Chemotherapy for second‐stage human African trypanosomiasis: drugs in use
What is the aim of this review?
Gambiense human African trypanosomiasis (g‐HAT), or sleeping sickness, is a severe disease transmitted through the bite of infected tsetse flies found in rural parts of sub‐Saharan Africa. Sleeping sickness has two clinical stages. This review only examines treating the second‐stage, where people develop symptoms caused by invasion of the central nervous system (CNS), resulting in changes in the nervous system. Death is inevitable without treatment. Drugs for treatment are few, often require intravenous infusion every day over several weeks, and have serious side effects. In this review we aimed to compare the effects of current drugs for gambiense sleeping sickness and we examined nifurtimox‐eflornithine combination (NECT) with a new drug, fexinidazole, that can be taken orally.
Whilst fexinidazole cures some people, deaths from any cause and treatment failure rates are higher than with conventional treatment. Adverse events were common in both groups. Fexinidazole is more practical to give, and means less time in hospital for intravenous treatment infusion.
What was studied in this review?
We looked at the evidence about the benefits and harms of current drugs used in people with second stage g‐HAT. We searched for randomized trials, which provide robust evidence about the various treatments. We aimed to determine whether any drug provides a definite advantage over the other, measured in terms of clinical outcomes and in relation to the severity of adverse effects.
What are the main results of the review?
We only identified one suitable trial, which included 394 people and was conducted in the Democratic Republic of the Congo and the Central African Republic. The trial showed that deaths from any cause at 24 months may be higher with fexinidazole compared with NECT. Nine of the 264 people who took fexinidazole died, compared with two of the 130 people who took NECT. Fexinidazole probably increases the number of people who relapse during two years. Fourteen people in the fexinidazole group relapsed, and none in the NECT group. Adverse events were very common in both groups over the two years, and there is not likely to be much difference between the two drugs (247/264 in the fexinidazole group and 121/130 in the NECT group). We do not know about the effect of fexinidazole on serious adverse events, as the evidence is very uncertain. There were 31/264 serious adverse events in the fexinidazole group and 13/130 in the NECT group at 24 months.
How up to date is this review?
The evidence is current to 14 May 2021.