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

• Published in: Revista da Sociedade Brasileira de Medicina Tropical
• Main Authors: Cirley Maria de Oliveira Lobato, Natalia Balassiano, Elodie Bomfim Hyppolito, Rafaela Liz Pellegrim Sanchez-Lermen, Izabelle Venturini Signorelli, Miguel Yasuo Tomita Nicacio, Alberto Pereira Firmino Filho, Thais Guaraná de Andrade, José Milton de Castro Lima, Talita Amorim de Arruda, Fernanda Schwanz Coutinho, Everton Felipe do Vale Araujo, Ticiana Mota Esmeraldo, Erlon Cortez, Rafaela Lorenzon Aragão Capeli, Melquior Brunno Mateus de Matos, Francisco Sérgio Rangel Pessoa, Hélder Cássio de Oliveira, Érico Antônio Gomes de Arruda, Patrícia Lofêgo Gonçalves, Antônio Haroldo Araújo Filho, Eliane Bordalo Cathalá Esberard, Francisco José Dutra Souto
• Format: Article in Journal/Newspaper
• Language: English
• Published: Sociedade Brasileira de Medicina Tropical (SBMT)
• Subjects: Hepatitis C vírus; Sustained virological response; Telaprevir; Boceprevir; Post-marketing surveillance; Arctic medicine. Tropical medicine; RC955-962; Arctic
• Online Access: https://doi.org/10.1590/0037-8682-0279-2017; https://doaj.org/article/c9689d0626c24242b3e598edfbc61171

Abstract INTRODUCTION: In 2013, combination therapy using peginterferon, ribavirin, and boceprevir or telaprevir was introduced to treat hepatitis C virus genotype 1 infection in Brazil. The effectiveness of this therapy in four Brazilian regions was evaluated. METHODS: Clinical and virological data were obtained from patients of public health institutions in five cities, including sustained virological response (SVR) and side effects. Patients with advanced fibrosis (F3/4), moderate fibrosis (F2) for > 3 years, or extra-hepatic manifestations were treated according to Ministry of Health protocol. Treatment effectiveness was verified by using bivariate and multivariate analysis; p-values of < 0.05 were considered significant. RESULTS: Of 275 patients (64.7% men; average age, 57 years old), most (61.8%) were treatment-experienced; 53.9% had subgenotype 1a infection, 85.1% had advanced fibrosis, and 85.5% were treated with telaprevir. SVR was observed in 54.2%. Rapid virological response (RVR) was observed in 54.6% of patients (data available for 251 patients). Overall, 87.5% reported side effects and 42.5% did not complete treatment. Skin rash, severe infection, and death occurred in 17.8%, 2.5%, and death in 1.4% of cases, respectively. SVR was associated with treatment completion, RVR, and anemia. CONCLUSIONS: The effectiveness of hepatitis C virus triple therapy was lower than that reported in phase III clinical trials, possibly owing to the prioritized treatment of patients with advanced liver fibrosis. The high frequency of side effects and treatment interruptions observed supported the decision of the Brazilian authorities to suspend its use when safer and more effective drugs became available in 2015.