Hepatitis C in Brazil: lessons learned with boceprevir and telaprevir

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.