Ribavirin monotherapy for chronic hepatitis C.
BACKGROUND
Hepatitis C is a major cause of liver-related morbidity and mortality. The disease progresses without symptoms for several decades. Ribavirin monotherapy may represent a treatment for some patients.


OBJECTIVE
To assess the beneficial and harmful effect of ribavirin monotherapy for patients with chronic hepatitis C.


METHODS
We identified trials through electronic databases, manual searches of bibliographies and journals, authors of trials, and pharmaceutical companies until May 2005.


METHODS
We included all randomised trials irrespective of blinding, language, or publication status comparing ribavirin versus no intervention, placebo, or interferon for chronic hepatitis C.


METHODS
The primary outcome measures were the six months sustained loss of hepatitis C virus RNA in blood after end of treatment and liver-related morbidity plus all-cause mortality. Secondary outcome measures were end of treatment virological response, biochemical response, histological response, and adverse events. Random- and fixed-effects meta-analyses with 95% confidence intervals (CI) were performed for all outcomes. We used Peto odds ratios (OR) for analysis of morbidity plus mortality and relative risks (RR) for the remaining outcomes.


RESULTS
We identified 13 randomised trials including 594 patients with chronic hepatitis C. Most trials had low methodological quality. Compared with placebo/no intervention, ribavirin had no significant effect on sustained (RR 1.01, 95% CI 0.96 to 1.07, five trials) or end of treatment virological response (RR 1.00, 95% CI 0.94 to 1.07, ten trials). Ribavirin had no significant effect on liver-related morbidity plus mortality (Peto OR 1.96, 95% CI 0.20 to 19.0, eleven trials). Ribavirin significantly improved end of treatment biochemical and histological response but not sustained biochemical response. Further, ribavirin significantly increased the risk of anaemia. Ribavirin was significantly inferior to interferon regarding virological and biochemical response (four trials).


CONCLUSIONS
We found that ribavirin versus placebo/no intervention had no significant beneficial effect on virological response and liver morbidity, but may improve biochemical and histological response transiently. Ribavirin increased the risk of anaemia. Therefore, we cannot recommend ribavirin monotherapy for patients with chronic hepatitis C outside randomised trials.
Brok
J
J
Centre for Clinical Intervention Research, Copenhagen University Hospital, Copenhagen Trial Unit, Department 7102, H:S Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark 2100 Ø. jbrok@ctu.rh.dk
Gluud
L  L
L
Gluud
C
C
D000998:Antiviral Agents / Q000627:therapeutic use*; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D012254:Ribavirin / Q000627:therapeutic use*
D000998:Antiviral Agents; D012254:Ribavirin