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Title: | 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: | CALLEFI, Luciana Azevedo; VILLELA-NOGUEIRA, Cristiane Alves; TENORE, Simone de Barros; CARNAUBA-JUNIOR, Dimas; COELHO, Henrique Sergio Moraes; PINTO, Paulo de Tarso A.; NABUCO, Leticia Cancella; PESSOA, Mario Guimaraes; FERRAZ, Maria Lucia Cardoso Gomes; FERREIRA, Paulo Roberto Abrao; MARTINELLI, Ana de Lourdes Candolo; CHACHA, Silvana Gama Florencio; FERREIRA, Adalgisa de Souza Paiva; BISIO, Alessandra Porto de Macedo; BRANDAO-MELLO, Carlos Eduardo; ALVARES-DA-SILVA, Mario Reis; REUTER, Tania; ALEXANDRA, Claudia; IVANTES, Pontes; PEREZ, Renata de Mello; MENDES-CORREA, Maria Cassia Jacintho |
Citation: | CLINICS, v.72, n.6, p.378-385, 2017 |
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/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. |
Appears in Collections: | Artigos e Materiais de Revistas Científicas - FM/MIP Artigos e Materiais de Revistas Científicas - HC/ICHC Artigos e Materiais de Revistas Científicas - LIM/52 Artigos e Materiais de Revistas Científicas - ODS/03 |
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