摘要
Background/Aims: To determine whether 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 1.5 μ g/kg per week and ribavirin 800- 1200 mg/day, plus either amantadine 200 mg/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 retreat-ment 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.
Background/Aims： To determine whether 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 1.5 μg/kg per week and ribavirin 800-1200 mg/day, plus either amantadine 200 mg/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.
