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

• Autor(a) principal: Callefi, Luciana Azevedo
• Data de Publicação: 2017
• Outros Autores: Villela-Nogueira, Cristiane Alves, Tenore, Simone de Barros, Carnauba Junior, Dimas, Coelho, Henrique Sérgio Moraes, Pinto, Paulo de Tarso Aparecida, Nabuco, Leticia Cancella, Pessôa, Mário Guimarães, Ferraz, Maria Lucia Cardoso Gomes, Ferreira, Paulo Roberto Abrão, Martinelli, Ana de Lourdes Candolo, Chachá, Silvana Gama Florencio, Ferreira, Adalgisa de Souza Paiva, Costa, Alessandra Porto de Macedo, Brandão-Mello, Carlos E., Álvares-da-Silva, Mário Reis, Reuter, Tania Queiroz, Ivantes, Cláudia Alexandra Pontes, Perez, Renata de Mello, Mendes-Corrêa, Maria Cássia Jacintho
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Institucional da UFRGS
• Texto Completo: http://hdl.handle.net/10183/184032
• topic: Proteínas recombinantes; Hepatite C crônica; Antivirais; RNA viral; Hepacivirus; Meia-idade; Brasil; Protease inhibitors; Safety; Hepatitis C; Chronic; Therapeutics

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-totreat 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%, po0.001) and a higher incidence of serious adverse events (50.7% vs. 34.8%, po0.001). 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/mm3, and achievement of a rapid viral response. Female gender, age465 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.