Published: Nov 26, 2013
By Michael Smith, North American Correspondent, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania
- In a randomized study of HIV-infected adults who had not received antiretroviral therapy-naive, 24-month supplementation with a single supplement containing multivitamins and selenium was safe, significantly reducing the risk of immune decline and morbidity.
- Multivitamins alone and selenium supplementation alone were not statistically different from placebo for any endpoint.
Early in HIV infection, a combination of multivitamin and selenium supplements slowed the progress of the disease, researchers reported.
In a randomized placebo-controlled clinical trial in Botswana, the combination cut -- by about half -- the risk of reaching the point of needing antiretroviral therapy, according to Marianna Baum, PhD, of Florida International University in Miami, and colleagues.
But multivitamins or selenium alone had no significant effect, Baum and colleagues reported in the Nov. 27 issue of the Journal of the American Medical Association.
The approach has previously been shown to improve mortality among people with HIV, the authors noted, but studies have focused on people with more advanced disease, with important comorbidities such as tuberculosis, or already on antiretroviral therapy.
The Botswana study is the first to study the effect of micronutrient supplementation on patients whose plasma CD4-positive T-cell count was greater than 350 per microliter and who were not on antiretroviral therapy during the study, Baum and colleagues reported.
One implication of the findings is that "you may not need always to use an HIV medication to achieve at least part of what we try to accomplish with therapy," commented David Wohl, MD, of the University of North Carolina in Chapel Hill, N.C., who was not part of the study.
"What's nice about this study," he told MedPage Today, is that a simple and inexpensive intervention could have "effects that were fairly profound" and that slowed the decline of immune function.
On the other hand, HIV therapy, when it's eventually used, would probably "trump any effect of micronutrients," he said.
In Botswana, Baum and colleagues enrolled 878 people with a median CD4 cell count of 420 cells per microliter and randomly assigned them to one of four study arms: placebo, micronutrients, selenium, or micronutrients plus selenium.
The study medications were taken daily. The micronutrient pills contained thiamine, riboflavin, niacin, B6, B12, folic acid, and vitamins C and E. Those in the selenium arms got 200 mg of the element daily.
The primary endpoint was HIV progression, defined originally as reaching a CD4 cell count of less than 200 per microliter. Because of a change in national guidelines in March 2008, the researchers redefined HIV progression as reaching a CD4 count of less than 250 cells per microliter.
In a Cox regression model, adjusted for a range of factors and taking interactions between the supplements into consideration, only micronutrients plus selenium had a significant effect, Baum and colleagues reported.
After a median follow-up of 24 months, the combination, compared with placebo, had an adjusted hazard ratio for reaching the endpoint of 0.46 (95% CI 0.25-0.85, which was significant (P=0.01).
The absolute event rate, the researchers reported, was 4.79 per 100 person-years among those getting the combination, and 9.22 per 100 person-years among those getting placebo, they reported.
Multivitamins plus selenium also reduced the risk of an important secondary endpoint -- the combination of disease progression, AIDS-defining conditions, or AIDS-related death, whichever occurred earlier. The adjusted HR was 0.56 and was significant (P=0.03).
The authors reported that there was was no effect of supplementation on HIV viral load. Also, reported adverse events were deemed as unlikely to be related to the intervention.
The study had support from the National Institute on Drug Abuse. The authors did not report any potential conflicts.
Primary source: Journal of the American Medical Association
Source reference: Baum MK, et al "Effect of micronutrient supplementation on disease progression in asymptomatic, antiretroviral-naive, HIV-infected adults in Botswana: A randomized clinical trial" JAMA 2013; 310(20): 2154-2163.