A PILOT, OPEN-LABELED, PHASE-II STUDY USING ORAL RIBAVIRIN IN THE TREATMENT OF PATIENTS WITH CHRONIC ACTIVE HEPATITIS-B

Background: Ribavirin is a synthetic purine nucleoside with demonstrat ed antiviral activity against several DNA and RNA viruses. Objectives: An open-labelled pilot study to evaluate the safety and effect of rib avirin in the treatment of patients with chronic active hepatitis B (C AH-B). Study design: 24 CAH-B patients were treated with oral ribaviri n 1200 mg daily in 3 divided doses for 4 weeks. Biochemical and virolo gical parameters were monitored at regular interval during and after t reatment. Results: The serum hepatitis B e antigen (HBeAg) and HBV DNA measured by dot-blot hybridization were positive in all patients befo re treatment. At the end of 4 weeks of therapy, the HBV DNA levels dec reased in 15 (63%) patients and became undetectable in 1 (4%) of these individuals. The mean HBV DNA decreased from 288 +/-78 pg/ml at basel ine to 219+/-79 pg/ml at the end of the 4 weeks of treatment (p=0.046) . Eight weeks after cessation of treatment, HBV DNA was undetectable i n 10 (42%) patients, and the mean HBV DNA was 46+/-23 pg/ml (p<0.001 w hen compared to mean baseline value). Seven (29%) patients seroconvert ed from HBeAg positive to anti-HBe positive but no patients lost hepat itis B surface antigen (HBsAg) during the 8 weeks of follow-up, At the end of 4 weeks of ribavirin treatment, serum levels of alanine aminot ransferase (ALT) decreased in all but 1 patient; only 1 patient normal ized serum ALT at this time. The mean serum ALT decreased significantl y from 416+/-72 IU/1 at baseline to 179+/-35 IU/1 at the end of 4 week s of treatment (p=0.001). Eight weeks after cessation of therapy, the mean serum ALT value was 151+/-32 IU/1 (p<0.001 when compared to mean baseline value) and 5 (21%) patients normalized serum ALT at this time , During ribavirin treatment, the main side effect was a decrease in t he hemoglobin level which returned to the pretreatment level in each i nstance within 2 months after discontinuance of therapy.