Safety and efficacy of locally manufactured pegylated interferon in hepatitis C patients.

Background: To evaluate the safety and effectiveness of locally produced pegylated interferon-alpha2a in treatment-naïve patients with chronic hepatitis C.

Methods: All treatment-naïve patients diagnosed with chronic hepatitis C who referred to two university based outpatient clinics in Tehran from December 2007 to May 2008 were enrolled. Exclusion criteria included the presence of a debilitating disease, decompensated cirrhosis, or refusal to participate in the study. Patients were treated with 180 microg pegylated interferon-alpha2a (Pegaferon) weekly and 800 - 1200 mg ribavirin daily for 24 or 48 weeks depending on genotype and weight. Viral and biochemical response and adverse drug reactions were recorded.

Results: A total of 108 patients were enrolled; 63 with genotype 1 and 45 with genotypes 2 and 3. The mean age of the patients was 39 years (range: 19 - 65). Ninety-seven patients completed the study and 76 achieved sustained viral response. The sustained viral response among patients completing the study was 67% for genotype 1 and 95% for genotypes 2 and 3. Adverse events were well tolerated and none led to discontinuation of treatment, however dose adjustment was necessitated in 16 patients. The most common adverse events were fatigue (73.5%), poor appetite (66.2%), and feverishness (57.4%). The mean hemoglobin drop was 2.9 g/dL.

Conclusion: Locally produced PEG-IFN in Iran is safe and effective in treatment-naïve chronic hepatitis C.