Pegaferon in hepatitis C: results of a multicenter study

ABSTRACT

Chronic hepatitis C [CHC] is a major contributor to cirrhosis and hepatocellular carcinoma and major global public health problem that causes mortality in both developed and developing countries. For the past decade, treatment with pegylated interferon [peg interferon alpha] ribavirin [RBV] has been associated with rates of sustained virologic response of patients with hepatitis C virus [HCV] infection. In this study, we report the response rate of Iranian treatment-na‹ve CHC patients to Pegaferon, a locally developed pegylated interferon-alpha2a [PEG-IFN alpha2a]. Patients diagnosed with CHC who referred to two university based outpatient clinics in Tehran from December 2007 to May 2011 were enrolled in a single-group, open-labeled experimental design. Eligible patients were above 15 years of age and had HCV infection with evidence of chronic hepatitis. Exclusion criteria included the presence of a debilitating disease, decompensated cirrhosis or refusal to participate in the study. Patients were treated with 180 micro g Pegaferon weekly in addition to 800-1200 mg daily, weight-based RBV for 24 or 48 weeks depending on genotype. Viral response and adverse effects were recorded. A total of 216 patients were enrolled in the study of which 83.3% were male and 16.7% were female. In 93 [43.1%] patients, the HCV RNA viral load was >/= 800,000 IU/ml before starting treatment. "As-treated analysis" indicated that a total of 168 [77.8%] patients achieved sustained viral response [SVR, undetectable plasma HCV RNA 24 weeks after the last planned dose of study treatment]. This study, with a larger number of participants, confirms the results of a previous study by the authors that Pegaferon, a PEG-IFN alpha 2a locally produced in Iran, is effective in treatment-na‹ve CHC patients