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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

Republic of Congo is a small country, with a population of around 5 million, and has a weak health system infrastructure. COVID-19 surveillance has been introduced in the country but gives only an incomplete picture of the spread of the virus.

Molecular methods for detecting the genetic material of SARS-CoV-2, using the polymerase chain reaction (PCR), are the standard approach for confirming infection, but require specialist facilities. They also take time to generate results, by which time a patient may no longer be in contact with the health system.

The ITAIL-COVID-19 project is assessing a range of methods for detecting SARS-CoV-2 infections suitable for use in different situations.

An overarching objective is to develop a clearer picture of the spread of SARS-CoV-2 in Republic of Congo. In part, this will be achieved by increasing capacity for molecular testing. A rapid antigen diagnostic test developed by one of the project’s European project’s partners is also being evaluated. Although not as sensitive as molecular methods, it is easy to use and gives results within 15 minutes, so isolation and contact tracing can be launched immediately while confirmatory testing is carried out. Antibody-based testing will also be evaluated, which could be used to identify individuals no longer at risk of infection and to provide estimates of the true number of infections in a community.

An additional strand of the project will focus on health care workers, who are at significant risk of infection. It is evaluating a modified version of PCR testing that incorporates an additional sample processing step – involving use of a bloodstream protein that sequesters viral proteins and could increase the sensitivity of PCR-based tests. 

Participants will be recruited by screening individuals presenting at a range of health facilities with flu-like symptoms. Blood samples from patients and household members will also be analysed to provide information on the dynamics of antibody responses to SARS-CoV-2 during the course of an infection, how they relate to clinical symptoms, and the prevalence of asymptomatic infections.

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 ITAIL-COVID project will increase testing capacity in Republic of Congo, to give a clearer picture of COVID-19 burden in the country, including the proportion of symptomatic and asymptomatic cases. Epidemic management in the country would also benefit from a validated antibody test, for determining individual protection from infection and levels of population immunity. Data from the project may also reveal whether past viral infections confer some degree of immunity to COVID-19, which would be of wider significance.

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