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