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Differences by Age for Women in Response to Initial ART: Meta-Analysis From Clinical Studies Submitted to the FDA

By Polly Clayden

January/February 2013

Data on the effect of age and/or menopause in response to ART in women are scant.

Preliminary analyses of the FDA database suggest a benefit of older age (50 years and above) for virological response, but no clinically or statistically significant gender differences in immunological responses overall (although some effect with NNRTI/NRTI).

US data has suggested that HIV positive women may undergo menopause earlier (46.5 years) than the general population (49 for African American and 51 years for white women). As menopause data was not collected in the trials included, J Yan, who presented findings from the FDA meta-analysis at the 3rd International Workshop on Women and HIV, explained that 50 years of age was used as a surrogate for this comparison.

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Datasets of all treatment naive women, enrolled in registrational ART trials submitted to the FDA between 2000-2010, were evaluated in this meta-analysis looking at age group differences at Week 24 and 48 in viral load < 400 copies/mL and CD4 change from baseline.

The database included 4,414 HIV positive treatment naive women enrolled in 32 RCTs. Women were stratified into three groups: <35 years old, 36-49 years old and >50 years old, with the group difference between the youngest and oldest age groups being the major focus. Analyses were also performed looking at types of antiretroviral regimens. The majority of the women received either 2 NRTI/NNRTI (45.6%) or 2 NRTI/PI (46.19%) regimens.

The investigators reported a statistically significant lower virological suppression rate in women aged < 35 than those in >50 age group at both weeks 24 and 48 (estimated 95% CI of the log odds ratio difference at week 24 and 48 were respectively: -0.94, -0.24, and -0.78, -0.17).

There were no clinically or statistically significant differences in CD4 increase (week 24 and 48 respectively: 95% CI -8.21, 25.25 and 95% CI -16, 22.76). However the younger group receiving NRTI/NNRTI regimens showed better responses at both time points albeit with huge confidence intervals (week 24 and 48 respectively: 95% CI 6.43, 52.59 and 95% CI 0.48, 53.88).


Reference

Yan J et al. Differences by age for women in the response to initial HAARTs: Meta-analysis from clinical studies submitted to the FDA (2000-2010). 3rd International Workshop on HIV & Women. 14-15 January 2013, Toronto, Canada. Oral abstract O_011.

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