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

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art_PESSOA_Re_treatment_of_previous_non_responders_and_relapsers_2012.PDF (244.63 KB)
Citações na Scopus
4
Tipo de produção
article
Data de publicação
2012
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
MEXICAN ASSOC HEPATOLOGY
Autores
CHEINQUER, Hugo
ALMEIDA, Paulo R. L.
SILVA, Giovanni F.
LIMA, Maria Patelli J. S.
PARANA, Raymundo
LACERDA, Marco A.
PARISE, Edison R.
PERNAMBUCO, Jose R. B.
PEDROSA, Suelene S.
Citação
ANNALS OF HEPATOLOGY, v.11, n.1, p.52-61, 2012
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
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.
Palavras-chave
Hepatitis C, Re-treatment, Peginterferon alfa-2a (40KD), Amantadine
URI
https://observatorio.fm.usp.br/handle/OPI/4363
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Coleções
Artigos e Materiais de Revistas Científicas - HC/ICHC