Females, African American Have Reduced Virologic Responses to Treatment: Presented at IAS
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Females, African American Have Reduced Virologic Responses to Treatment: Presented at IAS

By Charlene Laino

CAPE TOWN, South Africa --- July 21, 2009 --- Females and African Americans appear to have reduced treatment responses to abacavir sulfate/lamivudine and tenofovir/emtricitabine, researchers reported here on July 20 at the 5th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention.

"Differences in response to antiretroviral therapy appear to be associated with various factors, including sex and race," said Kimberly Smith, MD, Department of Infectious Diseases, Rush University Medical Center, Chicago, Illinois.

"So we evaluated week 96 responses by gender and by race in the HEAT [Head-to-Head Epzicom and Truvada] study, which previously demonstrated the noninferiority of abacavir sulfate/lamivudine versus tenofovir/emtricitabine, when each was combined with lopinavir/ritonavir, at 48 and 96 weeks in treatment-naïve subjects."

The randomised, double-blind, 96-week, noninferiority trial included 688 treatment- naïve participants at multiple sites in the United States, of which 343 were randomised to abacavir sulfate/lamivudine and 345 to tenofovir/emtricitabine, both combined with lopinavir/ritonavir. Of the patients, 18% were female and 36% were African American.

The median baseline viral load was lower in females in both arms and in African Americans in the abacavir sulfate/lamivudine arm, compared with the overall population, Dr. Smith said. "CD4 counts were generally lower at baseline in African American subjects as well," she said.

At week 96, the percentage of patients with plasma HIV RNA levels <50 copies/mL was lower among female (46% and 52% in the abacavir sulfate/lamivudine and tenofovir/emtricitabine arms, respectively) and African American (50% and 48%, respectively) patients, compared with the overall population (60% and 58%, respectively) and male (62% and 59%, respectively) and white subgroups (68% and 67%, respectively.

"However, females appeared to have greater CD4+ recovery compared with males," Dr. Smith said.

From baseline to week 96, the median CD4+ count increased from 213 to 307 cells/mm3 and from 168 to 262 cells/mm3 among females in the abacavir sulfate/lamivudine and tenofovir/emtricitabine arms, respectively.

In contrast, CD4 counts increased from 214 to 245 cells/mm3 and from 200 to 245 cells/mm3 among males in the abacavir sulfate/lamivudine and tenofovir/emtricitabine arms, respectively.

CD4 cell responses among African Americans were not different compared with the overall population, and small sample sizes prevented any statistical comparison among ethnic subgroups, she said.

Dr. Smith called for "large comparative trials of traditionally under-represented groups to further investigate these differences in outcomes."

Funding for this study was provided by GlaxoSmithKline.

[Presentation title: Differences in Virologic Response Among African-Americans and Females Regardless of Therapy in the HEAT Study. Abstract MOPEB033]


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