New sleeping sickness drug could be a key in eliminating disease transmission by 2030: Study

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A new study published in a new journal indicates that a new single-dose oral treatment for sleeping sickness is as effective as current treatments and could be a key factor in eliminating transmission of the disease by 2030. The Lancet Infectious Diseases.

This optical microscopy image stained with Giemsa revealed the presence of two Trypanosoma brucei parasites, which were found in the blood smear. photo/CDC

Sleeping sickness, or human African trypanosomiasis (HAT), is a neglected tropical disease that, if left untreated, can be fatal. The Gambian human African trypanosomiasis (g-HAT) variant of the disease has been found across countries in West and Central Africa with most cases in the Democratic Republic of the Congo.

Until 2019, treatment for patients in the early stage of the disease was a daily injection for seven days or more, and for patients in the late stage of the disease, it was intravenous drip treatment for seven days, which required hospitalization. Patients were also asked to undergo a spinal tap, in which fluid is collected from the spine, to diagnose the stage of sleeping sickness to determine the most appropriate treatment. In 2019, fexenidazole, a 10-day oral medication developed by the Drugs for Neglected Diseases Initiative (DNDi) was offered as a first-line treatment for both stages of the disease, but its administration still requires skilled staff and, often, hospitalization.

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The new prospective study investigates the efficacy of a single oral dose of acoziborole, a drug jointly developed by DNDi and Sanofi, in the treatment of g-HAT.

“Sleeping sickness threatens millions of people across sub-Saharan Africa. Many of the people at risk live in remote, rural areas where there are few adequate health services, and where acoxipurol could revolutionize the treatment of sleeping sickness. It is given in a single dose and is It is effective at every stage of the disease, thus eliminating many of the barriers that currently exist for people at high risk of disease, such as invasive treatments, long travel distances to hospital or clinic, and opening up, says Dr. Antoine Taral, Head of the Human African Trypanosomiasis Clinical Program at DNDi and lead author. For the study, “Door Approaches to Village-level Screening and Treatment.”

During the study, which recruited patients from 10 hospitals in the Democratic Republic of the Congo and Guinea, a single 960 mg oral dose of acosiburol was administered to 208 patients; 167 were diagnosed with late-stage HAT and 41 with early/intermediate-stage G-HAT. The patients were followed for 18 months to see if the treatment was successful.

The investigators found that, after 18 months of treatment, 95% (159/167) of patients with late-stage G-HAT treated with coxiburol were cured (no trypanosomes, the microscopic parasites that cause g-HAT, are found in body fluids). . In patients in the early and middle stages, 100% (41/41) were treated successfully. Analysis of the results found that it was similar to the success rate of the previous HAT treatment, nifurtimox eflornithine combination therapy (NECT), of 94%.

The incidence of treatment-related side effects was low and all events were mild or moderate. No drug-related safety signals were identified in this study.

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The World Health Organization has set a goal of eliminating g-HAT by 2030 by halting disease transmission. Although cases are decreasing across Africa, this will be a challenge and we believe that the use of acosiburol could be a critical future tool in efforts to reach our common goal of eradicating the disease,” says Dr Victor Candy Beto Comiso, principal investigator. In Trial and Ex.Expert Consultant in Neglected Tropical Diseases, Ministry of Health, Kinshasa, Democratic Republic of the Congo.

The authors acknowledge some limitations of their study, chief among them the lack of a control arm. Because enrolling patients with g-HAT into clinical trials is challenging, the study was designed as a single-arm trial with no comparison or control arm, based on advice from the European Medicines Agency. The sample size was based on the maximum possible enrollment within a reasonable time frame, due to the challenges of enrolling patients with HAT into clinical trials given the very low incidence. There is currently an ongoing double-blind study investigating the use of acoziborole versus placebo in sero-suspected but unconfirmed parasitologic cases to generate further safety data.

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