Chronic Hepatitis Delta
Conditions
Brief summary
The primary objective of this study is to evaluate the efficacy of bulevirtide administered subcutaneously (SC) for 48 weeks at a dose of 2 mg or 10 mg once daily for treatment of chronic hepatitis delta (CHD) in comparison to delayed treatment. The main goal of this study is to determine the effectiveness of bulevirtide in participants randomized to bulevirtide 2 mg or 10 mg once daily SC as compared to participants randomized to delayed treatment for 48 weeks. Treatment will continue through Week 144 (participants randomized to delayed treatment will change to bulevirtide 10 mg once daily SC after Week 48 through Week 144). All participants will be followed off-treatment for an additional 96 weeks.
Interventions
DRUGBulevirtide
Administered via SC injections
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of signed and dated informed consent form. 2. Positive serum anti-hepatitis delta virus (HDV) antibody results or polymerase chain reaction (PCR) results for serum/ plasma HDV ribonucleic acid (RNA) for at least 6 months before screening. 3. Positive PCR results for serum/plasma HDV RNA at screening. 4. Alanine transaminase level \> 1 x upper limit of normal (ULN), but less than 10 x ULN. 5. Serum albumin \> 28 g/L. 6. Negative urine pregnancy test for females of childbearing potential. 7. Inclusion criteria for females: * Postmenopausal for at least 2 years, or * Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or * Abstinence from heterosexual intercourse throughout the study, or * Willingness to use highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive) throughout the study and for 3 months after the last dose of the study medication for individuals discontinued during the treatment period. 8. Individuals must agree to use a highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) and not to donate sperm throughout the study and for 3 months after the last dose of the study medication for individuals discontinued during the treatment period.
Exclusion criteria
1. Child-Pugh hepatic insufficiency score over 7 points. Uncomplicated oesophageal varices allowed; Individuals with current bleeding or ligation, or history of bleeding or ligation within the last 2 years are excluded. 2. Hepatitis C virus (HCV) or uncontrolled human immunodeficiency virus (HIV) coinfection. Individuals with HCV antibodies can be enrolled, if screening HCV RNA test is negative. Individuals with HIV infection can be enrolled if cluster of differentiation (CD4+) cell counts are \>500/mL and HIV RNA is below limit of detection for at least 12 months. 3. Creatinine clearance \< 60 mL/min as estimated using Cockcroft-Gault formula. 4. Total bilirubin ≥ 34.2 µmol/L. (Individuals with higher total bilirubin values may be included after the consultation with the Study Medical Monitor, if such elevation can be clearly attributed to Gilbert's syndrome associated with low-grade hyperbilirubinemia.) 5. Evidence of an active or suspected malignancy or a history of malignancy, or an untreated pre-malignancy disorder within the last 5 years (with the exception of successfully treated carcinoma of the cervix in situ and successfully treated basal cell carcinoma and squamous cell carcinoma not less than 1 year prior to screening \[and no more than 3 excised skin cancer within the last 5 years prior to screening\]) or history of hepatic carcinoma. 6. Systemic connective tissue disorders. 7. New York Heart Association (NYHA) class III-IV congestive heart failure. 8. Individuals with uncontrolled arterial hypertension: systolic blood pressure \> 150 mm Hg and/ or diastolic blood pressure \> 100 mm Hg at Screening. 9. Previous or unstable concurrent diseases or conditions that prevent individual's enrolment into the study. 10. Individuals with mental disorders or social circumstances that preclude them from following protocol requirements. 11. Current or previous (within last 2 years) decompensated liver disease, including coagulopathy, hepatic encephalopathy and esophageal varices hemorrhage. 12. One or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.). Gilbert's syndrome, a benign disorder associated with low-grade hyperbilirubinemia, will not exclude individuals from participation in this trial. Autoimmune hepatitis stigmata attributed to HDV infection in the opinion of the investigator are allowed. 13. White blood cells (WBC) count \< 3000 cells/mm\^3 (\<1500 if African individuals). 14. Neutrophil count \< 1500 cells/mm\^3 (\<1000 if African individuals). 15. Platelet count \< 60,000 cells/mm\^3. 16. Use of prohibited psychotropic agents at Screening. 17. Use of interferons within 6 months before Screening. 18. History of solid organ transplantation. 19. Current alcohol abuse or alcohol abuse within 6 months prior to enrolment in this study; past or current drug addict. 20. History of disease requiring regular use of systemic glucocorticosteroids (inhalative glucocorticosteroids are allowed) or other immunosuppressants. 21. Pregnant or breast-feeding females. 22. Participation in another clinical study with investigational drugs within 30 days prior to randomization. 23. Receipt of bulevirtide previously, e.g. in clinical trials. 24. Inability to follow protocol requirements and undergo all protocol procedures. NOTE: Individuals with medical contraindication for liver biopsy are allowed to participate in this study. Such individuals will exempt from liver biopsy requirements in this study. Individuals receiving prohibited treatment at Screening cannot be included into the study unless this treatment is withdrawn prior to randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Combined Response at Week 48 | Week 48 | Combined response was defined as fulfilment of two conditions simultaneously: Undetectable (\< lower limit of quantification (LLOQ, target not detected)) HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline; and ALT normalization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | Week 48 | ALT normalization was defined as an ALT value within the normal range, based on the central laboratories \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\]) |
| Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 48 | ANCOVA was used for analysis. |
| Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 96 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 96 | Mixed model for repeated measurements (MMRM) was used for analysis. |
| Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144 | Baseline, Week 144 | MMRM was used for analysis. |
| Percentage of Participants With Undetectable HDV RNA at Week 48 | Week 48 | Undetectable HDV RNA at Week 48 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 48. |
| Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 240 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 240 | MMRM was used for analysis. |
| Percentage of Participants With Undetectable HDV RNA 24 Weeks After Scheduled End of Treatment (Sustained Virological Response) | Week 168 | Undetectable HDV RNA 24 Weeks after Scheduled End of Treatment means undetectable (\< LLOQ, target not detected) HDV RNA at Week 168 |
| Percentage of Participants With Undetectable HDV RNA 48 Weeks After Scheduled End of Treatment (Sustained Virological Response) | Week 192 | Undetectable HDV RNA 48 Weeks after Scheduled End of Treatment means undetectable (\< LLOQ, target not detected) HDV RNA at Week 192 |
| Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event (AE) by Week 144 | Delayed Treatment/Bulevirtide 10 mg/day arm: Week 48 up to Week 144; Bulevirtide 2mg/day and 10 mg/day arms: First dose date up to Week 144 | An AE was defined as any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug. |
| Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 192 | Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 192 | MMRM was used for analysis. |
Countries
Germany, Italy, Russia, Sweden, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in Germany, Italy, Russia, and Sweden.
Pre-assignment details
183 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| Delayed Treatment/Bulevirtide 10 mg/Day After an observational period of 48 weeks, participants received bulevirtide 10 mg/day SC injection for 96 weeks and were followed for up to 96 weeks (Up to Week 240). | 51 |
| Bulevirtide 2 mg/Day Participants received bulevirtide 2 mg/day SC injection for 144 weeks and were followed for up to 96 weeks (Up to Week 240). | 49 |
| Bulevirtide 10 mg/Day Participants received bulevirtide 10 mg/day SC injection for 144 weeks and were followed for up to 96 weeks (Up to Week 240). | 50 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 4 |
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Physician Decision | 5 | 4 | 1 |
| Overall Study | Pregnancy | 2 | 1 | 0 |
| Overall Study | Progressive disease | 1 | 4 | 1 |
| Overall Study | Reason not Specified | 3 | 3 | 5 |
| Overall Study | Withdrawal of consent | 8 | 8 | 9 |
Baseline characteristics
| Characteristic | Delayed Treatment/Bulevirtide 10 mg/Day | Total | Bulevirtide 10 mg/Day | Bulevirtide 2 mg/Day |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 150 Participants | 50 Participants | 49 Participants |
| Age, Continuous | 41 years STANDARD_DEVIATION 7.5 | 42 years STANDARD_DEVIATION 8.4 | 41 years STANDARD_DEVIATION 8.5 | 44 years STANDARD_DEVIATION 9 |
| Hepatitis Delta Virus (HDV) Ribonucleic Acid (RNA) | 5.08 log10 IU/mL STANDARD_DEVIATION 1.358 | 5.04 log10 IU/mL STANDARD_DEVIATION 1.336 | 4.96 log10 IU/mL STANDARD_DEVIATION 1.461 | 5.10 log10 IU/mL STANDARD_DEVIATION 1.194 |
| Liver stiffness | 15.3 kPa STANDARD_DEVIATION 8.95 | 14.7 kPa STANDARD_DEVIATION 8.77 | 14.8 kPa STANDARD_DEVIATION 9.26 | 14.0 kPa STANDARD_DEVIATION 8.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 25 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 40 Participants | 124 Participants | 43 Participants | 41 Participants |
| Region of Enrollment Germany | 7 Participants | 27 Participants | 14 Participants | 6 Participants |
| Region of Enrollment Italy | 7 Participants | 24 Participants | 6 Participants | 11 Participants |
| Region of Enrollment Russia | 29 Participants | 85 Participants | 28 Participants | 28 Participants |
| Region of Enrollment Sweden | 8 Participants | 14 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Female | 25 Participants | 64 Participants | 20 Participants | 19 Participants |
| Sex: Female, Male Male | 26 Participants | 86 Participants | 30 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 49 | 0 / 50 | 0 / 49 | 0 / 50 | 1 / 50 | 0 / 46 | 0 / 47 | 0 / 49 |
| other Total, other adverse events | 30 / 51 | 35 / 49 | 41 / 50 | 44 / 49 | 46 / 50 | 41 / 50 | 31 / 46 | 33 / 47 | 34 / 49 |
| serious Total, serious adverse events | 1 / 51 | 2 / 49 | 1 / 50 | 3 / 49 | 6 / 50 | 3 / 50 | 7 / 46 | 7 / 47 | 8 / 49 |
Outcome results
Primary
Percentage of Participants With Combined Response at Week 48
Combined response was defined as fulfilment of two conditions simultaneously: Undetectable (\< lower limit of quantification (LLOQ, target not detected)) HDV RNA or decrease by ≥ 2 log10 IU/mL from baseline; and ALT normalization.
Time frame: Week 48
Population: The Full Analysis Set included participants randomized to delayed treatment arm or randomized to bulevirtide and received bulevirtide at least once after randomization. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delayed Treatment | Percentage of Participants With Combined Response at Week 48 | 2.0 percentage of participants |
| Bulevirtide 2 mg/Day | Percentage of Participants With Combined Response at Week 48 | 44.9 percentage of participants |
| Bulevirtide 10 mg/Day | Percentage of Participants With Combined Response at Week 48 | 48.0 percentage of participants |
p-value: <0.000196% CI: [30.5, 61.4]Fisher Exact
p-value: <0.000196% CI: [27, 58.5]Fisher Exact
Secondary
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144
MMRM was used for analysis.
Time frame: Baseline, Week 144
Population: Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Delayed Treatment | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144 | -5.24 kPa |
| Bulevirtide 2 mg/Day | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 144 | -4.03 kPa |
p-value: 0.297795% CI: [-3.5, 1.08]MMRM
Secondary
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 192
MMRM was used for analysis.
Time frame: Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 192
Population: Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Delayed Treatment | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 192 | -3.74 kPa |
| Bulevirtide 2 mg/Day | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 192 | -3.70 kPa |
| Bulevirtide 10 mg/Day | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 192 | -1.91 kPa |
p-value: 0.971995% CI: [-2.23, 2.15]MMRM
Secondary
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 240
MMRM was used for analysis.
Time frame: Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 240
Population: Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Delayed Treatment | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 240 | -1.20 kPa |
| Bulevirtide 2 mg/Day | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 240 | -3.31 kPa |
| Bulevirtide 10 mg/Day | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 240 | -3.59 kPa |
p-value: 0.236995% CI: [-1.41, 5.63]MMRM
Secondary
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48
ANCOVA was used for analysis.
Time frame: Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 48
Population: Participants in the Full Analysis Set with available data were analyzed. Data is reported separately for changes from Baseline at Week 48 for the Delayed Treatment arm and for Delayed Treatment/Bulevirtide 10 mg/day arm after 48 weeks of bulevirtide 10 mg treatment. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Delayed Treatment | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48 | 0.87 kPa |
| Bulevirtide 2 mg/Day | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48 | -3.06 kPa |
| Bulevirtide 10 mg/Day | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48 | -3.16 kPa |
| Delayed Treatment / /Bulevirtide 10 mg/Day | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 48 | -3.36 kPa |
p-value: 0.00195% CI: [-6.39, -1.65]ANCOVA
p-value: 0.000995% CI: [-6.23, -1.63]ANCOVA
Secondary
Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 96
Mixed model for repeated measurements (MMRM) was used for analysis.
Time frame: Baseline (Baseline for Delayed Treatment/Bulevirtide 10 mg/day is reset at Week 48), Week 96
Population: Participants from Full Analysis Set with available data were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Delayed Treatment | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 96 | -4.31 kPa |
| Bulevirtide 2 mg/Day | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 96 | -4.88 kPa |
| Bulevirtide 10 mg/Day | Change From Baseline in Liver Stiffness, as Measured by Elastography at Week 96 | -4.20 kPa |
p-value: 0.515695% CI: [-1.16, 2.3]MMRM
Secondary
Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event (AE) by Week 144
An AE was defined as any untoward medical occurrence in a participant administered study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.
Time frame: Delayed Treatment/Bulevirtide 10 mg/day arm: Week 48 up to Week 144; Bulevirtide 2mg/day and 10 mg/day arms: First dose date up to Week 144
Population: Participants in the SAS were analyzed. The SAS included all participants who were randomized into the study and took at least 1 dose of bulevirtide study drug, or who were randomized to the delayed treatment group. Participants were grouped according to actual treatment received for time points Week 0 to 144. The arm titles and descriptions in this outcome measure are entered accordingly.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delayed Treatment | Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event (AE) by Week 144 | 0 percentage of participants |
| Bulevirtide 2 mg/Day | Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event (AE) by Week 144 | 0 percentage of participants |
| Bulevirtide 10 mg/Day | Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event (AE) by Week 144 | 0 percentage of participants |
Secondary
Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48
ALT normalization was 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: Week 48
Population: Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delayed Treatment | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | 11.8 percentage of participants |
| Bulevirtide 2 mg/Day | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | 51.0 percentage of participants |
| Bulevirtide 10 mg/Day | Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 48 | 56.0 percentage of participants |
p-value: <0.000195% CI: [20, 55.8]Fisher Exact
p-value: <0.000195% CI: [25.8, 59.9]Fisher Exact
Secondary
Percentage of Participants With Undetectable HDV RNA 24 Weeks After Scheduled End of Treatment (Sustained Virological Response)
Undetectable HDV RNA 24 Weeks after Scheduled End of Treatment means undetectable (\< LLOQ, target not detected) HDV RNA at Week 168
Time frame: Week 168
Population: Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delayed Treatment | Percentage of Participants With Undetectable HDV RNA 24 Weeks After Scheduled End of Treatment (Sustained Virological Response) | 18.4 percentage of participants |
| Bulevirtide 2 mg/Day | Percentage of Participants With Undetectable HDV RNA 24 Weeks After Scheduled End of Treatment (Sustained Virological Response) | 26.0 percentage of participants |
| Bulevirtide 10 mg/Day | Percentage of Participants With Undetectable HDV RNA 24 Weeks After Scheduled End of Treatment (Sustained Virological Response) | 18.0 percentage of participants |
p-value: 0.469595% CI: [-9.6, 24.4]Fisher Exact
p-value: 195% CI: [-16.3, 15.5]Fisher Exact
Secondary
Percentage of Participants With Undetectable HDV RNA 48 Weeks After Scheduled End of Treatment (Sustained Virological Response)
Undetectable HDV RNA 48 Weeks after Scheduled End of Treatment means undetectable (\< LLOQ, target not detected) HDV RNA at Week 192
Time frame: Week 192
Population: Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment and study design. The arm titles and descriptions in the outcome measure are entered accordingly.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delayed Treatment | Percentage of Participants With Undetectable HDV RNA 48 Weeks After Scheduled End of Treatment (Sustained Virological Response) | 16.3 percentage of participants |
| Bulevirtide 2 mg/Day | Percentage of Participants With Undetectable HDV RNA 48 Weeks After Scheduled End of Treatment (Sustained Virological Response) | 24.0 percentage of participants |
| Bulevirtide 10 mg/Day | Percentage of Participants With Undetectable HDV RNA 48 Weeks After Scheduled End of Treatment (Sustained Virological Response) | 16.0 percentage of participants |
p-value: 0.453995% CI: [-8.8, 24]Fisher Exact
p-value: 195% CI: [-15.6, 15.5]Fisher Exact
Secondary
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
Population: Participants in the Full Analysis Set were analyzed. Participants were grouped according to randomized treatment. The arm titles and descriptions in this outcome measure are entered accordingly.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delayed Treatment | Percentage of Participants With Undetectable HDV RNA at Week 48 | 0 percentage of participants |
| Bulevirtide 2 mg/Day | Percentage of Participants With Undetectable HDV RNA at Week 48 | 12.2 percentage of participants |
| Bulevirtide 10 mg/Day | Percentage of Participants With Undetectable HDV RNA at Week 48 | 20.0 percentage of participants |
p-value: 0.413996% CI: [-8.5, 24.3]Fisher Exact