RESUMEN
Background and aims: pegylation of Interferon 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 naïve 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