RIBAVIRIN AS THERAPY FOR CHRONIC HEPATITIS-C - A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Objective: To evaluate ribavirin, an oral antiviral agent, as therapy for chronic hepatitis C. Design: Randomized, double-blind, placebo-con trolled study. Setting: Clinical Center of the National Institutes of Health, a tertiary referral research hospital. Patients: 29 patients w ith chronic hepatitis C who received oral ribavirin (600 mg twice dail y) for 12 months and 29 controls with chronic hepatitis C who received placebo for 12 months. Measurements: Effects of therapy were evaluate d by measuring serum aminotransferase and hepatitis C virus (HCV) RNA levels before, during, and for 6 months after therapy and by histologi c examination of liver specimens before and at the end of treatment. R esults: Patients treated with ribavirin had a prompt decrease in serum aminotransferase levels (54% overall) compared with levels before tre atment and levels in controls (5% decrease). Serum aminotransferase le vels became normal or nearly normal in 10 patients treated with ribavi rin (35% [95% CI, 18% to 54%]) but in no controls (0% [CI, 0% to 12%]) . Aminotransferase levels remained normal in only 2 patients after rib avirin therapy was discontinued (7% [CI, 1% to 23%]). Serum HCV RNA le vels did not change during or after therapy. Liver biopsy specimens sh owed a decrease in hepatic inflammation and necrosis among ribavirin-t reated patients whose aminotransferase levels became normal. Conclusio ns: Ribavirin has beneficial effects on serum aminotransferase levels and histologic findings in the liver in patients with chronic hepatiti s C, but these effects are not accompanied by changes in HCV RNA level s and are not sustained when ribavirin therapy is discontinued. Thus, ribavirin alone for periods as long as 12 months is unlikely to be of value as therapy for chronic hepatitis C.