The international, multicenter, double-blind and placebo-controlled “Benznidazole Evaluation for Interrupting Trypanosomiasis” (BENEFIT) trial initiated more than 10 years ago in order to determine whether the estimated 1.2 million people now living with chronic Chagas heart disease could benefit from treatment with benznidazole. The answer seems to be “no”, according to an article published in Plos NTDs by the Global Chagas Disease Coalition.
The study did not show incremental benefits in cardiac outcome, underlining the need to revisit the current strategies for anti-parasitic chemotherapy in patients with chagasic heart disease. Furthermore, 17-18% of patients in both the treated and placebo arms died over a period of five years, meaning that roughly 200,000 people will die from Chagas cardiomyopathy in the next five years. This number is comparable to that of women in the US who will die from breast cancer in the same period. However, in contrast with breast cancer, there is little advocacy and support for research and development in Chagas disease.
Despite the negative results, the BENEFIT trial highlights research issues that need to be urgently addressed, such as the best dosing schedule for benznidazole, the development of reliable surrogate markers that can predict clinical outcomes, and the role of co-infections and non-communicable diseases when treating patients chronically infected with Trypansoma cruzi. It also presents new opportunities to evaluate new formulations and drugs that are currently in the pipeline.
"The newest information coming from the BENEFIT trial highlights the urgency to develop improved therapeutics for millions of people now living with Chagas disease", said Professor Peter Hotez, senior author of the article and Dean of the National School of Tropical Medicine at Baylor College of Medicine. For Dr. Joaquim Gascon, director of the Chagas Initiative at the Barcelona Institute for Global Health (ISGlobal), “the study emphasizes the need to initiate treatment at earlier stages of the disease”. Most importantly, as the authors conclude, it is a wake-up call for the international community to step up efforts in the diagnosis, treatment and research for Chagas.
Some numbers on Chagas Disease:
- 5.7-9.4 million people live with Chagas Disease
- Less than 1% has access to diagnosis and treatment
- More than 50% of infected persons live in Latin America’s wealthiest countries (Argentina, Brazil and Mexico)
- Hundreds of thousands of infected people live in USA and Europe, where parasite transmission can occur through blood and organ transfusions and from mother to child.
XII Workshop on Chagas Disease
The BENEFIT trial results will be the opening lecture of the XII Workshop on Chagas Disease that will take place on March 3 in Barcelona. The event offers a key space to discuss the latest advances in diagnosis and treatment of the disease.
Taking advantage of the presence of international experts in the field, the city of Barcelona will host other events related with Chagas research and treatment. The Ibero-American network NHEPACHA (New tools for the diagnosis and assessment of the patient with Chagas Disease) will meet on March 2, while the Global Chagas Coalition and the FIND organization will hold their meetings on March 4.
Bernard Pecoul, Carolina Batista, Eric Stobbaerts, Isabella Ribeiro, Rafael Vilasanjuan, Joaquim Gascon, Maria Jesus Pinazo, Silvia Moriana, Silvia Gold, Ana Pereiro, Miriam Navarro, Faustino Torrico, Maria Elena Bottazzi, Peter J. Hotez. The BENEFIT Trial: Where Do We Go from Here? Plos NTDs 2016 Feb 25;10(2):e0004343