Background: The efficacy of interferon-alpha plus ribavirin treatment for patients not responding to interferon monotherapy is not well established.
Aim: To assess the efficacy and safety of combination therapy with interferon-alpha 2a/2b plus ribavirin by performing a meta-analysis of randomized clinical trials.
Methods: A systematic search of electronic databases for randomized clinical trials of interferon-alpha 2a/2b plus ribavirin was conducted independently by two investigators. Data abstraction was performed. The primary end-point was a sustained virological response. Estimates of the common odds ratio were calculated using a random effects model.
Results: Of the 127 identified studies, 46 were considered for evaluation and 10 were included (1728 patients). The pooled sustained virological response was 12.6% (95% CI, 9.5-16.3%) for combination therapy vs. 2% (95% CI, 0.9-4.0%) for interferon monotherapy, with a common odds ratio of 5.49. Higher doses of interferon, a longer duration of therapy (48 weeks) and genotypes other than 1 and 4 were associated with an improvement in response. More side-effects and discontinuations were observed with combination therapy than with interferon monotherapy.
Conclusions: Non-responders to interferon may benefit from re-treatment with combination therapy, especially from a 48-week regimen.