A clinical trial has been launched in Argentina to see if a shorter regimen of the drug benznidazole has the potential to become a new standard treatment for Chagas disease to treat adult patients in the chronic phase of the disease, with fewer side effects.
The hope with a shorter regimen is to increase adherence to treatment, improve the overall risk profile versus the benefits of treatment, and expand treatment coverage.
Approved by the regulatory agency ANMAT, the NuestroBen clinical trial will be carried out at six sites in the cities of Buenos Aires, Corrientes, and Santiago del Estero. It is led by the Drugs for Neglected Diseases initiative (DNDi), in partnership with Laboratorio ELEA PHOENIX and the Mundo Sano Foundation, under the supervision of Argentina’s Ministry of Health.
‘We carried out the first controlled study in Bolivia between 2016 and 2018 to assess the efficacy of various regimens with benznidazole. We concluded that a two-week treatment is as effective as an eight-week treatment, and none of the patients discontinued the treatment due to side effects,’ said Sergio Sosa Estani, Head of DNDi’s Chagas Clinical Programme.
‘NuestroBen can confirm these findings with a higher number of patients in Argentina, as is the case with Benlatino and other studies currently in preparation in other Latin American countries. If these results are confirmed, people with Chagas could adopt the new regimen,’ said Sosa-Estani.
6 million people are estimated to be infected with Chagas in 21 countries in Latin America (6 to 7 million worldwide) and 75 million people worldwide are at risk of contracting the disease. Chagas is a neglected and silent tropical disease caused by the Trypanosoma cruzi parasite. It is transmitted to humans by an insect popularly known as the ‘kissing bug’, vinchuca, or chinche depending on the region.
As measures to control the transmission of the disease via insects and blood transfusions have made considerable progress, mother-to-child transmission has become proportionally more relevant in Latin American countries and has become the main source of new cases in non-endemic regions. According to WHO estimates, there are still 1.12 million women of childbearing age with the disease in Latin America, where between 8,000 and 15,000 babies are expected to be born with the disease every year.
‘If the expected results are obtained, this study will improve adherence to Chagas disease treatment regimens, benefitting all people affected, including girls and women of reproductive age. This way, we will be helping to prevent the vertical transmission of this disease and working for a future when there is Not a single baby with Chagas,’ said Marcelo Abril, Executive Director of the Mundo Sano Foundation.
‘Chagas disease is a public health issue, and public-private collaboration is essential to control it. The work carried out a few years ago with the development of benznidazole in Argentina shows that joint efforts are possible, especially when the goal is to improve the lives of people with Chagas disease.
‘Today in our country there are three dosage forms produced entirely in Argentina, which are supplied to the region of the Americas. We also have a paediatric formulation for better administration to infants with the condition,’ said Dr Matías Deprati, Director of Medical Affairs at Laboratorio Elea.
DNDi Latin America
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A non-profit research and development organization, the Drugs for Neglected Diseases initiative (DNDi) works to deliver new treatments for people living with neglected diseases, especially Chagas disease, sleeping sickness (human African trypanosomiasis), leishmaniasis, filarial infections, mycetoma, pediatric HIV, and hepatitis C. DNDi is also coordinating a clinical trial to find treatments for mild-to-moderate COVID-19 cases in Africa. Since its inception in 2003, DNDi has provided 9 new treatments, including new drug combinations for visceral leishmaniasis, two fixed-dose antimalarial drugs, and the first chemical entity it developed, fexinidazole, approved in 2018 for the treatment of both stages of sleeping sickness. dndi.org
Photo credit: Ana Ferreira-DNDi