A Phase 2 interventional study of Bulevirtide and Peginterferon Alfa-2a (PEG-IFN alfa) in Chronic Hepatitis Delta, sponsored by Gilead Sciences. Completed at 20 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment
The primary objective of this study is to evaluate the efficacy of bulevirtide in combination with pegylated interferon in participants with chronic hepatitis delta (CHD).
43 studies on the registry are indexed under Hepatitis D, Chronic; 9 are open to participants now.
This study's enrollment of 175 is above the median of 46 across 30 interventional studies indexed under Hepatitis D, Chronic.
Browse Hepatitis D, Chronic studies →Gilead Sciences is the lead sponsor of 692 studies on the registry; 26 are open to participants now.
Of its 261 completed or terminated interventional studies of FDA-regulated products, 251 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion criteria for female individuals:
Exclusion Criteria:
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and 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.
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 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.
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.
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.
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.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and 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.
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 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.
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.
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.
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.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.
Drug: Peginterferon Alfa-2a (PEG-IFN alfa)
Participants will receive bulevirtide 2 mg once a day subcutaneously incombination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 2 mg once a day for 48 weeks and additional 48 weeks follow-up.
Drug: Bulevirtide · Drug: Peginterferon Alfa-2a (PEG-IFN alfa)
Participants will receive bulevirtide 10 mg once a day subcutaneously in combination with PEG-IFN alfa 180 mcg once a week subcutaneously for 48 weeks followed by bulevirtide 10 mg once a day for 48 weeks and additional 48 weeks follow-up.
Drug: Bulevirtide · Drug: Peginterferon Alfa-2a (PEG-IFN alfa)
Participants will receive bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up
Drug: Bulevirtide
Administered via subcutaneous injections
Also known as: Myrcludex B, Hepcludex®
Administered via subcutaneous injections
Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24)
SVR24 was defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \< lower limit of quantitation \[LLOQ\] with target not detected) at 24 weeks after the scheduled end of treatment (EOT).
Time frame: 24 weeks after EOT (Week 72 for Arm A and study Week 120 for Arms B, C, and D)
Percentage of Participants With Undetectable HDV RNA at Week 48
Undetectable HDV RNA at Week 48 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 48.
Time frame: Week 48
Percentage of Participants With Undetectable HDV RNA at Week 96 (Arms B, C, and D Only)
Undetectable HDV RNA at Week 96 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 96.
Time frame: Week 96
Percentage of Participants With Combined Response at Week 24 After the Scheduled End of Treatment
Combined response was defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, alanine aminotransferase (ALT) normalization, defined as an ALT value within the normal range, based on the central laboratories \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\]).
Time frame: 24 weeks after EOT (Week 72 for Arm A and Week 120 for Arms B, C, and D)
Percentage of Participants With Combined Response at Week 48 After the Scheduled End of Treatment
Combined response is defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, ALT normalization, defined as an ALT value within the normal range, based on the central laboratories \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\]).
Time frame: 48 weeks after EOT (Week 96 for Arm A and Week 144 for Arm B, C, and D)
Percentage of Participants With Sustained Virological Response 48 After the Scheduled End of Treatment (SVR 48)
SVR 48 is defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \< lower limit of quantitation \[LLOQ\] with target not detected) at 48 weeks after the scheduled end of treatment.
Time frame: 48 weeks after EOT (Week 96 for Arm A; Week 144 for Arms B, C, and D)
Change From Baseline in Liver Stiffness as Measured by Elastography at Week 48
The mixed-effects models for repeated measurements (MMRM) model was used for analysis.
Time frame: Baseline, Week 48
Change From Baseline in Liver Stiffness as Measured by Elastography at Week 96
The MMRM model was used for analysis.
Time frame: Baseline, Week 96
Change From Baseline in Liver Stiffness as Measured by Elastography at Week 144
The MMRM model was used for analysis.
Time frame: Baseline, 48 weeks after EOT (Week 96 for Arm A and study Week 144 for Arms B, C, and D)
Participants were enrolled at study sites in the France, Moldova, Romania and Russia.
| Milestone | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day |
|---|---|---|---|---|
| Started | 25 | 50 | 50 | 50 |
| Completed | 17 | 38 | 45 | 45 |
| Not completed | 8 | 12 | 5 | 5 |
| Withdrew: Withdrawal of consent | 5 | 8 | 1 | 1 |
| Withdrew: Adverse event | 1 | 1 | 1 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 1 |
| Withdrew: Pregnancy | 0 | 1 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 1 |
| Withdrew: Death | 0 | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 | 0 | 0 |
| Withdrew: Non-compliance with study drug | 0 | 0 | 0 | 1 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 |
| Withdrew: Randomized but never treated | 1 | 0 | 0 | 0 |
SVR24 was defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \< lower limit of quantitation \[LLOQ\] with target not detected) at 24 weeks after the scheduled end of treatment (EOT).
| percentage of participants | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day |
|---|---|---|---|---|
| Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24) | 16.7 (4.7 to 37.4) | 32.0 (19.5 to 46.7) | 46.0 (31.8 to 60.7) | 12.0 (4.5 to 24.3) |
Undetectable HDV RNA at Week 48 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 48.
| percentage of participants | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day |
|---|---|---|---|---|
| Percentage of Participants With Undetectable HDV RNA at Week 48 | 20.8 (7.1 to 42.2) | 40.0 (26.4 to 54.8) | 60.0 (45.2 to 73.6) | 10.0 (3.3 to 21.8) |
Undetectable HDV RNA at Week 96 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 96.
| percentage of participants | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day |
|---|---|---|---|
| Percentage of Participants With Undetectable HDV RNA at Week 96 (Arms B, C, and D Only) | 44.0 (30.0 to 58.7) | 70.0 (55.4 to 82.1) | 22.0 (11.5 to 36.0) |
Combined response was defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, alanine aminotransferase (ALT) normalization, defined as an ALT value within the normal range, based on the central laboratories \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\]).
| percentage of participants | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day |
|---|---|---|---|---|
| Percentage of Participants With Combined Response at Week 24 After the Scheduled End of Treatment | 20.8 (7.1 to 42.2) | 36.0 (22.9 to 50.8) | 52.0 (37.4 to 66.3) | 26.0 (14.6 to 40.3) |
Combined response is defined as fulfilment of 2 conditions simultaneously: 1) undetectable HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline, ALT normalization, defined as an ALT value within the normal range, based on the central laboratories \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\]).
| percentage of participants | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day |
|---|---|---|---|---|
| Percentage of Participants With Combined Response at Week 48 After the Scheduled End of Treatment | 33.3 (15.6 to 55.3) | 32.0 (19.5 to 46.7) | 46.0 (31.8 to 60.7) | 18.0 (8.6 to 31.4) |
SVR 48 is defined as undetectable hepatitis delta virus (HDV) RNA (HDV RNA value \< lower limit of quantitation \[LLOQ\] with target not detected) at 48 weeks after the scheduled end of treatment.
| percentage of participants | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day |
|---|---|---|---|---|
| Percentage of Participants With Sustained Virological Response 48 After the Scheduled End of Treatment (SVR 48) | 25.0 (9.8 to 46.7) | 26.0 (14.6 to 40.3) | 46.0 (31.8 to 60.7) | 12.0 (4.5 to 24.3) |
The mixed-effects models for repeated measurements (MMRM) model was used for analysis.
| kPa | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day |
|---|---|---|---|---|
| Change From Baseline in Liver Stiffness as Measured by Elastography at Week 48 | -0.02 (-2.29 to 2.25) | -1.85 (-3.42 to -0.28) | -1.79 (-3.21 to -0.36) | -3.34 (-4.84 to -1.85) |
The MMRM model was used for analysis.
| kPa | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day |
|---|---|---|---|
| Change From Baseline in Liver Stiffness as Measured by Elastography at Week 96 | -3.37 (-4.94 to -1.80) | -3.70 (-5.11 to -2.29) | -3.85 (-5.35 to -2.35) |
The MMRM model was used for analysis.
| kPa | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg Once a Day |
|---|---|---|---|---|
| Change From Baseline in Liver Stiffness as Measured by Elastography at Week 144 | -0.31 (-2.75 to 2.12) | -2.35 (-4.20 to -0.50) | -2.47 (-4.12 to -0.83) | -0.79 (-2.53 to 0.94) |
Collected over All-cause mortality: Up to approximately 144 weeks; Adverse events: Pegylated Interferon Alfa-2a (PEG-IFN Alfa) arm: Week 48 plus 30 days; all other arms: Week 96 plus 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | 0/25 (0%) | 3/24 (12.5%) | 22/24 (91.7%) |
| Bulevirtide 2 mg/Day + PEG-IFN Alfa | 1/50 (2%) | 3/50 (6%) | 49/50 (98%) |
| Bulevirtide 10 mg/Day + PEG-IFN Alfa | 1/50 (2%) | 8/50 (16%) | 50/50 (100%) |
| Bulevirtide 10 mg/Day | 0/50 (0%) | 2/50 (4%) | 37/50 (74%) |
| Event | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day |
|---|---|---|---|---|
| PyrexiaGeneral disorders | 1/24 | 0/50 | 0/50 | 0/50 |
| AppendicitisInfections and infestations | 1/24 | 0/50 | 0/50 | 0/50 |
| Covid-19 pneumoniaInfections and infestations | 1/24 | 0/50 | 1/50 | 0/50 |
| Retinal detachmentEye disorders | 0/24 | 0/50 | 1/50 | 0/50 |
| Upper gastrointestinal haemorrhageGastrointestinal disorders | 0/24 | 0/50 | 1/50 | 0/50 |
| Cholecystitis acuteHepatobiliary disorders | 0/24 | 0/50 | 1/50 | 0/50 |
| Cholecystitis chronicHepatobiliary disorders | 0/24 | 0/50 | 1/50 | 0/50 |
| Drug-induced liver injuryHepatobiliary disorders | 0/24 | 0/50 | 1/50 | 0/50 |
| Chronic sinusitisInfections and infestations | 0/24 | 1/50 | 0/50 | 0/50 |
| Covid-19Infections and infestations | 0/24 | 0/50 | 1/50 | 1/50 |
| Event | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day |
|---|---|---|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 14/24 | 23/50 | 24/50 | 8/50 |
| NeutropeniaBlood and lymphatic system disorders | 12/24 | 23/50 | 28/50 | 6/50 |
| LeukopeniaBlood and lymphatic system disorders | 13/24 | 26/50 | 27/50 | 8/50 |
| Influenza like illnessGeneral disorders | 10/24 | 22/50 | 20/50 | 2/50 |
| Alanine aminotransferase increasedInvestigations | 8/24 | 5/50 | 12/50 | 5/50 |
| Aspartate aminotransferase increasedInvestigations | 8/24 | 6/50 | 10/50 | 3/50 |
| LymphopeniaBlood and lymphatic system disorders | 7/24 | 12/50 | 15/50 | 5/50 |
| PyrexiaGeneral disorders | 5/24 | 8/50 | 13/50 | 0/50 |
| Vitamin D deficiencyMetabolism and nutrition disorders | 3/24 | 9/50 | 13/50 | 13/50 |
| Gamma-glutamyltransferase increasedInvestigations | 6/24 | 2/50 | 7/50 | 3/50 |
All Randomized Analysis Set included all participants who were enrolled (informed consent signed) and randomized in the study.
| Age, Categorical(Participants) | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day | Total~(N=174) |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 50 | 49 | 50 | 174 |
| >=65 years | 0 | 0 | 1 | 0 | 1 |
| Age, Continuous(years) | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day | Total~(N=174) |
|---|---|---|---|---|---|
| Mean | 41 ± 8.2 | 41 ± 9.3 | 41 ± 8.6 | 40 ± 8.5 | 41 ± 8.7 |
| Sex: Female, Male(Participants) | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day | Total~(N=174) |
|---|---|---|---|---|---|
| Female | 6 | 17 | 15 | 12 | 50 |
| Male | 19 | 33 | 35 | 38 | 125 |
| Race (NIH/OMB)(Participants) | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day | Total~(N=174) |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 4 | 3 | 4 | 4 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 2 | 2 | 7 |
| White | 21 | 44 | 43 | 44 | 152 |
| More than one race | 0 | 0 | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day | Total~(N=174) |
|---|---|---|---|---|---|
| Ethnicity, Not Collected | — | — | — | — | 0 |
| Region of Enrollment(Participants) | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day | Total~(N=174) |
|---|---|---|---|---|---|
| Russia | 14 | 29 | 22 | 27 | 92 |
| Romania | 6 | 11 | 12 | 12 | 41 |
| Moldova | 3 | 7 | 12 | 9 | 31 |
| France | 2 | 3 | 4 | 2 | 11 |
| HDV RNA(log10 IU/mL) | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day | Total~(N=174) |
|---|---|---|---|---|---|
| Mean | 5.20 ± 1.064 | 5.27 ± 1.355 | 5.09 ± 1.343 | 5.45 ± 1.098 | 5.26 ± 1.242 |
| Liver Stiffness(kPa) | Pegylated Interferon Alfa-2a (PEG-IFN Alfa) | Bulevirtide 2 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day + PEG-IFN Alfa | Bulevirtide 10 mg/Day | Total~(N=174) |
|---|---|---|---|---|---|
| Mean | 15.8 ± 11.57 | 12.8 ± 6.43 | 12.5 ± 7.60 | 12.7 ± 6.65 | 13.1 ± 7.72 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2019 to primary completion in Apr 2022, 34 months.
Results were first posted in Jul 2024, 2 years 3 months after primary completion. A results delay was requested in Mar 2023.
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Studies of the drugs tested here: Bulevirtide · Peginterferon alfa-2a