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High-dose Vitamins Do Not Improve HIV Outcomes or Lower Mortality, but May Harm Liver

High-dose multivitamins do not reduce HIV disease progression or risk of death when added to combination antiretroviral therapy (ART), but may contribute to liver toxicity, according to a study in Tanzania described in the October 17, 2012, Journal of the American Medical Association.

Vitamins and other micronutrients are known to play a role in immune function, reducing oxidative stress, and other important biological processes. Some previous large trials have shown that micronutrient supplementation is associated with increased CD4 T-cell counts, reduced HIV disease progression, and lower mortality among people not receiving effective combination ART, but its safety and efficacy have not been established among people on HIV treatment.

Sheila Isanaka from Harvard School of Public Health and colleagues conducted a randomized controlled trial of high-dose versus standard-dose (recommended dietary allowance) daily oral multivitamin supplements containing vitamin B complex, vitamin C, and vitamin E. The study included 3418 HIV positive participants starting combination ART between November 2006 and November 2008 at 7 clinics in Dar es Salaam.

The study was halted ahead of schedule in March 2009, after a median follow-up period of 15 months, when researchers saw an increased likelihood of elevated alanine transaminase (ALT) -- an enzyme that can signal liver inflammation -- among people receiving the high-dose supplement.

Results

• A total of 2374 HIV disease progression events and 453 deaths occurred by the time the study was stopped.
• Participants in the high-dose multivitamin supplement arm had the same risk of HIV disease progression or death as those taking standard doses (72% in both groups).
• All-cause mortality (13%) and AIDS-related mortality (4%) were also the same in both groups.
• Looking at participants with the most severe malnutrition and low body weight, high-dose supplements were associated with a significant 36% increase in mortality (relative risk 1.36).
• High-dose supplements had no significant effect on CD4 counts or plasma HIV viral load.
• The frequency of anemia was similar in both groups, but the high-dose arm saw a reduction in neutropenia.
• However, high-dose supplements were associated with a 44% higher risk of serious ALT elevation (relative risk 1.44).

"In adults receiving [combination ART], use of high-dose multivitamin supplements compared with standard-dose multivitamin supplements did not result in a decrease in HIV disease progression or death but may have resulted in an increase in ALT levels," the study authors concluded.

"This study provides no clear evidence of a benefit of high-dose micronutrient supplementation compared to standard-dose supplementation in adults receiving HAART, but it highlights the need for further research on how micronutrient supplements can be better positioned alongside antiretroviral drugs to reduce morbidity and mortality due to HIV," Isanaka added in a HSPH press release.

10/26/12

Reference

S Isanaka, F Mugusi, C Hawkins, et al. Effect of High-Dose vs Standard-Dose Multivitamin Supplementation at the Initiation of HAART on HIV Disease Progression and Mortality in Tanzania: A Randomized Controlled Trial. JAMA 308(15):1535-1544. October 17, 2012.

Other Source

Harvard School of Public Health. No Benefit From High-Dose Multivitamins Seen for HIV Patients Receiving Antiretroviral Therapy. Press release. October 16, 2012.