Evaluate new therapeutic regimens of benznidazole as monotherapy, or in combination with fosravuconazole, for the treatment of adult patients with chronic Chagas disease.
current phase of drug development
updated 29 Feb 2020
Benznidazole, the current Chagas treatment, is effective but has limitations: it lasts 60 days, and some 20% of patients stop treatment due to side effects, which include gastric intolerance, skin rashes, or neuromuscular problems. To explore whether these were related to dose or treatment duration, DNDi decided to test the efficacy of new regimens where exposure to benznidazole would be reduced, either due to shorter treatment, lower doses, or both.
In 2013, a proof-of-concept trial showed that fosravuconazole, an azole-class antifungal drug discovered by Eisai, had good safety and was effective at clearing the parasite, but efficacy was not sustained. A Phase I drug-drug interaction study assessed the safety and pharmacokinetic interactions of fosravuconazole and benznidazole administered separately and in combination. No major clinically relevant safety or tolerability issues were identified. A Phase II, randomized, placebo-controlled study was carried out in three sites in Bolivia between 2016 and 2018. It tested, against a placebo, six benznidazole treatments of differing lengths and dosages, both as a monotherapy and in combination with fosravuconazole. The aim was to improve efficacy, safety, and tolerability of treatment of adults with chronic indeterminate Chagas. Results showed that the new regimens presented good safety profile. DNDi will now continue to work with national programmes, partners, and health ministries of endemic countries to confirm these results and encourage the necessary steps to register the new regimen.
News & publications
- 6 April 2021 – Chagas disease: Shorter treatment just as effective as longer one, according to study in Bolivia published by The Lancet
- 14 March 2019 – Study shows dramatically shorter treatment for Chagas disease could be just as effective, and significantly safer
- The BENDITA Study: Briefing document
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