Effectiveness and safety of first-generation protease inhibitors in real-world patients with hepatitis C virus genotype 1 infection in Brazil: a multicenter study

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dc.citation.issue6
dc.citation.volume72
dc.contributor.authorCallefi, Luciana Azevedo
dc.contributor.authorVillela-Nogueira, Cristiane Alves
dc.contributor.authorTenore, Simone de Barros
dc.contributor.authorCarnauba-Junior, Dimas
dc.contributor.authorMoraes Coelho, Henrique Sergio
dc.contributor.authorPinto, Paulo de Tarso A.
dc.contributor.authorNabuco, Leticia Cancella
dc.contributor.authorPessoa, Mario Guimaraes
dc.contributor.authorCardoso Gomes Ferraz, Maria Lucia [UNIFESP]
dc.contributor.authorAbrao Ferreira, Paulo Roberto [UNIFESP]
dc.contributor.authorCandolo Martinelli, Ana de Lourdes
dc.contributor.authorFlorencio Chacha, Silvana Gama
dc.contributor.authorPaiva Ferreira, Adalgisa de Souza
dc.contributor.authorde Macedo Bisio, Alessandra Porto
dc.contributor.authorBrandao-Mello, Carlos Eduardo
dc.contributor.authorAlvares-Da-Silva, Mario Reis
dc.contributor.authorReuter, Tania
dc.contributor.authorAlexandra, Claudia
dc.contributor.authorIvantes, Pontes
dc.contributor.authorPerez, Renata de Mello
dc.contributor.authorJacintho Mendes-Correa, Maria Cassia
dc.coverageSao Paulo
dc.date.accessioned2020-07-13T11:52:59Z
dc.date.available2020-07-13T11:52:59Z
dc.date.issued2017
dc.description.abstractOBJECTIVE: To evaluate the effectiveness and safety of first-generation protease inhibitors for the treatment of genotype 1 hepatitis C virus-infected patients at Brazilian reference centers. METHODS: This multicenter cross-sectional study included hepatitis C virus genotype 1 monoinfected patients treated with Peg-interferon, ribavirin, and either boceprevir (n=158) or telaprevir (n=557) between July 2013 and April 2014 at 15 reference centers in Brazil. Demographic, clinical, virological, and adverse events data were collected during treatment and follow-up. RESULTS: Of the 715 patients, 59% had cirrhosis and 67.1% were treatment-experienced. Based on intention-to-treat analysis, the overall sustained viral response was 56.6%, with similar effectiveness in both groups (51.9% for boceprevir and 58% for telaprevir, p=0.190). Serious adverse events occurred in 44.2% of patients, and six deaths (0.8%) were recorded. Cirrhotic patients had lower sustained viral response rates than non-cirrhotic patients (46.9% vs. 70.6%, p < 0.001) and a higher incidence of serious adverse events (50.7% vs. 34.8%, p < 0.001). Multivariate analysis revealed that sustained viral response was associated with the absence of cirrhosis, viral recurrence after previous treatment, pretreatment platelet count greater than 100,000/mm(3), and achievement of a rapid viral response. Female gender, age > 465 years, diagnosis of cirrhosis, and abnormal hemoglobin levels/platelet counts prior to treatment were associated with serious adverse events. CONCLUSION: Although serious adverse events rates were higher in this infected population, sustained viral response rates were similar to those reported for other patient cohorts.en
dc.description.affiliationUniv Sao Paulo, Fac Med, Dept Molestias Infecciosas & Parasitarias, Sao Paulo, SP, Brazil
dc.description.affiliationUniv Fed Rio de Janeiro, Rio De Janeiro, RJ, Brazil
dc.description.affiliationCtr Referencia & Treinamento DST Aids, Sao Paulo, SP, Brazil
dc.description.affiliationCDH, Rio De Janeiro, RJ, Brazil
dc.description.affiliationHosp Fed Servidores Estado Rio de Janeiro HFSE, Setor Gastrohepatol, Rio De Janeiro, RJ, Brazil
dc.description.affiliationUniv Sao Paulo, Fac Med, Dept Gastroenterol & Hepatol, Sao Paulo, SP, Brazil
dc.description.affiliationUniv Fed Sao Paulo UNIFESP, Disciplina Gastroenterol, EPM, Sao Paulo, SP, Brazil
dc.description.affiliationUniv Fed Sao Paulo UNIFESP, EPM, Disciplina Infectol, Sao Paulo, SP, Brazil
dc.description.affiliationUniv Sao Paulo, FMRP, Dept Clin Med, Div Gastroenterol, Sao Paulo, SP, Brazil| Univ Fed do Maranhao UFMA, HUPD, Ctr Pesquisa Clin, Sao Luis, MA, Brazil
dc.description.affiliationUniv Fed Estado Rio de Janeiro UNIRIO, Disciplina Clin Med & Gastroenterol, Rio De Janeiro, RJ, Brazil
dc.description.affiliationUniv Fed Rio do Grande Sul UFRGS, Dept Med Interna, Porto Alegre, RS, Brazil
dc.description.affiliationUniv Fed Espirito Santo, Ambulatorio HIV AIDS Hepatites Virais, Vitoria, ES, Brazil
dc.description.affiliationSMS, Ctr Orientacao & Aconselhamento, Foz Do Iguacu, PR, Brazil
dc.description.affiliationUniv Estado Rio de Janeiro UERJ, Serv Gastroenterol, Rio De Janeiro, RJ, Brazil
dc.description.affiliationIMT, Lab Virol LIM 52, Sao Paulo, SP, Brazil
dc.description.affiliationUnifespUniv Fed Sao Paulo UNIFESP, Disciplina Gastroenterol, EPM, Sao Paulo, SP, Brazil
dc.description.affiliationUnifespUniv Fed Sao Paulo UNIFESP, EPM, Disciplina Infectol, Sao Paulo, SP, Brazil
dc.description.provenanceMade available in DSpace on 2020-07-13T11:52:59Z (GMT). No. of bitstreams: 0 Previous issue date: 2017. Added 1 bitstream(s) on 2020-07-13T12:06:28Z : No. of bitstreams: 1 S1807-59322017000600378.pdf: 867982 bytes, checksum: 9d261f093aa4644f0e774cf7d2290616 (MD5)en
dc.description.sourceWeb of Science
dc.format.extent378-385
dc.identifierhttp://dx.doi.org/10.6061/clinics/2017(06)08
dc.identifier.citationClinics. Sao Paulo, v. 72, n. 6, p. 378-385, 2017.
dc.identifier.doi10.6061/clinics/2017(06)08
dc.identifier.fileS1807-59322017000600378.pdf
dc.identifier.issn1807-5932
dc.identifier.scieloS1807-59322017000600378.pdf
dc.identifier.urihttps://repositorio.unifesp.br/handle/11600/54337
dc.identifier.wosWOS:000404479600008
dc.language.isoeng
dc.publisherHospital Clinicas, Univ Sao Paulo
dc.relation.ispartofClinics
dc.rightsAcesso aberto
dc.subjectProtease inhibitorsen
dc.subjectSafetyen
dc.subjectHepatitis Cen
dc.subjectChronicen
dc.subjectTherapeuticsen
dc.titleEffectiveness and safety of first-generation protease inhibitors in real-world patients with hepatitis C virus genotype 1 infection in Brazil: a multicenter studyen
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