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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

National regulatory agencies have a complex function to perform, needing to identify the most appropriate regulatory pathways for medicinal products and to carry out sophisticated risk–benefit analyses. In Zimbabwe and many other countries in sub-Saharan Africa, medicines reviewers and regulatory science staff to support these activities are in short supply.

Although some postgraduate training courses do exist, these generally lack a practical dimension and first-hand application of knowledge in regulatory decision-making.  

The Reg. Science-Fellows project is addressing this gap by developing a fellowship scheme jointly managed by the Medicines Control Authority of Zimbabwe and the University of Zimbabwe. Its aim is to develop a cohort of medicines reviewers and regulatory science professionals with particular expertise in key areas of product assessment. These include the assessment of new medicines being introduced into southern Africa, of complex biopharmaceutical products, and product licensing applications based on bioequivalence data (data aiming to show that a new product has the same activity as an existing licensed product).

The project is developing three-week competency-based short courses, as well as a two-year fellowship in regulatory sciences, and will undertake annual proficiency testing of Medicines Control Authority staff. Training will be available to other national regulatory agencies.

At least 100 staff will undertake the short courses and up to ten fellows will be supported through the fellowship programme. Fellows will complete the short courses as well as training at the Utrecht WHO Collaborating Centre for Pharmaceutical Policy and Regulation, practical work assignments and case studies, and work on live medicines reviews.

In the first 18 months of the project, 102 regulators and regulatory affairs professionals from five Southern African Development Community (SADC) countries undertook three short courses, and eight individuals from Botswana, Eswatini, South Africa, Zambia and Zimbabwe were appointed to the fellowship scheme through a competitive application process.

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 Reg. Science-Fellows will build the capacity of staff at the Medicines Control Authority of Zimbabwe and other national regulatory authorities in the SADC area to undertake increasingly complex medicines reviews. It will also generate a pool of highly qualified experts in regulatory science able to further expand capacity in southern Africa.

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