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

• Main Author: Callefi, Luciana Azevedo
• Publication Date: 2017
• Other Authors: Villela-Nogueira, Cristiane Alves, Tenore, Simone de Barros, Carnauba-Junior, Dimas, Moraes Coelho, Henrique Sergio, Pinto, Paulo de Tarso A., Nabuco, Leticia Cancella, Pessoa, Mario Guimaraes, Cardoso Gomes Ferraz, Maria Lucia [UNIFESP], Abrao Ferreira, Paulo Roberto [UNIFESP], Candolo Martinelli, Ana de Lourdes, Florencio Chacha, Silvana Gama, Paiva Ferreira, Adalgisa de Souza, de Macedo Bisio, Alessandra Porto, Brandao-Mello, Carlos Eduardo, Alvares-Da-Silva, Mario Reis, Reuter, Tania, Alexandra, Claudia, Ivantes, Pontes, Perez, Renata de Mello, Jacintho Mendes-Correa, Maria Cassia
• Format: Article
• Language: eng
• Source: Repositório Institucional da UNIFESP
• Download full: https://repositorio.unifesp.br/handle/11600/54337; http://dx.doi.org/10.6061/clinics/2017(06)08
• topic: 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-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.