Academy of Medical Sciences of Islamic Republic of Iran Archives of Iranian Medicine 1029-2977 13 4 2010 7 1 Safety and Efficacy of Locally Manufactured Pegylated Interferon in Hepatitis C Patients EN Hossain Jabbari Digestive Disease Research Center, Tehran University of Medical Sciences, Iranian Research Center for HIV/AIDS (IRCHA), Tehran University of Medical Sciences, Tehran 14117, Iran. Ayatollah Bayatian Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran 14117, Iran. Amir Houshang Sharifi Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran 14117, Iran. Hanieh Zaer-Rezaee Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran 14117, Iran. Elham Fakharzadeh Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran 14117, Iran. Reyhaneh Asadi Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran 14117, Iran. Hediyeh Zamini Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran 14117, Iran. Kiana Shahzamani Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran 14117, Iran. Shahin Merat Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran 14117, Iran. Mohsen Nassiri-Toosi Digestive Disease Research Center, Tehran University of Medical Sciences, Tehran 14117, Iran. BACKGROUND: To evaluate the safety and effectiveness of locally produced pegylated interferon-α2a 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 μg pegylated interferon-α2a (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. ClinicalTrials.gov identifier: NCT01137383