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Ribavirin Monotherapy for Chronic Hepatitis C Infection

A Cochrane Hepato-Biliary Group Systematic Review and Meta-Analysis of Randomized Trials

Brok, Jesper, M.D.; Gluud, Lise L., Dr.Med.Sc.; Gluud, Christian, Dr.Med.Sc.

American Journal of Gastroenterology: April 2006 - Volume 101 - Issue 4 - p 842–847
CLINICAL REVIEW
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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.

The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen University Hospital, Denmark

Reprint requests and correspondence: Jesper Brok, M.D., The Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Center for Clinical Intervention Research, Department 7102, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen, Denmark.

Received September 9, 2005; accepted November 14, 2005.

© The American College of Gastroenterology 2006. All Rights Reserved.
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