Target product profile for a test for the early assessment of treatment efficacy in Chagas disease patients: An expert consensus.

Abstract

Six to 7 million people are estimated to be infected by Trypanosoma cruzi, the parasite causing Chagas disease. Thirty to 40% of them, i.e., 1.8 to 2.4 million people, will suffer cardiac disorders and/or digestive clinical manifestations if they are not treated early during the course of the infection [1, 2]. However, only a small fraction of patients are properly diagnosed and treated [3]. Current clinical guidelines recommend treating T. cruzi–infected people if they are asymptomatic or present early symptoms of the disease (Table 1) [4, 5]. Benznidazole (BNZ) and nifurtimox (NFX) are the first-line antiparasitic treatments currently available, both with long administration regimens (60 days) that can produce adverse side effects [6–8]. Despite the fact they are not 100% effective in patients with chronic disease [9–12], they are the only drugs currently registered, and the benefits of their administration have been confirmed in several clinical studies. Currently, clinical trials with new compounds, using alternative regimens that aim to maintain efficacy whilst reducing toxicity, are ongoing and could lead to new therapeutic opportunities and/or policy change.