REALITY trial finds way to reduce deaths among people starting HIV treatment late

22 Jul 2016

GIVING a package of drugs to prevent infections to people who are starting HIV treatment with advanced disease can reduce deaths, according to the REALITY trial results. These results were presented today at the 21st International AIDS Conference in Durban.

Many people with HIV in Africa do not start antiretroviral therapy (ART) 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 are at a high 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 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 Antretroviral medicines (ARVs). People who took part in the trial were followed up for 48 weeks.

In the enhanced prophylaxis comparison, people were randomised to receive either cotrimoxazole prophylaxis (an antibiotic that can be used to prevent bacterial infections) which is standard care, or a package that also included additional drugs:

  • Isoniazid to prevent tuberculosis
  • Fluconazole to prevent cryptococcal disease and candida
  • Azithromycin to prevent bacterial and protozoal diseases
  • Albendazole to treat worms

REALITY found there were three fewer deaths for every hundred people treated in the group who had the enhanced prophylaxis than the group who had standard cotrimoxazole prophylaxis. Or, putting this another way, enhanced prophylaxis reduced the risk of death by 25%. People in the enhanced prophylaxis group were also less likely to have severe AIDS illnesses, abnormal test results or require admission to hospital.

The results of the comparison that tested adding an extra ARV drug (raltegravir) to standard ART were also presented at the conference. Adding raltegravir decreased the amount of HIV virus in the blood much faster than standard ART. But this rapid reduction in viral load did not lead to a reduction in deaths or severe AIDS illnesses.

The researchers are now recommending that people starting HIV treatment with low CD4 counts should be given enhanced prophylaxis for the first few weeks of treatment.

The enhanced prophylaxis results were presented by James Hakim of the University of Zimbabwe Clinical Research Centre. Cissy Kityo of the Joint Clinical Research Centre in Uganda presented the raltegravir results.

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

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