Chronic Hepatitis B
Conditions
Keywords
Chronic Hepatitis B, Hep B, Non cirrhotic, Tenofovir disoproxil fumarate (TDF), Peginterferon α-2a (Peg-IFN)
Brief summary
The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN monotherapy for 48 weeks in non-cirrhotic adults with chronic hepatitis B virus (HBV) as determined by loss of hepatitis B surface antigen (HBsAg). The study will consist of 2 phases for participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups. Following an initial 48 weeks of treatment, participants in these groups will be monitored for 24 weeks for signs of worsening HBV, and those meeting TDF retreatment and flare management criteria will be eligible to receive TDF monotherapy during a retreatment phase, up to Week 120.
Interventions
DRUGTDF
TDF 300 mg tablets administered orally once daily
DRUGPeg-IFN
Peg-IFN 180 µg administered via subcutaneous injection once weekly
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults (age 18-75) with chronic HBV (positive for serum hepatitis B surface antigen (HBsAg) or HBV DNA for at least 6 months) prior to baseline * Anti-HBV treatment-naive adults; adults who have taken oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible. * Positive or negative for hepatitis B e antigen (HBeAg) * HBV DNA ≥ 20,000 IU/ml (HBeAg-positive participants) and ≥ 2,000 IU/ml (HBeAg-negative participants) * Alanine aminotransferase (ALT) \> 54 U/L and ≤ 400 U/L for men and \> 36 U/L and ≤ 300 U/L for women * Creatinine clearance ≥ 70 mL/min * Negative serum pregnancy test for females of childbearing potential * Sexually active females of childbearing potential must agree to use a protocol-recommended method of contraception throughout the study and for 30 days following the last dose of study medication * Lactating females must agree to discontinue nursing before initiation of study investigational medicinal product
Exclusion criteria
* Known bridging fibrosis or cirrhosis and/or decompensated liver disease * Evidence of hepatocellular carcinoma * Significant kidney, heart, lung, neurological, autoimmune disease, or bone disease (eg, osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochondrosis, multiple bone fractures) * Absolute neutrophil count \< 1,500/mm\^3, platelet \< 100,000/mm\^3, hemoglobin \< 10 g/dL (female) or \< 11 g/dL (male) * History of severe depression or severe psychiatric disease * Thyroid dysfunction * Coinfection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV) * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | Baseline; Week 72 | Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Baseline; Weeks 96 and 120 | Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis. |
| Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Baseline; Weeks 72, 96, and 120 | HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120. |
| Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | Baseline; Week 72 | Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72. |
| Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | Baseline; Week 96 | Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96. |
| Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | Baseline; Week 120 | Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120. |
| Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72 | Week 72 | For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72. |
| Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | Baseline; Week 72 | Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. |
| Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120 | Week 120 | For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120. |
| Percentage of Participants With Normal ALT at Week 72 | Week 72 | Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72. |
| Percentage of Participants With Normal ALT at Week 96 | Week 96 | Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96. |
| Percentage of Participants With Normal ALT at Week 120 | Week 120 | Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120. |
| Percentage of Participants Who Required Retreatment | Up to 120 weeks | Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented. |
| Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96 | Week 96 | For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96. |
Countries
Australia, Canada, France, Germany, Greece, Hong Kong, India, Italy, Netherlands, Poland, Portugal, Romania, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at study sites in North America, Europe, Asia, and Australia. The first participant was screened on 12 April 2011. The last study visit occurred on 17 July 2015.
Pre-assignment details
1597 participants were screened.
Participants by arm
| Arm | Count |
|---|---|
| TDF+Peg-IFN 48 Weeks TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks | 186 |
| TDF 48 Weeks + Peg-IFN 16 Week TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks | 184 |
| TDF 120 Weeks TDF 300 mg tablet once daily for 120 weeks | 185 |
| Peg-IFN 48 Weeks Peg-IFN 180 µg s.c. injection once weekly for 48 weeks | 185 |
| Total | 740 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 3 | 0 | 7 |
| Overall Study | Lost to Follow-up | 7 | 9 | 4 | 2 |
| Overall Study | Noncompliance with Study Drug | 1 | 3 | 2 | 0 |
| Overall Study | Physician Decision | 3 | 5 | 1 | 6 |
| Overall Study | Pregnancy | 2 | 2 | 4 | 1 |
| Overall Study | Protocol Violation | 0 | 2 | 5 | 0 |
| Overall Study | Subject Never Dosed with Study Drug | 1 | 2 | 3 | 1 |
| Overall Study | Subject Terminated from Study by Sponsor | 0 | 1 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 18 | 21 | 8 | 17 |
Baseline characteristics
| Characteristic | TDF+Peg-IFN 48 Weeks | Total | Peg-IFN 48 Weeks | TDF 120 Weeks | TDF 48 Weeks + Peg-IFN 16 Week |
|---|---|---|---|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 10.7 | 37 years STANDARD_DEVIATION 10.5 | 38 years STANDARD_DEVIATION 10.5 | 36 years STANDARD_DEVIATION 10.8 | 37 years STANDARD_DEVIATION 9.9 |
| Alanine Aminotransferase (ALT) | 121.2 U/L STANDARD_DEVIATION 180.82 | 110.3 U/L STANDARD_DEVIATION 116.94 | 106.6 U/L STANDARD_DEVIATION 91.51 | 100.9 U/L STANDARD_DEVIATION 67.65 | 112.2 U/L STANDARD_DEVIATION 94.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 18 Participants | 7 Participants | 3 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 182 Participants | 719 Participants | 177 Participants | 181 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| HBV Genotype Genotype A | 17 participants | 61 participants | 14 participants | 14 participants | 16 participants |
| HBV Genotype Genotype B | 50 participants | 203 participants | 53 participants | 49 participants | 51 participants |
| HBV Genotype Genotype C | 78 participants | 314 participants | 79 participants | 78 participants | 79 participants |
| HBV Genotype Genotype D | 39 participants | 154 participants | 38 participants | 41 participants | 36 participants |
| HBV Genotype Genotype E-H | 2 participants | 8 participants | 1 participants | 3 participants | 2 participants |
| Hepatitis B e Antigen (HBeAg) Status Nonreactive | 78 participants | 312 participants | 79 participants | 76 participants | 79 participants |
| Hepatitis B e Antigen (HBeAg) Status Reactive | 108 participants | 428 participants | 106 participants | 109 participants | 105 participants |
| Hepatitis B Surface Antigen (HBsAg) | 3.88 log 10 IU/mL STANDARD_DEVIATION 0.84 | 3.84 log 10 IU/mL STANDARD_DEVIATION 0.836 | 3.76 log 10 IU/mL STANDARD_DEVIATION 0.844 | 3.89 log 10 IU/mL STANDARD_DEVIATION 0.812 | 3.84 log 10 IU/mL STANDARD_DEVIATION 0.849 |
| Hepatitis B Virus (HBV) DNA | 7.06 log 10 IU/mL STANDARD_DEVIATION 1.542 | 7.04 log 10 IU/mL STANDARD_DEVIATION 1.553 | 6.94 log 10 IU/mL STANDARD_DEVIATION 1.619 | 7.02 log 10 IU/mL STANDARD_DEVIATION 1.55 | 7.13 log 10 IU/mL STANDARD_DEVIATION 1.505 |
| Race/Ethnicity, Customized Asian | 142 participants | 554 participants | 137 participants | 141 participants | 134 participants |
| Race/Ethnicity, Customized Black or African American | 5 participants | 18 participants | 6 participants | 4 participants | 3 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 participants | 3 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 1 participants | 4 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White | 36 participants | 161 participants | 41 participants | 39 participants | 45 participants |
| Region of Enrollment Australia | 10 participants | 53 participants | 14 participants | 15 participants | 14 participants |
| Region of Enrollment Canada | 19 participants | 58 participants | 11 participants | 14 participants | 14 participants |
| Region of Enrollment France | 6 participants | 13 participants | 3 participants | 1 participants | 3 participants |
| Region of Enrollment Germany | 6 participants | 20 participants | 3 participants | 4 participants | 7 participants |
| Region of Enrollment Greece | 0 participants | 9 participants | 4 participants | 2 participants | 3 participants |
| Region of Enrollment Hong Kong | 25 participants | 97 participants | 21 participants | 27 participants | 24 participants |
| Region of Enrollment India | 10 participants | 30 participants | 6 participants | 9 participants | 5 participants |
| Region of Enrollment Italy | 2 participants | 11 participants | 4 participants | 4 participants | 1 participants |
| Region of Enrollment Korea, Republic of | 34 participants | 145 participants | 35 participants | 38 participants | 38 participants |
| Region of Enrollment Netherlands | 2 participants | 4 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Poland | 4 participants | 22 participants | 5 participants | 6 participants | 7 participants |
| Region of Enrollment Portugal | 0 participants | 3 participants | 0 participants | 0 participants | 3 participants |
| Region of Enrollment Romania | 12 participants | 49 participants | 9 participants | 13 participants | 15 participants |
| Region of Enrollment Singapore | 7 participants | 27 participants | 8 participants | 7 participants | 5 participants |
| Region of Enrollment Spain | 3 participants | 14 participants | 5 participants | 3 participants | 3 participants |
| Region of Enrollment Taiwan | 20 participants | 66 participants | 19 participants | 12 participants | 15 participants |
| Region of Enrollment Turkey | 5 participants | 24 participants | 7 participants | 6 participants | 6 participants |
| Region of Enrollment United Kingdom | 2 participants | 10 participants | 4 participants | 1 participants | 3 participants |
| Region of Enrollment United States | 19 participants | 85 participants | 26 participants | 23 participants | 17 participants |
| Sex: Female, Male Female | 59 Participants | 254 Participants | 66 Participants | 64 Participants | 65 Participants |
| Sex: Female, Male Male | 127 Participants | 486 Participants | 119 Participants | 121 Participants | 119 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 147 / 186 | 26 / 112 | 142 / 184 | 31 / 115 | 89 / 185 | 152 / 185 | 33 / 117 |
| serious Total, serious adverse events | 21 / 186 | 7 / 112 | 18 / 184 | 3 / 115 | 13 / 185 | 18 / 185 | 6 / 117 |
Outcome results
Primary
Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.
Time frame: Baseline; Week 72
Population: Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants in the TDF+Peg-IFN 48 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed by randomized treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | 9.05 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | 0.00 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | 2.84 percentage of participants |
p-value: <0.001Log Rank
p-value: 0.002Log Rank
Secondary
Percentage of Participants Who Required Retreatment
Participants in the TDF 120 week group were not eligible to enter the retreatment phase and are not presented.
Time frame: Up to 120 weeks
Population: Safety Analysis Set. Participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants Who Required Retreatment | 60.2 percentage of participants |
| TDF 120 Weeks | Percentage of Participants Who Required Retreatment | 62.5 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants Who Required Retreatment | 63.2 percentage of participants |
Secondary
Percentage of Participants With HBeAg Loss and Seroconversion at Week 120
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120.
Time frame: Baseline; Week 120
Population: Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Loss | 38.6 percentage of participants |
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Seroconversion | 29.5 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Loss | 25.0 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Seroconversion | 21.9 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Loss | 37.5 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Seroconversion | 35.0 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Loss | 23.1 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Seroconversion | 15.4 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Loss | 20.2 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Seroconversion | 15.6 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Loss | 33.3 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Seroconversion | 25.0 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Loss | 18.6 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | HBeAg Seroconversion | 17.1 percentage of participants |
Secondary
Percentage of Participants With HBeAg Loss and Seroconversion at Week 72
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72.
Time frame: Baseline; Week 72
Population: Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Loss | 35.5 percentage of participants |
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Seroconversion | 28.9 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Loss | 15.6 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Seroconversion | 15.6 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Loss | 32.8 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Seroconversion | 31.1 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Loss | 15.9 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Seroconversion | 13.6 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Loss | 14.7 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Seroconversion | 12.8 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Loss | 32.8 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Seroconversion | 31.3 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Loss | 14.3 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | HBeAg Seroconversion | 14.3 percentage of participants |
Secondary
Percentage of Participants With HBeAg Loss and Seroconversion at Week 96
Loss of HBeAg was defined as change of detectable HBeAg from positive to negative. HBeAg seroconversion was defined as change of detectable antibody to HBeAg from negative to positive. Percentages were based on the number of subjects with non-missing HBeAg results or missing HBeAg results imputed as failures at each visit. For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96.
Time frame: Baseline; Week 96
Population: Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Seroconversion | 36.4 percentage of participants |
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Loss | 43.2 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Loss | 20.3 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Seroconversion | 18.8 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Loss | 45.5 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Seroconversion | 43.2 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Loss | 14.8 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Seroconversion | 13.1 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Seroconversion | 16.5 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Loss | 18.3 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Loss | 37.8 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Seroconversion | 29.7 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Loss | 14.5 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | HBeAg Seroconversion | 13.0 percentage of participants |
Secondary
Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis.
Time frame: Baseline; Week 72
Population: Full Analysis Set. Participants in the TDF 48 week + Peg-IFN 16 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | 2.83 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | 0.00 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | 2.84 percentage of participants |
Secondary
Percentage of Participants With HBsAg Loss at Weeks 96 and 120
Loss of HBsAg was defined as change of detectable HBsAg from positive to negative. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 96 comprised study Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised study Week 114 through Week 126, so results up to Week 126 are included in this analysis.
Time frame: Baseline; Weeks 96 and 120
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Week 120 | 10.36 percentage of participants |
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Week 96 | 9.69 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Week 96 | 3.49 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Week 120 | 3.49 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Week 96 | 0.00 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Week 120 | 0.00 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Week 120 | 3.51 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Week 96 | 2.84 percentage of participants |
Secondary
Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120
HBsAg seroconversion was defined as change of detectable antibody to HBsAg from negative to positive. Proportions are based on a Kaplan-Meier estimate. The analysis visit window for Week 72 comprised Week 70 through Week 78, so results up to Week 78 are included in this analysis. The analysis visit window for Week 96 comprised Week 90 through Week 102, so results up to Week 102 are included in this analysis. The analysis visit window for Week 120 comprised Week 114 through Week 120.
Time frame: Baseline; Weeks 72, 96, and 120
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 72 | 8.05 percentage of participants |
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 120 | 10.08 percentage of participants |
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 96 | 8.05 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 72 | 0.56 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 120 | 0.56 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 96 | 0.56 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 96 | 0.00 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 72 | 0.00 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 120 | 0.00 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 72 | 2.87 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 120 | 2.87 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Week 96 | 2.87 percentage of participants |
Secondary
Percentage of Participants With Normal ALT at Week 120
Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120.
Time frame: Week 120
Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 120 | AASLD Criteria | 39.2 percentage of participants |
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 120 | Central Laboratory Criteria | 44.6 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 120 | Central Laboratory Criteria | 72.3 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 120 | AASLD Criteria | 54.5 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 120 | Central Laboratory Criteria | 40.6 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 120 | AASLD Criteria | 30.4 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 120 | Central Laboratory Criteria | 78.3 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 120 | AASLD Criteria | 48.7 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 120 | AASLD Criteria | 48.6 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 120 | Central Laboratory Criteria | 73.0 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With Normal ALT at Week 120 | AASLD Criteria | 30.9 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With Normal ALT at Week 120 | Central Laboratory Criteria | 41.2 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With Normal ALT at Week 120 | Central Laboratory Criteria | 73.5 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With Normal ALT at Week 120 | AASLD Criteria | 47.0 percentage of participants |
Secondary
Percentage of Participants With Normal ALT at Week 72
Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72.
Time frame: Week 72
Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 72 | AASLD Criteria | 42.1 percentage of participants |
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 72 | Central Laboratory Criteria | 59.5 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 72 | Central Laboratory Criteria | 40.0 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 72 | AASLD Criteria | 18.3 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 72 | Central Laboratory Criteria | 57.6 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 72 | AASLD Criteria | 40.7 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 72 | Central Laboratory Criteria | 34.8 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 72 | AASLD Criteria | 18.2 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 72 | AASLD Criteria | 47.6 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 72 | Central Laboratory Criteria | 72.4 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With Normal ALT at Week 72 | AASLD Criteria | 35.0 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With Normal ALT at Week 72 | Central Laboratory Criteria | 57.5 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With Normal ALT at Week 72 | Central Laboratory Criteria | 33.8 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With Normal ALT at Week 72 | AASLD Criteria | 9.2 percentage of participants |
Secondary
Percentage of Participants With Normal ALT at Week 96
Normal ALT was ≤ 30 U/L for males and ≤ 19 U/L for females (based on the American Association for the Study of Liver Diseases (AASLD) 2008 guidelines), and ≤ 41 U/L for males and ≤ 31 U/L for females (based on central laboratory upper limit of the normal range (ULN) for ALT). For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96.
Time frame: Week 96
Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 96 | AASLD Criteria | 43.2 percentage of participants |
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 96 | Central Laboratory Criteria | 55.6 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 96 | AASLD Criteria | 42.9 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 96 | Central Laboratory Criteria | 71.4 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 96 | AASLD Criteria | 34.1 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 96 | Central Laboratory Criteria | 52.4 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 96 | AASLD Criteria | 46.1 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Normal ALT at Week 96 | Central Laboratory Criteria | 73.5 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 96 | AASLD Criteria | 48.1 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Normal ALT at Week 96 | Central Laboratory Criteria | 73.0 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With Normal ALT at Week 96 | AASLD Criteria | 34.7 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With Normal ALT at Week 96 | Central Laboratory Criteria | 47.2 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With Normal ALT at Week 96 | AASLD Criteria | 39.8 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With Normal ALT at Week 96 | Central Laboratory Criteria | 68.1 percentage of participants |
Secondary
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 120, and in the Retreated column for participants who did enter the retreatment phase by Week 120.
Time frame: Week 120
Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120 | 32.4 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120 | 81.3 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120 | 18.8 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120 | 83.5 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120 | 82.2 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120 | 13.2 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120 | 82.1 percentage of participants |
Secondary
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 72, and in the Retreated column for participants who did enter the retreatment phase by Week 72.
Time frame: Week 72
Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72 | 15.3 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72 | 26.2 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72 | 14.5 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72 | 15.1 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72 | 84.9 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72 | 11.7 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72 | 40.4 percentage of participants |
Secondary
Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96
For the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups, data are presented in the Not Retreated column for participants who had not entered the retreatment phase by Week 96, and in the Retreated column for participants who did enter the retreatment phase by Week 96.
Time frame: Week 96
Population: Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TDF+Peg-IFN 48 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96 | 21.7 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96 | 68.0 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96 | 15.7 percentage of participants |
| Peg-IFN 48 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96 | 80.2 percentage of participants |
| TDF 120 Weeks | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96 | 83.8 percentage of participants |
| Peg-IFN 48 Weeks (Not Retreated) | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96 | 13.9 percentage of participants |
| Peg-IFN 48 Weeks (Retreated) | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96 | 70.8 percentage of participants |