New treatment for sleeping sickness could end transmission of the disease by 2030

A new single-dose oral treatment for sleeping sickness could be a key factor in eliminating transmission of the disease by 2030, a study published in The Lancet Infectious Diseases suggests.

Sleeping sickness, or human African trypanosomiasis (Hat), is a neglected tropical disease that can be fatal if left untreated.

Gambiense form of human African trypanosomiasis (g-Hat) is found in West and Central African countries, with most cases in the Democratic Republic of the Congo.

Until 2019, treatment for patients with early-stage disease was a daily injection for seven or more days, and for patients with late-stage disease, an intravenous drip for seven days, which required hospital treatment .

Patients were also asked to undergo a spinal tap to diagnose the stage of their sleep disease and determine appropriate treatment.

In 2019, fexinidazole, a 10-day oral medication developed by the Drugs for Neglected Diseases initiative (DNDi) was introduced as first-line treatment for both stages of the disease.

But its administration still requires skilled personnel and often hospital treatment.

The new prospective study looks at the effectiveness of an oral dose of acoziborole, a drug jointly developed by DNDi and Sanofi, in treating g-Hat.

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“Sleeping sickness threatens millions of people in sub-Saharan Africa,” said Dr. Antoine Tarral, head of the human African trypanosomiasis clinical program at DNDi and lead author of the study.

“Many of the people at risk live in remote rural areas where there is little access to adequate health services and where acosiborol has the potential to revolutionize the treatment of sleeping sickness.

“It is administered in a single dose and is effective at every stage of the disease, thus removing the many barriers that currently exist for the most vulnerable people to the disease, such as invasive treatments and long travel distances to a hospital or clinic and opening . the door to village-level screen-and-treat approaches’.

The researchers found that 18 months after treatment, 95 percent of advanced-stage g-Hat patients treated with acoziborol were cured.

In early and intermediate stage patients, 100% were successfully treated.

A review of the results found that they were similar to the success rate for Hat’s previous treatment, nifurtimox eflornithine (Nect) combination therapy, of 94 percent.

The proportion of treatment-related side effects was low and all events were mild or moderate.

No significant drug-related safety signals were identified in this study.

The authors noted some limitations of their study, the main one being the lack of a control arm.

As enrollment of g-Hat patients in clinical trials is challenging, the study was designed as a single-arm trial with no comparator or control arm, following the approval of the European Medicines Agency.

The sample size was based on the maximum enrollment feasible in a reasonable time frame, due to the challenges of enrolling patients with Hat in clinical trials given the drastic fall in incidence.

A double-blind study investigating the use of acosiborol compared with placebo in serologically suspected but parasitologically unconfirmed cases is ongoing to generate additional safety data.

“Acosiborole combines all the desirable qualities of a trypanocidal drug: well absorbed orally, long half-life, good CNS penetration and few serious side effects,” said Professor Jacques Pepin of the University of Sherbrooke in Canada, who did not been involved. in study.

“Purists will say that acosiborol was not evaluated according to current standards because the study was not a randomized trial, there was no control group, and the number of participants was small.

“But these were difficult challenges to overcome, given the drastic reduction in the number of Hat patients and the dispersal over a vast territory, especially in the Democratic Republic of Congo.

“For these reasons, the authors adopted a pragmatic approach.

“Acosiborole represents a tremendous advance in the treatment of this neglected disease and could be the key to interrupting Hat transmission.”

Updated: November 29, 2022, 11:44 p.m

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