New results from the REALITY trial, which looked at how to reduce deaths among people starting HIV treatment late, were presented yesterday at the Conference on Retroviruses and Opportunistic Infections in Seattle.
Many people with HIV in Africa do not start antiretroviral medicines (ARVs) until their immune system has been badly damaged by the disease. Around one in four people starting ART have CD4 cell counts (a measure of the strength of the immune system) of less than 100cells/mm3, which is very low. People with low CD4 counts when they start HIV treatment have around a 1 in 10 risk of dying within the first few weeks of treatment.
The REALITY trial looked at ways to reduce these deaths in the early stages of treatment for people starting with low CD4 counts. It tested three strategies, in addition to standard HIV treatment, for the first 12 weeks of treatment:
- Enhanced prophylaxis (prevention) medicines 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.
1,805 adults and children over 5 years of age from Kenya, Malawi, Uganda and Zimbabwe took part in the REALITY trial. All had CD4 counts under 100 cells and were starting ARVs. People who took part in the trial were followed up for 48 weeks.
The results of the enhanced prophylaxis and raltegravir comparisons were presented at the International AIDS Conference in 2016. The results of the ready-to-use supplementary food comparison were presented for the first time yesterday.
In the ready-to-use supplementary food comparison, people 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 except for severely malnourished participants).
A small number of participants who were severely malnourished were given ready-to-use therapeutic food, as per local guidelines, instead.
Those in the arm that received the supplementary food did gain more weight (about 1kg) than those in the non-RUSF arm, with the difference emerging between 0-8 weeks, and being maintained out to 48 weeks. Their Body Mass Index also increased slightly more than those in the standard arm, as did mid-upper arm circumference. However, this increased weight gain did not lead to a reduction in mortality, nor a greater improvement in grip strength. It also had no effect on how well the virus was controlled, or the immune system of participants.
These results suggest that, for adults without severe malnutrition, supplementary feeding is not necessary in addition to a healthy balanced diet for those on ART.
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.