Several presentations at the 4th International Workshop on HIV and Women again highlighted the relative paucity of data to guide treatment decisions in women -- particularly with newer drugs.
A collaboration between IAS, IAVI and AMFAR reviewing the inclusion of women in HIV research -- trials of antiretrovirals, vaccines and cure strategies -- exposed the unsurprising finding that women are underrepresented, particularly in antiretroviral trials and cure strategies. 
Notably publically funded antiretroviral clinical trials (including US National Institute of Health [NIH] sponsored trials) only included small proportions of women despite existing regulation intended to correct this.
Although the proportion of women in antiretroviral trials remains low, there has been an increase over time. The proportion of women is particularly low in trials conducted in high-income countries. Vaccine trials do better and include a higher proportion of women.
Shirin Heidari presented results from this literature review for which the investigators performed systematic searches in PubMed for antiretroviral, vaccine and cure trials. Antiretroviral included articles describing trials published during three time periods (1994-1997, 2001-2004 and 2008-2011). Vaccine included articles published 2000-2012 that reported results from vaccine trials. Cure included articles describing cure trials published through 2012.
The review excluded trials that only enrolled one sex. The investigators extracted data describing the number of women compared to the total number of participants (enrolled, completed the trial and/or reached an endpoint), date of publication, trial phase, countries in which the trial was conducted and funding sources.
The analysis included 387 antiretroviral, 53 vaccine and 113 cure trials. Women participants made up a median of 19.2%, 38.2% and 11.1% of the total study population in antiretroviral, vaccine and cure trials respectively.
The proportion of women included in antiretroviral trials increased over time, overall p=0.0001. But this was no greater than 28% in any time period.
Antiretroviral trials conducted in high-income countries included the least women, median percentages (excluding eight trials without country classification) were: 50%, 18% and 23.2% in low- and middle-income, high-income, and mixed income countries respectively, p<0.001.
There was a significant variation in the proportion of women in antiretroviral trials according to funding source. Median percentages were: 19%, 29.2%, 16.7%, 19.8% and 17.8% for private (commercial), private (non-commercial), public mixed and trials with no data respectively, p=0.05 (p=0.03 excluding "no data").
NIH supported antiretroviral trials had a lower proportion of women compared to those sponsored by other sources, 15.3% (n=96) vs 22.3% (n=220), p=001.
The inclusion of women in vaccine trials also increased over time, p=0.03. No linear relationship was observed between the inclusion of women and time for cure trials. High-income countries were also associated with a lower proportion of women in cure trials, p=0.003, but a higher proportion in vaccine trials, p=0.02. Funding source did not have an effect on proportion of women in vaccine and cure trials.
The investigators noted that although federal policies have been established to address the gap between the proportion of men and women in trials, their analysis found that publically funded antiretroviral trials have even lower representation of women participants, suggesting that these policies are neither enforced nor monitored.
Sharon Warmsley illustrated the disparity between men and women in an invited lecture: State-of-the-ART new therapy options by showing an analysis of the proportion of women in pivotal clinical trials for more recently approved antiretrovirals. See Table 1.
|Table 1: Proportion of Women Included in Pivotal Trials|
|Trial||New Drug||Comparator||% Women|
Two presentations followed Dr Walmsley's lecture with data from subgroup analyses women receiving rilpivirine/emtricitabine/tenofovir DF (RPV/FTC/TDF), and raltegravir (RAL) in the respective pivotal trials. For both analyses the numbers were so few that the confidence intervals around any findings are so wide that there is not much to guide treatment decisions for women from these trials.
Dr Walmsley also showed two examples of ongoing phase 3b trials designed to look at newer treatments in women and help to address this lack of meaningful data. See Table 2.
|Table 2: Ongoing Phase 3b Trials of Antiretrovirals in Women|
|WAVES||EVG/COBI/FTC/TDF||ATV/RTV+FTC/TDF||GileadSciences||RCT, 1:1, blinded, placebo, trial in ART-naive womenNCT01705574Enroling||<50 copies/mL at 48 weeks||510255 per arm|
|ARIA||DTG/ABC/3TC||ATV/RTV+FTC/TDF||ViiVHealthcare||Randomised 1:1, open label trial in ART-naive womenNCT01910402Enroling||<50 copies/mL at 48 weeks||474237 per arm|
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