XIX International AIDS Conference

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THPE041 - Poster Exhibition


Gender differences in virologic outcomes in a systematic review of randomized controlled clinical trials in HIV-1-infected patients on antiretroviral therapy

H. Kwakwa1, L.L. Temme2, D.E. Spencer3, C. Evans4, I.L. Walker2, M.K. Rawlings2

1Philadelphia Department of Public Health, Philadelphia, United States, 2Gilead Sciences, Inc., Foster City, United States, 3Institute of Human Virology, University of Maryland School of Medicine, Baltimore, United States, 4AIDS ARMS Inc., Dallas, United States

Background: In 2009, women accounted for 24% of new HIV infections in the United States. Black and Hispanic women represent 81% of these new diagnoses in women, but account for < 25% of the female population in the United States. Globally, women account for nearly half of new infections. Despite the changing epidemiology of HIV among women, they are often underrepresented in clinical trials evaluating antiretroviral therapy (ART).
Methods: A systematic review was performed of randomized controlled trials (RCTs) and meta-analyses published from 1996- January 2012 that reported virologic suppression and/or virologic failure (VF) rates for both women and men. Thirteen studies were identified.
Results: In these­­ 13 clinical trials, 11,856 subjects (2,981 women; 8,875 men) were identified. Five of 10 trials reporting virologic suppression demonstrated lower suppression rates in women compared to men (difference, -16% to -4%). Two of 4 studies evaluating VF reported higher rates of VF in women compared to men (HR, 1.38-2.35).

StudyFollow-UpArmsWomen (n)Men (n)% With <50 copies/mL (Women vs. Men)Rate of VF (Women vs. Men)
ACTG 5142112 weeks2NRTIs + EFV vs. 2NRTIs + LPV/r vs. EFV + LPV/r151602n/aHR: 1.38 (1.01- 1.89)
ACTG 520296 weeksFTC/TDF vs. 3TC/ABC with EFV or ATV + RTV3221535n/aHR for ATV + RTV with: 3TC/ABC: 1.72 (0.99-2.98); P=0.006 FTC/TDF: 2.35 (1.30-4.26); P=0.03
ACTG Meta-Analysis48-120 weeksMultiple regimens; NNRTI- and PI-based4732022n/aNo difference in time to VF (HR 0.9 [0.8-1.1])
ARTEMIS96 weeksDRV + RTV vs. LPV/r with FTC/TDF104239No difference DRV + RTV: 79% for both (LPV/r not reported)n/a
CASTLE96 weeksLPV/r vs. ATV + RTV with FTC/TDF277606ATV + RTV: 67% vs. 77% LPV/r: 63% vs. 71%n/a
DART Substudy48 weeksAZT/3TC/TDF198102OR: 2.47 (1.48-4.15); P=0.001n/a
ECHO/ THRIVE96 weeksEFV vs. RPV with 2NRTIs3311037No difference EFV: 78% vs. 77% RPV: 74% vs. 79%EFV: 3% vs. 7% RPV: 13% vs. 11%
GRACE48 weeksDRV + RTV + OBR28714251% vs. 58%n/a
GSK Meta-Analysis48 weeksABC vs. PI or AZT-containing regimens4151122ABC: 68% vs. 71% Non-ABC: 60% vs. 68%n/a
[Outcomes for Women vs. Men Across 13 Studies]



StudyFollow-UpArmsWomen (n)Men (n)% With <50 copies/mL (Women vs. Men)Rate of VF (Women vs. Men)
HEAT96 weeksFTC/TDF vs. 3TC/ABC with LPV/r125563FTC/TDF: 52% vs. 59% 3TC/ABC: 46% vs. 62%n/a
KLEAN48 weeksFPV + RTV vs. LPV/r96338FPV + RTV: 64% vs. 75% LPV/r: 67% vs. 73%n/a
REALMRK48 weeksRAL open-label97109No difference 67.8% vs. 72.4%n/a
STARTMRK192 weeksRAL vs. EFV with FTC/TDF105458No difference RAL: 93% vs. 91% EFV: 86% vs. 85%n/a
[Outcomes for Women vs. Men, Continued]


Conclusions: In 7 of 13 studies, women had a lower virologic suppression rate or higher risk of VF compared to men across various regimens. In some studies, this difference was attributed to a higher discontinuation rate in women. The implication of poorer clinical outcomes among women raises additional research questions regarding factors (e.g., contraception, access to care, stigma and adherence) which may contribute to gender-based differences in ART outcomes for earlier treatment and treatment as prevention. As women become an increasingly impacted by the HIV epidemic, a better understanding of these differences and associated factors will be critical to develop targeted interventions for women.

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