Hepatitis C in Brazil: lessons learned with boceprevir and telaprevir

• Published in: Revista do Instituto de Medicina Tropical de São Paulo Vol. 60; pp. e29 - 8
• Main Authors: Gomes, Lenyta Oliveira, Teixeira, Marina Rodrigues, Rosa, Júnior André da, Feltrin, Alberi Adolfo, Rodrigues, João Paulo V, Vecchi, Mariane D'Avila, Carneiro, Jane Meire M, Noblat, Lúcia de Araújo C B, Chachá, Silvana Gama F, Martinelli, Ana de Lourdes C, Pereira, Leonardo Regis L, Silveira, Marysabel Pinto T, Blatt, Carine Raquel, Farias, Mareni Rocha
• Format: Journal Article
• Language: English
• Published: Brazil Instituto de Medicina Tropical de Sao Paulo 01.01.2018; Instituto de Medicina Tropical; Universidade de São Paulo (USP)
• Subjects: Antiviral Agents - administration & dosage; Antiviral Agents - economics; Chronic hepatitis C treatment; Clinical Protocols; Decision Making; Drug Therapy, Combination; Female; Genotype; Hepacivirus - genetics; Hepatitis C, Chronic - drug therapy; Hepatitis C, Chronic - economics; High cost medicines; Humans; Interferon-alpha - administration & dosage; Male; Middle Aged; Oligopeptides - administration & dosage; Oligopeptides - economics; Original; Polyethylene Glycols - administration & dosage; Proline - administration & dosage; Proline - analogs & derivatives; Proline - economics; Protease inhibitors; Protease Inhibitors - administration & dosage; Protease Inhibitors - economics; Real life studies; Recombinant Proteins - administration & dosage; Retrospective Studies; Ribavirin - administration & dosage; TROPICAL MEDICINE; High cost medicines; Chronic hepatitis C treatment; Protease inhibitors; Real life studies
• ISSN: 1678-9946; 0036-4665; 1678-9946
• DOI: 10.1590/s1678-9946201860029

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.