Treatment of patients with chronic hepatitis C not responding to interferon with high-dose interferon alpha with or without ribavirin: final results of a prospective randomized trial

Objective To investigate the efficacy of high-dose interferon alpha (IFN-a) with or without ribavirin in interferon (IFN) non-responders. Study design 304 chronic hepatitis C patients received 5 MU IFN-alpha 2b (I ntronA(R), Schering-Plough, Kenilworth, NJ, USA) three times a week for 3 m onths. Non-responders were randomized either to continue with IFN (IFN 5 MU /TIW followed by 10 MU/TIW, each for 3 months) alone (group A: n = 76, m:f = 54:22, age 45.7 +/- 12 years, 16% cirrhosis, alanine aminotransferase [AL T] 66 +/- 35 U/I) or in combination with ribavirin (similar to 14 mg/kg/day ) (group B: n = 81, m:f = 57 :24, age 48.2 +/- 12 years, 17% cirrhosis, ALT 71 +/- 40 U/I), At the end of treatment, patients were followed for 6 mont hs. Main outcome measures Virological response at end of treatment and 6 months thereafter. Setting University hospitals and tertiary referral centres. Results At the end of treatment, eight (10.8%) and 25 (31.3%, P= 0.0066) pa tients were HCV-RNA negative, and 51 and 39 were HCV-RNA positive, in group s A and B, respectively. There were 17 drop-outs in each group. Six months after treatment, only one patient in group A (1.3%) and seven patients (8.6 %, P= 0.06) in group B had normal ALT and undetectable serum HCV-RNA. Conclusions A combination of high-dose IFN with ribavirin induces a short-l asting complete response in about one-third of IFN-non-responders. Eur J Ga stroenterol Hepatol 13:699-705 (C) 2001 Lippincott Williams & Wilkins.