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

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

Author Callefi, Luciana Azevedo Google Scholar
Villela-Nogueira, Cristiane Alves Google Scholar
Tenore, Simone de Barros Google Scholar
Carnauba-Junior, Dimas Google Scholar
Moraes Coelho, Henrique Sergio Google Scholar
Pinto, Paulo de Tarso A. Google Scholar
Nabuco, Leticia Cancella Google Scholar
Pessoa, Mario Guimaraes Google Scholar
Cardoso Gomes Ferraz, Maria Lucia Autor UNIFESP Google Scholar
Abrao Ferreira, Paulo Roberto Autor UNIFESP Google Scholar
Candolo Martinelli, Ana de Lourdes Google Scholar
Florencio Chacha, Silvana Gama Google Scholar
Paiva Ferreira, Adalgisa de Souza Google Scholar
de Macedo Bisio, Alessandra Porto Google Scholar
Brandao-Mello, Carlos Eduardo Google Scholar
Alvares-Da-Silva, Mario Reis Google Scholar
Reuter, Tania Google Scholar
Alexandra, Claudia Google Scholar
Ivantes, Pontes Google Scholar
Perez, Renata de Mello Google Scholar
Jacintho Mendes-Correa, Maria Cassia Google Scholar
Abstract OBJECTIVE: 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.
Keywords Protease inhibitors
Safety
Hepatitis C
Chronic
Therapeutics
xmlui.dri2xhtml.METS-1.0.item-coverage Sao Paulo
Language English
Date 2017
Published in Clinics. Sao Paulo, v. 72, n. 6, p. 378-385, 2017.
ISSN 1807-5932 (Sherpa/Romeo, impact factor)
Publisher Hospital Clinicas, Univ Sao Paulo
Extent 378-385
Origin http://dx.doi.org/10.6061/clinics/2017(06)08
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000404479600008
SciELO ID S1807-59322017000600378.pdf (statistics in SciELO)
URI https://repositorio.unifesp.br/handle/11600/54337

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