The investigators evaluated the safety and efficacy of a short lead-in course (8 weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40 weeks.
Name: Entecavir and peginterferon
Description: Lack of data was considered to be treatment failure.
Measure: Proportion of Participants With HBeAg Loss (Lack of Detectable HBeAg) AND HBV DNA ≤1,000 IU/mL Time: End of follow-up (up to 96 weeks)Description: The number of AEs includes both AEs and Serious Adverse Events (SAEs). The incidence is calculated as the number of AEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
Measure: Incidence of Adverse Events (AEs) Per Person-Year of Observation Time: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)Description: The incidence is calculated as the number of SAEs divided by the number of person-years of observation, which is the sum, across all participants, of the number of years between the start of treatment and the end of treatment, or the end of follow-up, respectively.
Measure: Incidence of Serious Adverse Events (SAEs) Per Person-Year Time: From first treatment to the end of treatment (up to 48 weeks) and the end of follow-up (up to 96 weeks)Description: HBV drug resistance variant testing was performed at the CDC laboratory. The sequences of the HBV polymerase spanning nucleotide positions 311-1021 were determined by Sanger sequencing. Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.
Measure: Absence of Detectable Antiviral Drug-resistance HBV Mutations Time: End of treatment (up to 48 weeks)Allocation: N/A
Single Group Assignment
There are 13 SNPs
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N --- --- W153Q --- --- F166L --- --- I169T --- --- V173L --- --- L180M --- --- V191T --- --- A194T ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N --- --- W153Q --- --- F166L --- --- I169T --- --- V173L --- --- L180M --- --- V191T --- --- A194T --- --- A200V ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N --- --- W153Q --- --- F166L ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N --- --- W153Q --- --- F166L --- --- I169T --- --- V173L --- --- L180M --- --- V191T --- --- A194T --- --- A200V --- --- V207I --- --- N236T --- --- G145R ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N --- --- W153Q --- --- F166L --- --- I169T ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N --- --- W153Q --- --- F166L --- --- I169T --- --- V173L --- --- L180M ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N --- --- W153Q --- --- F166L --- --- I169T --- --- V173L --- --- L180M --- --- V191T --- --- A194T --- --- A200V --- --- V207I --- --- N236T ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N --- --- W153Q --- --- F166L --- --- I169T --- --- V173L ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N --- --- W153Q --- --- F166L --- --- I169T --- --- V173L --- --- L180M --- --- V191T ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N --- --- W153Q --- --- F166L --- --- I169T --- --- V173L --- --- L180M --- --- V191T --- --- A194T --- --- A200V --- --- V207I ---
Drug resistance mutations that were tested in this study included L80VI, L82M, T128N, W153Q, F166L, I169T, V173L, L180M, A181TV, T184ACFGILMS, V191T, A194T, A200V, S202ETV, M204IV, V207I, N236T, M250ILV, and G145R.. Inclusion Criteria: - Enrolled in & completed the baseline evaluation for NCT01263587 or completed the necessary components of NCT01263587 by the end of baseline visit. --- L82M --- --- T128N --- --- W153Q ---