The results debut the first HIV prevention tool specifically for women. But we need to be cautious of how much protection the ring can really offer, experts say.
International Partnership for Microbicides
Two groups of scientists presented results at an HIV conference on Monday suggesting that a vaginal ring could prevent HIV transmission in women. In both studies, the ring lowered HIV cases by about 30%, though its effectiveness appears to be much better for women who used the ring consistently.
The ring contains an antiretroviral medication called dapivirine, which prevents HIV from making copies of itself. In the ring, the drug is used as “pre-exposure prophylaxis,” or PrEP, slowly leaching out in the vagina and preventing the virus from taking hold in nearby cells.
One of the new studies, published today in the New England Journal of Medicine, tested the ring in more than 2,600 women in four countries — Malawi, SouthAfrica,Uganda,Zimbabwe — over nearly two years. At the end of the study, the group of volunteers who had used the dapivirine ring had 27% fewer HIV infections than a control group who had a placebo ring with no drug, the study found.
Looking by age, the researchers saw that the ring did not seem to help women younger than 21. But among women over the age of 21 who used it, new HIV cases went down by 61%.
The other study, which has not yet been published but was presented on Monday at the Conference on Retroviruses and Opportunistic Infections meeting in Boston, studied 2,000 women in South Africa and Uganda. Like the other study, in this one the ring had no visible effect in women younger than 21, whereas new HIV cases dropped by 37% in women over 21.
These age differences are probably due in part to how the women used the drug, the researchers say. Much like the contraceptive NuvaRing, the dapivirine ring should be kept in every day and replaced once a month for maximum effectiveness.
“If used perfectly, how much HIV protection could there be? We don’t know that yet,” Jared Baeten, professor of global health, medicine, and epidemiology at the University of Washington and lead author on the study, told BuzzFeed News.
Adherence is also a big issue for the only other PrEP on the market, a once-a-day pill called Truvada. Initial trials for the pill showed it led to a 44% decrease in HIV infection rates overall. But it’s now known that, when taken properly, Truvada cuts new cases of HIV by at least 92%. Because of its high effectiveness, the CDC has since recommended that 1 in 4 gay and bisexual men should be prescribed the drug to prevent the spread of HIV.
The ring adds a new HIV prevention tool, which some experts say will be particularly useful in African countries where women are at highest risk for HIV infection. More than half of the 35 million people living with HIV worldwide are women, and the vast majority live in sub-Saharan Africa.
“A prevention tool like a ring could be used discreetly, a woman would have control over it, and it could allow her to keep herself safe from HIV without having to ask a male partner to take on prevention strategies,” Baeten said. “That individual control of prevention is so powerful.”
The dapivirine ring has been in development for more than a decade, and the the new studies are the first to show that it prevents HIV transmission. Still, experts caution that the ring should not be a woman’s sole source of protection.
“There is absolute reason to celebrate. But 27% is a lower number than any of us would like to see,” Mitchell Warren, executive director of AVAC, a global HIV-prevention advocacy group, told BuzzFeed News.
“We obviously always want higher numbers. But 1 in 3 infections were prevented overall — and that’s huge.”
Warren noted that other rings with antiretrovirals are also being developed, as well as rings that could offer multipurpose protection, against not only HIV but pregnancy.
Like birth control, the more types of HIV prevention, the better, experts say.
“For some women, a pill every day might work really well. For others, that may be not achievable,” Baeten said. “Pills and rings should be sitting next to each other as options.”
This article discusses two studies surrounding a new device for preventing HIV infection. The device is a vaginal ring that dispenses an antiviral compound called dapivirine which can prevent the spread of HIV in women, according to scientists presenting their research at a medical conference. The device must be worn daily and replaced monthly in order to be effective. One of the studies described was published in the New England Journal of Medicine (NEJM) and the other was an unpublished abstract. The ring contains an antiviral agent that works against the virus, but experts caution this method only seems to curb about 27 percent of transmissions from one sexual partner to the other. This story does a good job of providing context, although we would have liked a more cautious headline (and less use of the word “huge,” in general, in the text) and a better definition of pre-exposure prophylaxis since previous efforts have mainly focused on treating those who already contracted the virus. We applaud the careful way the story gave details of the two research studies, including their size and length and where they were conducted. Because sub-Saharan Africa is hardest hit by HIV, and has few health resources, we wish the story had included discussion of how much the ring will cost.
Women and men worldwide are at risk of catching the HIV virus from sexual partners. While there are precautions that might limit the spread, they are often not under the control of women. This vaginal ring, with a compound that interferes with the virus, could be worn discreetly by women to protect themselves. While the 27 percent effectiveness may seem modest, these two studies being reported raise a new hope for putting control of limiting the spread of the virus into more women’s hands.
The story would have benefited by spending even one sentence on cost, since HIV is especially prevalent in countries with few resources. Will the ring be cheaper or more expensive than the pill? If the ring must be replaced monthly, what does that mean for the cost, and will people be more likely to fail to buy the replacements because of cost?
There was a lost opportunity here to compare the cost of the vaginal ring versus Truvada, the currently available option for pre-exposure prophylaxis.
The story gives numbers supporting the benefits claim in both of the studies mentioned, but they’re relative, presented in terms of a percentage, not absolute which relates to the actual numbers of patients, which are more definitive and useful for readers. The study published in the NEJM showed that the ring, used by volunteers, cut infections by 27 percent over a control group. The absolute numbers were included right in the studyabstract (but not the story) and were reported this way:
Among the 2629 women who were enrolled, 168 HIV-1 infections occurred: 71 in the dapivirine group and 97 in the placebo group (incidence, 3.3 and 4.5 per 100 person-years, respectively).
For another — unpublished study — the story reported a difference in effectiveness by age. The ring showed no impact on those age 21 and younger, but reduced new HIV cases by 37 percent in women over 21. We were glad to see the quote from a scientist explaining that how carefully the device is used may explain the difference in outcomes by age and warrants more study.
We would have liked to see some mention of whether there might be any harms associated with this. It is possible that long-term use might pose risks that don’t show up in shorter studies. The story does not even say, “We don’t know of any harms.”
The story explains the size of the studies — each including at least 2,000 women. One study was already published in the NEJM and the other is not yet published. Some of the details given help establish the credibility of the results, although we are not given much detail about study protocols. It would have been helpful to link to the conference abstract, similar in the way it linked to the NEJM study, for readers that wanted a bit more detail.
There was no disease mongering.
The story doesn’t mention the makers of the device or any potential conflicts of interest. However, one of the authors of the study presented in abstract form (the “SPIRE” study) is affiliated with the International Partnership for Microbicides, Silver Spring, MD, which is involved with product development, partnerships with pharmaceutical companies, and marketing of this and related devices. The device is licensed from Janssen Sciences, a large pharmaceutical company. The International Partnership for Microbes describes itself this way: “As a nonprofit product developer, IPM partners with a variety of organizations to facilitate strategic planning from the earliest stages of product design to ensure future access to products.”
There are two people quoted in the story, the lead author of the study and the head of AVAC, a global HIV-prevention advocacy group. (AVAC issued a news release on the two studies.) While the story includes insightful comments from these two sources, both have some investment (even if only on an intellectual level) in the project. The story would have been been stronger if it had included an expert with no relationship at all to the device studies, ideally someone active in providing health care in sub-Saharan Africa, who might have provided insights into adherence, product acceptance or any practical obstacles (such as costs) in the way.
A discussion of the alternatives is a real strength in the article. It mentions other rings in development as well as the Truvada pill which offers some protection against HIV, and examines some pros and cons of the different methods.
The story says that the dapivirine ring “has been in development for more than a decade,” suggesting that it is not yet available. Some comment on when the device might become available would have been useful.
The story tells us that vaginal rings already exist and are in widespread use but that the addition of the dapivirine antiviral agent makes this device novel. It also states that the well-known Nuvaring used to prevent pregnancy uses the same delivery method.
Since the article uses quotes not found in a news release on the studies, we are confident the story does not rely solely on a PR release.