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

• Published in: Revista da Sociedade Brasileira de Medicina Tropical 2018-03, Vol.51 (2), p.146-154
• Main Authors: Chachá, Silvana Gama Florencio, Rodrigues, João Paulo Vilela, Araújo, Roberta Chaves, Pereira, Leonardo Régis Leira, Villanova, Márcia Guimarães, Souza, Fernanda Fernandes, Santana, Rodrigo de Carvalho, Martinelli, Ana de Lourdes Candolo
• Format: Article
• Language: English
• Subjects: Adverse drug reaction; Antiviral drugs; Boceprevir; Cirrhosis; Drug development; Genotypes; Hepatitis; Hepatitis C; Hepatitis C vírus; Interferon; Liver; Liver cirrhosis; Marketing; Patients; Protease; Protease inhibitors; Proteinase inhibitors; Ribavirin; Side effects; Telaprevir; TROPICAL MEDICINE; Viruses
• ISSN: 0037-8682; 1678-9849; 1678-9849
• DOI: 10.1590/0037-8682-0153-2017

Licensed for chronic hepatitis C treatment in 2011, the protease inhibitors (PIs) telaprevir (TVR) and boceprevir (BOC), which have high sustained viral responses (SVR), ushered a new era characterized by the development of direct-action drugs against the hepatitis C virus (HCV). The aim of this study was to analyze the effectiveness and safety of BOC and TVR administered with pegylated interferon and ribavirin and to share the experience of a Brazilian reference center. A retrospective descriptive study was conducted in patients with HCV genotype 1 infection who started treatment between July 2013 and December 2015. Data were collected using a computerized system. A total of 115 subjects were included, of which 58 (50.4 %) had liver cirrhosis and 103 (89.6 %) used TVR. The overall SVR rate was 61.7 % (62.1 % for TVR and 58.3 % for BOC). The presence of cirrhosis was associated with a lower SVR rate, whereas patients who relapsed after prior therapy had a greater chance of showing SVR than did non-responders. The incidence of adverse drug reactions (ADRs) was high. Almost all patients (~100 %) presented with hematologic events. Furthermore, treatment had to be discontinued in 15 subjects (13 %) due to severe ADRs. In conclusion, the SVR rates in our study were lower than those reported in pre-marketing studies but were comparable to real-life data. ADRs, particularly hematological ADRs, were more common compared to those in previous studies and resulted in a high rate of treatment discontinuity.