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

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.

Effectiveness of first-wave protease inhibitors in hepatitis C virus genotype 1 infection: a multicenter study in Brazil

“…Our results were similar to the findings of the French cohort and other studies conducted by Brazilian researchers [14][15][16]18 . In addition, the rates of treatment cessation because of intolerance or side effects were very high and medications were not well tolerated by the majority of the subjects.…”

“…More than half of the patients had failed to reach SVR in a previous treatment. For the triple therapy, 54.2% of patients reached SVR, which was similar to that reported by other Brazilian authors 16,18 . Our findings suggested that the attainment of SVR was lower in patients with advanced fibrosis than that reported in the initial studies.…”

“…Borba et al showed a 79% RVR rate in 117 patients in the five centers in the State of Paraná, South Brazil; however, these authors did not describe the SVR rates 17 . Recently, Callefi et al described a multicenter experience involving six Brazilian states 18 . Among the 715 patients, 59% had cirrhosis and 67% were treatmentexperienced; SVR was reached in 56.6%.…”

First-wave protease inhibitors for hepatitis C genotype 1 treatment: a real-life experience in Brazilian patients

“…There are few published, real-life studies that have evaluated the use of first-generation PIs in Latin America, particularly in Brazil [7][8][9] . Thus, this study was aimed at analyzing the safety and effectiveness of the above-mentioned triple regimens, in addition to sharing the experience of a referral center established at a tertiary/quaternary university hospital in Southeastern Brazil.…”

Avaliação da efetividade e segurança dos novos fármacos de ação direta indicados no tratamento da hepatite C

“…Além disso, foram relatadas reações adversas severas em 40% dos pacientes do estudo, como hospitalizações, infecções severas, descompensação da doença hepática, alterações dermatológicas, cutâneas e morte(HÉZODE et al, 2013). Verificou-se taxa de RVS média de 56,6% (51,9% para BOC e 58% para TVR) e reações adversas severas ocorreram em 44,2% dos pacientes, com seis mortes registradas(CALLEFI et al, 2017). Em outro estudo multicêntrico brasileiro, realizado por Lobato e colaboradores, encontrou-se taxa global de RVS de 54,2% e observou-se ocorrência de reações adversas em 87,5% dos pacientes(LOBATO et.…”