Author/Authors :
Jabbari, Hossain tehran university of medical sciences tums - Digestive Disease Research Center,, تهران, ايران , Jabbari, Hossain tehran university of medical sciences tums - Iranian Research Center for HIV/AIDS(IRCHA), تهران, ايران , Bayatian, Ayatollah tehran university of medical sciences tums - Digestive Disease Research Center, تهران, ايران , Sharifi, Amir Houshang tehran university of medical sciences tums - Digestive Disease Research Center, تهران, ايران , Zaer-Rezaee, Hanieh tehran university of medical sciences tums - Digestive Disease Research Center, تهران, ايران , Fakharzadeh, Elham tehran university of medical sciences tums - Digestive Disease Research Center, تهران, ايران , Asadi, Reyhaneh tehran university of medical sciences tums - Digestive Disease Research Center,, تهران, ايران , Zamini, Hediyeh tehran university of medical sciences tums - Digestive Disease Research Center, تهران, ايران , Shahzamani, Kiana tehran university of medical sciences tums - Digestive Disease Research Center, تهران, ايران , Merat, Shahin tehran university of medical sciences tums - Digestive Disease Research Center, تهران, ايران , Nassiri-Toosi, Mohsen tehran university of medical sciences tums - Digestive Disease Research Center,, تهران, ايران
Abstract :
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 debilitat- ing 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 geno- types 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. Conclusions: Locally produced PEG-IFN in Iran is safe and effective in treatment-naïve chronic hepatitis C. ClinicalTri- als.gov identifier: NCT01137383
