Extended peginterferon alfa-2a (Pegasys) therapy in Chinese patients with HBeAg-negative chronic hepatitis B.

The present study compared the efficacy of standard and extended durations of PEG-IFNα-2a monotherapy for treatment of HBeAg-negative Chinese patients with chronic hepatitis B. Patients were randomized to receive standard therapy (n = 38; 48 weeks treatment) or extended therapy (n = 42; 72 weeks treatment). Extended therapy resulted in a significantly higher HBV DNA inhibition at 24 and 48 weeks after the end of treatment, a significantly higher sustained HBV DNA inhibition at the end of treatment, and a significantly lower HBsAg level at 24 and 48 weeks after the end of treatment (P < 0.05 for all comparisons). The HBsAg clearance rate was significantly greater in the extended therapy group than in the standard therapy group at 24 and 48 weeks post-treatment (33.3% vs. 10.5% and 35.7% vs. 10.5%, respectively; P < 0.05 for both). In addition, patients with an increase of more than 1 log10  IU/ml in HBsAg level from baseline to week 24 had a significantly lower level of HBsAg at end of treatment (0.54 ± 1.76 vs. 2.89 ± 1.27, P < 0.001), but a higher level of HBsAg clearance (64.3% vs. 7.6%, P < 0.001). Assessment of HBsAg level at week 24 appears to be a suitable checkpoint. These results indicate that 72 weeks of PEG-IFNα-2a monotherapy benefits HBeAg-negative Chinese patients with chronic hepatitis B who are infected with HBV genotype B or C.

RCT Entities:   Population Interventions Outcomes