Trial Outcomes & Findings for Study to Assess Efficacy and Safety of Bulevirtide in Combination With Pegylated Interferon Alfa-2a in Participants With Chronic Hepatitis Delta (CHD) (NCT NCT03852433)

Last Updated: 2024-10-08

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

175 participants

Primary outcome timeframe

24 weeks after EOT (Week 72 for Arm A and study Week 120 for Arms B, C, and D)

Results posted on

2024-10-08

Participant Flow

Participants were enrolled at study sites in the France, Moldova, Romania and Russia.

258 participants were screened. Participants were assigned to arms A: Pegylated Interferon Alfa-2a (PEG-IFN Alfa), B: Bulevirtide 2 mg/Day + PEG-IFN Alfa, C: Bulevirtide 10 mg/Day + PEG-IFN Alfa and D: Bulevirtide 10 mg/Day to the respective treatment.

Participant milestones

Participant milestones
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa Participants received bulevirtide 10 mg once 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. .	Bulevirtide 10 mg/Day Participants received bulevirtide 10 mg once day subcutaneously for 96 weeks with additional 48 weeks follow-up.
Overall Study STARTED	25	50	50	50
Overall Study COMPLETED	17	38	45	45
Overall Study NOT COMPLETED	8	12	5	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa Participants received bulevirtide 10 mg once 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. .	Bulevirtide 10 mg/Day Participants received bulevirtide 10 mg once day subcutaneously for 96 weeks with additional 48 weeks follow-up.
Overall Study Withdrawal of consent	5	8	1	1
Overall Study Adverse Event	1	1	1	1
Overall Study Lost to Follow-up	0	1	0	1
Overall Study Pregnancy	0	1	1	0
Overall Study Protocol Violation	0	0	1	1
Overall Study Death	0	0	1	0
Overall Study Lack of Efficacy	0	1	0	0
Overall Study Non-compliance with study drug	0	0	0	1
Overall Study Physician Decision	1	0	0	0
Overall Study Randomized but never treated	1	0	0	0

Baseline Characteristics

Ethnicity data was not collected in this study.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) n=25 Participants Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa n=50 Participants Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa n=50 Participants Participants received 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.	Bulevirtide 10 mg/Day n=50 Participants Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.	Total~(N=174) n=175 Participants
Age, Categorical <=18 years	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=175 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=25 Participants	50 Participants n=50 Participants	49 Participants n=50 Participants	50 Participants n=50 Participants	174 Participants n=175 Participants
Age, Categorical >=65 years	0 Participants n=25 Participants	0 Participants n=50 Participants	1 Participants n=50 Participants	0 Participants n=50 Participants	1 Participants n=175 Participants
Age, Continuous	41 years STANDARD_DEVIATION 8.2 • n=25 Participants	41 years STANDARD_DEVIATION 9.3 • n=50 Participants	41 years STANDARD_DEVIATION 8.6 • n=50 Participants	40 years STANDARD_DEVIATION 8.5 • n=50 Participants	41 years STANDARD_DEVIATION 8.7 • n=175 Participants
Sex: Female, Male Female	6 Participants n=25 Participants	17 Participants n=50 Participants	15 Participants n=50 Participants	12 Participants n=50 Participants	50 Participants n=175 Participants
Sex: Female, Male Male	19 Participants n=25 Participants	33 Participants n=50 Participants	35 Participants n=50 Participants	38 Participants n=50 Participants	125 Participants n=175 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=175 Participants
Race (NIH/OMB) Asian	4 Participants n=25 Participants	3 Participants n=50 Participants	4 Participants n=50 Participants	4 Participants n=50 Participants	15 Participants n=175 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=175 Participants
Race (NIH/OMB) Black or African American	0 Participants n=25 Participants	3 Participants n=50 Participants	2 Participants n=50 Participants	2 Participants n=50 Participants	7 Participants n=175 Participants
Race (NIH/OMB) White	21 Participants n=25 Participants	44 Participants n=50 Participants	43 Participants n=50 Participants	44 Participants n=50 Participants	152 Participants n=175 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants	0 Participants n=50 Participants	1 Participants n=50 Participants	0 Participants n=50 Participants	1 Participants n=175 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=50 Participants	0 Participants n=175 Participants
Race/Ethnicity, Customized Ethnicity, Not Collected	—	—	—	—	0 Participants Ethnicity data was not collected in this study.
Region of Enrollment Russia	14 Participants n=25 Participants	29 Participants n=50 Participants	22 Participants n=50 Participants	27 Participants n=50 Participants	92 Participants n=175 Participants
Region of Enrollment Romania	6 Participants n=25 Participants	11 Participants n=50 Participants	12 Participants n=50 Participants	12 Participants n=50 Participants	41 Participants n=175 Participants
Region of Enrollment Moldova	3 Participants n=25 Participants	7 Participants n=50 Participants	12 Participants n=50 Participants	9 Participants n=50 Participants	31 Participants n=175 Participants
Region of Enrollment France	2 Participants n=25 Participants	3 Participants n=50 Participants	4 Participants n=50 Participants	2 Participants n=50 Participants	11 Participants n=175 Participants
HDV RNA	5.20 log10 IU/mL STANDARD_DEVIATION 1.064 • n=25 Participants	5.27 log10 IU/mL STANDARD_DEVIATION 1.355 • n=50 Participants	5.09 log10 IU/mL STANDARD_DEVIATION 1.343 • n=50 Participants	5.45 log10 IU/mL STANDARD_DEVIATION 1.098 • n=50 Participants	5.26 log10 IU/mL STANDARD_DEVIATION 1.242 • n=175 Participants
Liver Stiffness	15.8 kPa STANDARD_DEVIATION 11.57 • n=25 Participants	12.8 kPa STANDARD_DEVIATION 6.43 • n=50 Participants	12.5 kPa STANDARD_DEVIATION 7.60 • n=50 Participants	12.7 kPa STANDARD_DEVIATION 6.65 • n=50 Participants	13.1 kPa STANDARD_DEVIATION 7.72 • n=175 Participants

PRIMARY outcome

Timeframe: 24 weeks after EOT (Week 72 for Arm A and study Week 120 for Arms B, C, and D)

Population: Full Analysis Set, is defined as all randomized participants who received at least 1 dose of study drug (Peg-IFNα and/or BLV).

Outcome measures

Outcome measures
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) n=24 Participants Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa n=50 Participants Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa n=50 Participants Participants received 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.	Bulevirtide 10 mg/Day n=50 Participants Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.
Percentage of Participants With Sustained Virological Response at Week 24 After the Scheduled End of Treatment (SVR24)	16.7 percentage of participants Interval 4.7 to 37.4	32.0 percentage of participants Interval 19.5 to 46.7	46.0 percentage of participants Interval 31.8 to 60.7	12.0 percentage of participants Interval 4.5 to 24.3

SECONDARY outcome

Timeframe: Week 48

Population: Participants from Full Analysis Set were analyzed.

Undetectable HDV RNA at Week 48 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 48.

Outcome measures

Outcome measures
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) n=24 Participants Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa n=50 Participants Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa n=50 Participants Participants received 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.	Bulevirtide 10 mg/Day n=50 Participants Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.
Percentage of Participants With Undetectable HDV RNA at Week 48	20.8 percentage of participants Interval 7.1 to 42.2	40.0 percentage of participants Interval 26.4 to 54.8	60.0 percentage of participants Interval 45.2 to 73.6	10.0 percentage of participants Interval 3.3 to 21.8

SECONDARY outcome

Timeframe: Week 96

Population: Participants from Full Analysis Set were analyzed. Per prespecified analysis, the data for this outcome measure was collected only for Arms B, C, and D at the scheduled Week 96 visit. Hence the data for Arm A is not reported for this outcome measure.

Undetectable HDV RNA at Week 96 means undetectable (\< LLOQ, target not detected) HDV RNA at Week 96.

Outcome measures

Outcome measures
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) n=50 Participants Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa n=50 Participants Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa n=50 Participants Participants received 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.	Bulevirtide 10 mg/Day Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.
Percentage of Participants With Undetectable HDV RNA at Week 96 (Arms B, C, and D Only)	44.0 percentage of participants Interval 30.0 to 58.7	70.0 percentage of participants Interval 55.4 to 82.1	22.0 percentage of participants Interval 11.5 to 36.0	—

SECONDARY outcome

Timeframe: 24 weeks after EOT (Week 72 for Arm A and Week 120 for Arms B, C, and D)

Population: Participants from Full Analysis Set were analyzed.

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 \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\]).

Outcome measures

Outcome measures
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) n=24 Participants Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa n=50 Participants Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa n=50 Participants Participants received 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.	Bulevirtide 10 mg/Day n=50 Participants Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.
Percentage of Participants With Combined Response at Week 24 After the Scheduled End of Treatment	20.8 percentage of participants Interval 7.1 to 42.2	36.0 percentage of participants Interval 22.9 to 50.8	52.0 percentage of participants Interval 37.4 to 66.3	26.0 percentage of participants Interval 14.6 to 40.3

SECONDARY outcome

Timeframe: 48 weeks after EOT (Week 96 for Arm A and Week 144 for Arm B, C, and D)

Population: Participants from Full Analysis Set were analyzed.

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 \[Russian sites: ≤ 31 U/L for females and ≤ 41 U/L for males; all other sites: ≤ 34 U/L for females and ≤ 49 U/L for males\]).

Outcome measures

Outcome measures
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) n=24 Participants Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa n=50 Participants Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa n=50 Participants Participants received 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.	Bulevirtide 10 mg/Day n=50 Participants Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.
Percentage of Participants With Combined Response at Week 48 After the Scheduled End of Treatment	33.3 percentage of participants Interval 15.6 to 55.3	32.0 percentage of participants Interval 19.5 to 46.7	46.0 percentage of participants Interval 31.8 to 60.7	18.0 percentage of participants Interval 8.6 to 31.4

SECONDARY outcome

Timeframe: 48 weeks after EOT (Week 96 for Arm A; Week 144 for Arms B, C, and D)

Population: Participants from Full Analysis Set were analyzed.

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.

Outcome measures

Outcome measures
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) n=24 Participants Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa n=50 Participants Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa n=50 Participants Participants received 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.	Bulevirtide 10 mg/Day n=50 Participants Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.
Percentage of Participants With Sustained Virological Response 48 After the Scheduled End of Treatment (SVR 48)	25.0 percentage of participants Interval 9.8 to 46.7	26.0 percentage of participants Interval 14.6 to 40.3	46.0 percentage of participants Interval 31.8 to 60.7	12.0 percentage of participants Interval 4.5 to 24.3

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants from Full Analysis Set with available data were analyzed.

The mixed-effects models for repeated measurements (MMRM) model was used for analysis.

Outcome measures

Outcome measures
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) n=18 Participants Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa n=45 Participants Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa n=47 Participants Participants received 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.	Bulevirtide 10 mg/Day n=48 Participants Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.
Change From Baseline in Liver Stiffness as Measured by Elastography at Week 48	-0.02 kPa Interval -2.29 to 2.25	-1.85 kPa Interval -3.42 to -0.28	-1.79 kPa Interval -3.21 to -0.36	-3.34 kPa Interval -4.84 to -1.85

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants from Full Analysis Set with available data were analyzed. Per prespecified analysis, the data for this outcome measure was collected only for Arms B, C, and D at the scheduled Week 96 visit. Hence the data for Arm A is not reported for this outcome measure.

The MMRM model was used for analysis.

Outcome measures

Outcome measures
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) n=43 Participants Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa n=47 Participants Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa n=46 Participants Participants received 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.	Bulevirtide 10 mg/Day Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.
Change From Baseline in Liver Stiffness as Measured by Elastography at Week 96	-3.37 kPa Interval -4.94 to -1.8	-3.70 kPa Interval -5.11 to -2.29	-3.85 kPa Interval -5.35 to -2.35	—

SECONDARY outcome

Timeframe: Baseline, 48 weeks after EOT (Week 96 for Arm A and study Week 144 for Arms B, C, and D)

Population: Participants from Full Analysis Set were analyzed.

The MMRM model was used for analysis.

Outcome measures

Outcome measures
Measure	Pegylated Interferon Alfa-2a (PEG-IFN Alfa) n=16 Participants Participants received PEG-IFN alfa 180 microgram (mcg) once a week subcutaneously for 48 weeks with additional 48 weeks follow-up.	Bulevirtide 2 mg/Day + PEG-IFN Alfa n=32 Participants Participants received bulevirtide 2 mg once a day subcutaneously in combination 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.	Bulevirtide 10 mg/Day + PEG-IFN Alfa n=40 Participants Participants received 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.	Bulevirtide 10 mg/Day n=40 Participants Participants received bulevirtide 10 mg once a day subcutaneously for 96 weeks with additional 48 weeks follow-up.
Change From Baseline in Liver Stiffness as Measured by Elastography at Week 144	-0.31 kPa Interval -2.75 to 2.12	-2.35 kPa Interval -4.2 to -0.5	-2.47 kPa Interval -4.12 to -0.83	-0.79 kPa Interval -2.53 to 0.94

Adverse Events

Pegylated Interferon Alfa-2a (PEG-IFN Alfa)

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Bulevirtide 2 mg/Day + PEG-IFN Alfa

Serious events: 3 serious events

Other events: 49 other events

Deaths: 1 deaths

Bulevirtide 10 mg/Day + PEG-IFN Alfa

Serious events: 8 serious events

Other events: 50 other events

Deaths: 1 deaths

Bulevirtide 10 mg/Day

Serious events: 2 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER