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Title: Re-treatment of previous non-responders and relapsers to interferon plus ribavirin with peginterferon alfa-2a (40KD), ribavirin +/- amantadine in patients with chronic hepatitis C: randomized multicentre clinical trial
Authors: Pessoa, Mario G.
Cheinquer, Hugo
Almeida, Paulo R. L.
Silva, Giovanni F.
Lima, Maria Patelli J. S.
Parana, Raymundo
Lacerda, Marco A.
Parise, Edison Roberto [UNIFESP]
Pernambuco, Jose R. B.
Pedrosa, Suelene S.
Teixeira, Rosangela
Sette, Hoel
Tatsch, Fernando
Universidade de São Paulo (USP)
Inst Infectol Emilio Ribas
Univ Fed Rio Grande do Sul
Fed Univ Hlth Sci Porto Alegre
Pontificia Univ Catolica Campinas
Universidade Federal da Bahia (UFBA)
Indiana Univ
Universidade Federal de São Paulo (UNIFESP)
Universidade Federal de Pernambuco (UFPE)
Santa Casa de Misericordia de Goiania
Universidade Federal de Minas Gerais (UFMG)
Hosp Alemao Oswaldo Cruz
Roche Prod Quim & Farmaceut
Keywords: Hepatitis C
Peginterferon alfa-2a (40KD)
Issue Date: 1-Jan-2012
Publisher: Mexican Assoc Hepatology
Citation: Annals Of Hepatology. Mexico: Mexican Assoc Hepatology, v. 11, n. 1, p. 52-61, 2012.
Abstract: Introduction. A large number of patients with chronic hepatitis C have not been cured with interferon-based therapy. Therefore, we evaluated the efficacy of amantadine combined with the standard of care (pegylated interferon plus ribavirin) in patients who had not responded to or had relapsed after 24 weeks of treatment with conventional interferon plus ribavirin. Material and methods. Patients stratified by previous response (i.e., non-response or relapse) were randomized to 48 weeks of open-label treatment with peginterferon alfa-2a (401(D) 180 pg/week plus ribavirin 1,000/1,200 mg/day plus amantadine 200 mg/day (triple therapy), or the standard of care (peginterferon alfa-2a [40KD] plus ribavirin). Results. The primary outcome was sustained virological response (SVR), defined as undetectable hepatitis C virus RNA in serum (< 50 IU/mL) at end of follow-up (week 72). Among patients with a previous non-response, 12/53 (22.6%; 95% confidence interval [CI] 12.3-36.2%) randomized to triple therapy achieved an SVR compared with 16/52 (30.8%; 95% CI 18.7-45.1%) randomized to the standard of care. Among patients with a previous relapse 22/39 (56.4%; 95% CI 39.6-72.2%) randomized to triple therapy achieved an SVR compared with 23/38 (60.5%; 95% CI 43.4-76.0%) randomized to the standard of care. Undetectable HCV RNA (< 50 IU/mL) at week 12 had a high positive predictive value for SVR. A substantial proportion of non-responders and relapsers to conventional interferon plus ribavirin achieve an SVR when re-treated with peginterferon alfa-2a (40KD) plus ribavirin. Conclusion. Amantadine does not enhance SVR rates in previously treated patients with chronic hepatitis C and cannot be recommended in this setting.
ISSN: 1665-2681
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