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

Objective: The aim of the study was to assess the efficacy of interferon (I FN)-alpha-2b and ribavirin in combination in the treatment of chronic hepat itis C (CHC) patients unresponsive to a previous treatment with IFN-alpha-2 b alone. Methods: We conducted a randomized study in 303 CHC patients. One hundred fifty-two patients received subcutaneous administration of recombin ant 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 ri bavirin and IFN-alpha-2b were given for 24 wk, regardless of treatment resp onse. Alanine aminotransferase (ALT) levels and HCV RNA titer were checked during the treatment period and for a further 24 wk. Results: Normal ALT le vels were observed in 64.5% of the patients treated with IFN-alpha and riba virin and in 22.6% of the patients treated with IFN-alpha alone. In the gro up of patients receiving IFN-alpha and ribavirin HCV RNA was not detectable in 40% of patients responders and remained undetectable in 44.2% of sustai ned responders. In the group of patients receiving IFN-alpha alone HCV RNA was not detectable in 24.2% of patients responders and remained not detecta ble 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 res ponse to IFN-alpha alone offers a chance of a sustained biochemical and vir ological response, at least in a subset of such patients. The role of long- term therapy in inducing prolonged remission still remains to be explored. (C) 1998 by Am. Coll. of Gastroenterology.