Ribavirin monotherapy for chronic hepatitis C infection: a Cochrane Hepato-Biliary Group systematic review and meta-analysis of randomized trials

OBJECTIVES: Adding ribavirin to interferon improves treatment response for patients with chronic hepatitis C, but the effects of ribavirin monotherapy are unclear. We conducted a systematic review to assess the benefits and harms of ribavirin monotherapy for patients with chronic hepatitis C. METHODS: Randomized trials were identified through the Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Library, MEDLINE, and EMBASE (last search May 2005). The primary outcomes were sustained virological response (loss of HCV RNA) and liver-related morbidity plus all-cause mortality. Secondary outcomes included end-of-treatment virological response, biochemical response (normalization of transaminases), histological response, and adverse events. RESULTS: We included 11 randomized trials with 521 patients. Ten trials had unclear control of bias. Ribavirin had no significant effect on sustained (risk difference (RD), 0%; 95% confidence intervals (CI), -2% to 3%) or end-of-treatment virological response (RD, 0%; 95% CI, -3% to 3%). Ribavirin had no significant effect on liver-related morbidity plus mortality (RD, 0%; 95% CI, -2% to 3%). Ribavirin significantly improved histological response and end-of-treatment biochemical response, but not sustained biochemical response. Ribavirin significantly increased the risk of anemia and treatment discontinuation. CONCLUSIONS: We found no evidence to support ribavirin monotherapy for patients with chronic hepatitis C, but trials were small and type II errors cannot be excluded. Patients intolerant to interferon should not continue treatment with ribavirin alone outside randomized trials.