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Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Ferenci, P; Formann, E; Laferl, H; Gschwantler, M; Hackl, F; Brunner, H; Hubmann, R; Datz, C; Stauber, R; Steindl-Munda, P; Kessler, HH; Klingler, A; Gangl, A; Austrian Hepatitis Study Group.
Randomized, double-blind, placebo-controlled study of peginterferon alfa-2a (40KD) plus ribavirin with or without amantadine in treatment-naïve patients with chronic hepatitis C genotype 1 infection.
J HEPATOL. 2006; 44(2): 275-282.
Doi: 10.1016/j.jhep.2005.09.015
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- Co-authors Med Uni Graz
- Kessler Harald
- Stauber Rudolf
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- Abstract:
- BACKGROUND/AIMS: Amantadine may augment virological response rates to interferon-based therapy in chronic hepatitis C patients. Using a novel design, amantadine was studied in naïve genotype 1 patients treated in combination with peginterferon alfa-2a (40KD)/ribavirin. METHODS: Patients enrolled in this randomized, placebo-controlled multicenter trial were stratified by single-dose interferon sensitivity (stratum I, 24-h HCV-RNA decline >1.4-log10; II, 0.8-1.39-log10; III, <0.8-log10; a reliable means of identifying nonresponders to interferon/ribavirin) and fibrosis grade (F0/1/2 vs. F3/4) at baseline. All patients received peginterferon alfa-2a (40KD) 180 microg/week plus ribavirin 1000-1200 mg/day and were randomized to receive amantadine 100 mg twice daily (N = 114) or placebo (N = 95) for 48 weeks. RESULTS: Week-24 virological response rates in strata II and III, the primary outcome, were similar in patients treated with amantadine (63.7%) or placebo (65.7%), as were sustained virological response rates at week 72 (46.5 and 51.6%, respectively). Adverse event profiles were similar and amantadine did not improve health-related quality of life compared with placebo. Interferon sensitivity was the only significant predictor of treatment outcome. CONCLUSIONS: Adding amantadine to peginterferon alfa-2a (40KD)/ribavirin combination therapy does not augment virological response rates in genotype 1 patients. Virological response was almost exclusively determined by interferon sensitivity at baseline.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult -
- Amantadine - therapeutic use
- Antiviral Agents - therapeutic use
- Disease Progression - therapeutic use
- Double-Blind Method - therapeutic use
- Drug Carriers - therapeutic use
- Drug Therapy, Combination - therapeutic use
- Female - therapeutic use
- Follow-Up Studies - therapeutic use
- Genotype - therapeutic use
- Hepacivirus - genetics
- Hepatitis C, Chronic - drug therapy
- Humans - drug therapy
- Interferon Alfa-2a - therapeutic use
- Male - therapeutic use
- Middle Aged - therapeutic use
- Polyethylene Glycols - therapeutic use
- Quality of Life - therapeutic use
- RNA, Viral - genetics
- Ribavirin - therapeutic use
- Treatment Outcome - therapeutic use
- Find related publications in this database (Keywords)
- chronic hepatitis C
- genotype 1
- antiviral therapy
- amantadine