Interferon-alpha-2B and ribavirin in combination for chronic hepatitis C patients not responding to interferon-alpha alone: an Italian multicenter, randomized, controlled, clinical study.

ABSTRACT

OBJECTIVE: The aim of the study was to assess the efficacy of interferon (IFN)-alpha-2b and ribavirin in combination in the treatment of chronic hepatitis C (CHC) patients unresponsive to a previous treatment with IFN-alpha-2b alone. METHODS: We conducted a randomized study in 303 CHC patients. One hundred fifty-two patients received subcutaneous administration of recombinant IFN-alpha-2b (3 MU thrice weekly) and ribavirin (1000-1200 mg/daily per os), whereas 151 received IFN-alpha-2b alone (6 MU thrice weekly). Both ribavirin and IFN-alpha-2b were given for 24 wk, regardless of treatment response. Alanine aminotransferase (ALT) levels and HCV RNA titer were checked during the treatment period and for a further 24 wk. RESULTS: Normal ALT levels were observed in 64.5% of the patients treated with IFN-alpha and ribavirin and in 22.6% of the patients treated with IFN-alpha alone. In the group of patients receiving IFN-alpha and ribavirin HCV RNA was not detectable in 40% of patients responders and remained undetectable in 44.2% of sustained responders. In the group of patients receiving IFN-alpha alone HCV RNA was not detectable in 24.2% of patients responders and remained not detectable in 33.3% of sustained responders. CONCLUSIONS: A 24-wk treatment course with IFN-alpha and ribavirin given to patients with a previous lack of response to IFN-alpha alone offers a chance of a sustained biochemical and virological response, at least in a subset of such patients. The role of long-term therapy in inducing prolonged remission still remains to be explored.