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Package of prophylaxis against infections reduces the risk of death for people starting HIV treatment very late
Keith Alcorn, 2016-08-08 07:10:00

A package of enhanced prophylaxis against infections significantly reduced the risk of death in adults and children with advanced HIV disease after starting antiretroviral treatment in a randomised study, Professor James Hakim of the University of Zimbabwe told the 21st International AIDS Conference in Durban, South Africa, last month.

Professor Hakim was presenting the results of the REALITY study, a large clinical trial designed to evaluate strategies for reducing the risk of death in people who start antiretroviral treatment with very low CD4 cell counts (below 100 cells/mm3). Late presentation with HIV disease, often with symptomatic disease, remains common in sub-Saharan Africa. The risk of death in the first six months after starting treatment remains high for adults and children.

Professor Hakim told a press conference that death rates in the first six months of treatment can be six to ten times higher in low and middle-income countries than in the developed world in people who start treatment with very advanced HIV disease, due to infections such as tuberculosis (TB) and Cryptococcus, and due to severe malnourishment.

Identifying ways of reducing the risk of death in people who start antiretroviral therapy with very low CD4 counts is essential if the number of AIDS-related deaths is to be reduced. In particular, more evidence is needed to show whether a package of aggressive prophylaxis against the infections that most frequently cause deaths in the first months after starting ART can bring down death rates. Although cotrimoxazole prophylaxis is widely implemented, isoniazid preventive treatment still fails to be provided despite a World Health Organization recommendation for its use in people living with HIV.

The REALITY trial, carried out in Kenya, Malawi, Uganda and Zimbabwe evaluated three strategies for reducing the risk of death:

  • Prophylaxis against the infections most commonly associated with death in advanced HIV disease (tuberculosis, cryptoccus, bacterial infections and protozoal infections), compared to cotrimoxazole prophylaxis alone.
  • Intensification of antiretroviral therapy with an integrase inhibitor in order to reduce viral load more quickly, leading to more rapid immune reconstitution, compared to three-drug ART alone.
  • Supplementary ready-to-use food for 12 weeks (two packets of a high energy, low protein food per day) to improve nutrition, compared to targeted nutritional support for those with poor nutritional status according to local protocols.

All participants in the study received antiretroviral therapy according to national guidelines (predominantly tenofovir/emtricitabine and efavirenz). In addition, participants underwent three randomisations (factorial randomisation), to each of the study interventions or to a control arm. Participants were therefore randomised to one intervention and then each group was randomised to receive a further intervention or control, and so on.