Background and aim: Although the anti-hepatitis C virus (HCV) effect of statins in vitro and clinical efficacy of fluvastatin combined with Pegylated interferon (PEG-IFN)/ribavirin therapy for chronic hepatitis C (CHC) have been reported, the details of clinical presentation are largely unknown. We focused on viral relapse that influences treatment outcome, and performed a post-hoc analysis by using data from a randomized controlled trial.
Methods: Thirty-four patients in the fluvastatin group and 33 patients in the non-fluvastatin group who achieved virological response (complete early virological response [cEVR] or late virological response [LVR]) with PEG-IFN/ribavirin therapy were subjected to this analysis. Factors contributing to viral relapse were identified by using multiple logistic regression analysis.
Results: Relapse rate in patients with cEVR was significantly lower in the fluvastatin group (2 of 23, 8.7%) than in the non-fluvastatin group (9 of 26, 34.6%; P = 0.042). The use of fluvastatin decreased relapse rate in patients with LVR (27.3% vs 57.1%), though not significantly. Overall, relapse rate was significantly lower in the fluvastatin group (14.7%; 5 of 34) than in the non-fluvastatin group (39.4%; 13 of 33; P = 0.027). Multivariate analysis identified absence of fluvastatin (P = 0.027, odds ratio [OR] = 3.98, 95% confidence interval [CI] = 1.05-15.11) and low total ribavirin dose (P = 0.002, OR = 2.41, 95% CI = 1.38-4.19) as independent factors contributing to relapse.
Conclusion: The concomitant addition of fluvastatin significantly suppressed viral relapse, resulting in the improvement of sustained virological response rate, in PEG-IFN/ribavirin therapy for CHC patients with HCV genotype 1b and high viral load.
© 2012 Journal of Gastroenterology and Hepatology Foundation and Wiley Publishing Asia Pty Ltd.