Efficacy of treatment with lamivudine in patients with chronic active e-minus variant hepatitis B virus infection: A nonrandomized, open-label study

Objective: The aim of the present study was to assess the efficacy of lamiv udine in the treatment of chronic active hepatitis B virus (HBV) infection in patients with the e-minus variant (HBeAb-HBV DNA positive). Background: Lamivudine is a nucleoside analogue that inhibits the synthesis of DNA. Its efficacy in the treatment of chronic HBV infection of the wild type and the e-minus variant has recently been demonstrated. Methods: The study patients, all of whom were nonresponders to previous the rapy with interferon alfa, were assigned to receive oral lamivudine (group A; n = 10) or placebo (group B; n = 8). Eleven patients had chronic active hepatitis and 7 had cirrhosis; the average histologic score was 13. The tre atment period lasted 52 weeks. Results: All patients completed the study. At week 52, 7 of 10 patients sho wed evidence of clearance of HBV DNA and 6 of 10 had normal serum alanine a minotransferase (ALT) levels. At the end of the 12-month follow-up period, only 2 patients still showed both the virologic and biochemical response, w hereas the other patients had relapsed. The histologic test at the end of t he follow-up period showed a sustained response in 2 patients-a reduction o f greater than or equal to 2 points in the necroinflammatory score. No sign ificant differences in response were noted between the 2 groups. Conclusions: Lamivudine 100 mg/d administered orally for 52 weeks may be ef fective in normalizing serum ALT levels and HBV DNA negativity in patients with chronic active e-minus variant HBV infection who do not respond to ant iviral therapy with interferon alfa. The long-term results were modest, how ever, with frequent relapses, even considering the difficult type of patien ts included in our study (ie, interferon alfa nonresponders).