Evaluation of long-term efficacy of interferon alpha-2b and ribavirin in combination in naive patients with chronic hepatitis C: an Italian multicenter experience

Background/Aims: A combination of interferon alpha and ribavirin has been s uggested to reach a higher rate of sustained virological response in patien ts with chronic hepatitis C than monotherapy, In this study we assessed the long-term efficacy of this combination therapy in the treatment of selecte d Italian naive chronic hepatitis C patients compared to interferon alpha m onotherapy, Methods: We enrolled 428 naive patients who were randomly assigned to recei ve either recombinant interferon alpha-2b and ribavirin for 24 weeks or int erferon alpha-2b alone for 48 weeks. The primary endpoint of the study was the rate of sustained virological response. Serum HCV RNA levels were deter mined before treatment; during treatment at weeks 12 and 24 in the patients receiving the combination therapy; at weeks 12, 24, 36 and 48 in the patie nts receiving monotherapy; and after therapy at weeks 12, 24 and 48 in the patients in both study groups. Results: Sustained virological response was observed in 43% of the patients treated with combination therapy and in 14% of the patients treated with m onotherapy, Logistic regression analysis showed that sustained response was associated with the combination therapy, with HCV genotype other than 1b w ith an HCV viral load of 3x10(6) copies/ml or less, with an inflammation sc ore of 7 or less, and with an estimated duration of disease of 10 years or less. Conclusions: A 24-week treatment course with interferon alpha-2b and ribavi rin offers a greater chance of sustained virological response compared to t reatment with interferon alpha-2b alone for 48 weeks, and may be indicated as initial therapy in such patients.