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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 Feb; 44(2):275-82.JH

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.

Authors+Show Affiliations

Department of Internal Medicine IV, Medical University, Vienna, Austria. peter.ferenci@meduniwien.ac.atNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16338019

Citation

Ferenci, Peter, et al. "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." Journal of Hepatology, vol. 44, no. 2, 2006, pp. 275-82.
Ferenci P, Formann E, Laferl H, et al. 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):275-82.
Ferenci, P., Formann, E., Laferl, H., Gschwantler, M., Hackl, F., Brunner, H., Hubmann, R., Datz, C., Stauber, R., Steindl-Munda, P., Kessler, H. H., Klingler, A., & Gangl, A. (2006). 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. Journal of Hepatology, 44(2), 275-82.
Ferenci P, et al. 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):275-82. PubMed PMID: 16338019.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Ferenci,Peter, AU - Formann,Elisabeth, AU - Laferl,Hermann, AU - Gschwantler,Michael, AU - Hackl,Franz, AU - Brunner,Harald, AU - Hubmann,Rainer, AU - Datz,Christian, AU - Stauber,Rudolf, AU - Steindl-Munda,Petra, AU - Kessler,Harald H, AU - Klingler,Anton, AU - Gangl,Alfred, AU - ,, Y1 - 2005/11/07/ PY - 2005/06/29/received PY - 2005/09/07/revised PY - 2005/09/20/accepted PY - 2005/12/13/pubmed PY - 2006/5/26/medline PY - 2005/12/13/entrez SP - 275 EP - 82 JF - Journal of hepatology JO - J. Hepatol. VL - 44 IS - 2 N2 - 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. SN - 0168-8278 UR - https://www.unboundmedicine.com/medline/citation/16338019/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-8278(05)00668-9 DB - PRIME DP - Unbound Medicine ER -