Cingles Info

Amantadine triple therapy for non-responder hepatitis C patients. Clues for
controversies (ANRS HC 03 BITRI).
Maynard M, Pradat P, Bailly F, Rozier F, Nemoz C, Ahmed SN, Adeleine P, Trepo C,
A French Multicenter Group A.
Department of Hepato-gastroenterology, Hotel-Dieu, 1 place de l'Hopital, 69288
Lyon Cedex 02, France.
BACKGROUND/AIMS: To determine if addition of amantadine to pegylated
interferon/ribavirin improved response rates among chronic hepatitis C patients,
non-responders to interferon/ribavirin and study the dynamic of response.
METHODS: In a double blind, multicenter, randomized trial, 200 non-responder
patients received pegylated interferon 1.5mug/kg per week and ribavirin
800-1200mg/day, plus either amantadine 200mg/day or placebo for 48 weeks.
Endpoints were virological responses, ALT normalization, and histological
benefit overtime. RESULTS: Twenty percent of all patients achieved a sustained
virological response (SVR). This rate was 8% higher in the triple therapy group
(24%) compared with the double therapy group (16%) (P=0.22). A better
virological response rate at week 24 was observed in the triple regimen group
(43 vs 29%; P=0.06), which was lost at week 48 suggesting viral escape. The
biochemical response rate was also significantly higher with triple therapy at
week 12 (63 vs 49%; P=0.05) and week 24 (64 vs 49%; P=0.03). Fibrosis stabilized
or improved in 77% of all patients. CONCLUSIONS: Re-treatment of
interferon/ribavirin non-responder patients should be encouraged since a
substantial proportion benefits from re-treatment with pegylated
interferon/ribavirin +/- amantadine. In triple therapy involving amantadine, a
time wise response and an increased SVR rate in subgroups less prone to viral
breakthrough suggest clues for existing controversies.
PMID: 16426697 [PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=1\
6426697&dopt=Abstract