F Fabrizi1, G Lunghi, V Dixit, P Martin. 1. Division of Nephrology, Maggiore Hospital, IRCCS, Milan, Italy. fabrizi@policlinico.mi.it
Abstract
BACKGROUND: The efficacy and safety of interferon-based therapy in renal transplant recipients with hepatitis C remains unclear, although a number of small clinical trials have been published addressing this issue. AIM: To evaluate efficacy and safety of antiviral therapy with interferon (interferon alone or interferon plus ribavirin) in renal transplant patients with hepatitis C by performing a systematic review of the literature with a meta-analysis of clinical trials. METHODS: The primary outcomes were sustained virological response (as a measure of efficacy) and/or drop-out rate (as a measure of tolerability). We used the random-effects model of DerSimonian and Laird, with heterogeneity and sensitivity analysis. RESULTS: We identified 12 clinical trials (102 unique patients); there was one controlled study. The summary estimate for sustained virological response and drop-out rate was 18.0% (95% CI 7.0-29.0%) and 35.0% (95% CI 20-50%), respectively. The most frequent side-effect requiring interruption of treatment was graft dysfunction (n = 28; 71.7%). Meta-regression analysis showed an inverse and significant association between reference year and drop-out logit rate (P = 0.012); an inverse link between sustained virological response logit rate and frequency of hepatitis C virus genotype 1 (P = 0.067) and cirrhosis (P = 0.08) was found, even if no statistical significance was reached. No publication bias was observed. CONCLUSIONS: Interferon-based therapy of hepatitis C has poor tolerance and safety after renal transplant. The optimal treatment of hepatitis C after renal transplant requires additional agents or alternative therapeutic approaches.
BACKGROUND: The efficacy and safety of interferon-based therapy in renal transplant recipients with hepatitis C remains unclear, although a number of small clinical trials have been published addressing this issue. AIM: To evaluate efficacy and safety of antiviral therapy with interferon (interferon alone or interferon plus ribavirin) in renal transplant patients with hepatitis C by performing a systematic review of the literature with a meta-analysis of clinical trials. METHODS: The primary outcomes were sustained virological response (as a measure of efficacy) and/or drop-out rate (as a measure of tolerability). We used the random-effects model of DerSimonian and Laird, with heterogeneity and sensitivity analysis. RESULTS: We identified 12 clinical trials (102 unique patients); there was one controlled study. The summary estimate for sustained virological response and drop-out rate was 18.0% (95% CI 7.0-29.0%) and 35.0% (95% CI 20-50%), respectively. The most frequent side-effect requiring interruption of treatment was graft dysfunction (n = 28; 71.7%). Meta-regression analysis showed an inverse and significant association between reference year and drop-out logit rate (P = 0.012); an inverse link between sustained virological response logit rate and frequency of hepatitis C virus genotype 1 (P = 0.067) and cirrhosis (P = 0.08) was found, even if no statistical significance was reached. No publication bias was observed. CONCLUSIONS: Interferon-based therapy of hepatitis C has poor tolerance and safety after renal transplant. The optimal treatment of hepatitis C after renal transplant requires additional agents or alternative therapeutic approaches.