Hepatitis C in Brazil: lessons learned with boceprevir and telaprevir

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.

Aspects that facilitate access to care for viral hepatitis: An evaluative research

“… 31 It has facilitated the technological incorporation of treatment, particularly for hepatitis C treatment. 32 Since 2014, access to treatment with DAA has been guaranteed, despite the high cost. 31 …”

Cost and Effectiveness of the Treatment of Chronic Hepatitis C in Brazil: Real-World Data

“…20,21,25 All of the schemes used showed a high percentage of cures, higher than those obtained with the previous treatments, in a shorter time frame, in addition to a lower incidence of adverse effects compared with other studies. 23,[26][27][28][29] We did not perform the incremental cost-effectiveness analysis because each therapeutic scheme was selected according to the hepatitis C virus genotype and clinical criteria of the patient. The schemes were not competitors; therefore they could not be compared.…”

“…The treatment using the first generation DAAs telaprevir and boceprevir indicated SVR rates of about 60% in international studies 30,31 and between 45% and 57% in national studies. 26,29,32 These medicines also entailed significant adverse events, which often required additional treatments, 28,30 with drop-out rates owing to adverse events ranging between 12% and 27%. 26,29,31…”

“…26,29,32 These medicines also entailed significant adverse events, which often required additional treatments, 28,30 with drop-out rates owing to adverse events ranging between 12% and 27%. 26,29,31…”

Adherence, Adverse Drug Reaction and Effectiveness of the Hepatitis C Chronic Treatment

“…The medicines to treat hepatitis C -interferon, ribavirin, peginterferon and the first-generation direct-acting antivirals (DAAs) (boceprevir and telaprevir) -caused frequent and severe adverse effects. Due to these adverse reactions, the dropout rates are high, contributing to lower effectiveness rates (CLEO STUDY GROUP et al, 2016;GOMES et al, 2018;MIOTTO et al, 2016;WEHMEYER et al, 2014).…”