title: Rapid virological response of telaprevir and boceprevir in a Brazilian cohort of HCV genotype 1 patients: a multicenter longitudinal study.
abstract: BACKGROUND
  Chronic hepatitis C is a major public health issue, but there is a gap in the literature regarding the effectiveness and safety of direct-acting antiviral agents in the Brazilian population. The main aim of this study was to describe the effectiveness of boceprevir and telaprevir in patients treated at public health care institutions in Brazil.
  
  
  METHODS
  A prospective longitudinal and multicenter study was conducted in five centers in the State of Paraná between September 2014 and June 2016. Data regarding effectiveness and safety were collected from medical records of patients treated with boceprevir or telaprevir. The effectiveness outcome comprised the rapid virological response (RVR). Multivariate analysis was performed to verify the influence of independent variables (ie, age, gender, baseline viral load) on RVR achievement.
  
  
  RESULTS
  Data were collected from 117 patients with chronic hepatitis C virus (HCV) genotype 1 infection. Fifteen patients received treatment with boceprevir and 102 received telaprevir. The mean age was 51.6 years, 64.1% were male, 44.4% were infected with HCV subtype 1a, 62.4% had a high baseline viral load (≥800,000 IU/mL) and 33% were cirrhotic. Furthermore, 79.5% of patients achieved RVR (26.7% in the boceprevir group and 87.3% in the telaprevir group). Multivariate analysis demonstrated that the type of protease inhibitor (boceprevir or telaprevir) and the baseline viral load had an influence on the RVR rate (odds ratio [OR] =0.011; 95% confidence interval [CI]: 0.001-0.119;P<0.001/OR =13.004; 95% CI: 1.522-111.115;P=0.019, respectively).
  
  
  CONCLUSIONS
  In this longitudinal multicenter cohort study conducted from the Brazilian perspective, differences were found in the RVR rates, favoring telaprevir over boceprevir for genotype 1 HCV-infected patients. In addition, the baseline viral load was associated with RVR achievement in both evaluated groups. As RVR is also reported in the literature as a predictor of the sustained virological response (SVR), further analyses of RVR as predictor of SVR outcomes should be further evaluated in Brazil.
authors.affiliation: Pharmaceutical Sciences Postgraduate Research Program, Department of Pharmacy.
authors.forename: Helena Hl
authors.initials: HH
authors.lastname: Borba
authors.affiliation: Pharmaceutical Sciences Postgraduate Research Program, Department of Pharmacy.
authors.forename: Astrid
authors.initials: A
authors.lastname: Wiens
authors.affiliation: Pharmaceutical Sciences Postgraduate Research Program, Department of Pharmacy.
authors.forename: Laiza M
authors.initials: LM
authors.lastname: Steimbach
authors.affiliation: Pharmaceutical Sciences Postgraduate Research Program, Department of Pharmacy.
authors.forename: Fernanda S
authors.initials: FS
authors.lastname: Tonin
authors.affiliation: Gastroenterology Service, Hospital de Clínicas, Federal University of Paraná.
authors.forename: Maria LA
authors.initials: M
authors.lastname: Pedroso
authors.affiliation: Guidance and Counseling Center, Curitiba City Hall, Curitiba, Paraná, Brazil.
authors.forename: Cláudia Ap
authors.initials: CA
authors.lastname: Ivantes
authors.affiliation: Department of Social Pharmacy, Faculty of Pharmacy, Research Institute for Medicines, University of Lisboa, Lisbon, Portugal.
authors.forename: Fernando
authors.initials: F
authors.lastname: Fernandez-Llimos
authors.affiliation: Pharmaceutical Sciences Postgraduate Research Program, Department of Pharmacy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Pontarolo
keywords: boceprevir; hepatitis C; multicenter; protease inhibitors; rapid virological response; telaprevir