Giving ready-to-use supplementary food to people starting HIV treatment with advanced disease does not reduce deaths, according to results from the REALITY trial published in The Lancet HIV journal.
Many people with HIV in Africa do not start antiretroviral therapy (ART) until their immune system has been badly damaged by the disease. People with low CD4 counts (a measure of the strength of the immune system) when they start HIV treatment are at a high risk of dying within the first few weeks of treatment. Around one in five people starting ART in Africa have CD4 cell counts of less than 100cells/mm3, which is very low.
The REALITY trial looked at ways to reduce these deaths in the early stages of treatment. It tested three strategies, in addition to standard HIV treatment, for the first 12 weeks of treatment:
- Enhanced prophylaxis to prevent infections
- Increasing the potency of ART by adding the anti-HIV drug raltegravir to reduce the amount of virus in the blood faster
- Ready-to-Use Supplementary Food to improve nutritional status
The results published today focus on the ready-to-use supplementary food comparison. In this comparison, people who were not severely malnourished were randomised to receive either:
- A high energy, low protein, lipid-based paste made from a peanut base for the first 12 weeks of their treatment. Adults and adolescents were given two foil packets per day, providing an additional 1000 kCal, and children were give one packet per day (500 kCal). The paste was fortified with multi-vitamins and minerals.
- Standard care (no supplements)
897 participants were randomised to receive supplementary food for the first 12 weeks of HIV treatment, and 908 were randomised to receive no supplementary food. Participants who were severely malnourished all received therapeutic food instead.
It was thought that supplementary food may help reduce deaths, as people with lower body mass index have a higher mortality after starting ART, even if they are not severely malnourished.
People in the group who received supplementary food gained about 1kg more weight than people in the group who did not receive supplementary food. But this increase in weight did not lead to improvements in grip strength, or reduce deaths. It also made no difference to how much virus people had in their blood.
These results suggest that, for adults without severe malnutrition, supplementary feeding is not necessary in addition to a healthy balanced diet for those initiating ART with very low CD4 counts. The ready-to-use supplementary food is relatively expensive, so it is useful to know that it is not universally needed for people without severe malnutrition.
Around 1 in 10 people in the trial, who all started ART very late, died. This shows the need for effective interventions to help people starting ART late to get through the first few months of treatment. Another of the approaches tested in the REALITY trial, an enhanced package of prophylaxis to reduce infections, was successful in reducing deaths.
The REALITY trial was led by the MRC Clinical Trials Unit at UCL, in collaboration with: Joint Clinical Research Centre (JCRC), Kampala, Fort Portal, Mbarara, Mbale, and Gulu, Uganda; University of Zimbabwe Clinical Research Centre (UZCRC), Harare, Zimbabwe; University of Malawi, Department of Medicine, Blantyre, Malawi; Moi University Clinical Research Centre (MUCRC), Eldoret, Kenya; and KEMRI Wellcome Trust Centre, Kilifi, Kenya. The REALITY trial was funded by the Department for International Development, UK (DFID), the Wellcome Trust and the Medical Research Council (MRC) UK. Additional funding support is provided by the PENTA foundation.