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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

Liberia was badly affected by the 2014–16 West Africa Ebola outbreak. As well as the immediate loss of life, the outbreak also had a devastating economic impact and led to major disruption in Liberia’s health systems. These setbacks undid much of the progress in Liberia achieved after the end of more than a decade of civil unrest in 2003.

As well as Ebola, the country faces the threat of multiple existing and emerging infectious disease threats, emphasising the need for strong health research systems, including regulatory and ethics review capacity.

The LiberHetica project is establishing a collaboration between the EU and Liberia in order to strengthen ethics review practices. A key focus is on the institutional review board of the University of Liberia–Pacific Institute for Research and Evaluation, Liberia’s leading site for infectious disease research, and the National Research Ethics Board of Liberia.

As well as working with these individual bodies, the project is also developing an ethics capacity improvement strategy to be presented to the Ministry of Health, Liberia for nationwide implementation.

The projects aims to enhance links between Liberia and national ethics committees in Europe and other European organisations involved in oversight of clinical research. It will also build and strengthen links with African ethics networks and projects, including the EDCTP-funded REECAO project and ALERRT pandemic preparedness network.

The project is also improving collaboration and consistency of practice across other bodies in Liberia involved in ethics review, by developing and implementing standardised guidelines and operating procedures. Through subregional networks and engagement with surrounding countries, the project will develop collaborations and promote adoption of harmonised ethics procedures. It will also address the balance of gender, expertise and representation of vulnerable populations on ethics review bodies.

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 LiberHetica project will create a sustainable European–African collaborative network that will support the development and introduction of more efficient procedures, standardised guidelines, and ethics training programmes. Its activities will help to establish a stronger framework for clinical research in Liberia and a foundation for future capacity development.

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