Hepatitis C in Brazil: lessons learned with boceprevir and telaprevir

• Published in: Revista do Instituto de Medicina Tropical de São Paulo
• Main Authors: Lenyta Oliveira Gomes, Marina Rodrigues Teixeira, Júnior André da Rosa, Alberi Adolfo Feltrin, João Paulo V. Rodrigues, Mariane D’Avila Vecchi, Jane Meire M. Carneiro, Lúcia de Araújo C. B. Noblat, Silvana Gama F. Chachá, Ana de Lourdes C. Martinelli, Leonardo Regis L. Pereira, Marysabel Pinto T. Silveira, Carine Raquel Blatt, Mareni Rocha Farias
• Format: Article in Journal/Newspaper
• Language: English
• Published: Universidade de São Paulo (USP) 2018
• Subjects: Chronic hepatitis C treatment; Protease inhibitors; High cost medicines; Real life studies; Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Arctic
• Online Access: https://doi.org/10.1590/s1678-9946201860029; https://doaj.org/article/9d02ad81afa6421089067f67acde4271

ABSTRACT In 2012, the first-generation protease inhibitors telaprevir (TVR) and boceprevir (BOC) were introduced in the Brazilian health system for treatment of chronic hepatitis C, after their approval by the National Committee for Health Technology Incorporation (CONITEC). However, these medicines were discontinued in 2015. The short period of use in therapy and their high cost require a discussion about the consequences for patients and for the health system of the early incorporation of new therapies. The article presents a qualitative analysis of the incorporation process of both medications in Brazil and the results of a multicenter study that included patients treated with BOC or TVR between January 2011 and December 2015 in five Brazilian cities. The study included 855 patients (BOC: n=247) and (TVR: n=608). The document analysis showed that CONITEC’s decision to incorporate BOC and TVR was based on results of phase III clinical trials that compared sustained virologic response (SVR) rates of patients treated with BOC and TVR with rates of those that received placebo. However, these studies included a low percentage of cirrhotic patients. The SVR rates observed in this multicenter study were worse than clinical trials pointed out (BOC: 45.6%; TVR: 51.8%), but similar to those achieved with previously adopted therapies. The discontinuation rate due to adverse events was (BOC: 15.4%; TVR: 12.7%). Based on these unsatisfactory results, the study brings a discussion that goes beyond the therapy outcomes, exploring the incorporation of these high-cost medicines and the related decision-making process, contributing to future decisions in medicine policies and in the treatment of chronic hepatitis C.