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Comparative study of the efficacy of an induction dose of interferon‐α2b with ribavirin compared with standard combined treatment in naive patients with chronic hepatitis C

Summary. The efficacy and secondary effects of an induction dose of interferon‐α2b (IFN‐α2b) with ribavirin compared with standard combined treatment in naive patients with chronic hepatitis C infection were compared. A prospective study was undertaken between March 1998 and November 2001 in which 84 Spanish hospitals took part. Six hundred and fourteen naive patients (age range 18–65 years) diagnosed with chronic hepatitis C virus (HCV) infection and without cirrhosis or co‐infection by other viruses, were included. Patients were divided into two groups. Group A (n = 304) received induction treatment with a daily dose of 5 MU of IFN‐α2b for 4 weeks, followed by 5 MU three times a week with ribavirin (1000–1200 mg/day, according to weight) until completing 1 year of treatment. Group B (n = 310) received the standard dose of IFN‐α2b of 3 MU three times per week for 48 weeks together with ribavirin (1000–1200 mg/day, according to weight). Both groups were completely comparable according to age, gender, body weight, transaminase levels, genotype, viral load and hepatic inflammatory activity (Knodell Index). No control group was included for ethical reasons. Pegylated interferon was not available at the time of the study. Serum baseline samples were collected for the determination of genotype. Samples were also collected at baseline, weeks 4, 12, 24, 48 and 72, in order to detect and quantify HCV‐RNA. The efficacy of treatment was evaluated by means of sustained viral response (SVR) characterized by persistent negativity of HCV‐RNA at the end of the follow‐up period.