DNDi-led Study Finds Safer, Shorter Treatment For Debilitating Chagas Disease

Severe side effects make the current course of prolonged drug treatment difficult for many patients with Chagas disease, but a Phase II clinical trial in Bolivia may have found an alternative treatment that is both quicker and significantly safer.

Healthcare practitioners often prefer not to suggest benznidazole treatments due to high rates of serious side effects, but the results of DNDi’s clinical trial may make treatment more attractive to both providers and recipients.

The trials, carried out at three Bolivian health centers and led by the Drugs for Neglected Diseases Initiative (DNDi), found that a two-week treatment was just as effective in treating the disease as the conventional eight-week course of treatment for Chagas, with treatment succeeding for about 80 percent of patients, according to a DNDi press release issued yesterday.

The short treatment course also reduced side-effects and therefore improved treatment adherence. No one dropped out of the two-week course, while an average of two out of every ten patients quit the eight-week course due to side effects. This is critical for the control and elimination of the disease that affects about 6 million people worldwide, mostly in poor households of Latin America.

DNDi partnered in the study with the Fundacion Ciencia y Estudios Aplicados para el Desarrollo en Salud y Medio Ambiente (CEADES Foundation) in Bolivia, the Barcelona Institute for Global Health (ISGlobal), as well as other pharmaceutical industry and local partners.

This major step forward for Chagas disease treatment is part of a DNDi effort to make the disease much less debilitating for future patients. “DNDi will now continue to work with national programmes, partners and ministries of health of endemic countries to confirm these results and encourage necessary steps to register the new regimen and turn this breakthrough discovery into a reality for people affected by the disease,” Sergio Sosa Estani, head of the Chagas Clinical Programme at DNDi, said in the press release.

Chagas disease is chronic and can result in permanent damage to the heart as well as the nervous and digestive systems, and in some cases, death. It is caused by the parasite Trypanosoma cruzi, which often live in the walls and floors of poorly-built homes. While it is most commonly transferred to humans through a blood-sucking triatomine bug, transmission can also occur through blood transfusions, organ transplantation, and consumption of food contaminated by the insect’s feces. Infected pregnant women can also pass the disease to their children.

A healthcare practitioner meets with a Chagas patient in Bolivia.

The current procedure recommended by World Health Organization guidelines is an eight-week course of benznidazole administered twice a day, either on its own or in combination with another drug like fosravuconazole. Benznidazole is highly effective at treating the disease in its acute stages, but its side effects, ranging from skin rashes to peripheral neuropathy, discourage patients from agreeing to the treatment.

According to the release, a two-week treatment procedure carried out in the clinical trial administered the same dose of benznidazole as the standard eight-week procedure. Despite the significant difference in length, both treatments eliminated the parasite’s presence in 80 percent of patients from each group, who remained disease-free 12 months after the treatment course was finished.

These results could change the way Chagas disease is treated, potentially preventing millions more people from living with the toll it takes on the body. “We’ve shown that shorter treatment could be just as effective, and much safer,” Faustino Torrico, principal investigator in the trial and president of CEADES Foundation in Bolivia, said in the release.

“This could change the paradigm for Chagas treatment, by improving adherence and encouraging wider adoption by the medical community,” he said.

“We believe treatment can spare people with Chagas the risk of a lifetime of debilitating complications associated with the disease. However, the current treatment can cause severe side effects, which has often discouraged some people from seeking treatment and healthcare workers from recommending it,” Joaquim Gascon, director of the Chagas Initiative at ISGlobal and a principal investigator in the trial, said in the release.

DNDi has partnered with ISGlobal and the CEADES Foundation as well as Elea, an Argentinian pharmaceutical company which manufactures benznidazole, Eisai Co. Ltd., a Japanese pharmaceutical company and manufacturer of fosravuconazole, the non-profit foundation Fundación Mundo Sano, and other non-profits in order to conduct these trials. Funding was provided by the Global Health Innovative Technology Fund.

Image Credits: Ana Ferreira/DNDi.

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