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Publishing ID: 410 Abstractid ID: 102006
Combination of PegInterferon Alfa-2b and Lamivudine is Superior to Lamivudine Alone in the Treatment of Chronic Hepatitis B Infection
Joseph J. Y. Sung, Henry L. Y. Chan, Alex Y. Hui, Vincent W. S. Wong, Choong-Tsek Liew, Angel M. L. Chim, Francis K. L. Chan, Lawrence C. T. Hung, Yuk-Tong Lee, Nancy W. Y. Leung
Background: Treatment of chronic hepatitis B infection is still unsatisfactory and previous studies combining conventional interferon with lamivudine yielded conflicting results. Aim: This prospective randomized study set to evaluate the efficacy and safety of peginterferon alfa-2b and lamivudine combination for chronic hepatitis B infection. Methods: HBeAg-positive treatment-naive patients were randomized to receive either a combination of 32-week peginterferon alfa-2b (1.5mcg/kg/wk, max 100mcg) and 52-week lamivudine (100mg daily) or 52-week lamivudine (100mg) monotherapy alone. HBV DNA levels (measured by TaqMan real-time PCR assay), HBeAg status, HBV genotype, drug resistant mutant (INNO-LiPA HBV DR line probe assay), serum transaminase levels were monitored. Pre- and post-treatment liver histology (necro-inflammatory score according to Knodell system and fibrosis score according to Ishak system) were compared. The primary endpoint was sustained virological response (HBeAg seroconversion and HBV DNA <500,000 copies/ml) at 24 weeks after finishing medication. Secondary endpoints include end-of-treatment virological response, reduction in HBV DNA levels, biochemical responses and histologic necro-inflammatory and fibrosis scores. Results: 100 patients were randomized into the 2 treatment groups. Sustained virological response was significantly higher in combination therapy than lamivudine monotherapy (36% vs 14%, p=0.03, adjusted odds ratio=3.74, 95% CI 1.14-12.29). At the end of treatment, patients received combination therapy had a higher rate of virological response (60% vs 28%, p=0.003), had more substantial reduction of log10 HBV DNA (3.91 vs 2.83, p<0.001) and were less likely to have lamivudine resistant mutant (21% vs 40% p=0.045) than those who received lamivudine monotherapy. The median reduction in necro-inflammatory score in the combination group and lamivudine monotherapy group were 2 and 3 respectively (p=0.21). There was no significant change in the median fibrosis score in the two treatment groups. Conclusions: In patients with HBeAg-positive chronic hepatitis B infection, combination of peginterferon alfa-2b and lamivudine yielded significantly better results than lamivudine monotherapy. |
