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


CONCLUSIONS
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.
Wenger
Christa
C
Gastroenterology and Hepatology, University Hospital Zurich, Switzerland.
Bischof
Thomas
T
Gonvers
Jean-Jacques
JJ
Renner
Eberhard L
EL
Mullhaupt
Beat
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D000547:Amantadine / Q000008:administration & dosage / Q000627:therapeutic use*; D002908:Chronic Disease; D004359:Drug Therapy, Combination; D005260:Female; D006526:Hepatitis C / Q000188:drug therapy* / Q000235:genetics; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use*; D017211:Treatment Failure; D016896:Treatment Outcome
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D012254:Ribavirin; D000547:Amantadine