Background/aims: The most prevalent type of chronic hepatitis B in Turkey is anti-HBe-positive. No consistently effective therapy is yet available for the treatment of these patients. The aim of this study was to assess the efficacy and safety of interferon-alpha and thymosin-alpha 1 combination in the treatment of naive anti-HBe-positive and HBV DNA-positive chronic hepatitis B patients.
Methodology: Twenty-one patients were enrolled in the study. All patients had documented anti-HBe-positive, HBV DNA-positive chronic active hepatitis B without evidence of cirrhosis. Patients received a 26-week combination course of 1.6 mg thymosin-alpha 1 subcutaneously twice a week and 10 MIU interferon-alpha subcutaneously three times a week, followed by interferon-alpha monotherapy at the same dose for another 26 weeks. After treatment patients were observed for a further 26 weeks. Endpoints were a normalization of alanine aminotransferase and negativity of HBV DNA at weeks 52 and 78, as well as an improvement in liver histology at week 78.
Results: Eighteen (87.7%) of the 21 patients responded by losing serum HBV DNA and normalizing alanine aminotransferase values at the end of the 52-week treatment period. Sixteen (76.2%) of these patients became sustained responders, with normal alanine aminotransferase and negative HBV DNA at the end of 78 weeks. Two patients were non-responders, two relapsed and one had a breakthrough during therapy. Significant improvements in the Knodell histological activity index were observed in the responders. No adverse events other than those seen previously with interferon monotherapy were reported.
Conclusions: Combination interferon-alpha 2b and thymosin-alpha 1 treatment may provide a safe and effective therapeutic approach for the difficult-to-treat anti-HBe-positive chronic hepatitis B patients. Further controlled studies are needed to assess the full role of this treatment strategy.