September 22, 2010
HIV Treatment: Men vs. Women
(Ivanhoe Newswire) "“ Higher clinical drop-out rates among women are a concern when testing for effectiveness of HIV treatments. This new landmark study showed that after recruiting and keeping women in the study, there are no major gender differences in the effectiveness of treating HIV.
Previously, women were dropping out of the GRACE study (Gender, Race, and Clinical Experience) like flies, for reasons that weren't due to the ineffectiveness of the drug. This showed that there needed to be more done to keep women in the clinical study.
The study was testing the drugs darunavir and ritonavir, and about one third of the females dropped out, compared to less than one fourth of the males. "It is critical that women are involved in clinical trials to evaluate the efficacy and toxicity of new treatment "” not just for HIV but for all diseases," Dr. Judith Currier, a professor of medicine and chief of the division of infectious diseases at the David Geffen School of Medicine at UCLA and chief author of the study was quoted as saying.
The researchers examined the drugs' effectiveness, their adverse effects, and tolerability in both men and women. They recruited 429 HIV positive subjects who had taken HIV therapy before, and of those 66 percent we women and 33 percent were men. In most studies, women account for just about 25 percent of the participants.
The participants received 600 mg of darunavir and 100 mg of ritonavir two times a day. In addition, etravirine, tenofovir and emtricitabine were available for use as needed. The percentages of women and men who were able to suppress the HIV virus during the study were generally similar, but a significantly higher amount of women than men aborted the study (32.8 percent vs. 23.2 percent).
When the researchers examined the response to HIV treatment, they found that the response was lower in women than men (51percent v. 59 percent). The researchers believe that this is due to the increased drop-out rates of women, because when they excluded that people who aborted the study the responses seemed to be similar.
"The GRACE study shows that it is possible to enroll large numbers of women into HIV treatment trials," the researchers concluded. "The higher discontinuation rate in women, which was driven by reasons other than virologic failure, highlights the need for additional efforts to retain diverse populations in studies."
SOURCE: Annals of Internal Medicine, published online September 21, 2010