CHICAGO – The last time she visited Africa, Sharon Hillier recounts, she met a local woman who was unimpressed with the work scientists had done so far to protect women living in low-resource settings, exposed to multiple risks.
You need to get back to work and make something we can use, Hillier, a microbiologist at the University of Pittsburgh recalls the woman telling her. At best right now, the woman noted, if she wanted to have sex without fear, she could try the new antiretroviral-laced vaginal ring to prevent HIV, get a long-acting hormonal contraceptive implant to prevent pregnancy, and still have to use a condom to avoid catching other sexually transmitted infections. Why, especially in a place where health service access is a challenge in its own right, couldn’t she have one product that would meet all of these needs?
It is the kind of challenge that Hillier, who discussed “Rings and Things” in a plenary session here this morning, embraces with ardor. It also is a challenge that the scientist who has referred to herself as a “vaginal ecologist,” who also can discuss a quest for health-protecting products that can be used in “the back door as well as the front door,” (what other scientists might call “multi-compartment” products), and who played a central role in the ASPIRE trial of the vaginal dapivirine ring that has shown protective power against HIV acquisition among women who used it, has immersed herself.
She is straightforward in her discussion of the ASPIRE trial and parallel Ring Study that yielded that positive information, along with the information that many of the women in both trials, particularly the youngest, who would have benefited the most from the device chose not to use it, saying “I think it is safe to say all of us were quite subdued when we saw the results of those trials.”
But she also remains enthusiastic about the promise of the product to meet an essential need of the women who do use it. She cites product safety results she calls outstanding, with no difference in side effects between product and placebo users, ease of use after a learning curve, the potential for long-acting protection, and privacy (“people can’t find your ring unless they visit your private parts,” she notes).
“They found it empowering,” Hillier said, citing a trial participant’s remark that the ring, inserted into the vagina and left there for a month at a time, offered her the chance to use a product no one in her family had to know she used, an elusive and critical advantage in crowded settings where shame surrounding HIV risks and infection can be pervasive. An open-label trial, in which participants will know they are using a product that offers at least some protection against HIV has begun, and investigators are hopeful that knowledge will lead more women to use the product consistently.
“We still have a huge job ahead of us,” Hillier noted, “to take our early successes and develop them into products that fit into people’s lives.”
That’s where other kinds of rings — ones that would offer protection from HIV, other sexually transmitted infections, and pregnancy — come in. Hillier is particularly enthusiastic about the development of a vaginal ring with “pods” that would allow it to be customized according to users needs, “like pizza toppings.”
But, she knows that rings won’t meet the needs of all women, and for that matter all receptive sex partners, who are greatest risk for HIV infection. A gel carrying an antiretroviral agent showed some efficacy in 2010 CAPRISA trial results, but also showed issues, including wetness and leakage that made it unacceptable to participants in larger scale trials that followed. No plans exist to further develop an antiretroviral gel, HIllier says. That means other “things,” for women, for vaginal and rectal use (“because everyone who has a front door has a back door”), and for men. Those include fast dissolving tablets, films in the same form as the popular breath fresheners, that could be inserted in the vagina or rectum, and rectal douches.
Most of those could be produced and distributed at relatively little cost, Hillier said, but the most critical element that they offer is choice, she told journalists a few days ago.
“What’s the most expensive thing to do?” she asked, before answering her own question, “nothing. Doing nothing will have the biggest cost.”