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CROI 2009: Large Meta-analysis Indicates Antiretroviral Therapy Works as Well for Women as for Men

Since the early years of the AIDS epidemic, researchers and advocates have debated whether HIV positive women benefit as much as men from antiretroviral therapy. Some studies in the early HAART era suggested that women did not fare as well, but many believe this was a reflection of poorer access to care, differences in socioeconomic status, or other factors.

At the 16th Conference on Retroviruses and Opportunistic Infections (CROI 2009) last week in Montreal, Kimberly Struble and colleagues from the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research presented results from a meta-analysis of efficacy outcomes among women in trials of antiretroviral therapy conducted over nearly a decade.

The researchers combed through datasets for registrational randomized controlled trials submitted to the FDA, looking for any gender differences in 48 week efficacy outcomes, defined as HIV RNA < 400 copies/mL, as well as differences in treatment effect size.

Studies were stratified by whether participants were antiretroviral treatment-naive or treatment-experienced. Efficacy analyses by antiretroviral class were also performed for nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), fusion inhibitors, and CCR5 antagonists.


Results

  • The combined database included 17,826 HIV positive participants in 38 randomized controlled trials of 14 antiretroviral drugs.
  • There were no clinically or statistically significant gender differences in 48 week efficacy outcomes (assuming mean effect size difference between men and women were equal, the estimated 95% confidence interval [CI] of equal mean effect size difference was -0.07, 0.09).
  • For treatment-naive study participants, the estimated 95%CI of equal mean effect size difference between men and women included zero (-0.1 to 0.09), indicating no differences.
  • For treatment-experienced patients, the estimated 95% CI also included zero (-0.095 to 0.16), again revealing no gender differences.
  • For all antiretroviral drug classes analyzed, the estimated 95% CI all included zero, or no differences:

- NRTIs: -0.15 to 0.11;
- NNRTIs: -0.29 to 0.35;
- PIs: -0.08 to 0.13;
- Fusion inhibitors: -0.50 to 0.37;
- CCR5 antagonists: -0.46 to 0.50.

"Preliminary analyses of the FDA database are the most detailed review of gender-related antiretroviral efficacy data so far," the researchers stated.

"These analyses suggest no clinically or statistically significant gender differences in week 48 efficacy outcomes, regardless of treatment history or drug class," they continued.

"Such data could help healthcare providers and HIV-1-infected patients when considering different antiretroviral regimens," they concluded. "From scientific and regulatory perspectives, the cumulative data could help identify issues requiring additional investigation."

2/20/09

Reference

Meta-analysis of Efficacy Outcomes for Treatment-naïve and Treatment-experienced HIV-infected Women in Randomized Controlled Clinical Trials: 2000 to 2008. 16th Conference on Retroviruses and Opportunistic Infections (CROI 2009). Montreal, Canada. February 8-11, 2009. Abstract 987b.