Efficacy and safety of Interferon-alpha (PDferon B®) and Ribavirin Combination Therapy in patients with Chronic Hepatitis C in Iran

Background and Aims: There are different treatment regimens for chronic HCV (CHC). The regimen that combines interferon a (IFN a) and ribavirin (RIBA) is one of the best known effective regimens. Aim: to assess the therapeutic efficacy (as end treatment and sustained response) and safety of a particular brand of IFN a (PDferon B®) in combination with RIBA on Iranian patients with CHC considering genotype characteristics of subjects. Methods: A quasi-experimental study of 176 adult patients with chronic hepatitis C, regardless of previous IFN a treatment carried out between December 2002 and February 2006 in Tehran Hepatitis Center and then divided in two comparison groups: group 1 with genotype (la, Ib, non-typable) treated for 48 weeks and group 2 with genotype 2,3 (2a,3a,3b) treated for 24 weeks. Treatments consisted of 48 or 24 weeks of 3 million units subcutaneous PDferon B® three times weekly pius 1000-1200 mg oral RIBA twice daily depending on body mass index (BMI). The Main outcomes were the end treatment virologic response (EVR), biochemical response (EBR) and sustained virologic response (SVR) and their influencing factors. Results: 115 patient with genotype 1 (male/female: 91/24) and 61 patients with genotype 2,3 (male/female: 50/11) were included and matched for age, BMI and cirrhosis. The rate of EVR, EBR and SVR for all patients were 76.1%,83.50/ 0 and 68.2% respectively and EVR and SVR were significantly higher in group 2 than group 1 (71.3% and 61.7% for group 1 and 85.2% and 80.3% for group 2 respectively; P 0.05). In 5.7% and 9.1% of patients adverse drug reactions led to dose modification of PDferon B® and RIBA respectively. Conclusions: The genotype and age of patients are the only two independent factors influencing efficacy of treatment either as end treatment or sustained response. The particular brand of IFN in this study (PDferon B®) in combination with RIBA had comparable adverse effects with other reports and a somewhat higher rate end treatment and sustained responses.