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 str ong predictor of failure of alpha-interferon therapy for chronic hepatitis C, Therefore we compared the efficacy of ribavirin addition to alpha-interf eron with a doubling of the dosage of alpha-interferon in case of lack of e arly virological response to alpha-interferon therapy, Methods: Sixty patients were administered interferon alpha 2b at the dosage of 3 million units 3 times a week, After the first 4 weeks of therapy, ser um 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 alpha-interferon plus ribavirin (1000 mg/day) or double dosage of alpha-interferon (6 millio n units tiw) for 11 months, We considered sustained response to be the main tenance of normal alanine aminotransferase and negativity at HCV-RNA testin g until the end of a 6-month post-treatment follow-up. Results: After the first 4 weeks of treatment, 12 (20%) patients showed vir ological response and 48 patients (80%) remained positive on HCV-RNA testin g. Sustained response was observed in 5/12 (42%) patients with early virolo gical response, in 10/24 (42%) patients without early virological response who were administered ribavirin and alpha-interferon, and in only 1/24 (4%) patients who were administered the double dosage of alpha-interferon (p=0. 006). Conclusions: This study shows the efficacy of the addition of ribavirin to alpha-interferon and the lack of efficacy of doubling the dosage of alpha-i nterferon in patients without clearance of hepatitis C virus early on in tr eatment.