Interferon and ribavirin with or without amantadine for interferon non-responders with chronic hepatitis C. A randomized, controlled pilot study.

Author(s): Wenger C, Bischof T, Gonvers JJ, Renner EL, Mullhaupt B

Affiliation(s): Gastroenterology and Hepatology, University Hospital Zurich, Switzerland.

Publication date & source: 2007-07-28, Swiss Med Wkly., 137(29-30):418-23.

Publication type: Clinical Trial; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND/AIMS: Treatment options for interferon-non-responders (INF-NR) with chronic hepatitis C are limited. Our aim was to compare efficacy and tolerability of an interferon-alfa-2a (INF), ribavirin (RIBA) and amantadine (AMA) combination with those of an INF and RIBA combination. METHODS: 30 patients with biopsy proven chronic hepatitis C were randomised to INFRIBA-AMA or INF-RIBA, stratified according to genotype (1/4 versus 2/3) and presence or absence of cirrhosis. They were treated with INF 6 million units subcutaneously daily for the first four weeks, RIBA (>or=75 kg 1200 mg, <75 kg 1000 mg) with or without AMA 200 mg daily. If serum hepatitis C RNA was undetectable after 28 days, therapy was continued for a total of 48 weeks and INF was reduced to 6 million units thrice weekly (tiw). After stopping therapy all patients were followed up for six months. RESULTS: The end of treatment response was 25% (4/16) after INF-RIBA-AMA and 29% (4/14) after INF-RIBA, and a sustained virologic response (SVR) was observed in 19% (3/16) in the triple therapy group compared to 14% (2/14) in the double therapy group, with a similar safety and tolerability profile. CONCLUSION: Although similarly tolerated triple combination with INF, RIBA and AMA does not seem to offer relevant efficacy advantages over double combination with INF and RIBA in INF non-responders with chronic hepatitis C.