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

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

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(ES)

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

FONTE

Clinics

DATA DE PUBLICAÇÃO

2017-06

RESUMO

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.