A Study of Pegylated Interferon Alfa-2a and Lamivudine in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)

Combined response was defined as alanine aminotransferase (ALT) normalization plus lowering of hepatitis B virus (HBV) deoxyribo nucleic acid (DNA) levels to \<20,000 copies/mL (\<3,400 IU/mL) and was measured at the end of the 48-week follow-up period. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.

Time frame: At the end of the 48-week follow-up period at Week 144

Population: The ITT population included all participants randomized who received at least one dose of study medication.

Time frame: At the end of treatment at Week 48 or 96 depending on the study arm

Population: The ITT population included all participants randomized who received at least one dose of study medication. Baseline values are included for those participants for whom a baseline value was measured. Change from baseline values includes only those participants with both a baseline value and a value for the summarized time period.

Combined response was defined here as ALT normalization plus lowering HBV-DNA levels to a cutt-off \<2,000 IU/mL. In case of missing end of treatment measurements, the next available post-treatment value was used. In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used. Participants with missing 48 weeks follow-up measurements were considered as non-responders. However, if the scheduled 48-weeks post-treatment tests were performed earlier or later than 48 weeks post-treatment, but not earlier than 36 weeks post-treatment, the corresponding results were considered to determine response.

Time frame: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144

Population: The ITT population included all participants randomized who received at least one dose of study medication.

Histological response was defined as an improvement by \>/= 2 in the Necroinflammatory Grading and/or by an improvement by \>/= 1 score in Fibrosis Staging according to Ishak. Necroinflammatory Grading ranges 0-14 and is the combined score for necrosis, range 0-10 and inflammation, range 0-4. The participant is scored for only one inflammatory condition. A higher score indicates worse condition. Fibrosis Staging according to Ishak ranges 0-6 and a higher score indicates greater fibrosis.

Time frame: At the end of the 48-week follow-up period at Week 144

Population: The ITT population included all participants randomized who received at least one dose of study medication.

Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to \<20,000 copies/mL (\<3,400 IU/mL). In case of missing week-24 post-treatment measurements, the nearest value with respect to the schedule time point in the time window 12 weeks post treatment until study end was used.

Time frame: At the end of 24 weeks of follow-up at Week 120

Population: The ITT population included all participants randomized who received at least one dose of study medication.

Combined response was defined as ALT normalization plus lowering of HBV-DNA levels to \<20,000 copies/mL (\<3,400 IU/mL). In case of missing end of treatment measurements, the next available post-treatment value was used.

Time frame: At end of treatment at Week 48 or 96 depending on the study arm

Population: The ITT population included all participants randomized who received at least one dose of study medication.

Lamivudine resistance mutations were assessed by detection of the following mutations: rtL80V, rtL80I, rtV173G, rtV173L, rtL180M, rtA181T, rtA181V, rtM204V, rtM204I and rtN236T.

Time frame: At the end of the treatment period at Week 96

Population: The ITT population for arm PEG-IFN+LAM96 included all participants randomized to PEG-IFN+LAM96 who received at least one dose of study medication.

Time frame: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144

Population: The ITT population included all participants randomized who received at least one dose of study medication.

HBV-DNA limit \< 6 IU/mL was defined as below quantification.

Time frame: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144

Population: The ITT population included all participants randomized who received at least one dose of study medication.

Time frame: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144

Population: The ITT population included all participants randomized who received at least one dose of study medication.

This outcome measure presents percentage of participants with a combined response of HBsAg \< 5 IU/mL and anti-HBs positive. Positive anti-HBs represents antibodies produced against Hepatitis B Surface Antigen (HBsAg) and is an indication of recovery and immunity from HBV infection.

Time frame: At end of treatment at Week 48 or 96 depending on the study arm, at the end of 24 weeks of follow-up at Week 120 and at the end of the follow-up period at Week 144

Population: The ITT population included all participants randomized who received at least one dose of study medication.