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test the safety and efficacy of this new formulation in young children

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Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

The challenge

Among parasites, schistosomes (flatworms) are second only to malaria in terms of their health and socioeconomic impact. Around 700 million people live in countries where schistosomiasis occurs, and 90% of those requiring treatment live in Africa.

Control of schistosomiasis relies mainly on mass drug administration with praziquantel. As the condition becomes less common, there is an increasing need for accurate diagnostics to support more targeted strategies. In particular, diagnostics could ensure that vulnerable groups, such as pregnant women and young children, are not unnecessarily exposed to praziquantel.

Diagnostic tests have been developed to detect schistosome infections. The point-of-care POC-CCA test is good for detecting intestinal schistosomiasis but has lower sensitivity for urinary schistosomiasis. By contrast, the UCP-LF test is highly sensitive and specific but requires laboratory facilities.

The FREEBILY project is evaluating the use of these tests to detect schistosome infections in women and young children in different contexts. One application being assessed is use of the POC-CCA test in routine mother and child clinics, to support ‘test and treat’ strategies.

The project is also evaluating use of the UCP-LF test to detect S. haematobium and provide an accurate measure of praziquantel efficacy in a trial of praziquantel use in pregnant women in Gabon.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

FREEBILY will provide evidence on the effectiveness and cost-effectiveness of test-and-treat strategies for schistosomiasis in pregnant women and young children, as well as additional data on the UCP-LF test. Although the studies are being conducted in areas of high and low schistosome endemicity in Madagascar and Gabon, the results will be generalisable to other countries affected by schistosomiasis.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact