Efficacy and Safety of Pegylated Interferon Alfa-2a plus Ribavirin for Treatment of Chronic Hepatitis C and Cirrhosis in Iranian

Background and Aims: 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. 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%). 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%) adverse event led to treatment discontinuation and in eight patients (15.3%) dose modification of medication was required.

Conclusion: This study showed that combination therapy with PEG-IFN plus ribavirin was associated with a promising SVR rate and acceptable tolerability in Iranian patients. This regimen may be effective for patients who failed prior IFN-based treatment.