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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

The sub-Saharan Africa region accounts for 94% of all malaria deaths. Following many years of progress, control of malaria in the region has slowed. Revitalised efforts are required to lower further the malaria burden, and to protect vulnerable populations such as children and pregnant women.

One strategy known to be effective is seasonal malaria chemoprevention (SMC). In areas where transmission is greatly affected by weather conditions, such as high rainfall, children can be given regular doses of antimalarial drugs to ensure they are not infected at times of high transmission. Although this strategy is recommended by WHO, it is not fully implemented in the region – less than 50% of eligible children had access to SMC in 2017.

The OPT-SMC project aims to both widen and strengthen implementation of SMC in sub-Saharan Africa. It is strengthening the capacity of national malaria control programmes to plan effectively and to procure and distribute drugs efficiently to target populations. It is also strengthening capacity for implementation research so national programmes can gain insight into and overcome programmatic barriers. A further aim is to improve the ability of national control programmes to monitor and evaluate performance of SMC campaigns, with new tools being developed to support planning, monitoring and evaluation.

The project is being coordinated by centres in Senegal, Switzerland and the UK, which are building on an existing partnership of 14 countries, 12 of which are already using SMC and two that have plans to introduce it. Enhanced collaboration between partners will support sharing of expertise and experience. The project is also receiving input from WHO (through TDR) and the Medicines for Malaria Venture, as well as academic support from partners in Senegal and the UK.

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.

The OPT-SMC project will increase use of a simple intervention with proven life-saving potential, preventing children’s deaths from malaria and reducing its clinical, social and economic impact.

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