CLINICS

Clinics (Sao Paulo). 2017 June; 72(6): 378-385.
doi:10.6061/clinics/2017(06)08

Copyright © 2017 CLINICS

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

Luciana Azevedo Callefi I * , Cristiane Alves Villela-Nogueira II , Simone de Barros Tenore III , Dimas Carnaúba-Júnior III , Henrique Sérgio Moraes Coelho II IV , Paulo de Tarso A. Pinto V , Letícia Cancella Nabuco V , Mário Guimarães Pessoa VI , Maria Lucia Cardoso Gomes Ferraz VII , Paulo Roberto Abrão Ferreira VIII , Ana de Lourdes Candolo Martinelli IX , Silvana Gama Florencio Chachá IX , Adalgisa de Souza Paiva Ferreira X , Alessandra Porto de Macedo Bisio X , Carlos Eduardo Brandão-Mello XI , Mário Reis Álvares-Da-Silva XII , Tânia Reuter XIII , Claudia Alexandra Pontes Ivantes XIV , Renata de Mello Perez XV , Maria Cássia Jacintho Mendes-Correa I XVI

Departamento de Molestias Infecciosas e Parasitarias, Faculdade de Medicina, Universidade de Sao Paulo (USP), SP, BR

Servico de Hepatologia, Departamento de Clinica Medica, Universidade Federal do Rio de Janeiro (UFRJ), RJ, BR

Centro de Referencia e Treinamento em DST/Aids, SP, BR

Centro de Doencas Hepaticas (CDH), RJ, BR

Setor de Gastro/Hepatologia, Hospital Federal dos Servidores do Estado do Rio de Janeiro (HFSE), RJ, BR

Departamento de Gastroenterologia e Hepatologia, Faculdade de Medicina, Universidade de Sao Paulo (USP), SP, BR

Disciplina de Gastroenterologia, Escola Paulista de Medicina (EPM), Universidade Federal de Sao Paulo (UNIFESP), SP, BR

Disciplina de Infectologia, Escola Paulista de Medicina (EPM), Universidade Federal de Sao Paulo (UNIFESP), SP, BR

Divisao de Gastroenterologia, Departamento de Clinica Medica, Faculdade de Medicina de Ribeirao Preto (FMRP), Universidade de Sao Paulo (USP), SP, BR

Centro de Pesquisa Clinica, Hospital Universitario Presidente Dutra (HUPD), Universidade Federal do Maranhao (UFMA), MA, BR

Disciplina de Clinica Medica e Gastroenterologia, Universidade Federal do Estado do Rio de Janeiro (UNIRIO), RJ, BR

Departamento de Medicina Interna, Universidade Federal do Rio Grande do Sul (UFRGS), RS, BR

Ambulatorio HIV/AIDS/ Hepatites Virais, Universidade Federal do Espirito Santo (UFES), ES, BR

Centro de Orientacao e Aconselhamento, Secretaria Municipal de Saude (SMS), PR, BR

Servico de Gastroenterologia, Universidade do Estado do Rio de Janeiro (UERJ), RJ, BR

Laboratorio de Virologia-LIM 52, Instituto de Medicina Tropical (IMT), SP, BR

*Corresponding author: E-mail: lucianacallefi@gmail.com

received December 15, 2016; revised March 15, 2017; accepted April 17, 2017.

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/mm3, and achievement of a rapid viral response. Female gender, age>65 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


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