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

Authors

  • Luciana Azevedo Callefi Universidade de São Paulo; Faculdade de Medicina; Departamento de Molestias Infecciosas e Parasitarias
  • Cristiane Alves Villela-Nogueira Universidade Federal do Rio de Janeiro; Departamento de Clinica Medica; Servico de Hepatologia
  • Simone de Barros Tenore Centro de Referencia e Treinamento em DST/Aids
  • Dimas Carnaúba-Júnior Centro de Referencia e Treinamento em DST/Aids
  • Henrique Sérgio Moraes Coelho Centro de Doencas Hepaticas
  • Paulo de Tarso A. Pinto Hospital Federal dos Servidores do Estado do Rio de Janeiro; Setor de Gastro/Hepatologia
  • Letícia Cancella Nabuco Hospital Federal dos Servidores do Estado do Rio de Janeiro; Setor de Gastro/Hepatologia
  • Mário Guimarães Pessoa Universidade de São Paulo; Faculdade de Medicina; Departamento de Gastroenterologia e Hepatologia
  • Maria Lucia Cardoso Gomes Ferraz Universidade Federal de Sao Paulo; Escola Paulista de Medicina (EPM); Disciplina de Gastroenterologia
  • Paulo Roberto Abrão Ferreira Universidade Federal de Sao Paulo; Escola Paulista de Medicina (EPM); Disciplina de Infectologia
  • Ana de Lourdes Candolo Martinelli Universidade de São Paulo; Faculdade de Medicina de Ribeirao Preto (FMRP); Divisao de Gastroenterologia, Departamento de Clinica Medica
  • Silvana Gama Florencio Chachá Universidade de São Paulo; Faculdade de Medicina de Ribeirao Preto (FMRP); Divisao de Gastroenterologia, Departamento de Clinica Medica
  • Adalgisa de Souza Paiva Ferreira Universidade Federal do Maranhao; Hospital Universitario Presidente Dutra (HUPD); Centro de Pesquisa Clinica
  • Alessandra Porto de Macedo Bisio Universidade Federal do Maranhao; Hospital Universitario Presidente Dutra (HUPD); Centro de Pesquisa Clinica
  • Carlos Eduardo Brandão-Mello Universidade Federal do Estado do Rio de Janeiro; Disciplina de Clinica Medica e Gastroenterologia
  • Mário Reis Álvares-Da-Silva Universidade Federal do Rio Grande do Sul; Departamento de Medicina Interna
  • Tânia Reuter Universidade Federal do Espirito Santo; Ambulatorio HIV/AIDS/ Hepatites Virais
  • Claudia Alexandra Pontes Ivantes Secretaria Municipal de Saude; Centro de Orientacao e Aconselhamento
  • Renata de Mello Perez Universidade do Estado do Rio de Janeiro; Servico de Gastroenterologia
  • Maria Cássia Jacintho Mendes-Correa Instituto de Medicina Tropical; Laboratorio de Virologia-LIM 52

DOI:

https://doi.org/10.6061/clinics/2017(06)08

Keywords:

Protease inhibitors, Safety, Hepatitis C, Chronic, Therapeutics

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.

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Published

2017-06-01

How to Cite

Callefi, L. A., Villela-Nogueira, C. A., de Barros Tenore, S., Carnaúba-Júnior, D., Coelho, H. S. M., Pinto, P. de T. A., Nabuco, L. C., Pessoa, M. G., Ferraz, M. L. C. G., Ferreira, P. R. A., de Lourdes Candolo Martinelli, A., Chachá, S. G. F., de Souza Paiva Ferreira, A., de Macedo Bisio, A. P., Brandão-Mello, C. E., Álvares-Da-Silva, M. R., Reuter, T., Ivantes, C. A. P., de Mello Perez, R., & Mendes-Correa, M. C. J. (2017). Effectiveness and safety of first-generation protease inhibitors in real-world patients with hepatitis C virus genotype 1 infection in Brazil: a multicenter study. Clinics, 72(6), 378-385. https://doi.org/10.6061/clinics/2017(06)08

Issue

Section

Clinical Sciences