Adverse effects of HIV therapy differ by race, sex

NEW YORK (Reuters Health) - Among patients infected with HIV, the virus that causes AIDS, initiating antiretroviral therapy, there are significant differences in specific adverse events according to sex and race, but not in the overall rate of adverse events, death from any cause, or treatment withdrawal rates because of drug toxicity, new research indicates.

Published data on the rate and types of adverse events by sex and race are limited, note researchers in the Journal of Acquired Immune Deficiency Syndromes.

Dr. Ellen M. Tedaldi from Temple University School of Medicine, Philadelphia, and colleagues compared the frequency and types of side effects by sex and race in 1,301 patients in an antiretroviral therapy (ART) initiation trial, including 701 blacks, 225 Latinos and 273 women.

During an average follow-up of 5 years, there were 409 grade 4 adverse events -- a rate of 8.9 per person per 100 years. Rated on a scale of 1 to 4, an adverse event of grade 4 is the most severe.

There were 176 deaths -- a rate of 3.0 per person per 100 years; and 523 ART discontinuations for any toxicity -- a rate of 13 per person per 100 years.

Compared with white patients or patients of any other race, cardiovascular and kidney adverse events were 2.64- and 3.83-times more frequent, respectively, in black patients. This finding is consistent with the greater rates of heart disease, diabetes, and kidney disease found in the general black population, the investigators point out.

Rates of serious psychiatric events were 2.45-times higher in black men than in men of other races. "It is likely that grade 4 psychiatric adverse events represent a constellation of factors that include psychosocial and biologic associations," Tedaldi and colleagues suggest. For example, this may reflect undiagnosed mental illness or the central nervous system effects of HIV infection.

They also found that women had a 2.34-fold greater risk of grade 4 anemia compared with men, which was "not unexpected" given that the women were predominantly premenopausal and African American.

"Use of these results could inform HIV treating clinicians about particular issues to consider in the selection of antiretroviral regimens for diverse populations," the clinicians conclude.

SOURCE: Journal of Acquired Immune Deficiency Syndromes, April 1, 2008.

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