Are Poz Women Being Ignored By Science And Researchers?

Over half of people living with HIV in the world are women, yet they're often at the bottom of the totem pole in research. 

With recent reports swirling of a second person having achieved complete HIV eradication — not just undetectable, but essentially, cured — the global scientific community is worker harder than ever to find a functional cure for the virus. However, researchers are beginning to realize that in order to do so, they must deal with a long-ignored demographic: women.

According to a recent in-depth report by The New York Times, despite the fact that women make up just over half of the 35 million people living with HIV worldwide, there is a noticeable lack of women involved in the research of potential treatments, cures, and vaccines.

Globally, HIV is the leading cause of death among women of reproductive age. We repeat: HIV is the leading cause of death among women of reproductive age. In Africa, parts of South America, and even the Southern United States, new diagnoses in young women are helping to sustain the epidemic.

Now, many researchers are calling for science to stop ignoring this reality and focus more on the global numbers, not just statistics in developed areas like the U.S. or the U.K. (where HIV rates tend to be higher among gay and bi men).

A 2016 analysis by AMFAR found that women represented a median of 11 percent in cure trials. Trials of antiretroviral drugs fared slightly better with 19 percent of the participants being women. Vaccine studies were the closest to having equal gender representation with 38 percent female participation.

“If we’re going to find a cure, it’s important that we find a cure that actually works for everybody,” Rowena Johnston, AMFAR’s director of research, told the Times.

There are well-known differences in the immune systems of men and women--including its response to HIV. The immune system in women initially responds forcefully, maintaining tight control over the virus for five to seven years. But long-term, this state of high alert takes its toll on female bodies, which typically progress faster to late-stage HIV (or AIDS) than men--and are more likely to have heart attacks and strokes.

“There are all sorts of differences between men and women, probably mediated partially by hormonal effects,” said Dr. Monica Gandhi, professor of medicine at the University of California, San Francisco. For example, the female hormone estrogen seems to lull HIV into a dormant state — which may sound like a good thing, but the dormant virus is harder for the immune system, or drugs, to kill.

Other differences between genders may be evident even before puberty. In one study, 10 out of 11 children who were found to be “elite controllers” — those who seem to suppress HIV to undetectable levels without drugs — were girls.

Women also respond differently to some drug treatments. Researchers have found that dolutegravir may increase the risk of neural tube defects in children born to women taking the drug, nevirapine is far more likely to cause a severe rash in women than in men — yet men accounted for 85 percent of the trial subjects in which the drug was tested.

Early on, the epidemic was largely concentrated in gay men, who often enrolled in clinical to gain access to new drugs as early as possible. Gay men “were literally dying to get into these trials,” said Jeff Taylor, 56, an HIV advocate in Palm Springs, Calif., who enrolled in dozens of trials after his diagnosis in 1982.

Over the past 30 years since Taylor's diagnosis, gay men have formed strong support networks that alert potential participants to clinical trials, and they often live in cities where the research is conducted. By contrast, women with HIV tend to be isolated, and may not advocate for themselves. They may need help with child care or transportation, or be more comfortable with female doctors — accommodations few trials offer.

For women of color, there are even more obstacles involved when navigating a heath care system that has ignored and exploited them for decades. “[There's] a lot of stigma still in our community around research,” said Ublanca Adams, 60, who is living with HIV in Concord, Calif.

“How information is given out to our community and our people is just not in a way to be inclusive," Adams told the Times, "nor is it inviting.”

In the rare cases where scientists go the extra mile to enroll women, they face additional scrutiny from the Food and Drug Administration, which has strict rules for including women of childbearing age. Ultimately, most researchers just opt for the easiest route and enroll men, and collect their data on women only once the drug is on the market.

Two recent trials of long-acting injectable HIV drugs managed to recruit significant numbers of women (33 percent were female in one study, 23 percent in the other), most likely due to the promise of less frequent treatment, a big convenience for say, an overwhelmed mother.

“Patients lined up outside the clinic,” said Dr. Kimberly Smith, head of research and development at ViiV Healthcare, the company that led the research. Though in general, Smith said that trials in the United States struggle to enroll women because about 75 percent of the infected still are men.

In hopes of starting to address this disparity, Dr. Bruce Walker and his colleagues at the Ragon Institute of M.G.H., M.I.T., and Harvard have set up a group called Fresh in South Africa where nearly 2,000 young women in the Umlazi Township check in twice weekly for HIV testing. The researchers provide preventive therapy, but a small proportion of the women still become positive. Walker’s team have tracked these diagnoses from the start and plan to test cures in the group.

Still, it’s difficult to get scientists to take the need to enroll women seriously, said Dr. Eileen Scully, assistant professor of medicine at Johns Hopkins University. “Some of the hard scientists dismiss this type of discussion as being more socially determined, or some sort of women’s liberation thing,” she commented.

Scully led the only cure trial so far to focus solely on women, testing whether a drug that blocks estrogen makes it easier to kill HIV. To skirt the restrictions limiting participation by women of childbearing age, she and her colleagues recruited menopausal women. But these participants have lower levels of circulating estrogen, which may skew results. (The article made no mention of how transgender women and their hormone levels factor in research.)

Still, the team has already made one key discovery: “We were one of the fastest trials ever to enroll,” Scully noted. “Women are ready to be engaged.”