A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B

A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00922207

Enrollment

280

Registered

2009-06-17

Start date

2010-05-07

Completion date

2014-09-29

Last updated

2017-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Brief summary

This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.

Interventions

DRUGAdefovir

From week -4 to week 2

DRUGEntecavir

From week -4 to week 2

DRUGPlacebo

From week -4 to week 2

DRUGpeginterferon alfa-2a [Pegasys]

180 micrograms sc weekly, from week 1-48

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* adult patients, 18-65 years of age; * HBeAg+ve for \>=3 months; * positive serum HBV DNA within 3 months prior to entry; * patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues; * \>=3 months treatment-free interval from nucleotide analogues.

Exclusion criteria

* evidence of decompensated liver disease; * history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis; * co-infection with active hepatitis A,C or D, or HIV.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment	Week 100	HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).

Secondary

Measure	Time frame	Description
Percentage of Participants Who Were HBeAg Negative	Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	—
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	—
Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	HBV DNA (copies per milliliter \[copies/mL\]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.
Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	—
Percentage of Participants With Combined Response	Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Combined response was defined as having negative HBeAg, HBV DNA less than (\<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100	The normal range for ALT is 10 to 40 international units per liter (IU/L).

Countries

Taiwan

Participant flow

Participants by arm

Arm	Count
Peg-IFN-Alfa-2a + Adefovir Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.	91
Peg-IFN-Alfa-2a + Entecavir Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.	95
Peg-IFN-Alfa-2a + Placebo Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.	94
Total	280

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Abnormality of Laboratory Test	0	1	1
Overall Study	Adverse Event/Intercurrent Illness	3	0	0
Overall Study	Insufficient Therapeutic Response	0	0	1
Overall Study	Refused Treatment/Did Not Cooperate	1	0	0
Overall Study	Violation of Selection Criteria at Entry	0	1	0
Overall Study	Withdrew Consent	2	5	2

Baseline characteristics

Characteristic	Peg-IFN-Alfa-2a + Adefovir	Peg-IFN-Alfa-2a + Entecavir	Peg-IFN-Alfa-2a + Placebo	Total
Age, Continuous	38.7 years STANDARD_DEVIATION 9.7	37.7 years STANDARD_DEVIATION 10	38.2 years STANDARD_DEVIATION 9.7	38.2 years STANDARD_DEVIATION 9.8
Sex: Female, Male Female	25 Participants	28 Participants	28 Participants	81 Participants
Sex: Female, Male Male	66 Participants	67 Participants	66 Participants	199 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	85 / 91	83 / 94	89 / 93
serious Total, serious adverse events	7 / 91	12 / 94	7 / 93

Outcome results

Primary

Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment

HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).

Time frame: Week 100

Population: ITT analysis population. Here, number of participants analyzed = participants who were evaluable for this outcome.

Arm	Measure	Value (NUMBER)
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment	27.4 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment	29.5 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment	36.3 percentage of participants

p-value: 0.685395% CI: [0.46, 1.75]Cochran-Mantel-Haenszel

p-value: 0.197795% CI: [0.35, 1.26]Cochran-Mantel-Haenszel

p-value: 0.291695% CI: [0.39, 1.38]Cochran-Mantel-Haenszel

Secondary

Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 8 (n=90,94,92)	-0.33 International Units/milliliter (IU/mL)	Standard Deviation 0.78
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 64 (n=90,94,92)	-0.67 International Units/milliliter (IU/mL)	Standard Deviation 1.18
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 76 (n=90,94,92)	-0.58 International Units/milliliter (IU/mL)	Standard Deviation 0.95
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 88 (n=90,94,92)	-0.50 International Units/milliliter (IU/mL)	Standard Deviation 1.11
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 4 (n=90,94,92)	-0.26 International Units/milliliter (IU/mL)	Standard Deviation 0.48
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 100 (n=90,94,92)	-0.41 International Units/milliliter (IU/mL)	Standard Deviation 0.75
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 16 (n=90,94,92)	-0.40 International Units/milliliter (IU/mL)	Standard Deviation 0.78
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Baseline (n=91,95,94)	3.97 International Units/milliliter (IU/mL)	Standard Deviation 0.72
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 28 (n=90,94,92)	-0.61 International Units/milliliter (IU/mL)	Standard Deviation 0.96
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 40 (n=90,94,92)	-0.71 International Units/milliliter (IU/mL)	Standard Deviation 1.09
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 52 (n=90,94,92)	-0.78 International Units/milliliter (IU/mL)	Standard Deviation 1.27
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 52 (n=90,94,92)	-0.69 International Units/milliliter (IU/mL)	Standard Deviation 1.11
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 16 (n=90,94,92)	-0.49 International Units/milliliter (IU/mL)	Standard Deviation 0.74
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 40 (n=90,94,92)	-0.67 International Units/milliliter (IU/mL)	Standard Deviation 1.04
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 76 (n=90,94,92)	-0.45 International Units/milliliter (IU/mL)	Standard Deviation 1.01
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 8 (n=90,94,92)	-0.31 International Units/milliliter (IU/mL)	Standard Deviation 0.58
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 64 (n=90,94,92)	-0.54 International Units/milliliter (IU/mL)	Standard Deviation 1.07
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 88 (n=90,94,92)	-0.44 International Units/milliliter (IU/mL)	Standard Deviation 0.9
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 28 (n=90,94,92)	-0.68 International Units/milliliter (IU/mL)	Standard Deviation 0.98
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 4 (n=90,94,92)	-0.18 International Units/milliliter (IU/mL)	Standard Deviation 0.44
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 100 (n=90,94,92)	-0.60 International Units/milliliter (IU/mL)	Standard Deviation 1.15
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Baseline (n=91,95,94)	3.76 International Units/milliliter (IU/mL)	Standard Deviation 0.83
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 100 (n=90,94,92)	-0.56 International Units/milliliter (IU/mL)	Standard Deviation 1.1
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Baseline (n=91,95,94)	3.84 International Units/milliliter (IU/mL)	Standard Deviation 0.71
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 64 (n=90,94,92)	-0.67 International Units/milliliter (IU/mL)	Standard Deviation 1.21
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 4 (n=90,94,92)	-0.02 International Units/milliliter (IU/mL)	Standard Deviation 0.33
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 8 (n=90,94,92)	-0.25 International Units/milliliter (IU/mL)	Standard Deviation 0.56
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 16 (n=90,94,92)	-0.48 International Units/milliliter (IU/mL)	Standard Deviation 0.83
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 28 (n=90,94,92)	-0.70 International Units/milliliter (IU/mL)	Standard Deviation 1.08
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 40 (n=90,94,92)	-0.82 International Units/milliliter (IU/mL)	Standard Deviation 1.27
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 52 (n=90,94,92)	-0.88 International Units/milliliter (IU/mL)	Standard Deviation 1.41
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 76 (n=90,94,92)	-0.53 International Units/milliliter (IU/mL)	Standard Deviation 1.19
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 88 (n=90,94,92)	-0.62 International Units/milliliter (IU/mL)	Standard Deviation 1.2

Comparison: Baselinep-value: 0.064995% CI: [-0.01, 0.43]ANCOVA

Comparison: Baselinep-value: 0.186795% CI: [-0.06, 0.33]ANCOVA

Comparison: Baselinep-value: 0.500395% CI: [-0.3, 0.15]ANCOVA

Comparison: Change at Week 4p-value: 0.225995% CI: [-0.22, 0.05]ANCOVA

Comparison: Change at Week 4p-value: <0.00195% CI: [-0.36, -0.11]ANCOVA

Comparison: Change at Week 4p-value: 0.008595% CI: [-0.27, -0.04]ANCOVA

Comparison: Change at Week 8p-value: 0.81695% CI: [-0.22, 0.18]ANCOVA

Comparison: Change at Week 8p-value: 0.439395% CI: [-0.27, 0.12]ANCOVA

Comparison: Change at Week 8p-value: 0.48995% CI: [-0.22, 0.11]ANCOVA

Comparison: Change at Week 16p-value: 0.465695% CI: [-0.14, 0.3]ANCOVA

Comparison: Change at Week 16p-value: 0.501695% CI: [-0.15, 0.31]ANCOVA

Comparison: Change at Week 16p-value: 0.958295% CI: [-0.23, 0.22]ANCOVA

Comparison: Change at Week 28p-value: 0.621495% CI: [-0.21, 0.36]ANCOVA

Comparison: Change at Week 28p-value: 0.549395% CI: [-0.21, 0.39]ANCOVA

Comparison: Change at Week 28p-value: 0.888195% CI: [-0.28, 0.32]ANCOVA

Comparison: Change at Week 40p-value: 0.791295% CI: [-0.36, 0.27]ANCOVA

Comparison: Change at Week 40p-value: 0.542795% CI: [-0.24, 0.46]ANCOVA

Comparison: Change at Week 40p-value: 0.378895% CI: [-0.19, 0.49]ANCOVA

Comparison: Change at Week 52p-value: 0.617295% CI: [-0.44, 0.26]ANCOVA

Comparison: Change at Week 52p-value: 0.600295% CI: [-0.29, 0.5]ANCOVA

Comparison: Change at Week 52p-value: 0.310195% CI: [-0.18, 0.56]ANCOVA

Comparison: Change at Week 64p-value: 0.425695% CI: [-0.47, 0.2]ANCOVA

Comparison: Change at Week 64p-value: 0.976295% CI: [-0.35, 0.36]ANCOVA

Comparison: Change at Week 64p-value: 0.450495% CI: [-0.21, 0.47]ANCOVA

Comparison: Change at Week 76p-value: 0.407695% CI: [-0.42, 0.17]ANCOVA

Comparison: Change at Week 76p-value: 0.759195% CI: [-0.37, 0.27]ANCOVA

Comparison: Change at Week 76p-value: 0.644995% CI: [-0.25, 0.4]ANCOVA

Comparison: Change at Week 88p-value: 0.710895% CI: [-0.36, 0.25]ANCOVA

Comparison: Change at Week 88p-value: 0.472595% CI: [-0.22, 0.47]ANCOVA

Comparison: Change at Week 88p-value: 0.243995% CI: [-0.13, 0.5]ANCOVA

Comparison: Change at Week 100p-value: 0.186295% CI: [-0.1, 0.5]ANCOVA

Comparison: Change at Week 100p-value: 0.305795% CI: [-0.14, 0.43]ANCOVA

Comparison: Change at Week 100p-value: 0.800295% CI: [-0.38, 0.29]ANCOVA

Secondary

Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

HBV DNA (copies per milliliter \[copies/mL\]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.

Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Arm	Measure	Group	Value (MEAN)	Dispersion
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 52 (n=90,94,92)	-2.75 copies/mL	Standard Deviation 2.29
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 28 (n=90,94,92)	-2.34 copies/mL	Standard Deviation 1.9
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 8 (n=90,94,92)	-1.87 copies/mL	Standard Deviation 1.4
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 100 (n=90,94,92)	-2.00 copies/mL	Standard Deviation 2.35
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 16 (n=90,94,92)	-2.14 copies/mL	Standard Deviation 1.72
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 76 (n=90,94,92)	-1.91 copies/mL	Standard Deviation 2.24
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 64 (n=90,94,92)	-1.87 copies/mL	Standard Deviation 2.26
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Baseline (n=91,95,94)	8.65 copies/mL	Standard Deviation 1.03
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 88 (n=90,94,92)	-1.78 copies/mL	Standard Deviation 2.36
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 40 (n=90,94,92)	-2.61 copies/mL	Standard Deviation 2.11
Peg-IFN-Alfa-2a + Adefovir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 4 (n=90,94,92)	-2.15 copies/mL	Standard Deviation 0.94
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 28 (n=90,94,92)	-3.07 copies/mL	Standard Deviation 1.88
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 52 (n=90,94,92)	-2.81 copies/mL	Standard Deviation 2.43
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Baseline (n=91,95,94)	8.30 copies/mL	Standard Deviation 1.21
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 4 (n=90,94,92)	-2.76 copies/mL	Standard Deviation 0.97
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 8 (n=90,94,92)	-3.58 copies/mL	Standard Deviation 1.12
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 16 (n=90,94,92)	-3.77 copies/mL	Standard Deviation 1.53
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 40 (n=90,94,92)	-2.97 copies/mL	Standard Deviation 2.11
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 64 (n=90,94,92)	-1.37 copies/mL	Standard Deviation 2.31
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 76 (n=90,94,92)	-1.39 copies/mL	Standard Deviation 2.46
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 88 (n=90,94,92)	-1.39 copies/mL	Standard Deviation 2.42
Peg-IFN-Alfa-2a + Entecavir	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 100 (n=90,94,92)	-1.78 copies/mL	Standard Deviation 2.41
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 88 (n=90,94,92)	-2.30 copies/mL	Standard Deviation 2.34
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 100 (n=90,94,92)	-2.17 copies/mL	Standard Deviation 2.44
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 64 (n=90,94,92)	-2.11 copies/mL	Standard Deviation 2.42
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 52 (n=90,94,92)	-3.32 copies/mL	Standard Deviation 2.48
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 28 (n=90,94,92)	-2.84 copies/mL	Standard Deviation 2.14
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 8 (n=90,94,92)	-1.32 copies/mL	Standard Deviation 1.32
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 76 (n=90,94,92)	-2.20 copies/mL	Standard Deviation 2.57
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 16 (n=90,94,92)	-2.13 copies/mL	Standard Deviation 1.93
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 4 (n=90,94,92)	-0.23 copies/mL	Standard Deviation 0.88
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Baseline (n=91,95,94)	8.41 copies/mL	Standard Deviation 0.96
Peg-IFN-Alfa-2a + Placebo	Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100	Change at Week 40 (n=90,94,92)	-3.27 copies/mL	Standard Deviation 2.25

Comparison: Change at Week 76p-value: 0.134795% CI: [-1.24, 0.17]ANCOVA

Comparison: Change at Week 76p-value: 0.402795% CI: [-0.41, 1.01]ANCOVA

Comparison: Change at Week 64p-value: 0.041295% CI: [0.03, 1.41]ANCOVA

Comparison: Baselinep-value: 0.035395% CI: [0.02, 0.66]ANCOVA

Comparison: Baselinep-value: 0.111495% CI: [-0.05, 0.52]ANCOVA

Comparison: Baselinep-value: 0.51595% CI: [-0.42, 0.21]ANCOVA

Comparison: Change at Week 4p-value: <0.00195% CI: [0.34, 0.89]ANCOVA

Comparison: Change at Week 4p-value: <0.00195% CI: [-2.19, -1.65]ANCOVA

Comparison: Change at Week 4p-value: <0.00195% CI: [-2.81, -2.27]ANCOVA

Comparison: Change at Week 8p-value: <0.00195% CI: [1.34, 2.06]ANCOVA

Comparison: Change at Week 8p-value: 0.007195% CI: [-0.95, -0.15]ANCOVA

Comparison: Change at Week 8p-value: <0.00195% CI: [-2.61, -1.9]ANCOVA

Comparison: Change at Week 16p-value: <0.00195% CI: [1.16, 2.08]ANCOVA

Comparison: Change at Week 16p-value: 0.955795% CI: [-0.56, 0.53]ANCOVA

Comparison: Change at Week 16p-value: <0.00195% CI: [-2.15, -1.14]ANCOVA

Comparison: Change at Week 28p-value: 0.009495% CI: [0.18, 1.27]ANCOVA

Comparison: Change at Week 28p-value: 0.094395% CI: [-0.09, 1.11]ANCOVA

Comparison: Change at Week 28p-value: 0.435495% CI: [-0.82, 0.35]ANCOVA

Comparison: Change at Week 40p-value: 0.250995% CI: [-0.26, 0.98]ANCOVA

Comparison: Change at Week 40p-value: 0.042995% CI: [0.02, 1.31]ANCOVA

Comparison: Change at Week 40p-value: 0.358595% CI: [-0.34, 0.93]ANCOVA

Comparison: Change at Week 52p-value: 0.901495% CI: [-0.65, 0.74]ANCOVA

Comparison: Change at Week 52p-value: 0.112295% CI: [-0.13, 1.28]ANCOVA

Comparison: Change at Week 52p-value: 0.160295% CI: [-0.2, 1.23]ANCOVA

Comparison: Change at Week 64p-value: 0.159995% CI: [-1.17, 0.19]ANCOVA

Comparison: Change at Week 64p-value: 0.504595% CI: [-0.45, 0.92]ANCOVA

Comparison: Change at Week 76p-value: 0.031195% CI: [0.07, 1.55]ANCOVA

Comparison: Change at Week 88p-value: 0.318395% CI: [-1.07, 0.35]ANCOVA

Comparison: Change at Week 88p-value: 0.137195% CI: [-0.17, 1.22]ANCOVA

Comparison: Change at Week 88p-value: 0.011395% CI: [0.21, 1.6]ANCOVA

Comparison: Change at Week 100p-value: 0.560895% CI: [-0.92, 0.5]ANCOVA

Comparison: Change at Week 100p-value: 0.632395% CI: [-0.53, 0.88]ANCOVA

Comparison: Change at Week 100p-value: 0.275295% CI: [-0.32, 1.11]ANCOVA

Secondary

Percentage of Participants Who Were HBeAg Negative

Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Arm	Measure	Group	Value (NUMBER)
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants Who Were HBeAg Negative	Baseline (n=91,95,94)	3.3 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants Who Were HBeAg Negative	Week 8 (n=90,94,92)	6.7 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants Who Were HBeAg Negative	Week 4 (n=90,94,92)	5.6 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants Who Were HBeAg Negative	Week 100 (n=84,87,91)	28.6 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants Who Were HBeAg Negative	Week 16 (n=90,94,92)	6.7 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants Who Were HBeAg Negative	Week 28 (n=90,94,92)	11.1 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants Who Were HBeAg Negative	Week 40 (n=90,94,92)	18.9 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants Who Were HBeAg Negative	Week 52 (n=90,94,92)	22.2 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants Who Were HBeAg Negative	Week 64 (n=90,92,92)	24.4 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants Who Were HBeAg Negative	Week 76 (n=88,88,92)	25.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants Who Were HBeAg Negative	Week 88 (n=86,87,90)	27.9 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants Who Were HBeAg Negative	Week 16 (n=90,94,92)	8.5 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants Who Were HBeAg Negative	Week 28 (n=90,94,92)	10.6 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants Who Were HBeAg Negative	Week 40 (n=90,94,92)	18.1 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants Who Were HBeAg Negative	Week 88 (n=86,87,90)	27.6 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants Who Were HBeAg Negative	Week 52 (n=90,94,92)	22.3 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants Who Were HBeAg Negative	Week 4 (n=90,94,92)	4.3 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants Who Were HBeAg Negative	Week 64 (n=90,92,92)	25.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants Who Were HBeAg Negative	Baseline (n=91,95,94)	2.1 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants Who Were HBeAg Negative	Week 100 (n=84,87,91)	32.2 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants Who Were HBeAg Negative	Week 8 (n=90,94,92)	6.4 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants Who Were HBeAg Negative	Week 76 (n=88,88,92)	28.4 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants Who Were HBeAg Negative	Week 88 (n=86,87,90)	34.4 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants Who Were HBeAg Negative	Week 16 (n=90,94,92)	10.9 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants Who Were HBeAg Negative	Week 76 (n=88,88,92)	37.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants Who Were HBeAg Negative	Baseline (n=91,95,94)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants Who Were HBeAg Negative	Week 28 (n=90,94,92)	16.3 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants Who Were HBeAg Negative	Week 100 (n=84,87,91)	37.4 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants Who Were HBeAg Negative	Week 4 (n=90,94,92)	1.1 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants Who Were HBeAg Negative	Week 40 (n=90,94,92)	22.8 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants Who Were HBeAg Negative	Week 64 (n=90,92,92)	31.5 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants Who Were HBeAg Negative	Week 8 (n=90,94,92)	4.3 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants Who Were HBeAg Negative	Week 52 (n=90,94,92)	29.3 percentage of participants

Comparison: Baselinep-value: 0.610795% CI: [0.26, 9.71]Cochran-Mantel-Haenszel

Comparison: Baselinep-value: 0.0788Cochran-Mantel-Haenszel

Comparison: Baselinep-value: 0.1761Cochran-Mantel-Haenszel

Comparison: Week 4p-value: 0.704495% CI: [0.34, 5.09]Cochran-Mantel-Haenszel

Comparison: Week 4p-value: 0.092795% CI: [0.61, 46.76]Cochran-Mantel-Haenszel

Comparison: Week 4p-value: 0.185895% CI: [0.44, 36.89]Cochran-Mantel-Haenszel

Comparison: Week 8p-value: 0.938595% CI: [0.33, 3.38]Cochran-Mantel-Haenszel

Comparison: Week 8p-value: 0.506895% CI: [0.43, 5.77]Cochran-Mantel-Haenszel

Comparison: Week 8p-value: 0.554495% CI: [0.41, 5.5]Cochran-Mantel-Haenszel

Comparison: Week 16p-value: 0.65195% CI: [0.26, 2.31]Cochran-Mantel-Haenszel

Comparison: Week 16p-value: 0.319295% CI: [0.2, 1.69]Cochran-Mantel-Haenszel

Comparison: Week 16p-value: 0.581895% CI: [0.29, 2.03]Cochran-Mantel-Haenszel

Comparison: Week 28p-value: 0.879695% CI: [0.41, 2.66]Cochran-Mantel-Haenszel

Comparison: Week 28p-value: 0.30595% CI: [0.27, 1.52]Cochran-Mantel-Haenszel

Comparison: Week 28p-value: 0.241495% CI: [0.26, 1.44]Cochran-Mantel-Haenszel

Comparison: Week 40p-value: 0.850295% CI: [0.5, 2.22]Cochran-Mantel-Haenszel

Comparison: Week 40p-value: 0.595% CI: [0.38, 1.61]Cochran-Mantel-Haenszel

Comparison: Week 40p-value: 0.388295% CI: [0.36, 1.53]Cochran-Mantel-Haenszel

Comparison: Week 52p-value: 0.958495% CI: [0.5, 1.99]Cochran-Mantel-Haenszel

Comparison: Week 52p-value: 0.257695% CI: [0.35, 1.34]Cochran-Mantel-Haenszel

Comparison: Week 52p-value: 0.236295% CI: [0.36, 1.34]Cochran-Mantel-Haenszel

Comparison: Week 64p-value: 0.986195% CI: [0.49, 1.9]Cochran-Mantel-Haenszel

Comparison: Week 64p-value: 0.291995% CI: [0.37, 1.35]Cochran-Mantel-Haenszel

Comparison: Week 64p-value: 0.267495% CI: [0.38, 1.38]Cochran-Mantel-Haenszel

Comparison: Week 76p-value: 0.614895% CI: [0.43, 1.64]Cochran-Mantel-Haenszel

Comparison: Week 76p-value: 0.090495% CI: [0.3, 1.08]Cochran-Mantel-Haenszel

Comparison: Week 76p-value: 0.207395% CI: [0.36, 1.27]Cochran-Mantel-Haenszel

Comparison: Week 88p-value: 0.99895% CI: [0.52, 1.98]Cochran-Mantel-Haenszel

Comparison: Week 88p-value: 0.348995% CI: [0.39, 1.4]Cochran-Mantel-Haenszel

Comparison: Week 88p-value: 0.284795% CI: [0.38, 1.38]Cochran-Mantel-Haenszel

Comparison: Week 100p-value: 0.559695% CI: [0.44, 1.62]Cochran-Mantel-Haenszel

Comparison: Week 100p-value: 0.211295% CI: [0.36, 1.27]Cochran-Mantel-Haenszel

Comparison: Week 100p-value: 0.406695% CI: [0.43, 1.48]Cochran-Mantel-Haenszel

Secondary

Percentage of Participants With Combined Response

Combined response was defined as having negative HBeAg, HBV DNA less than (\<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).

Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Arm	Measure	Group	Value (NUMBER)
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants With Combined Response	Week 88 (n=86,88,91)	3.5 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants With Combined Response	Week 16 (n=90,93,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants With Combined Response	Week 76 (n=88,89,92)	3.4 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants With Combined Response	Week 100 (n=84,88,91)	2.4 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants With Combined Response	Week 28 (n=90,93,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants With Combined Response	Baseline (n=91,95,94)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants With Combined Response	Week 40 (n=90,93,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants With Combined Response	Week 52 (n=90,93,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participants With Combined Response	Week 64 (n=90,92,92)	2.2 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants With Combined Response	Week 40 (n=90,93,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants With Combined Response	Week 64 (n=90,92,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants With Combined Response	Week 28 (n=90,93,92)	1.1 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants With Combined Response	Baseline (n=91,95,94)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants With Combined Response	Week 76 (n=88,89,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants With Combined Response	Week 16 (n=90,93,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants With Combined Response	Week 52 (n=90,93,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants With Combined Response	Week 100 (n=84,88,91)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participants With Combined Response	Week 88 (n=86,88,91)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants With Combined Response	Week 100 (n=84,88,91)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants With Combined Response	Baseline (n=91,95,94)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants With Combined Response	Week 16 (n=90,93,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants With Combined Response	Week 28 (n=90,93,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants With Combined Response	Week 40 (n=90,93,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants With Combined Response	Week 52 (n=90,93,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants With Combined Response	Week 64 (n=90,92,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants With Combined Response	Week 88 (n=86,88,91)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participants With Combined Response	Week 76 (n=88,89,92)	0.0 percentage of participants

Secondary

Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive

Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Arm	Measure	Group	Value (NUMBER)
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 100 (n=84,87,91)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 76 (n=88,88,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Baseline (n=91,95,94)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 4 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 8 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 16 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 28 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 52 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 64 (n=90,92,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 88 (n=86,87,90)	1.2 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 40 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 16 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 40 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 64 (n=90,92,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 8 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 88 (n=86,87,90)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 100 (n=84,87,91)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 28 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 52 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Baseline (n=91,95,94)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 76 (n=88,88,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 4 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 52 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 4 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 8 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 16 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 76 (n=88,88,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 28 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 40 (n=90,94,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 64 (n=90,92,92)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 88 (n=86,87,90)	3.4 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Week 100 (n=84,87,91)	0.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive	Baseline (n=91,95,94)	0.0 percentage of participants

Secondary

Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels

The normal range for ALT is 10 to 40 international units per liter (IU/L).

Time frame: Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100

Population: ITT analysis population. Here, n = participants who had available assessment at specified time-point.

Arm	Measure	Group	Value (NUMBER)
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 64 (n=90,92,92)	32.2 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 28 (n=90,93,92)	26.7 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 12 (n=90,93,92)	15.6 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 52 (n=90,93,92)	33.3 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 34 (n=90,93,92)	26.7 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 100 (n=84,88,91)	36.9 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 46 (n=90,93,92)	30.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 40 (n=90,93,92)	30.0 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 76 (n=89,89,92)	43.8 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 16 (n=90,93,92)	21.1 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 6 (n=90,93,92)	4.4 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Baseline (n=91,95,94)	4.4 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 22 (n=90,93,92)	25.6 percentage of participants
Peg-IFN-Alfa-2a + Adefovir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 88 (n=86,88,91)	32.6 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 64 (n=90,92,92)	37.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Baseline (n=91,95,94)	3.2 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 6 (n=90,93,92)	5.4 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 12 (n=90,93,92)	17.2 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 16 (n=90,93,92)	24.7 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 22 (n=90,93,92)	34.4 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 28 (n=90,93,92)	30.1 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 34 (n=90,93,92)	34.4 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 40 (n=90,93,92)	39.8 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 46 (n=90,93,92)	41.9 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 52 (n=90,93,92)	34.4 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 76 (n=89,89,92)	38.2 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 88 (n=86,88,91)	33.0 percentage of participants
Peg-IFN-Alfa-2a + Entecavir	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 100 (n=84,88,91)	40.9 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 88 (n=86,88,91)	48.4 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 52 (n=90,93,92)	32.6 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 22 (n=90,93,92)	22.8 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 16 (n=90,93,92)	20.7 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 64 (n=90,92,92)	42.4 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 12 (n=90,93,92)	13.0 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Baseline (n=91,95,94)	2.1 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 76 (n=89,89,92)	46.7 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 6 (n=90,93,92)	6.5 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 40 (n=90,93,92)	32.6 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 34 (n=90,93,92)	32.6 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 100 (n=84,88,91)	49.5 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 46 (n=90,93,92)	33.7 percentage of participants
Peg-IFN-Alfa-2a + Placebo	Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels	Week 28 (n=90,93,92)	23.9 percentage of participants

Comparison: Baselinep-value: 0.6921Cochran-Mantel-Haenszel

Comparison: Baselinep-value: 0.3939Cochran-Mantel-Haenszel

Comparison: Baselinep-value: 0.6818Cochran-Mantel-Haenszel

Comparison: Week 6p-value: 0.7582Cochran-Mantel-Haenszel

Comparison: Week 6p-value: 0.5381Cochran-Mantel-Haenszel

Comparison: Week 6p-value: 0.7747Cochran-Mantel-Haenszel

Comparison: Week 12p-value: 0.8034Cochran-Mantel-Haenszel

Comparison: Week 12p-value: 0.6306Cochran-Mantel-Haenszel

Comparison: Week 12p-value: 0.4574Cochran-Mantel-Haenszel

Comparison: Week 16p-value: 0.5824Cochran-Mantel-Haenszel

Comparison: Week 16p-value: 0.9321Cochran-Mantel-Haenszel

Comparison: Week 16p-value: 0.5263Cochran-Mantel-Haenszel

Comparison: Week 22p-value: 0.2025Cochran-Mantel-Haenszel

Comparison: Week 22p-value: 0.6702Cochran-Mantel-Haenszel

Comparison: Week 22p-value: 0.0818Cochran-Mantel-Haenszel

Comparison: Week 28p-value: 0.6214Cochran-Mantel-Haenszel

Comparison: Week 28p-value: 0.6774Cochran-Mantel-Haenszel

Comparison: Week 28p-value: 0.3154Cochran-Mantel-Haenszel

Comparison: Week 34p-value: 0.2709Cochran-Mantel-Haenszel

Comparison: Week 34p-value: 0.3804Cochran-Mantel-Haenszel

Comparison: Week 34p-value: 0.7645Cochran-Mantel-Haenszel

Comparison: Week 40p-value: 0.182Cochran-Mantel-Haenszel

Comparison: Week 40p-value: 0.7167Cochran-Mantel-Haenszel

Comparison: Week 40p-value: 0.3104Cochran-Mantel-Haenszel

Comparison: Week 46p-value: 0.091Cochran-Mantel-Haenszel

Comparison: Week 46p-value: 0.6094Cochran-Mantel-Haenszel

Comparison: Week 46p-value: 0.2166Cochran-Mantel-Haenszel

Comparison: Week 52p-value: 0.901Cochran-Mantel-Haenszel

Comparison: Week 52p-value: 0.906Cochran-Mantel-Haenszel

Comparison: Week 52p-value: 0.7268Cochran-Mantel-Haenszel

Comparison: Week 64p-value: 0.5372Cochran-Mantel-Haenszel

Comparison: Week 64p-value: 0.1588Cochran-Mantel-Haenszel

Comparison: Week 64p-value: 0.4268Cochran-Mantel-Haenszel

Comparison: Week 76p-value: 0.4389Cochran-Mantel-Haenszel

Comparison: Week 76p-value: 0.6708Cochran-Mantel-Haenszel

Comparison: Week 76p-value: 0.2145Cochran-Mantel-Haenszel

Comparison: Week 88p-value: 0.8608Cochran-Mantel-Haenszel

Comparison: Week 88p-value: 0.0283Cochran-Mantel-Haenszel

Comparison: Week 88p-value: 0.0369Cochran-Mantel-Haenszel

Comparison: Week 100p-value: 0.4606Cochran-Mantel-Haenszel

Comparison: Week 100p-value: 0.0832Cochran-Mantel-Haenszel

Comparison: Week 100p-value: 0.2655Cochran-Mantel-Haenszel

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment

Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100

Percentage of Participants Who Were HBeAg Negative

Percentage of Participants With Combined Response

Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive

Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels