Revista de Ciências Farmacêuticas Básica e Aplicada Journal of Basic and Applied Pharmaceutical Sciences Rev Ciênc Farm Básica Apl, 2018;39:e629 ISSN 1808-4532 Effectiveness and safety of protease inhibitors for the Hepatitis C treatment in a hospital of South Brazil: real life data Aline Bianca Borba Mattana 1 *; Karin Hepp Schwambach 1 ; Alberi Adolfo Feltrin 2 ; Mareni Rocha Farias 3 ; Carine Raquel Blatt 1 1 Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, RS, Brasil. 2 Grupo Hospitalar Conceição, Centros de Aplicação e Monitorização de Medicamentos Injetáveis (CAMMI), Porto Alegre, RS, Brasil. 3 Universidade Federal de Santa Catarina (UFSC), Florianópolis, SC, Brasil. ABSTRACT The combination of Inhibitors of protease boceprevir (BOC) or telaprevir (TLV) concomitantly with peginterferon (PEG) and ribavirin (RBV) constitute the triple therapy (TT) for Hepatitis C treatment. To describe the experience of the TT treatment of chronic hepatitis C patients, besides discussing safety issues, in real life. Observational and retrospective study with 180 patients attended in a specialized center, between July 2014 and December 2015. Were evaluated variables as gender, age, access to drugs, pattern of alcohol consumption, pathway of contamination reported by the patient, previous treatment, degree of fbrosis, treatment regimen, treatment interruption and reason and Sustained Viral Response (SVR). Adverse Drug Reactions (ADRs) were collect through monthly self‑report by the patient to the pharmacist. 65 patients used BOC and 115 TLV, and the mean age was 54.20 (BOC) and 53.92 (TLV) years. End of treatment rate was 52.3% (BOC) and 53.3% (TLV). ADRs occurred in 18.5% of the patients (BOC) and 13.9% (TLV), being more frequent the severe anemia. Erythropoietin (EPO) used in 45.4% (BOC) and 58.2% (TLV). SVR rate calculated by intention to treat was 38.5% (BOC) e 50.4% (TLV). This study has shown that the efectiveness of TT is not signifcantly higher than double therapy and is lower than the reported in clinical trials. High dropout rates due to ADRs have been demonstrated, as well as a lower SVR found in clinical trials. Keywords: Hepatitis C. Drug-related Side Efects and Adverse Reactions. Treatment Outcome. INTRODUCTION It is estimate around 3% of the world’s population infected with the hepatitis C virus (HCV), that it is mean 170 million people. To make matters worse, a signifcant number of people carry the virus unaware of the fact (Lavanchy, 2011; Cammà et al., 2012; Pavio & Lai, 2003). In Brazil is estimated between 1.4 and 1.7 million people with hepatitis C don´t know the diagnosis. There has been a worldwide efort increase to reduce the global impact of hepatitis C not only by implementing programmatic actions to promote awareness about viral hepatitis C but also by improving the monitoring, prevention, and treatment (Miotto et al., 2018). The goal of hepatitis C treatment is eliminate the virus and the disease progression to cirrhosis, thereby reducing the possibility of terminal hepatic failure and hepatocellular carcinoma (Ghany et al., 2011; Teixeira et al., 2013). In the year 2013, triple therapy (TT) was standardized with protease inhibitors (PI) boceprevir (BOC) or telaprevir (TLV) both associated with peginterferon (PEG) and ribavirin (RBV) for patients with hepatitis C Chronic, carriers of genotype 1 (Brasil, 2013). Shortly thereafter, in 2015, after researches and the development of new drugs, the Direct-Acting Antivirals (DAAs) in the Guideline replaced the PI for Hepatitis C in Brazil. The DAAs to be more efective, safer, and dosage convenience (Brasil, 2015a; Brasil, 2015b). Although TT has been already replaced, the analysis of this results in real-life obtained during the treatment brings invaluable lessons that help to understand the diference from clinical trials to real life studies, and it is helps policy makers to anticipate challenges in healthcare to achieve satisfactory efectiveness rates in available therapies. Thus, the aim of this study is to describe the experience of the treatment of chronic hepatitis C boceprevir or telaprevir, both associated with peginterferon and ribavirina, besides discussing safety issues regarding this therapy. MATERIAL AND METHODS Study design This study is an observational cross sectional study with retrospective data from medical records. *Corresponding author: alinemattana@gmail.com