Purpose: Low-density lipoprotein (LDL) is involved in hepatitis C virus (HCV) life-cycle and may be regarded as a prognostic indicator of treatment response in patients with HCV infection. Fluvastatin, a hydroxy-methyl-glutaryl-coenzyme-A reductase inhibitor, has demonstrated in vitro antiviral activity by inhibiting HCV replication and modulating T-cell activation. However, in vivo data on the efficacy and safety of fluvastatin for the treatment of HCV are limited. The purpose of this study was to evaluate the safety and antiviral effects of fluvastatin monotherapy in patients with chronic hepatitis C. Methods: This randomized, double-blinded, placebo-controlled study was conducted in a single tertiary care hospital (Rajavithi hospital, Bangkok, Thailand) between April 2009 and May 2010. Patients with chronic HCV infection who were unable to receive or tolerate, or did not respond to standard therapy were included in the study. Eligible patients were randomly assigned either to receive fluvastatin 80 mg tablet (n=17) or an identical placebo tablet (n=16) once daily for 12 weeks. Biochemical, virological, and safety parameters (symptoms and serum creatine kinase) were assessed at baseline, then every month during treatment period. Results: Thirty-three HCV patients were enrolled and completed study. Twenty patients (61%) were women and the median age was 50 years. Baseline LDL and alanine aminotransferase (ALT) levels were 100 (30-217) mg/dl and 71 (22-179) U/L, respectively. Baseline median HCV-RNA was 859,386 (1,402-4,393,059) IU/ml; 61% were genotype 3, 24% were genotype 1 and 15% were genotype 6. After 12 weeks of treatment, there was no difference in ALT reduction between groups (p>0.99). Six of 17 patients (35.3%) in the fluvastatin group achieved HCV-RNA decreased > 0.5 log10 compared to 0/16 in the placebo group during treatment (P=0.018). Among 17 patients in fluvastatin group, the significant predictor of response was higher baseline HCVRNA (p<0.001). Treatment was well-tolerated and no serious adverse events were reported in both groups. Myalgia was more frequently reported in the fluvastatin group (P=0.019); all were mild and spontaneously resolved without requiring dose modification. Conclusion: Fluvastatin is safe and effective in achieving HCV-RNA reduction in patients with chronic hepatitis C.Table: Treatment outcomes - fluvastatin monotherapy in HCV patients