | 1 |
| Bilirubin, Grade 4 | 0 | 0 |
| CO2, Grade 1 | 73 | 70 |
| CO2, Grade 2 | 1 | 1 |
| CO2, Grade 3 | 0 | 0 |
| CO2, Grade 4 | 0 | 0 |
| Cholesterol, Grade 1 | 27 | 52 |
| Cholesterol, Grade 2 | 12 | 19 |
| Cholesterol, Grade 3 | 1 | 0 |
| Cholesterol, Grade 4 | 0 | 0 |
| CK, Grade 1 | 28 | 19 |
| CK, Grade 2 | 4 | 9 |
| CK, Grade 3 | 9 | 8 |
| CK, Grade 4 | 6 | 5 |
| Creatinine, Grade 1 | 16 | 7 |
| Creatinine, Grade 2 | 3 | 1 |
| Creatinine, Grade 3 | 0 | 0 |
| Creatinine, Grade 4 | 0 | 0 |
| Direct bilirubin, Grade 1 | 0 | 0 |
| Direct bilirubin, Grade 2 | 0 | 0 |
| Direct bilirubin, Grade 3 | 8 | 1 |
| Direct bilirubin, Grade 4 | 0 | 0 |
| GFR from creatinine adjusted using CKD EPI,Grade 1 | 0 | 0 |
| GFR from creatinine adjusted using CKD EPI,Grade 2 | 135 | 83 |
| GFR from creatinine adjusted using CKD EPI,Grade 3 | 26 | 13 |
| GFR from creatinine adjusted using CKD EPI,Grade 4 | 0 | 0 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 1 | 0 | 0 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 2 | 52 | 66 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 3 | 5 | 4 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 4 | 1 | 0 |
| Hypercalcemia, Grade 1 | 7 | 3 |
| Hypercalcemia, Grade 2 | 0 | 0 |
| Hypercalcemia, Grade 3 | 0 | 0 |
| Hypercalcemia, Grade 4 | 0 | 0 |
| Hyperglycemia, Grade 1 | 56 | 64 |
| Hyperglycemia, Grade 2 | 21 | 19 |
| Hyperglycemia, Grade 3 | 2 | 2 |
| Hyperglycemia, Grade 4 | 0 | 0 |
| Hyperkalemia, Grade 1 | 0 | 2 |
| Hyperkalemia, Grade 2 | 2 | 0 |
| Hyperkalemia, Grade 3 | 0 | 0 |
| Hyperkalemia, Grade 4 | 0 | 0 |
| Hypernatremia, Grade 1 | 1 | 1 |
| Hypernatremia, Grade 2 | 0 | 0 |
| Hypernatremia, Grade 3 | 0 | 0 |
| Hypernatremia, Grade 4 | 0 | 0 |
| Hypocalcemia, Grade 1 | 8 | 1 |
| Hypocalcemia, Grade 2 | 0 | 1 |
| Hypocalcemia, Grade 3 | 0 | 0 |
| Hypocalcemia, Grade 4 | 0 | 0 |
| Hypoglycemia, Grade 1 | 5 | 6 |
| Hypoglycemia, Grade 2 | 3 | 2 |
| Hypoglycemia, Grade 3 | 0 | 0 |
| Hypoglycemia, Grade 4 | 0 | 0 |
| Hypokalemia, Grade 1 | 7 | 1 |
| Hypokalemia, Grade 2 | 1 | 0 |
| Hypokalemia, Grade 3 | 0 | 0 |
| Hypokalemia, Grade 4 | 0 | 0 |
| Hyponatremia, Grade 1 | 8 | 13 |
| Hyponatremia, Grade 2 | 0 | 2 |
| Hyponatremia, Grade 3 | 0 | 0 |
| Hyponatremia, Grade 4 | 0 | 0 |
| LDL cholesterol, Grade 1 | 28 | 35 |
| LDL cholesterol, Grade 2 | 13 | 15 |
| LDL cholesterol, Grade 3 | 6 | 3 |
| LDL cholesterol, Grade 4 | 0 | 0 |
| Phosphate, Grade 1 | 38 | 47 |
| Phosphate, Grade 2 | 2 | 7 |
| Phosphate, Grade 3 | 0 | 0 |
| Phosphate, Grade 4 | 0 | 0 |
| Triglycerides, Grade 1 | 34 | 48 |
| Triglycerides, Grade 2 | 4 | 11 |
| Triglycerides, Grade 3 | 4 | 4 |
| Triglycerides, Grade 4 | 4 | 0 |
samples were collected up to the Week 36 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
| Participants | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| ALT, Grade 1 | 0 |
| ALT, Grade 2 | 0 |
| ALT, Grade 3 | 0 |
| ALT, Grade 4 | 0 |
| Albumin, Grade 1 | 0 |
| Albumin, Grade 2 | 0 |
| Albumin, Grade 3 | 0 |
| Albumin, Grade 4 | 0 |
| ALP, Grade 1 | 0 |
| ALP, Grade 2 | 0 |
| ALP, Grade 3 | 0 |
| ALP, Grade 4 | 0 |
| AST, Grade 1 | 0 |
| AST, Grade 2 | 0 |
| AST, Grade 3 | 0 |
| AST, Grade 4 | 0 |
| Bilirubin, Grade 1 | 0 |
| Bilirubin, Grade 2 | 0 |
| Bilirubin, Grade 3 | 0 |
| Bilirubin, Grade 4 | 0 |
| CO2, Grade 1 | 0 |
| CO2, Grade 2 | 0 |
| CO2, Grade 3 | 0 |
| CO2, Grade 4 | 0 |
| Cholesterol, Grade 1 | 0 |
| Cholesterol, Grade 2 | 0 |
| Cholesterol, Grade 3 | 0 |
| Cholesterol, Grade 4 | 0 |
| CK, Grade 1 | 0 |
| CK, Grade 2 | 0 |
| CK, Grade 3 | 0 |
| CK, Grade 4 | 0 |
| Creatinine, Grade 1 | 0 |
| Creatinine, Grade 2 | 0 |
| Creatinine, Grade 3 | 0 |
| Creatinine, Grade 4 | 0 |
| Direct bilirubin, Grade 1 | 0 |
| Direct bilirubin, Grade 2 | 0 |
| Direct bilirubin, Grade 3 | 0 |
| Direct bilirubin, Grade 4 | 0 |
| GFR from creatinine adjusted using CKD EPI,Grade 1 | 0 |
| GFR from creatinine adjusted using CKD EPI,Grade 2 | 0 |
| GFR from creatinine adjusted using CKD EPI,Grade 3 | 0 |
| GFR from creatinine adjusted using CKD EPI,Grade 4 | 0 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 1 | 0 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 2 | 0 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 3 | 0 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 4 | 0 |
| Hypercalcemia, Grade 1 | 0 |
| Hypercalcemia, Grade 2 | 0 |
| Hypercalcemia, Grade 3 | 0 |
| Hypercalcemia, Grade 4 | 0 |
| Hyperglycemia, Grade 1 | 0 |
| Hyperglycemia, Grade 2 | 0 |
| Hyperglycemia, Grade 3 | 0 |
| Hyperglycemia, Grade 4 | 0 |
| Hyperkalemia, Grade 1 | 0 |
| Hyperkalemia, Grade 2 | 0 |
| Hyperkalemia, Grade 3 | 0 |
| Hyperkalemia, Grade 4 | 0 |
| Hypernatremia, Grade 1 | 0 |
| Hypernatremia, Grade 2 | 0 |
| Hypernatremia, Grade 3 | 0 |
| Hypernatremia, Grade 4 | 0 |
| Hypocalcemia, Grade 1 | 0 |
| Hypocalcemia, Grade 2 | 0 |
| Hypocalcemia, Grade 3 | 0 |
| Hypocalcemia, Grade 4 | 0 |
| Hypoglycemia, Grade 1 | 0 |
| Hypoglycemia, Grade 2 | 0 |
| Hypoglycemia, Grade 3 | 0 |
| Hypoglycemia, Grade 4 | 0 |
| Hypokalemia, Grade 1 | 0 |
| Hypokalemia, Grade 2 | 0 |
| Hypokalemia, Grade 3 | 0 |
| Hypokalemia, Grade 4 | 0 |
| Hyponatremia, Grade 1 | 0 |
| Hyponatremia, Grade 2 | 0 |
| Hyponatremia, Grade 3 | 0 |
| Hyponatremia, Grade 4 | 0 |
| LDL cholesterol, Grade 1 | 0 |
| LDL cholesterol, Grade 2 | 0 |
| LDL cholesterol, Grade 3 | 0 |
| LDL cholesterol, Grade 4 | 0 |
| Phosphate, Grade 1 | 0 |
| Phosphate, Grade 2 | 0 |
| Phosphate, Grade 3 | 0 |
| Phosphate, Grade 4 | 0 |
| Triglycerides, Grade 1 | 1 |
| Triglycerides, Grade 2 | 0 |
| Triglycerides, Grade 3 | 0 |
| Triglycerides, Grade 4 | 0 |
Blood samples were collected up to Week 144 for the analysis of clinical chemistry parameters: ALT, albumin, ALP, AST, bilirubin, CO2, cholesterol, CK, creatinine, direct bilirubin, GFR from creatinine adjusted for BSA, GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, LDL cholesterol, phosphate triglycerides and lactate dehydrogenase. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| ALT, Grade 1 | 55 | 49 |
| ALT, Grade 2 | 11 | 9 |
| ALT, Grade 3 | 5 | 3 |
| ALT, Grade 4 | 0 | 1 |
| Albumin, Grade 1 | 1 | 0 |
| Albumin, Grade 2 | 2 | 0 |
| Albumin, Grade 3 | 0 | 0 |
| Albumin, Grade 4 | 0 | 0 |
| ALP, Grade 1 | 6 | 0 |
| ALP, Grade 2 | 0 | 0 |
| ALP, Grade 3 | 0 | 1 |
| ALP, Grade 4 | 0 | 0 |
| AST, Grade 1 | 34 | 45 |
| AST, Grade 2 | 13 | 9 |
| AST, Grade 3 | 3 | 0 |
| AST, Grade 4 | 3 | 3 |
| Bilirubin, Grade 1 | 24 | 12 |
| Bilirubin, Grade 2 | 9 | 4 |
| Bilirubin, Grade 3 | 3 | 1 |
| Bilirubin, Grade 4 | 0 | 0 |
| CO2, Grade 1 | 110 | 97 |
| CO2, Grade 2 | 2 | 4 |
| CO2, Grade 3 | 1 | 0 |
| CO2, Grade 4 | 0 | 0 |
| Cholesterol, Grade 1 | 42 | 70 |
| Cholesterol, Grade 2 | 26 | 34 |
| Cholesterol, Grade 3 | 1 | 2 |
| Cholesterol, Grade 4 | 0 | 0 |
| CK, Grade 1 | 41 | 30 |
| CK, Grade 2 | 12 | 13 |
| CK, Grade 3 | 12 | 12 |
| CK, Grade 4 | 10 | 10 |
| Creatinine, Grade 1 | 21 | 12 |
| Creatinine, Grade 2 | 5 | 2 |
| Creatinine, Grade 3 | 1 | 1 |
| Creatinine, Grade 4 | 0 | 0 |
| Direct bilirubin, Grade 1 | 0 | 0 |
| Direct bilirubin, Grade 2 | 0 | 0 |
| Direct bilirubin, Grade 3 | 13 | 3 |
| Direct bilirubin, Grade 4 | 0 | 0 |
| GFR from creatinine adjusted using CKD EPI,Grade 1 | 0 | 0 |
| GFR from creatinine adjusted using CKD EPI,Grade 2 | 165 | 101 |
| GFR from creatinine adjusted using CKD EPI,Grade 3 | 38 | 24 |
| GFR from creatinine adjusted using CKD EPI,Grade 4 | 0 | 1 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 1 | 0 | 0 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 2 | 169 | 183 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 3 | 46 | 58 |
| GFR from cystatin C adjusted using CKD-EPI,Grade 4 | 1 | 1 |
| Hypercalcemia, Grade 1 | 8 | 9 |
| Hypercalcemia, Grade 2 | 0 | 0 |
| Hypercalcemia, Grade 3 | 0 | 0 |
| Hypercalcemia, Grade 4 | 0 | 0 |
| Hyperglycemia, Grade 1 | 73 | 77 |
| Hyperglycemia, Grade 2 | 40 | 31 |
| Hyperglycemia, Grade 3 | 4 | 4 |
| Hyperglycemia, Grade 4 | 0 | 0 |
| Hyperkalemia, Grade 1 | 3 | 2 |
| Hyperkalemia, Grade 2 | 2 | 1 |
| Hyperkalemia, Grade 3 | 0 | 0 |
| Hyperkalemia, Grade 4 | 0 | 0 |
| Hypernatremia, Grade 1 | 4 | 3 |
| Hypernatremia, Grade 2 | 1 | 0 |
| Hypernatremia, Grade 3 | 0 | 0 |
| Hypernatremia, Grade 4 | 0 | 0 |
| Hypocalcemia, Grade 1 | 14 | 5 |
| Hypocalcemia, Grade 2 | 1 | 2 |
| Hypocalcemia, Grade 3 | 0 | 0 |
| Hypocalcemia, Grade 4 | 0 | 0 |
| Hypoglycemia, Grade 1 | 9 | 10 |
| Hypoglycemia, Grade 2 | 4 | 3 |
| Hypoglycemia, Grade 3 | 0 | 0 |
| Hypoglycemia, Grade 4 | 0 | 0 |
| Hypokalemia, Grade 1 | 10 | 7 |
| Hypokalemia, Grade 2 | 3 | 0 |
| Hypokalemia, Grade 3 | 1 | 0 |
| Hypokalemia, Grade 4 | 0 | 0 |
| Hyponatremia, Grade 1 | 21 | 26 |
| Hyponatremia, Grade 2 | 0 | 2 |
| Hyponatremia, Grade 3 | 0 | 0 |
| Hyponatremia, Grade 4 | 0 | 0 |
| LDL cholesterol, Grade 1 | 41 | 56 |
| LDL cholesterol, Grade 2 | 19 | 24 |
| LDL cholesterol, Grade 3 | 8 | 9 |
| LDL cholesterol, Grade 4 | 0 | 0 |
| Phosphate, Grade 1 | 61 | 71 |
| Phosphate, Grade 2 | 3 | 9 |
| Phosphate, Grade 3 | 0 | 0 |
| Phosphate, Grade 4 | 0 | 0 |
| Triglycerides, Grade 1 | 60 | 77 |
| Triglycerides, Grade 2 | 6 | 15 |
| Triglycerides, Grade 3 | 6 | 5 |
| Triglycerides, Grade 4 | 4 | 2 |
| Lactate Dehydrogenase Grade 1 | 0 | 1 |
| Lactate Dehydrogenase Grade 2 | 0 | 0 |
| Lactate Dehydrogenase Grade 3 | 0 | 0 |
| Lactate Dehydrogenase Grade 4 | 0 | 0 |
Urine samples were collected at Baseline, Week 24 and Week 48. Baseline is defined as Day 1. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. Change from Baseline in UP/C and UA/C was calculated as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio calculated at Baseline, respectively. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Ratio | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| UA/C, Week 24, n=235, 230 | 1.080 (1.007 to 1.158) | 1.022 (0.956 to 1.091) |
| UA/C, Week 48, n=230, 224 | 1.125 (1.036 to 1.222) | 1.059 (0.963 to 1.165) |
| UP/C, Week 24, n=267, 261 | 0.955 (0.917 to 0.995) | 0.976 (0.937 to 1.016) |
| UP/C, Week 48, n=261, 257 | 0.971 (0.926 to 1.018) | 1.016 (0.964 to 1.070) |
Urine samples were collected at Baseline, Week 24 and Week 48 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline was defined as the latest pre-dose assessment value with a non-missing value. (Day 1). Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Change from Baseline in UP/C was calculated as UP/C ratio at post-Baseline visit minus UP/C ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Ratio | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| UA/C, Week 24, n=1 | 0 |
| UP/C, Week 24, n=1 | 0.3 |
Urine samples were collected at Baseline, Weeks 96 and 144. Baseline is defined as Day 1. Change from Baseline in UA/C is defined as UA/C ratio at post-Baseline visit minus UA/C ratio at Baseline. Change from Baseline in UP/C and UA/C is defined as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio at Baseline, respectively. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen.
| Ratio | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| UA/C, Week 96, n=208, 175 | 1.058 (0.974 to 1.149) | 1.075 (0.968 to 1.195) |
| UA/C, Week 144, n=202, 179 | 1.203 (1.093 to 1.324) | 1.200 (1.051 to 1.371) |
| UP/C, Week 96, n=245, 206 | 1.048 (0.997 to 1.102) | 1.105 (1.044 to 1.169) |
| UP/C, Week 144, n=237, 220 | 1.182 (1.121 to 1.247) | 1.188 (1.104 to 1.278) |
Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine beta-2 microglobulin/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Ratio | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 24, n=136, 141 | 0.991 (0.899 to 1.093) | 1.034 (0.931 to 1.149) |
| Week 48, n=126, 141 | 0.973 (0.870 to 1.088) | 0.922 (0.832 to 1.022) |
Urine biomarker samples were collected to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
No measurements were reported for this outcome.
Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine is defined as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen.
| Ratio | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| Week 96, n=109, 107 | 1.080 (0.931 to 1.253) | 0.986 (0.844 to 1.152) |
| Week 144, n=101, 97 | 0.904 (0.768 to 1.065) | 0.958 (0.808 to 1.136) |
Urine biomarker samples were collected at Baseline and at Weeks 24 and 48 to assess urine phosphate. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Ratio | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 24, n=348, 352 | 0.955 (0.888 to 1.028) | 0.940 (0.871 to 1.014) |
| Week 48, n=342, 340 | 0.969 (0.892 to 1.052) | 0.970 (0.900 to 1.044) |
Urine biomarker samples were collected to assess urine phosphate. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Ratio | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| Week 24, n=1 | 2.9 |
Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine phosphate. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate is defined as urine phosphate at post-Baseline visit minus urine phosphate at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen
| Ratio | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 96, n=312, 286 | 0.960 (0.871 to 1.057) | 0.978 (0.882 to 1.085) |
| Week 144, n=313, 298 | 0.890 (0.805 to 0.985) | 0.912 (0.825 to 1.007) |
Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine retinol binding protein 4/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio was calculated as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Ratio | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 24, n=344, 343 | 0.860 (0.790 to 0.936) | 0.920 (0.847 to 0.999) |
| Week 48, n=340, 335 | 1.063 (0.992 to 1.139) | 1.068 (0.996 to 1.144) |
Urine biomarker samples were collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine was calculated as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Ratio | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| Week 24, n=1 | 1.04 |
Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio is defined as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen
| Ratio | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 96, n=310, 282 | 0.926 (0.845 to 1.014) | 0.851 (0.775 to 0.933) |
| Week 144, n=304, 288 | 1.188 (1.086 to 1.298) | 1.227 (1.109 to 1.359) |
Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma high density lipoprotein (HDL) cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Millimoles per liter | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Plasma cholesterol, Week 24, n=282, 264 | -0.325 (-0.750 to 0.150) | 0.000 (-0.400 to 0.400) |
| Plasma cholesterol, Week 48, n=275, 263 | -0.200 (-0.750 to 0.150) | 0.100 (-0.350 to 0.500) |
| Plasma LDL Cholesterol, Week 24, n=282, 264 | -0.210 (-0.570 to 0.130) | -0.060 (-0.340 to 0.410) |
| Plasma LDL Cholesterol, Week 48, n=275, 263 | -0.170 (-0.560 to 0.210) | 0.070 (-0.320 to 0.430) |
| Plasma Triglycerides, Week 24, n=282, 264 | -0.100 (-0.460 to 0.160) | 0.060 (-0.200 to 0.350) |
| Plasma Triglycerides, Week 48, n=275, 263 | -0.100 (-0.440 to 0.160) | 0.100 (-0.280 to 0.380) |
| Plasma HDL Cholesterol, Week 24, n=282, 264 | -0.050 (-0.150 to 0.100) | 0.050 (-0.150 to 0.150) |
| Plasma HDL Cholesterol, Week 48, n=275, 263 | 0.000 (-0.200 to 0.150) | 0.050 (-0.150 to 0.150) |
Blood samples were collected at Baseline (Day 1), weeks 24 and 48 visit (participant withdrew from the study at Week 36) to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for fasting lipids in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Millimoles per liter | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| Plasma cholesterol, Week 24, n=1 | 0 |
| Plasma LDL Cholesterol, Week 24, n=1 | -0.67 |
| Plasma Triglycerides, Week 24, n=1 | 1.36 |
| Plasma HDL Cholesterol, Week 24, n=1 | 0.05 |
Blood samples were collected at Baseline (Day 1), Weeks 96 and 144 to assess fasting lipids which includes plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value is the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen.
| Millimoles per liter | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Plasma cholesterol, Week 96, n=238, 213 | -3.7 (-12.4 to 5.6) | 1.2 (-6.0 to 10.6) |
| Plasma cholesterol, Week 144, n=243, 230 | -4.0 (-13.0 to 6.4) | 3.8 (-5.0 to 14.5) |
| Plasma LDL Cholesterol, Week 96, n=238, 213 | -5.6 (-17.3 to 10.8) | 1.7 (-8.9 to 15.8) |
| Plasma LDL Cholesterol, Week 144, n=243, 230 | -5.0 (-16.2 to 10.7) | 4.2 (-9.0 to 20.9) |
| Plasma Triglycerides, Week 96, n=238, 213 | -2.1 (-25.8 to 22.2) | 4.9 (-20.0 to 38.9) |
| Plasma Triglycerides, Week 144, n=243, 230 | -9.4 (-32.8 to 21.2) | 2.2 (-23.0 to 30.3) |
| Plasma HDL Cholesterol, Week 96, n=238, 213 | -3.8 (-13.8 to 8.5) | 0.0 (-10.8 to 13.0) |
| Plasma HDL Cholesterol, Week 144, n=243, 230 | -3.8 (-14.3 to 12.0) | 3.8 (-8.0 to 17.4) |
Plasma samples were collected for drug resistance testing. Number of participants, who met confirmed virologic withdrawal (CVW) criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with genotypic resistance to INSTI, nucleoside reverse transcriptase inhibitor (NRTI), NNRTI and PI was summarized.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| INSTI | — | 0 |
| NRTI | — | 0 |
| NNRTI | — | 0 |
| PI | — | 0 |
Plasma samples were collected for drug resistance testing. Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with genotypic resistance to INSTI, NRTI, NNRTI and PI are summarized.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| INSTI | — | 0 |
| NRTI | — | 0 |
| NNRTI | — | 0 |
| PI | — | 0 |
Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with phenotypic resistance to INSTI, NNRTI,NRTI and PI were summarized. Assessment of antiviral activity of ART using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| INSTI, DTG, Sensitive | — | 1 |
| INSTI, DTG, Resistant | — | 0 |
| INSTI, Bictegravir (BIC), Sensitive | — | 1 |
| INSTI, BIC, Resistant | — | 0 |
| INSTI, Elvitegravir (EVG), Sensitive | — | 1 |
| INSTI, EVG, Resistant | — | 0 |
| INSTI, Raltegravir (RAL), Sensitive | — | 1 |
| INSTI, RAL, Resistant | — | 0 |
| NNRTI, Delavirdine (DLV), Sensitive | — | 1 |
| NNRTI, DLV, Resistant | — | 0 |
| NNRTI, Efavirenz (EFV), Sensitive | — | 1 |
| NNRTI, EFV, Resistant | — | 0 |
| NNRTI, Etravirine (ETR), Sensitive | — | 1 |
| NNRTI, ETR, Resistant | — | 0 |
| NNRTI, Nevirapine (NVP), Sensitive | — | 1 |
| NNRTI, NVP, Resistant | — | 0 |
| NNRTI, Rilpivirine (RPV), Sensitive | — | 1 |
| NNRTI, RPV, Resistant | — | 0 |
| NRTI, 3TC, Sensitive | — | 1 |
| NRTI, 3TC, Resistant | — | 0 |
| NRTI, Abacavir (ABC), Sensitive | — | 1 |
| NRTI, ABC, Resistant | — | 0 |
| NRTI, Zidovudine (AZT), Sensitive | — | 1 |
| NRTI, AZT, Resistant | — | 0 |
| NRTI, Stavudine (D4T), Sensitive | — | 1 |
| NRTI, D4T, Resistant | — | 0 |
| NRTI, Didanosine (DDI), Sensitive | — | 1 |
| NRTI, DDI, Resistant | — | 0 |
| NRTI, Emtricitabine (FTC), Sensitive | — | 1 |
| NRTI, FTC, Resistant | — | 0 |
| NRTI, Tenofovir (TDF), Sensitive | — | 1 |
| NRTI, TDF, Resistant | — | 0 |
| PI, Atazanavir (ATV), Sensitive | — | 1 |
| PI, ATV, Resistant | — | 0 |
| PI, Darunavir (DRV), Sensitive | — | 1 |
| PI, DRV, Resistant | — | 0 |
| PI, Fosamprenavir (FPV), Sensitive | — | 1 |
| PI, FPV, Resistant | — | 0 |
| PI, Indinavir (IDV), Sensitive | — | 1 |
| PI, IDV, Resistant | — | 0 |
| PI, Lopinavir (LPV), Sensitive | — | 1 |
| PI, LPV, Resistant | — | 0 |
| PI, Nelfinavir (NFV), Sensitive | — | 1 |
| PI, NFV, Resistant | — | 0 |
| PI, Ritonavir (RTV), Sensitive | — | 1 |
| PI, RTV, Resistant | — | 0 |
| PI, Saquinavir (SQV), Sensitive | — | 1 |
| PI, SQV, Resistant | — | 0 |
| PI, Tipranavir (TPV), Sensitive | — | 1 |
| PI, TPV, Resistant | — | 0 |
Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with phenotypic resistance to INSTI,NNRT,NRTI and PI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented.
| Participants | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| INSTI, DTG, Sensitive | — | 2 |
| INSTI, DTG, Resistant | — | 0 |
| INSTI, Bictegravir (BIC), Sensitive | — | 2 |
| INSTI, BIC, Resistant | — | 0 |
| INSTI, Elvitegravir (EVG), Sensitive | — | 2 |
| INSTI, EVG, Resistant | — | 0 |
| INSTI, Raltegravir (RAL), Sensitive | — | 2 |
| INSTI, RAL, Resistant | — | 0 |
| NNRTI, Delavirdine (DLV), Sensitive | — | 2 |
| NNRTI, DLV, Resistant | — | 0 |
| NNRTI, Efavirenz (EFV), Sensitive | — | 2 |
| NNRTI, EFV, Resistant | — | 0 |
| NNRTI, Etravirine (ETR), Sensitive | — | 2 |
| NNRTI, ETR, Resistant | — | 0 |
| NNRTI, Nevirapine (NVP), Sensitive | — | 2 |
| NNRTI, NVP, Resistant | — | 0 |
| NNRTI, Rilpivirine (RPV), Sensitive | — | 2 |
| NNRTI, RPV, Resistant | — | 0 |
| NRTI, 3TC, Sensitive | — | 2 |
| NRTI, 3TC, Resistant | — | 0 |
| NRTI, Abacavir (ABC), Sensitive | — | 2 |
| NRTI, ABC, Resistant | — | 0 |
| NRTI, Zidovudine (AZT), Sensitive | — | 2 |
| NRTI, AZT, Resistant | — | 0 |
| NRTI, Stavudine (D4T), Sensitive | — | 2 |
| NRTI, D4T, Resistant | — | 0 |
| NRTI, Didanosine (DDI), Sensitive | — | 2 |
| NRTI, DDI, Resistant | — | 0 |
| NRTI, Emtricitabine (FTC), Sensitive | — | 2 |
| NRTI, FTC, Resistant | — | 0 |
| NRTI, Tenofovir (TDF), Sensitive | — | 2 |
| NRTI, TDF, Resistant | — | 0 |
| PI, Atazanavir (ATV), Sensitive | — | 2 |
| PI, ATV, Resistant | — | 0 |
| PI, Darunavir (DRV), Sensitive | — | 2 |
| PI, DRV, Resistant | — | 0 |
| PI, Fosamprenavir (FPV), Sensitive | — | 2 |
| PI, FPV, Resistant | — | 0 |
| PI, Indinavir (IDV), Sensitive | — | 2 |
| PI, IDV, Resistant | — | 0 |
| PI, Lopinavir (LPV), Sensitive | — | 2 |
| PI, LPV, Resistant | — | 0 |
| PI, Nelfinavir (NFV), Sensitive | — | 2 |
| PI, NFV, Resistant | — | 0 |
| PI, Ritonavir (RTV), Sensitive | — | 2 |
| PI, RTV, Resistant | — | 0 |
| PI, Saquinavir (SQV), Sensitive | — | 2 |
| PI, SQV, Resistant | — | 0 |
| PI, Tipranavir (TPV), Sensitive | — | 2 |
| PI, TPV, Resistant | — | 0 |
Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, body mass index (BMI) (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Micrograms per liter | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| Bone-ALP, Week 24, n=350, 354 | -0.77 ± 0.112 | -1.05 ± 0.089 |
| Bone-ALP, Week 48, n=343, 342 | -0.03 ± 0.145 | -0.34 ± 0.117 |
| Osteocalcin, Week 24, n=350 ,353 | -1.08 ± 0.248 | 0.26 ± 0.229 |
| Osteocalcin, Week 48, n=343, 342 | -1.15 ± 0.260 | 0.69 ± 0.279 |
| P1NP, Week24, n=349 ,356 | 7.0 ± 0.87 | 5.0 ± 0.72 |
| P1NP, Week48, n=342, 343 | 9.3 ± 1.06 | 6.4 ± 1.00 |
| CTX-1, Week 24,n=350,356 | 0.0350 ± 0.01057 | -0.0031 ± 0.00833 |
| CTX-1, Week 48, n=343, 343 | 0.0602 ± 0.01024 | 0.0310 ± 0.00889 |
Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1) . Change from Baseline is post-dose visit value minus Baseline value. Change from Baseline in bone biomarkers-serum bone-specific ALP (Bone-ALP), osteocalcin, serum P1NP and serum CTX-1 in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Micrograms per liter | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| Bone-ALP, Week 24, n=1 | 0.3 |
| Osteocalcin, Week 24, n=1 | 13.4 |
| P1NP, Week24, n=1 | 11 |
| CTX-1, Week 24,n=1 | 0.045 |
Serum samples were collected for analysis of bone biomarkers. Baseline is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
| Micrograms per liter | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Bone-ALP, Week 96, n=316, 289 | -0.62 ± 0.145 | -0.79 ± 0.137 |
| Bone-ALP, Week 144, n=314, 301 | -0.27 ± 0.163 | -0.40 ± 0.177 |
| Osteocalcin, Week 96, n=315 , 288 | -1.97 ± 0.288 | -0.10 ± 0.306 |
| Osteocalcin, Week 144, n=315, 301 | -0.74 ± 0.266 | 1.21 ± 0.320 |
| P1NP, Week 96, n=316 ,290 | 6.7 ± 0.87 | 4.7 ± 0.80 |
| P1NP, Week 144, n=315, 302 | 3.9 ± 0.94 | 3.5 ± 1.04 |
| CTX-1, Week 96 ,n=315, 289 | 0.0201 ± 0.01123 | 0.0050 ± 0.00929 |
| CTX-1, Week 48, n=315, 300 | 0.0022 ± 0.00947 | -0.0104 ± 0.00907 |
Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value was latest pre-dose assessment (Day 1) with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Nanomoles per liter | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 24, n=351, 355 | 0.0 ± 1.10 | 2.1 ± 1.15 |
| Week 48, n=344, 343 | -5.8 ± 1.21 | -3.5 ± 1.13 |
Serum samples were collected for the analysis of 25-hydroxyvitamin D. Baseline value was the value from latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum 25-hydroxyvitamin D in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Nanomoles per liter | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| Week 24, n=1 | 2 |
Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
| Nanomoles per liter | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 96, n=315, 291 | -11.5 ± 1.17 | -2.2 ± 2.06 |
| Week 144, n=315, 303 | -7.5 ± 1.28 | -1.9 ± 1.50 |
Serum samples were collected to assess renal biomarker. Baseline was latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for following:treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
| Milligrams per liter | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 24, n=351, 357 | -0.03 ± 0.005 | -0.02 ± 0.004 |
| Week 48, n=344, 343 | 0.00 ± 0.006 | 0.01 ± 0.005 |
Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - cystatin C. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum cystatin -C biomarker in TDF based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Milligrams per liter | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| Week 24, n=1 | 0 |
Serum samples were collected to assess renal biomarker. Baseline is latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
| Milligrams per liter | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| Week 96, n=316, 290 | 0.07 ± 0.008 | 0.10 ± 0.009 |
| Week 144, n=315, 302 | 0.13 ± 0.006 | 0.14 ± 0.006 |
Serum samples assessed:serum GFR from cystatin C and from creatinine adjusted using CKD-EPI Baseline(Day 1) was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value.Adjusted mean and standard error is presented.Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class,CD4+ cell count(continuous),age(continuous), sex, race, BMI(continuous),presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
| Milliliters/minute/1.73*meter square | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| GFR from cystatin C CKD-EPI, Week 24, n=351, 357 | 3.2 ± 0.52 | 1.5 ± 0.46 |
| GFR from cystatin C CKD-EPI, Week 48, n=344, 343 | 0.1 ± 0.61 | -1.6 ± 0.59 |
| GFR from creatinine CKD-EPI, Week 24, n=351, 359 | -8.8 ± 0.48 | -3.8 ± 0.47 |
| GFR from creatinine CKD-EPI, Week 48, n=344, 345 | -7.7 ± 0.48 | -2.9 ± 0.48 |
Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarkers - serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Milliliters/minute/1.73*meter square | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| GFR from cystatin C CKD-EPI, Week 24, n=1 | 0 |
| GFR from creatinine CKD-EPI, Week 24, n=1 | 4 |
Serum samples were collected to assess serum GFR from cystatin C and from creatinine adjusted for BSA. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
| Milliliters/minute/1.73*meter square | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| GFR from cystatin C CKD-EPI, Week 96, n=316, 290 | -7.6 ± 0.89 | -11.7 ± 0.99 |
| GFR from cystatin C CKD-EPI, Week 144, n=315, 302 | -13.9 ± 0.71 | -15.8 ± 0.70 |
| GFR from creatinine adjusted for BSA, Week 96, n=315, 294 | -7.2 ± 0.55 | -1.9 ± 0.52 |
| GFR from creatinine adjusted for BSA, Week 144, n=311, 300 | -11.5 ± 0.62 | -7.0 ± 0.60 |
Serum samples assessed: renal inflammation biomarker serum creatinine.Baseline(Day 1)was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
| Micromoles per liter | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 24, n=351, 359 | 7.47 ± 0.466 | 3.11 ± 0.495 |
| Week 48, n=344, 345 | 6.67 ± 0.493 | 2.18 ± 0.450 |
Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - serum creatinine. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum creatinine in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."
| Micromoles per liter | Randomized to TBR But Received TDF-based Regimen (Early Switch) |
|---|---|
| Week 24, n=1 | -8 |
Serum samples were collected to assess renal inflammation biomarker - serum creatinine. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"
| Micromoles per liter | DTG+3TC FDC (Early Switch) | TAF-based Regimen (Early Switch) |
|---|---|---|
| Week 96, n=316, 294 | 5.53 ± 0.553 | 0.58 ± 0.515 |
| Week 144, n=311, 302 | 9.25 ± 0.637 | 5.17 ± 0.633 |
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.
| Scores on a scale | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 24 | 0.0029 ± 0.00383 | 0.0046 ± 0.00352 |
| Week 48 | 0.0037 ± 0.00407 | 0.0023 ± 0.00373 |
EQ-5D-5L questionnaire provides profile of participant function and global health state rating. Five-item measure has 1question assessing each of 5dimensions:mobility,self-care,usual activities,pain/discomfort,anxiety/depression and 5 levels for each dimension including 1=no problems,2=slight problems,3=moderate problems,4=severe problems,5=extreme problems. Health state is defined by combining levels of answers from each of 5 questions. Each health state is referred to in terms of a 5 digit code.Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state.EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health.Baseline is latest pre-dose assessment value with a non-missing value (Day 1).Change from Baseline is post-dose visit value minus Baseline value.
| Scores on a scale | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 96, n=364, 370 | -0.0036 ± 0.00442 | -0.0038 ± 0.00446 |
| Week 144, n=364, 369 | -0.0151 ± 0.00502 | -0.0042 ± 0.00492 |
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset. Baseline was the latest pre-dose assessment value with a non-missing value (Day 1) and change from Baseline is defined as post-dose value minus Baseline value.
| Scores on a scale | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 24 | 1.2 ± 0.49 | 1.3 ± 0.44 |
| Week 48 | 1.1 ± 0.52 | 1.7 ± 0.43 |
EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value.
| Scores on a scale | DTG+3TC FDC (Early Switch) | TAF Based Regimen (Early Switch) |
|---|---|---|
| Week 96, n=364, 369 | 0.7 ± 0.52 | 1.9 ± 0.48 |
| Week 144, n=364, 368 | 0.2 ± 0.58 | 1.4 ± 0.50 |
Collected over All-cause mortality, serious adverse events (SAEs) and non-serious AEs were collected for DTG + 3TC FDC (Early Switch + Late Switch)-Overall arm up to Week 196; TAF Based Regimen (Early Switch) up to Week 148; for Randomized to TBR but received TDF-based regimen arm up to week 48; and for TAF Based Regimen (Early Switch) followed by DTG + 3TC FDC (Late Switch) from Week 148 to Week 196. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DTG + 3TC FDC (Early Switch + Late Switch)-Overall | 4/369 (1.1%) | 65/369 (17.6%) | 327/369 (88.6%) |
| TAF Based Regimen (Early Switch) | 0/371 (0%) | 44/371 (11.9%) | 304/371 (81.9%) |
| Randomized to TBR But Received TDF-based Regimen (Early Switch) | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| TAF Based Regimen (Early Switch) Followed by DTG + 3TC FDC (Late Switch) | 0/298 (0%) | 15/298 (5%) | 187/298 (62.8%) |
| Event | DTG + 3TC FDC (Early Switch + Late Switch)-Overall | TAF Based Regimen (Early Switch) | Randomized to TBR But Received TDF-based Regimen (Early Switch) | TAF Based Regimen (Early Switch) Followed by DTG + 3TC FDC (Late Switch) |
|---|---|---|---|---|
| SyncopeNervous system disorders | 4/369 | 0/371 | 0/1 | 0/298 |
| PneumoniaInfections and infestations | 3/369 | 1/371 | 0/1 | 0/298 |
| Hodgkin's diseaseNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/369 | 0/371 | 0/1 | 0/298 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 2/369 | 3/371 | 0/1 | 0/298 |
| Bipolar disorderPsychiatric disorders | 0/369 | 3/371 | 0/1 | 1/298 |
| CholecystitisHepatobiliary disorders | 2/369 | 2/371 | 0/1 | 0/298 |
| Suicidal ideationPsychiatric disorders | 2/369 | 2/371 | 0/1 | 0/298 |
| Lung adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/369 | 0/371 | 0/1 | 0/298 |
| Suicide attemptPsychiatric disorders | 2/369 | 1/371 | 0/1 | 0/298 |
| AppendicitisInfections and infestations | 2/369 | 0/371 | 0/1 | 0/298 |
| Event | DTG + 3TC FDC (Early Switch + Late Switch)-Overall | TAF Based Regimen (Early Switch) | Randomized to TBR But Received TDF-based Regimen (Early Switch) | TAF Based Regimen (Early Switch) Followed by DTG + 3TC FDC (Late Switch) |
|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 52/369 | 42/371 | 1/1 | 7/298 |
| DiarrhoeaGastrointestinal disorders | 54/369 | 43/371 | 1/1 | 12/298 |
| COVID-19Infections and infestations | 76/369 | 25/371 | 0/1 | 55/298 |
| NasopharyngitisInfections and infestations | 71/369 | 64/371 | 0/1 | 16/298 |
| SyphilisInfections and infestations | 49/369 | 33/371 | 0/1 | 13/298 |
| Back painMusculoskeletal and connective tissue disorders | 47/369 | 49/371 | 0/1 | 11/298 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 46/369 | 39/371 | 0/1 | 15/298 |
| AnxietyPsychiatric disorders | 43/369 | 29/371 | 0/1 | 7/298 |
| HeadacheNervous system disorders | 41/369 | 23/371 | 0/1 | 17/298 |
| FatigueGeneral disorders | 32/369 | 11/371 | 0/1 | 11/298 |
Baseline Characteristics data are reported for participants in the ITT-E Population
| Age, Continuous(Years) | DTG+3TC FDC | TAF-based Regimen | Total |
|---|---|---|---|
| Mean | 40.6 ± 10.76 | 40.9 ± 11.54 | 40.8 ± 11.15 |
| Sex: Female, Male(Participants) | DTG+3TC FDC | TAF-based Regimen | Total |
|---|---|---|---|
| Female | 25 | 33 | 58 |
| Male | 344 | 339 | 683 |
| Race/Ethnicity, Customized(Participants) | DTG+3TC FDC | TAF-based Regimen | Total |
|---|---|---|---|
| American Indian or Alaska Native | 7 | 8 | 15 |
| Asian-Central/South Asian Heritage (H) | 3 | 4 | 7 |
| Asian-Japanese H/East Asian H/South East Asian H | 10 | 9 | 19 |
| Black or African American | 50 | 58 | 108 |
| Native Hawaiian or other Pacific Islander | 1 | 3 | 4 |
| White-Arabic/North African (NA) H | 5 | 2 | 7 |
| White-Arabic/NA H and white/caucasia/European H | 0 | 1 | 1 |
| White-White/caucasian/European H | 292 | 286 | 578 |
| Asian and White | 0 | 1 | 1 |
| Black or African American and White | 1 | 0 | 1 |
| Cluster of differentiation 4 plus (CD4+) cell count(Cells per cubic millimeter (cells/mm^3)) | DTG+3TC FDC | TAF-based Regimen | Total |
|---|---|---|---|
| Median | 682.0 (492.0 to 862.0) | 720.0 (531.5 to 901.5) | 688.0 (514.0 to 885.0) |
| Baseline third agents(Participants) | DTG+3TC FDC | TAF-based Regimen | Total |
|---|---|---|---|
| NNRTI | 51 | 48 | 99 |
| INSTI | 289 | 296 | 585 |
| PI | 29 | 28 | 57 |
| HIV infection by Centers for Disease Control and Prevention (CDC) classification(Participants) | DTG+3TC FDC | TAF-based Regimen | Total |
|---|---|---|---|
| HIV infection Stage 1 | 255 | 259 | 514 |
| HIV infection Stage 2 | 94 | 94 | 188 |
| HIV infection Stage 3 | 20 | 19 | 39 |
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PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · viivhealthcare.com
Ran from Jan 2018 to primary completion in May 2019, 16 months.
Results were first posted in Jun 2020, 1 year after primary completion.
Of 57 industry-sponsored phase 3 interventional studies under HIV Infections, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 30. This study's 16 months is below that.
Counting every sponsor, half of 101 studies reached it within 27 months; a quarter within 20 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dolutegravir · Lamivudine