By Nina Hasen, Director of HIV and TB Programs, PSI
The Washington Post recently published an article assessing the potential of a new product – a vaginal ring that secretes the antiretroviral drug dapivirine – to protect women from the HIV virus. PSI’s Director of HIV and Tuberculosis Programs, Nina Hasen responds:
We applaud the Washington Post and other news outlets for their recent coverage of two studies on the dapivirine ring. Ariana Eunjung Cha and others highlight the promise this new option presents but also echo a pervading hesitancy about it. And this is understandable; both studies found that the ring reduced HIV infections by only 27% – hardly a stunning result. And the fact that further analyses showed virtually no effect in the youngest participants, aged 18-21, only reinforced a long history of disappointing results in HIV prevention efforts for young women. But we think this attitude misses the boat: those same analyses showed over 50% protection in women over 21 – protection that rose past 60% in women over 25. Women in these age groups who did not receive the ring had the highest incidence of HIV of any in the study. The real take home from the ring studies is that this tool –imperfect though it is – could be a game-changer.
Women, particularly in sub-Saharan Africa, bear a disproportionate burden of the HIV epidemic. The most recent population level data from South Africa show that over a quarter of women are HIV positive by age 29, and well over a third are positive by the time they turn 34 years old. Women have few options for protecting themselves from HIV beyond condoms and many men refuse to use them. The situation is even worse for women who want to conceive. Clearly, women need choices and the dapivirine ring could be an important one. So what are we waiting for? Every day we wait to ensure women’s access to the dapivirine ring, more women become infected.
We applaud the National Institutes of Allergy and Infectious Diseases (NIAID) for funding one of the ring studies and for their swift action in agreeing to fund an extension of that trial. This open label extension study will allow women who participated in the ASPIRE study to have access to the ring for another year. NIAID will also fund further clinical research to understand why the ring was less effective in younger women. But these studies are just the beginning of what should be happening to move the ring forward.
Here are steps donors, governments and regulators can take today to bring the dapivirine ring quickly to women who need it most:
1. Expand the open label studies beyond women who participated in the original research to others who wish to try the ring. This provides an important opportunity to learn about adherence to the ring in a real world setting, with women who have heard about the product and know that it works if they use it. Recall that when women didn’t know if they were getting real drugs or placebos in clinical trials of oral PrEP, adherence was also low. But adherence in follow up demonstration projects, where women know they are getting real drugs, has been high. Let’s apply that lesson to the ring now.
2. Add studies that offer a choice between the ring and oral PrEP – the once-a-day pill proven to prevent HIV transmission by 99%. We know from experience with contraception that offering women a choice of prevention tools increases uptake and adherence. Let’s learn if offering a woman a choice of PrEP options increases her uptake, adherence and satisfaction with HIV prevention, too.
3. Provide additional support to the International Microbicides Partnership (IPM) – the creators of the ring – to help them move the ring more rapidly through the regulatory approval process. Ideally, the ring would be approved by multiple agencies, including the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the regulatory bodies for each of the countries where the recent trials were done. But these processes can be lengthy and difficult, and IPM has limited staff and resources. Foundations, corporate donors and governments should step forward to provide both additional funding and assistance to get this product moving.
4. In the meantime, roll out oral PrEP more widely and rapidly to women at risk. It will be at least 18-24 months before the ring gets regulatory approval and is ready for implementation at scale. Oral PrEP offers substantial HIV protection and appropriate drugs are already approved for HIV treatment, if not prevention, in most countries. Let’s take our current efforts up a notch to ensure this product is accessible, available and delivered in an acceptable way.
Oh, and one more thing – we are going to need a name, because “Dapivirine Ring” just doesn’t roll off the tongue. How about we call it Lifesaver.
Photo Credit: International Partnership for Microbicides