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Ribavirin monotherapy for chronic hepatitis C
Jesper Brok1, Lise Lotte Gluud, Christian Gluud
1Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, Denmark, DK-2100.
Insights
Ribavirin monotherapy for hepatitis C showed no significant benefit in virological response or mortality but increased adverse events like anemia. It is less effective than interferon and not recommended outside clinical trials.
Area of Science:
- Hepatology
- Infectious Diseases
- Clinical Pharmacology
Background:
- Chronic hepatitis C is a significant global health concern, leading to liver disease and mortality.
- While peginterferon plus ribavirin is standard, ribavirin monotherapy is sometimes considered.
- Understanding the efficacy and safety of ribavirin monotherapy is crucial for treatment decisions.
Purpose of the Study:
- To evaluate the beneficial and harmful effects of ribavirin monotherapy in chronic hepatitis C patients.
- To compare ribavirin monotherapy against placebo, no intervention, or interferon.
Main Methods:
- Systematic review and meta-analysis of 14 randomized controlled trials involving 657 patients.
- Primary outcomes included sustained virological response, liver-related morbidity, all-cause mortality, and adverse events.
- Data analysis employed fixed-effect and random-effects models, presenting results as risk difference with 95% confidence intervals.
Main Results:
- Ribavirin monotherapy showed no significant effect on sustained or end-of-treatment virological response compared to placebo.
- No significant impact on liver-related morbidity or mortality was observed.
- Ribavirin significantly increased adverse events, particularly anemia, and was inferior to interferon in virological and biochemical responses.
Conclusions:
- Ribavirin monotherapy demonstrates no clear benefits for virological response or liver disease outcomes in chronic hepatitis C.
- The therapy significantly elevates the risk of adverse reactions and is less effective than interferon.
- Ribavirin monotherapy is not recommended outside of rigorous randomized clinical trials due to limited efficacy and safety concerns.
Background:
Hepatitis C is a major cause of liver-related morbidity and mortality. A high proportion of patients never experience symptoms. Peginterferon plus ribavirin is the recommended treatment for chronic hepatitis C. However, ribavirin monotherapy may be considered for some patients.
Objectives:
To assess the beneficial and harmful effects of ribavirin monotherapy for patients with chronic hepatitis C.
Search Strategy:
We identified trials through electronic databases, manual searches of bibliographies and journals, authors of trials, and pharmaceutical companies until March 2009.
Selection Criteria:
We included all randomised trials irrespective of blinding, language, or publication status comparing ribavirin versus no intervention, placebo, or interferon for chronic hepatitis C.
Data Collection And Analysis:
The primary outcome measures were serum sustained virological response (loss of hepatitis C virus RNA at least six months after treatment), liver-related morbidity plus all-cause mortality, and adverse events. Secondary outcome measures were end of treatment virological response, biochemical response (transaminase activity), and histological response. Randomisation methods, blinding, data handling, and funding were extracted as measures of bias control. Random-effects and fixed-effect meta-analyses were performed for all outcomes. We only present the results of the fixed-effect model if both models provide the same result regarding statistical significance. We present data as risk difference (RD) with 95% confidence intervals (CI).
Main Results:
We included 14 randomised trials with 657 patients. The majority of trials had unclear control of bias. Compared with placebo or no intervention, ribavirin had no significant effect on the sustained virological response (RD 0%, 95% CI -2% to 3%, five trials) or end of treatment virological response (RD 0% 95% CI -3% to 3%, ten trials). Ribavirin had no significant effect on liver-related morbidity plus mortality (RD 0%, 95% CI -2% to 3%, 11 trials). Ribavirin significantly increased the risk of adverse reactions, including anaemia. Ribavirin significantly improved end of treatment biochemical and histological response but not the sustained biochemical response. Ribavirin was significantly inferior to interferon regarding virological and biochemical responses (five trials).
Authors' Conclusions:
Ribavirin seems without beneficial effects on serum virological response and liver-related morbidity or mortality, and significantly increased the risk of adverse reactions. Ribavirin monotherapy seems significantly inferior to interferon monotherapy. The total number of included patients is small, and more trials are perhaps needed. The use of ribavirin monotherapy for chronic hepatitis C cannot be recommended outside randomised trials.
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