Efficacy and safety of pegylated interferon alpha-2a (40 KD) plus ribavirin for treatment of chronic hepatitis C and cirrhosis in Iranian patients

BACKGROUND/OBJECTIVES: Pegylation of interferon (IFN) prolongs the medication half-life, which has resulted in introducing pegylated interferon (Peg-IFN) as the new modality for treatment of chronic hepatitis C. As the first experience in Iran, this clinical trial was conducted to assess the efficacy and safety of Peg-INF in combination with ribavirin in a number of Iranian patients with chronic hepatitis C or cirrhosis. METHODS: Fifty-two patients with HCV RNA in serum, persistently elevated aminotransferase levels, and chronic hepatitis (n = 45) or cirrhosis (n = 7) on liver biopsy were enrolled to this study. The patients received Peg-IFN (40 KD) 180 micg per week plus ribavirin 10-15 mg/kg per day. Treatment lasted 48 weeks and was followed by a 24-week follow-up period to assess sustained virologic response (SVR). The patients consisted of 46 males and 6 females, with a mean age of 38.5 ± 10.9 years. RESULTS: In an intention-to-treat analysis, HCV RNA was undetectable in 43 patients (83.7%) at week 48 and SVR was achieved in 28 patients (53.8%). Among non-responders/relapsers, HCV genotype was 1a or 1b in 8 patients, 3a in one patient, and non-typeable in the last case. SVR was achieved in 62.9% of naive patients, 35.3% of the patients who had a past failed treatment with IFN-based therapy, 60.0% of patients with chronic hepatitis, and 14.3% of cirrhotic patients. In two patients (3.8%), an adverse event led to treatment discontinuation, and in eight patients (15.3%), dose modification of medication was required. CONCLUSION: Combination therapy with Peg-IFN plus ribavirin showed a promising SVR rate and acceptable tolerability in Iranian patients. The SVR among previously treated cases was high and among cirrhotic cases was low when compared with other similar studies from other countries.