Hepatitis B, Chronic
Conditions
Brief summary
The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.
Interventions
1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults with chronic hepatitis B: * Serum hepatitis B surface antigen positive for at least 6 months * Serum hepatitis B e antigen positive * Serum negative for hepatitis B surface and e antibodies * Plasma hepatitis B virus deoxyribonucleic acid (DNA) level greater than 20,000 IU/mL * Alanine aminotransferase (ALT) 2- to 10-times the upper limit of normal * Compensated liver disease with certain minimum hematological and serum biochemical criteria
Exclusion criteria
* Significant hepatic disease from an etiology other than hepatitis B virus * Antiviral treatment for hepatitis within previous 6 months * History of severe psychiatric disease, especially depression * Unstable or significant cardiovascular disease * Prolonged exposure to known hepatotoxins such as alcohol or drugs * Any condition that could interfere with the subject participating in and completing the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | 24 weeks after end of treatment (EOT) | HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBe Seroconversion | End of treatment (EOT) and 24 weeks after EOT | HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA. |
| Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | End of treatment (EOT) and 24 weeks after EOT | HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL) |
| Number of Participants With HBV-DNA < 200 IU/mL | End of treatment (EOT) and 24 weeks after EOT | HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL) |
| Number of Participants With HBV-DNA Undetectable | End of treatment (EOT) and 24 weeks after EOT | Undetectable HBV-DNA was defined as having a level \<6 IU/mL by polymerase chain reaction (PCR). |
| Number of Participants With HBeAg Loss | Up to Treatment Week 48 | HBeAg Loss was tested by assay of Abbott MEIA |
| Number of Participants With Combined Response | End of treatment (EOT) and 24 weeks after EOT | Combined response was defined as HBV DNA \<20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization |
| Hepatitis B Surface Antigen (HBsAg) Loss | End of treatment (EOT) and 24 weeks after EOT | HBsAg Loss was tested by assay of Abbott MEIA |
| Hepatitis B Surface Antigen (HBs) Seroconversion | End of treatment (EOT) and 24 weeks after EOT | HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive |
| Change From Baseline in Liver Biopsy Score | Baseline to 24 weeks after end of treatment | Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System): Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis). Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked \[involvement of \>2/3 of lobules or nodules\]). Score III (portal inflammation): 0 (none) to 4 (Marked \[dense packing of inflammatory cells in \>2/3 of portal tracts\]). Score IV (fibrosis): 0 (none) to 4 (cirrhosis). |
| Number of Participants With Biochemical Response | End of treatment (EOT) and 24 weeks after EOT | Biochemical response was defined as alanine aminotransferase (ALT) normalization. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PEG 1.0 mcg/kg QW * 24 Weeks PegIntron 1.0 mcg/kg QW \* 24 weeks + 24 weeks follow-up; treated participants | 225 |
| PEG 1.5 mcg/kg QW * 24 Weeks PegIntron 1.5 mcg/kg QW \* 24 weeks + 24 weeks follow-up; treated participants | 221 |
| PEG 1.5 mcg/kg QW * 48 Weeks PegIntron 1.5 mcg/kg QW \* 48 weeks + 24 weeks follow-up; treated participants. | 224 |
| Total | 670 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 5 | 7 |
| Overall Study | Did not meet protocol eligibility | 1 | 2 | 2 |
| Overall Study | Lost to Follow-up | 3 | 4 | 4 |
| Overall Study | Noncompliance with protocol | 0 | 0 | 1 |
| Overall Study | Subject withdrew - not treatment related | 2 | 0 | 5 |
| Overall Study | Subject withdrew - treatment related | 0 | 3 | 2 |
Baseline characteristics
| Characteristic | PEG 1.0 mcg/kg QW * 24 Weeks | PEG 1.5 mcg/kg QW * 24 Weeks | PEG 1.5 mcg/kg QW * 48 Weeks | Total |
|---|---|---|---|---|
| Age, Continuous | 28.2 Years STANDARD_DEVIATION 7.2 | 27.5 Years STANDARD_DEVIATION 7.1 | 28.4 Years STANDARD_DEVIATION 7.6 | 28.0 Years STANDARD_DEVIATION 7.3 |
| Sex: Female, Male Female | 54 Participants | 57 Participants | 55 Participants | 166 Participants |
| Sex: Female, Male Male | 171 Participants | 164 Participants | 169 Participants | 504 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 | 173 / 225 | 169 / 221 | 182 / 224 |
| serious Total, serious adverse events | 10 / 225 | 11 / 221 | 15 / 224 |
Outcome results
Primary
Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss
HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA)
Time frame: 24 weeks after end of treatment (EOT)
Population: Treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | 39 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | 40 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | 70 Participants |
Comparison: Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm.p-value: 0.8695% CI: [-0.063, 0.079]Cochran-Mantel-Haenszel
Comparison: Null hypothesis: no difference in the proportion with HBeAg loss.~Based on the targeted sample size, there was 80% statistical power (2-sided 0.05 alpha) to detect a true 36% HBeAg loss rate in this treatment arm versus a true rate of 23% in the control arm.p-value: <0.00195% CI: [0.061, 0.217]Cochran-Mantel-Haenszel
90% CI: [-0.198, -0.065]
Secondary
Change From Baseline in Liver Biopsy Score
Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System): Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis). Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked \[involvement of \>2/3 of lobules or nodules\]). Score III (portal inflammation): 0 (none) to 4 (Marked \[dense packing of inflammatory cells in \>2/3 of portal tracts\]). Score IV (fibrosis): 0 (none) to 4 (cirrhosis).
Time frame: Baseline to 24 weeks after end of treatment
Population: Treated participants from designated sites
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Change From Baseline in Liver Biopsy Score | Baseline | 8.0 Units on a scale | Standard Deviation 3.06 |
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Change From Baseline in Liver Biopsy Score | Change from Baseline | -1.1 Units on a scale | Standard Deviation 3.57 |
| PEG 1.5 mcg/kg QW * 24 Weeks | Change From Baseline in Liver Biopsy Score | Baseline | 8.4 Units on a scale | Standard Deviation 2.92 |
| PEG 1.5 mcg/kg QW * 24 Weeks | Change From Baseline in Liver Biopsy Score | Change from Baseline | -1.7 Units on a scale | Standard Deviation 3.66 |
| PEG 1.5 mcg/kg QW * 48 Weeks | Change From Baseline in Liver Biopsy Score | Baseline | 8.2 Units on a scale | Standard Deviation 3.33 |
| PEG 1.5 mcg/kg QW * 48 Weeks | Change From Baseline in Liver Biopsy Score | Change from Baseline | -1.6 Units on a scale | Standard Deviation 3.96 |
p-value: 0.014t-test, 2 sided
p-value: <0.001t-test, 2 sided
p-value: 0.01t-test, 2 sided
p-value: 0.63195% CI: [-1.2, 0.8]ANCOVA
p-value: 0.61795% CI: [-1.4, 0.8]ANCOVA
95% CI: [-1.1, 1.1]
Secondary
HBe Seroconversion
HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA.
Time frame: End of treatment (EOT) and 24 weeks after EOT
Population: Treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | HBe Seroconversion | EOT | 31 Participants |
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | HBe Seroconversion | 24 weeks after EOT | 38 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | HBe Seroconversion | EOT | 27 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | HBe Seroconversion | 24 weeks after EOT | 36 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | HBe Seroconversion | EOT | 40 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | HBe Seroconversion | 24 weeks after EOT | 67 Participants |
Comparison: End of treatmentp-value: 0.59895% CI: [-0.078, 0.047]Cochran-Mantel-Haenszel
Comparison: End of treatmentp-value: 0.2495% CI: [-0.027, 0.108]Cochran-Mantel-Haenszel
Comparison: End of treatment90% CI: [-0.112, -0.001]
Comparison: 24 weeks after EOTp-value: 0.8395% CI: [-0.075, 0.063]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOTp-value: 0.00195% CI: [0.053, 0.208]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOT90% CI: [-0.201, -0.071]
Secondary
Hepatitis B Surface Antigen (HBsAg) Loss
HBsAg Loss was tested by assay of Abbott MEIA
Time frame: End of treatment (EOT) and 24 weeks after EOT
Population: Treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Hepatitis B Surface Antigen (HBsAg) Loss | EOT | 1 Participants |
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Hepatitis B Surface Antigen (HBsAg) Loss | 24 weeks after EOT | 1 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Hepatitis B Surface Antigen (HBsAg) Loss | EOT | 1 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Hepatitis B Surface Antigen (HBsAg) Loss | 24 weeks after EOT | 1 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Hepatitis B Surface Antigen (HBsAg) Loss | EOT | 4 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Hepatitis B Surface Antigen (HBsAg) Loss | 24 weeks after EOT | 4 Participants |
Comparison: End of treatmentp-value: 0.99195% CI: [-0.012, 0.012]Cochran-Mantel-Haenszel
Comparison: End of treatmentp-value: 0.18195% CI: [-0.006, 0.033]Cochran-Mantel-Haenszel
Comparison: End of treatment90% CI: [-0.03, 0.003]
Comparison: 24 weeks after EOTp-value: 0.97195% CI: [-0.012, 0.012]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOTp-value: 0.17995% CI: [-0.006, 0.033]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOT90% CI: [-0.03, 0.003]
Secondary
Hepatitis B Surface Antigen (HBs) Seroconversion
HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive
Time frame: End of treatment (EOT) and 24 weeks after EOT
Population: Treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Hepatitis B Surface Antigen (HBs) Seroconversion | 24 weeks after EOT | 0 Participants |
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Hepatitis B Surface Antigen (HBs) Seroconversion | EOT | 0 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Hepatitis B Surface Antigen (HBs) Seroconversion | EOT | 0 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Hepatitis B Surface Antigen (HBs) Seroconversion | 24 weeks after EOT | 0 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Hepatitis B Surface Antigen (HBs) Seroconversion | EOT | 1 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Hepatitis B Surface Antigen (HBs) Seroconversion | 24 weeks after EOT | 2 Participants |
Comparison: End of treatmentp-value: 0.32295% CI: [-0.004, 0.013]Cochran-Mantel-Haenszel
Comparison: End of treatmentp-value: 0.991Cochran-Mantel-Haenszel
Comparison: End of treatment90% CI: [-0.012, 0.003]
Comparison: 24 weeks after EOTp-value: 0.991Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOTp-value: 0.15795% CI: [-0.003, 0.021]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOT90% CI: [-0.019, 0.001]
Secondary
Number of Participants With Biochemical Response
Biochemical response was defined as alanine aminotransferase (ALT) normalization.
Time frame: End of treatment (EOT) and 24 weeks after EOT
Population: Treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With Biochemical Response | EOT | 75 Participants |
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With Biochemical Response | 24 weeks after EOT | 63 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With Biochemical Response | EOT | 86 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With Biochemical Response | 24 weeks after EOT | 80 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With Biochemical Response | EOT | 103 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With Biochemical Response | 24 weeks after EOT | 103 Participants |
Comparison: End of treatmentp-value: 0.21995% CI: [-0.033, 0.145]Cochran-Mantel-Haenszel
Comparison: End of treatmentp-value: 0.00695% CI: [0.037, 0.216]Cochran-Mantel-Haenszel
Comparison: End of treatment90% CI: [-0.148, 0.006]
Comparison: 24 weeks after EOTp-value: 0.06795% CI: [-0.004, 0.168]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOTp-value: <0.00195% CI: [0.092, 0.268]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOT90% CI: [-0.174, -0.021]
Secondary
Number of Participants With Combined Response
Combined response was defined as HBV DNA \<20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization
Time frame: End of treatment (EOT) and 24 weeks after EOT
Population: Treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With Combined Response | EOT | 11 Participants |
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With Combined Response | 24 weeks after EOT | 18 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With Combined Response | EOT | 11 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With Combined Response | 24 weeks after EOT | 23 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With Combined Response | EOT | 23 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With Combined Response | 24 weeks after EOT | 45 Participants |
Comparison: End of treatmentp-value: 0.99595% CI: [-0.039, 0.041]Cochran-Mantel-Haenszel
Comparison: End of treatmentp-value: 0.03195% CI: [0.005, 0.103]Cochran-Mantel-Haenszel
Comparison: End of treatment90% CI: [-0.094, -0.012]
Comparison: 24 weeks after EOTp-value: 0.38995% CI: [-0.03, 0.078]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOTp-value: <0.00195% CI: [0.058, 0.184]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOT90% CI: [-0.152, -0.041]
Secondary
Number of Participants With HBeAg Loss
HBeAg Loss was tested by assay of Abbott MEIA
Time frame: Up to Treatment Week 48
Population: Treated participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With HBeAg Loss | 31 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With HBeAg Loss | 28 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With HBeAg Loss | 43 Participants |
p-value: 0.795% CI: [-0.074, 0.052]Cochran-Mantel-Haenszel
p-value: 0.12595% CI: [-0.014, 0.123]Cochran-Mantel-Haenszel
90% CI: [-0.122, -0.008]
Secondary
Number of Participants With HBV-DNA < 200 IU/mL
HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)
Time frame: End of treatment (EOT) and 24 weeks after EOT
Population: Treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With HBV-DNA < 200 IU/mL | EOT | 10 Participants |
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With HBV-DNA < 200 IU/mL | 24 weeks after EOT | 12 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With HBV-DNA < 200 IU/mL | EOT | 14 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With HBV-DNA < 200 IU/mL | 24 weeks after EOT | 12 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With HBV-DNA < 200 IU/mL | EOT | 21 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With HBV-DNA < 200 IU/mL | 24 weeks after EOT | 22 Participants |
Comparison: End of treatmentp-value: 0.37395% CI: [-0.023, 0.061]Cochran-Mantel-Haenszel
Comparison: End of treatmentp-value: 0.0495% CI: [0.003, 0.096]Cochran-Mantel-Haenszel
Comparison: End of treatment90% CI: [-0.072, 0.011]
Comparison: 24 weeks after EOTp-value: 0.96995% CI: [-0.041, 0.043]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOTp-value: 0.07495% CI: [-0.004, 0.094]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOT90% CI: [-0.085, -0.003]
Secondary
Number of Participants With HBV-DNA Undetectable
Undetectable HBV-DNA was defined as having a level \<6 IU/mL by polymerase chain reaction (PCR).
Time frame: End of treatment (EOT) and 24 weeks after EOT
Population: Treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With HBV-DNA Undetectable | EOT | 4 Participants |
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With HBV-DNA Undetectable | 24 weeks after EOT | 4 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With HBV-DNA Undetectable | EOT | 3 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With HBV-DNA Undetectable | 24 weeks after EOT | 3 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With HBV-DNA Undetectable | EOT | 8 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With HBV-DNA Undetectable | 24 weeks after EOT | 8 Participants |
Comparison: End of treatmentp-value: 0.72495% CI: [-0.027, 0.019]Cochran-Mantel-Haenszel
Comparison: End of treatmentp-value: 0.24395% CI: [-0.012, 0.048]Cochran-Mantel-Haenszel
Comparison: End of treatment90% CI: [-0.046, 0.002]
Comparison: 24 weeks after EOTp-value: 0.72495% CI: [-0.027, 0.019]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOTp-value: 0.23295% CI: [-0.012, 0.048]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOT90% CI: [-0.046, 0.002]
Secondary
Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL
HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL)
Time frame: End of treatment (EOT) and 24 weeks after EOT
Population: Treated participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | EOT | 46 Participants |
| PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks | Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | 24 weeks after EOT | 44 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | EOT | 61 Participants |
| PEG 1.5 mcg/kg QW * 24 Weeks | Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | 24 weeks after EOT | 47 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | EOT | 76 Participants |
| PEG 1.5 mcg/kg QW * 48 Weeks | Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | 24 weeks after EOT | 75 Participants |
Comparison: End of treatmentp-value: 0.07695% CI: [-0.007, 0.151]Cochran-Mantel-Haenszel
Comparison: End of treatmentp-value: 0.00195% CI: [0.053, 0.216]Cochran-Mantel-Haenszel
Comparison: End of treatment90% CI: [-0.135, 0.009]
Comparison: 24 weeks after EOTp-value: 0.66295% CI: [-0.058, 0.092]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOTp-value: <0.00195% CI: [0.059, 0.22]Cochran-Mantel-Haenszel
Comparison: 24 weeks after EOT90% CI: [-0.191, -0.053]