LAMIVUDINE THERAPY FOR CHRONIC HEPATITIS-B - A 6-MONTH RANDOMIZED DOSE-RANGING STUDY

Background & Aims: Lamivudine inhibits hepatitis B virus replication. This study investigated 6 months of lamivudine treatment at three dose s. Methods: Fifty-one patients(43% white, 49% Asian) with chronic hepa titis B were randomly assigned to receive 25,100, or 300 mg of lamivud ine ovally once daily for 24 weeks with 24 weeks' follow-up. Results: Serum hepatitis B DNA by liquid hybridization decreased in all patient s and was undetectable at the end of the treatment in 7 of 12 (58%, 25 mg), 13 of 14 (93%, 100 mg), and 14 of 16 (88%, 300 mg) patients. Of the 36 patients with abnormal alanine aminotransferase (ALT) levels at baseline, 7 of 11 (64%, 25 mg), 5 of 11 (45%, 100 mg), and 5 of 14 (3 6%, 300 mg) normalized ALT at treatment completion. Quantitative decre ases hepatitis Be antigen and hepatitis B surface antigen concentratio ns were observed at ail doses. In most patients, markers of replicatio n returned after treatment. Two patients (4%) were anti-HBe positive a t the end of follow-up. Lamivudine was well tolerated. the incidence o f adverse events was similar across all dose groups. However, 2 patien ts developed temporary hepatic decompensation after-increase in transa minase levels after treatment. Conclusions: Lamivudine was well tolera ted and induced sustained suppression of hepatitis B replication durin g treatment in all patients at all doses. These data support investiga tion of longer treatment durations of 100 mg once daily.