A Phase 3 interventional study of DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC in HIV-1, sponsored by Janssen Scientific Affairs, LLC. Completed at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-04.
Sponsored by Janssen Scientific Affairs, LLC · Phase 3, Interventional, and Treatment
The purpose of this study is to assess the efficacy of Darunavir/ Cobicistat/ Emtricitabine/ Tenofovir Alafenamide (D/C/F/TAF) fixed-dose combination (FDC) in a Test and Treat model of care in newly diagnosed human immunodeficiency virus (HIV-1)-infected, treatment-naive participants as determined by the proportion of virologic responders defined as having (HIV)-1 ribonucleic acid (RNA) lesser than 50 copies per milliliter (copies/mL) at Week 48.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
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Browse Acquired Immunodeficiency Syndrome studies →Janssen Scientific Affairs, LLC is the lead sponsor of 40 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Participants will receive oral tablet containing Darunavir 800 milligram (mg)/ Cobicistat 150 mg/ Emtricitabine 200 mg/ Tenofovir Alafenamide 10 mg (D/C/F/TAF) fixed-dose combination (FDC) once daily within 24 hours of the screening/baseline visit.
Drug: DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC
Participants will receive oral tablet containing D 800 mg /C 150 mg /F 200 mg /TAF 10 mg FDC once daily within 24 hours of the screening/ baseline visit.
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach
Percentage of participants with a HIV-1 RNA \< 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is \< 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
Time frame: Week 48
Change From Baseline in log10 HIV-1 RNA Viral Load (<50/200 Copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48
Change from baseline in log10 HIV-1 RNA viral load (\<50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported.
Time frame: Baseline, Weeks 2, 4, 8, 12, 24, 36, and 48
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24
Percentage of participants with HIV-1 RNA \< 50 copies/mL were reported.
Time frame: Week 24
Change From Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Weeks 12, 24 and 48
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed.
Time frame: Baseline, Weeks 12, 24 and 48
Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules
Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula \< 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (\>=) 2.5\*upper limit of normal (ULN); c). Serum lipase \>=1.5\*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.
Time frame: Up to Week 48
Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs)
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Up to Week 48
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
Time frame: Up to Week 48
Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
Time frame: Up to Week 48
Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings
Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study.
Time frame: Up to Day 35
Percentage of Participants With Baseline Protease (PI), Reverse Transcriptase (RT) and Integrase (INI)-Resistance-associated Mutation (RAMs)
Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor \[NRTIs\] and non-nucleoside/nucleotide reverse transcriptase inhibitor \[NNRTIs\]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) \[\<500 copies/mL\], reduced viral fitness, compromised sample collection/handling, primer incompatibility).
Time frame: Baseline (Day 1)
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 24 and 48
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA \>= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
Time frame: Week 24 and 48
Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF)
Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (\>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
Time frame: Up to Week 48
Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment
Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported.
Time frame: Up to Week 48
Percentage of Participants With Retention in Care Completed and With Documented Clinical Visit
Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported.
Time frame: Up to Week 48
Percentage of Participants With Treatment Adherence >95% Based on Pill Count at Weeks 4, 8, 12, 24, 36, and 48
Percentage of participants with treatment adherence \>95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (\>) 95 percent (%) by pill count.
Time frame: Weeks 4, 8, 12, 24, 36, and 48
Percentage of Participants With 100% Treatment Adherence Based on Participants Self-Report, Using a 4-Day Recall at Weeks 4, 8, 12, 24, 36, and 48
Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported.
Time frame: Weeks 4, 8, 12, 24, 36, and 48
Mean Total Scores for the HIV-Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4, 24, and 48
The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the treatment satisfaction.
Time frame: Weeks 4, 24, and 48
Number of Participants With Hospitalizations
Number of participants with hospitalizations (overnight) was reported.
Time frame: Up to Week 48
Duration of Hospitalizations
Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM.
Time frame: Up to Week 48
Number of Participants With Outpatient Visits
Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported.
Time frame: Up to Week 48
Number of Participants With Emergency Room Visits
Number of participants with emergency room visits was reported.
Time frame: Up to Week 48
Median Medical Costs of Care ((United States of America [USA] Dollars) Based on Healthcare Resource Utilization [HRU])
Median medical costs of care (United States of America \[USA\] dollars) based on healthcare resource utilization \[HRU\]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit.
Time frame: Up to Week 48
Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Up to Week 96
Percentage of Participants Experiencing Grade 3 and 4 Adverse Events Through Week 96
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
Time frame: Up to Week 96
Percentage of Participants Experiencing Grade 3 and 4 Laboratory Abnormalities Through Week 96
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
Time frame: Up to Week 96
Percentage of Participants With Protocol-defined Virologic Failure (PDVF) at Week 72 and 96
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA \>= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
Time frame: Weeks 72 and 96
Out of 97 participants who completed the main study, 80 participants continued into the extension phase and were treated with Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide (D/C/F/TAF) fixed dose combination (FDC).
| Milestone | D/C/F/TAF |
|---|---|
| Started | 109 |
| Completed | 97 |
| Not completed | 12 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Other | 5 |
| Milestone | D/C/F/TAF |
|---|---|
| Started | 80 |
| Completed | 0 |
| Not completed | 80 |
| Withdrew: Transition to commercial d/c/f/taf | 55 |
| Withdrew: Transition to other arv treatment | 16 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Adverse event | 1 |
| Withdrew: Other | 2 |
Percentage of participants with a HIV-1 RNA \< 50 copies per mL were assessed using FDA snapshot approach which defines a participant's virologic response status using only the viral load at the predefined time point within a window of time, along with study drug discontinuation status. If HIV RNA level is \< 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
| Percentage of participants | D/C/F/TAF: Main Study |
|---|---|
| Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) Less Than (<) 50 Copies Per Milliliter (Copies/mL) (Virologic Response) at Week 48 Defined by Food and Drug Administration (FDA) Snapshot Approach | 84.4 (76.44 to 90.03) |
Change from baseline in log10 HIV-1 RNA viral load (\<50/200 copies/mL) at Weeks 2, 4, 8, 12, 24, 36, and 48 were reported.
| log10 HIV-1 RNA copies per mL | D/C/F/TAF: Main Study |
|---|---|
| Change at Week 2 | -1.65 ± 0.056 |
| Change at Week 4 | -2.02 ± 0.066 |
| Change at Week 8 | -2.43 ± 0.086 |
| Change at Week 12 | -2.78 ± 0.080 |
| Change at Week 24 | -3.08 ± 0.096 |
| Change at Week 36 | -3.14 ± 0.102 |
| Change at Week 48 | -3.14 ± 0.099 |
Percentage of participants with HIV-1 RNA \< 50 copies/mL were reported.
| Percentage of Participants | D/C/F/TAF: Main Study |
|---|---|
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 | 81.7 (73.35 to 87.80) |
The immunologic change was determined by changes in Cluster of CD4+ cell count. Change from baseline in CD4+ cell count at Weeks 12, 24 and 48 were assessed.
| Cells per millimeter cube (cells/mm^3) | D/C/F/TAF: Main Study |
|---|---|
| Change at Week 12 | 149.56 ± 16.621 |
| Change at Week 24 | 182.11 ± 16.885 |
| Change at Week 48 | 222.60 ± 20.618 |
Number of participants that required discontinuation after enrollment based on safety stopping rules were reported. Stopping rules include the following reasons: a). Estimated glomerular filtration rate (eGFR) according to the Modification of Diet in Renal Disease (MDRD) formula \< 50 milliliter per minute (mL/min) b). Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than or equal to (\>=) 2.5\*upper limit of normal (ULN); c). Serum lipase \>=1.5\*ULN; d). Positive serum human chorionic gonadotropin pregnancy test (beta-hCG) for women of childbearing potential; e). Laboratory results that the investigator believes should result in discontinuation of study medication; f). Participants identified with active hepatitis C virus (HCV) infection that in the opinion of the investigator requires HCV treatment immediately or expected to be needed during the course of the study with agents not compatible with D/C/F/TAF FDC.
| Participants | D/C/F/TAF: Main Study |
|---|---|
| Number of Participants That Required Discontinuation After Enrollment Based on Safety Stopping Rules | 3 |
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
| Percentage of participants | D/C/F/TAF: Main Study |
|---|---|
| Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) | 0.9 |
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
| Percentage of participants | D/C/F/TAF: Main Study |
|---|---|
| Grade 3 | 11.9 |
| Grade 4 | 0.9 |
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities was assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
| Percentage of participants | D/C/F/TAF: Main Study |
|---|---|
| ALT: Grade 3 | 0 |
| ALT: Grade 4 | 2.8 |
| AST: Grade 3 | 0.9 |
| AST: Grade 4 | 3.7 |
| Calcium: Grade 3 | 0 |
| Calcium: Grade 4 | 0.9 |
| Glucose: Grade 3 | 0.9 |
| Glucose: Grade 4 | 0 |
| Hyperbilirubinemia: Grade 3 | 2.8 |
| Hyperbilirubinemia: Grade 4 | 0 |
| Hypophosphatemia: Grade 3 | 0.9 |
| Hypophosphatemia: Grade 4 | 0 |
| Sodium: Grade 3 | 0 |
| Sodium: Grade 4 | 0.9 |
| Absolute Lymphocytes Count: Grade 3 | 0.9 |
| Absolute Lymphocytes Count: Grade 4 | 0.9 |
| Platelet Count: Grade 3 | 0 |
| Platelet Count: Grade 4 | 0.9 |
Percentage of participants meeting resistance stopping rules, requiring discontinuation of study treatment due to baseline resistance findings were reported. Investigator reviewed antiretroviral screening/baseline resistance data at Week 4, depending on availability of screening/baseline HIV genotypic drug resistance testing results from central laboratory. Participants who do not show full sensitivity to all drugs in the fixed-dose combination (FDC) study regimen according to the susceptibility assessment in the Genosure Prime report will be contacted to return to study site for early study treatment discontinuation (ESTD). Participants with identified resistance to lamivudine/Emtricitabine, attributed to the presence of the M184I/V mutation alone will be permitted to remain in the study.
| Percentage of participants | D/C/F/TAF: Main Study |
|---|---|
| Percentage of Participants Meeting Resistance Stopping Rules, Requiring Discontinuation of Study Treatment Due to Baseline Resistance Findings | 0 |
Percentage of Participants with resistance-associated mutations present at baseline were reported and included mutations in the domain of PR, RT (including nucleoside reverse transcriptase inhibitor \[NRTIs\] and non-nucleoside/nucleotide reverse transcriptase inhibitor \[NNRTIs\]), INI, RAMs as determined by the GenoSure Prime assay. Genotypes were not available for 7 participants due to failed amplification of viral deoxyribo nucleic acid (DNA) (that is, low viral load (VL) \[\<500 copies/mL\], reduced viral fitness, compromised sample collection/handling, primer incompatibility).
| Percentage of Participants | D/C/F/TAF: Main Study |
|---|---|
| Primary PI RAM | 4.9 |
| Secondary PI RAM | 98.0 |
| Darunavir RAM | 0 |
| Emtricitabine RAM | 2.0 |
| NNRTI RAM | 27.5 |
| Primary INI RAM | 0 |
| Secondary INI RAM | 4.9 |
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA \>= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
| Percentage of participants | D/C/F/TAF: Main Study |
|---|---|
| Week 24 | 0 |
| Week 48 | 0 |
Percentage of participants developing RAMs and loss of phenotypic susceptibility, upon meeting PDVF were reported. Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA greater than or equal to (\>=) 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
| Percentage of participants | D/C/F/TAF: Main Study |
|---|---|
| Percentage of Participants Developing Resistance-associated Mutation (RAMs) and Loss of Phenotypic Susceptibility, Upon Meeting Protocol-defined Virologic Failure (PDVF) | 0 |
Percentage of participants lost-to-follow-up throughout the 48 Weeks of treatment were reported.
| Percentage of participants | D/C/F/TAF: Main Study |
|---|---|
| Percentage of Participants Lost-to-Follow-up Throughout the 48 Weeks of Treatment | 3.67 |
Percentage of participants with retention in care completed and with documented clinical visit (within 90 days of discontinuation) were reported.
| Percentage of participants | D/C/F/TAF: Main Study |
|---|---|
| Retention in care: Completed | 63.6 |
| Documented Clinical Visit | 85.7 |
Percentage of participants with treatment adherence \>95% based on pill count at Weeks 4, 8, 12, 24, 36, and 48 were reported. Treatment adherence was defined as having a treatment adherence of greater than (\>) 95 percent (%) by pill count.
| Percentage of participants | D/C/F/TAF: Main Study |
|---|---|
| >95% at Week 4 | 83.5 |
| >95% at Week 8 | 84.5 |
| >95% at Week 12 | 79.4 |
| >95% at Week 24 | 76.5 |
| >95% at Week 36 | 75.8 |
| >95% at Week 48 | 65.6 |
Percentage of participants with 100 % adherence based on participants self-report, using a 4-Day recall at Weeks 4, 8, 12, 24, 36, and 48 was reported.
| Percentage of participants | D/C/F/TAF: Main Study |
|---|---|
| Week 4 | 99.76 ± 2.440 |
| Week 8 | 99.50 ± 3.518 |
| Week 12 | 99.02 ± 6.967 |
| Week 24 | 98.04 ± 10.949 |
| Week 36 | 99.49 ± 3.535 |
| Week 48 | 99.48 ± 3.571 |
The HIV treatment satisfaction questionnaire (HIVTSQ) is based on a 10-item self-reported scale that measures overall satisfaction with treatment. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6). The higher the score, the greater the treatment satisfaction.
| Units on a scale | D/C/F/TAF: Main Study |
|---|---|
| Week 4 | 56.52 ± 0.472 |
| Week 24 | 57.87 ± 0.387 |
| Week 48 | 57.88 ± 0.442 |
Number of participants with hospitalizations (overnight) was reported.
| Participants | D/C/F/TAF: Main Study |
|---|---|
| Number of Participants With Hospitalizations | 11 |
Duration of hospitalizations in days was reported for those participants hospitalized during the course of the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this OM.
| Days | D/C/F/TAF: Main Study |
|---|---|
| Duration of Hospitalizations | 5.0 (1 to 15) |
Number of participants with outpatient visits (in addition to study visits, including General practitioner visit, Specialist visit, Nurse practitioner visit, Physician assistant visit, Home healthcare nurse visit and Other visit) was reported.
| Participants | D/C/F/TAF: Main Study |
|---|---|
| General practitioner visit | 33 |
| Specialist visit | 28 |
| Nurse practitioner visit | 16 |
| Physician assistant visit | 6 |
| Home healthcare nurse visit | 0 |
| Other visit | 25 |
Number of participants with emergency room visits was reported.
| Participants | D/C/F/TAF: Main Study |
|---|---|
| Number of Participants With Emergency Room Visits | 19 |
Median medical costs of care (United States of America \[USA\] dollars) based on healthcare resource utilization \[HRU\]) were reported. The cost of care specified for overnight hospitalization, hospital day care ward (without overnight), emergency room visit, general practitioner visit, specialist visit, nurse practitioner visit, physician assistant visit and Other visit.
| USA dollars | D/C/F/TAF: Main Study |
|---|---|
| Overnight hospitalization | 2035.0 (2035 to 4070) |
| Hospital day care ward (without overnight) | 341.0 (341 to 341) |
| Emergency room visit | 212.0 (212 to 424) |
| General practitioner visit | 142.0 (71 to 355) |
| Specialist visit | 94.0 (94 to 752) |
| Nurse practitioner visit | 66.0 (66 to 264) |
| Physician assistant visit | 47.0 (47 to 94) |
| Other visit | 148.0 (16 to 788) |
Percentage of participants discontinuing therapy due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
| Percentage of participants | D/C/F/TAF: Extension Study |
|---|---|
| Percentage of Participants Discontinuing Therapy Due to Adverse Events (AEs) Through Week 96 | 1.3 |
AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Events with Grade 3 or higher (3=Severe; 4=life-threatening; 5=fatal) are events that significantly interrupt usual daily activity, require systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable events.
| Percentage of participants | D/C/F/TAF: Extension Study |
|---|---|
| Grade 3 | 7.5 |
| Grade 4 | 2.5 |
Percentage of participants experiencing grade 3 and 4 laboratory abnormalities were assessed by Division of Acquired Immunodeficiency Syndrome (DAIDS) Adverse Event (AE) Grading Table. Abnormal laboratory values with Grade 3 or higher (3=Severe; 4=potentially life-threatening) signifies an interruption of usual daily activity, requiring systemic drug therapy/other treatment and are, in many situations, considered unacceptable or intolerable.
| Percentage of participants | D/C/F/TAF: Extension Study |
|---|---|
| Glucose: Grade 3 | 2.5 |
| Glucose: Grade 4 | 0 |
| Hypophosphatemia: Grade 3 | 1.3 |
| Hypophosphatemia: Grade 4 | 0 |
Virologic failure is defined as: a) Virologic Nonresponse: HIV-1 RNA \<1 log10 reduction from baseline, and HIV-1 RNA \>= 400 copies/mL at the Week 12 visit, subsequently confirmed at an unscheduled visit conducted within 2 to 4 weeks after Week 12. b) Virologic Rebound: At any visit, after achieving confirmed consecutive HIV-1 RNA \<50 copies/mL, a rebound in HIV 1 RNA to \>= 50 copies/mL, which is subsequently confirmed at a scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result; or At any visit, a \>1 log10 increase in HIV-1 RNA from the nadir, which is subsequently confirmed at the following scheduled or unscheduled visit conducted within 2 to 4 weeks of the HIV-1 RNA result.
| Percentage of participants | D/C/F/TAF: Extension Study |
|---|---|
| Week 72 | 10.6 |
| Week 96 | 9.1 |
Collected over Main study: Up to 48 Weeks; Extension Study: Up to 96 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| D/C/F/TAF: Main Study | 0/109 (0%) | 10/109 (9.2%) | 92/109 (84.4%) |
| D/C/F/TAF: Extension Study | 0/80 (0%) | 4/80 (5%) | 45/80 (56.3%) |
| Event | D/C/F/TAF: Main Study | D/C/F/TAF: Extension Study |
|---|---|---|
| Abdominal InjuryInjury, poisoning and procedural complications | 1/109 | 1/80 |
| Muscle RuptureInjury, poisoning and procedural complications | 1/109 | 1/80 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/109 | 1/80 |
| Meningitis asepticInfections and infestations | 0/109 | 1/80 |
| Head injuryInjury, poisoning and procedural complications | 0/109 | 1/80 |
| ColitisGastrointestinal disorders | 1/109 | 0/80 |
| Pancreatitis AcuteGastrointestinal disorders | 1/109 | 0/80 |
| AppendicitisInfections and infestations | 1/109 | 0/80 |
| CellulitisInfections and infestations | 1/109 | 0/80 |
| PneumoniaInfections and infestations | 1/109 | 0/80 |
| Event | D/C/F/TAF: Main Study | D/C/F/TAF: Extension Study |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 27/109 | 5/80 |
| NauseaGastrointestinal disorders | 17/109 | 1/80 |
| VomitingGastrointestinal disorders | 10/109 | 1/80 |
| Weight DecreasedInvestigations | 10/109 | 3/80 |
| HeadacheNervous system disorders | 10/109 | 0/80 |
| HypertensionVascular disorders | 8/109 | 3/80 |
| FatigueGeneral disorders | 7/109 | 2/80 |
| Vitamin D DeficiencyMetabolism and nutrition disorders | 4/109 | 5/80 |
| LymphadenopathyBlood and lymphatic system disorders | 6/109 | 3/80 |
| PyrexiaGeneral disorders | 6/109 | 0/80 |
| Age, Continuous(years) | D/C/F/TAF |
|---|---|
| Mean | 32.5 ± 12.02 |
| Sex: Female, Male(Participants) | D/C/F/TAF |
|---|---|
| Female | 14 |
| Male | 95 |
| Race (NIH/OMB)(Participants) | D/C/F/TAF |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 35 |
| White | 65 |
| More than one race | 3 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(Participants) | D/C/F/TAF |
|---|---|
| United States | 109 |
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