Long-term follow-up of peginterferon and lamivudine combination treatment in HBeAg-positive chronic hepatitis B.

We have previously demonstrated that combination peginterferon and lamivudine treatment has superior antiviral efficacy to lamivudine monotherapy in chronic hepatitis B. In this study, we investigated the long-term posttreatment virological response to this combination treatment. Sustained virological response of patients who completed 32-week peginterferon and 52-week lamivudine combination treatment was compared to patients who completed 52-week lamivudine monotherapy. Sustained response was defined as sustained hepatitis B e antigen (HBeAg) loss and HBV DNA < 100,000 copies/mL from treatment cessation until the end of follow-up. Forty-eight patients receiving combination treatment and 47 patients receiving lamivudine monotherapy were studied. The posttreatment follow-up of patients who received combination treatment was 117 +/- 34 weeks and that of patients receiving lamivudine monotherapy was 124 +/- 29 weeks. At the end of treatment, HBeAg loss occurred in 63% of patients in the combination group and 28% of patients in the lamivudine group (P = .001). The probabilities of sustained response for combination treatment and lamivudine monotherapy were 33% and 13% at week 24, 31% and 11% at week 52, and 29% and 9% at week 76, respectively (log-rank test, P = .0015). No patients developed virological relapse after week 76 until the last visit in either treatment group. All sustained responders had no biochemical relapse (alanine aminotransferase [ALT] > 2 times upper limit of normal) during follow-up. Among the non-sustained responders, biochemical relapse occurred in 32 patients (94%) in the combination group and 38 patients (88%) in the lamivudine group, respectively. In conclusion, combination treatment of peginterferon and lamivudine has a higher sustained virological response than lamivudine monotherapy up to 3 years after treatment.

RCT Entities:   Population Interventions Outcomes