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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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.authorPESSOA, Mario G.
dc.contributor.authorCHEINQUER, Hugo
dc.contributor.authorALMEIDA, Paulo R. L.
dc.contributor.authorSILVA, Giovanni F.
dc.contributor.authorLIMA, Maria Patelli J. S.
dc.contributor.authorPARANA, Raymundo
dc.contributor.authorLACERDA, Marco A.
dc.contributor.authorPARISE, Edison R.
dc.contributor.authorPERNAMBUCO, Jose R. B.
dc.contributor.authorPEDROSA, Suelene S.
dc.contributor.authorTEIXEIRA, Rosangela
dc.contributor.authorSETTE JR., Hoel
dc.contributor.authorTATSCH, Fernando
dc.date.accessioned2014-01-28T22:29:54Z
dc.date.available2014-01-28T22:29:54Z
dc.date.issued2012
dc.description.abstractIntroduction. 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.
dc.description.indexMEDLINE
dc.description.sponsorshipRoche Produtos Quimicos e Farmaceuticos
dc.identifier.citationANNALS OF HEPATOLOGY, v.11, n.1, p.52-61, 2012
dc.identifier.issn1665-2681
dc.identifier.urihttps://observatorio.fm.usp.br/handle/OPI/4363
dc.language.isoeng
dc.publisherMEXICAN ASSOC HEPATOLOGY
dc.relation.ispartofAnnals of Hepatology
dc.rightsopenAccess
dc.rights.holderCopyright MEXICAN ASSOC HEPATOLOGY
dc.subjectHepatitis C
dc.subjectRe-treatment
dc.subjectPeginterferon alfa-2a (40KD)
dc.subjectAmantadine
dc.subject.othersustained virological response
dc.subject.othergene-expression
dc.subject.othercombination therapy
dc.subject.othervirus-infection
dc.subject.othermetaanalysis
dc.subject.othermanagement
dc.subject.othercirrhosis
dc.subject.wosGastroenterology & Hepatology
dc.titleRe-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
dc.typearticle
dc.type.categoryoriginal article
dc.type.versionpublishedVersion
dspace.entity.typePublication
hcfmusp.affiliation.countryEstados Unidos
hcfmusp.affiliation.countryisous
hcfmusp.author.externalCHEINQUER, Hugo:Univ Fed Rio Grande do Sul, Porto Alegre, RS, Brazil
hcfmusp.author.externalALMEIDA, Paulo R. L.:Fed Univ Hlth Sci Porto Alegre, Porto Alegre, RS, Brazil
hcfmusp.author.externalSILVA, Giovanni F.:State Univ Botucatu, Botucatu, SP, Brazil
hcfmusp.author.externalLIMA, Maria Patelli J. S.:Pontificia Univ Catolica Campinas, Campinas, SP, Brazil
hcfmusp.author.externalPARANA, Raymundo:Univ Fed Bahia, Salvador, BA, Brazil
hcfmusp.author.externalLACERDA, Marco A.:Indiana Univ, Indiana, PA USA
hcfmusp.author.externalPARISE, Edison R.:Univ Fed Sao Paulo, Sao Paulo, Brazil
hcfmusp.author.externalPERNAMBUCO, Jose R. B.:Univ Fed Pernambuco, Recife, PE, Brazil
hcfmusp.author.externalPEDROSA, Suelene S.:Santa Casa de Misericordia de Goiania, Goiania, Go, Brazil
hcfmusp.author.externalTEIXEIRA, Rosangela:Univ Fed Minas Gerais, Belo Horizonte, MG, Brazil
hcfmusp.author.externalSETTE JR., Hoel:Hosp Alemao Oswaldo Cruz, Sao Paulo, Brazil
hcfmusp.author.externalTATSCH, Fernando:Roche Prod Quim & Farmaceut, Sao Paulo, Brazil
hcfmusp.citation.scopus4
hcfmusp.contributor.author-fmusphcMARIO GUIMARAES PESSOA
hcfmusp.description.beginpage52
hcfmusp.description.endpage61
hcfmusp.description.issue1
hcfmusp.description.volume11
hcfmusp.origemWOS
hcfmusp.origem.pubmed22166561
hcfmusp.origem.scopus2-s2.0-83055161408
hcfmusp.origem.wosWOS:000300213500006
hcfmusp.publisher.cityMEXICO
hcfmusp.publisher.countryMEXICO
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hcfmusp.remissive.sponsorshipRoche
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