The findings, published in JAMA, randomly assigned early stage HIV-infected patients who had not received antiretroviral therapy in Botswana to receive various combinations of B-vitamins and minerals or a placebo in order to assess whether micronutrient supplementation is safe and effective for delaying the onset of HIV in people with the early phases of the disease who are yet to receive antiretroviral therapy (ART).
"In ART-naive HIV-infected adults, 24-month supplementation with a single supplement containing multivitamins and selenium was safe and significantly reduced the risk of immune decline and morbidity," revealed the research team, led by Marianna Baum from Florida International University. "Micronutrient supplementation may be effective when started in the early stages of HIV disease."
Baum and her team noted that with nearly a quarter of 15-49 year olds in Botswana infected with HIV, the country has become one of the large-scale efforts to provide ART. However, there remains ongoing discussions between govebments and the World Health Organisation as to when the best time to commence ART is, with a CD4 cell count of 350/μL or less currently used in many areas.
"Micronutrient deficiencies, known to influence immune function, are prevalent even before the development of symptoms of HIV disease and are associated with accelerated HIV disease progression," the team explained.
"Micronutrient supplementation has improved markers of HIV disease progression (CD4 cell count, HIV viral load) and mortality in clinical trials; however, these studies were conducted either in the late stages of HIV disease or in pregnant women," they added - noting that there are no studies testing the effect of long-term micronutrient supplementation in early stages of HIV disease when patients do not receive ART.
The 24 month randomised clinical was conducted in 878 patients with early stage HIV, all of whom had a CD4 cell count greater than 350/μL and so were not receiving ART. The trial randomly assigned participants to receive either a multivitamin containing B vitamins and vitamins C and E, selenium alone, the multivitamins with selenium, or a placebo.
Participants receiving the combined supplement of multivitamins plus selenium were reported to have a lower risk of reaching a CD4 cell count 250/µL or less than those given placebo. The team noted that a CD4 cell count of 250/µL or less is a measure that is consistent with the standard of care in Botswana for initiation of ART at the time of the study.
Supplementation was also shown to reduce the risk of a combination of measures of disease progression (CD4 cell count ≤ 250/µL, AIDS-defining conditions, or AIDS-related death, whichever occurred earlier).
"This evidence supports the use of specific micronutrient supplementation as an effective intervention in HIV-infected adults in early stages of HIV disease, significantly reducing the risk for disease progression in asymptomatic, ART-naive, HIV-infected adults.," said the authors.
"This reduced risk may translate into delay in the time when the HIV-infected patients experience immune dysfunction and into broader access to HIV treatment in developing countries," they said.
Baum and her colleagues added that their findings "are generalizable to other HIV subtype C-infected cohorts in resource-limited settings where the provision of ART is being scaled up, rolled out, or not yet available to all in conditions similar to those in Botswana at the time of this study."
Volume 310, Number 20, Pages 2154-2163, doi:10.1001/jama.2013.280923
"Effect of Micronutrient Supplementation on Disease Progression in Asymptomatic, Antiretroviral-Naive, HIV-Infected Adults in Botswana. A Randomized Clinical Trial"
Authors: Marianna K. Baum, Adriana Campa, et al