Early addition of ribavirin to interferon in chronic hepatitis C not responsive to interferon monotherapy

Background/Aim: Persistence of HCV-RNA in serum early in treatment is a strong predictor of failure of α-interferon therapy for chronic hepatitis C. Therefore, we compared the efficacy of ribavirin addition to α-interferon with a doubling of the dosage of α-interferon in case of lack of early virological response to α-interferon therapy. Methods: Sixty patients were administered interferon α2b at the dosage of 3 million units 3 times a week. After the first 4 weeks of therapy, serum HCV-RNA was evaluated. The patients with negative HCV-RNA test received the same treatment for a further 11 months, while those with detectable HCV-RNA were randomized to receive either the same dosage of α-interferon plus ribavirin (1000 mg/day) or double dosage of α-interferon (6 million units tiw) for 11 months. We considered sustained response to be the maintenance of normal alanine aminotransferase and negativity at HCV-RNA testing until the end of a 6-month post-treatment follow-up. Results: After the first 4 weeks of treatment, 12 (20%) patients showed virological response and 48 patients (80%) remained positive on HCV-RNA testing. Sustained response was observed in 5/12 (42%) patients with early virological response, in 10/24 (42%) patients without early virological response who were administered ribavirin and α-interferon, and in only 1/24 (4%) patients who were administered the double dosage of α-interferon (p=0.006). Conclusions: This study shows the efficacy of the addition of ribavirin to α-interferon and the lack of efficacy of doubling the dosage of α-interferon in patients without clearance of hepatitis C virus early on in treatment.