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WHO Prequalifies Vaginal Ring to Prevent HIV

The dapivirine vaginal ring to prevent HIV.

Andrew Loxley/International Partnership for Microbicides

Key Takeaways

  • The dapivirine ring has received pre-qualification from the World Health Organization (WHO).
  • The vaginal ring can help reduce the risk of HIV infection in women.
  • Experts are hopeful that at-risk women will use the ring once it becomes available.

A vaginal ring to prevent HIV has received pre-qualification from the World Health Organization (WHO), putting it one step closer to being an HIV-preventative for people with vaginas around the world.

The device, called the dapivirine ring, is a monthly vaginal ring designed to reduce the wearer’s HIV risk. It was designed by a nonprofit organization, the International Partnership for Microbicides (IPM), as a product to protect high-risk people around the world from HIV.

What Is HIV?

Human immunodeficiency virus (HIV) is a virus that attacks the body’s immune system. If HIV is not treated, it can lead to acquired immunodeficiency syndrome (AIDS), according to the Centers for Disease Control and Prevention (CDC). Most people don’t know that they’re infected with HIV. There is no cure for HIV, but the virus and its symptoms can be controlled with proper medical care.

HIV Around the World

Between 2000 and 2019, new HIV infections fell by 39% and HIV-related deaths fell by 51%, according to the WHO. The global health organization cited increased testing and antiretroviral therapy (ART), which suppresses the HIV virus and stops the progression of the disease, as reasons for the decrease.

However, the WHO also reported that 690,000 people died from HIV-related causes in 2019 and 1.7 million people were newly infected. The WHO website states: “We will need to redouble our efforts to avoid the worst-case scenario a half-million excess deaths in Sub Saharan Africa, increasing HIV infections due to HIV service disruptions during COVID-19, and the slowing public health response to HIV."

Zeda Rosenberg, ScD, founder and chief executive officer of the IPM (the nonprofit that developed the ring) tells Verywell that it took four prototypes and 16 years to get to this point with the device.

"As a public health scientist, I always felt very strongly that this was something we should be doing," she says. "The public health community understands that women bear the brunt of the HIV/AIDS epidemic because of biological reasons—during sex, women are exposed to more virus. Women are often not able to negotiate safe sex. They need prevention options."

When Rosenberg started developing the ring in 2004, vaginal rings were already on the market for contraception and hormone replacement therapy. "We thought, 'Why not do something like that for HIV prevention?'"

Zeda Rosenberg, ScD

Women are often not able to negotiate safe sex. They need prevention options.

How Dapivirine Ring Works

The dapivirine ring is made of flexible silicone and contains dapivirine, an anti-retroviral drug that is slowly released over the course of a month.

The ring delivers dapivirine directly at the site of a potential HIV infection and only small amounts of the drug are absorbed into the body. To use it, women insert the flexible ring into the vagina and leave it there for a month. When the recommended timeframe is up, they remove the ring and insert a new one.

Why a Ring?

One of the most commonly used medications to help prevent HIV is pre-exposure prophylaxis (PrEP), which works to prevent the HIV virus from replicating in the body.

“Daily oral PrEP is great if you can use it. It is safe and effective,” Sharon Hillier, PhD, Richard Sweet Professor of Reproductive Infectious Disease at the Magee-Women's Research Institute, tells Verywell. “But many people who start PrEP stop PrEP after a few weeks. I like to say that PrEP is easy to start, but hard for some people to continue because it is hard to keep doing something every day.”

While using a vaginal ring “takes some getting used to” for women, it’s also “easy to use because you insert it once a month and then you can forget about it,” Hillier says. “Since HIV prevention has to continue over not days but rather years, persistence of use is a key feature of a successful prevention product."

The amount of exposure to antiretroviral drugs is lower with the ring as compared to a daily oral PrEP. “That means that the vaginal ring has an outstanding safety profile—no bone or kidney effects and no systemic side effects, like nausea or GI upset,” Hillier says. “So, for people who have problems with the side effects of daily oral PrEP the dapivirine vaginal ring is a great option.”

Rosenberg says that, for women, condom usage "is not entirely under their control, [but] having a ring that she can insert and forget about changes that."

“This product broadens choices for women,” women’s health expert Jennifer Wider, MD, tells Verywell. “It can be inserted by the woman and doesn't require a healthcare provider.”

How Effective Is the Dapivirine Ring?

Two Phase 3 clinical trials have found that the ring reduced the risk of HIV-1 (the most prevalent form of HIV) in women and was well-tolerated over long-term use. The Ring Study, which was led by IPM, found that the ring reduced the overall risk of acquiring HIV-1 by 35%. The ASPIRE study, which was conducted by the National Institutes of Health-funded Microbicide Trials Network, determined that the ring reduced overall risk by 27%.

IPM says that final results from open-label extension trials that enrolled former participants of The Ring Study and ASPIRE both showed increased use of the ring. Modeling data suggested that with increased use, the risk of contracting HIV-1 could be reduced by more than 50%.

What’s Next for the Dapivirine Ring

Rosenberg says that this year, IPM plans to submit applications through the WHO’s collaborative registration procedure to countries in eastern and southern Africa where HIV incidence in women is high. Rosenberg is hopeful that the ring will be available in some African countries by the middle of next year.

IPM also plans to submit an application to the Food and Drug Administration (FDA). If it is approved by the FDA, the ring could be available in the United States.

The company is working with a network of government, donor, private, and civil society partners to determine how the ring could fit into HIV prevention programs and be affordable.

“I do think that the dapivirine vaginal ring will be an important new tool in the fight against HIV,” Hillier aTA. “When people have more options of what they can use to protect themselves from HIV, they are more likely to find something that works for them.”

What This Means For You

The dapivirine ring is not available in the United States because it has not been approved by the FDA. However, if it gains FDA approval, it would be another HIV-prevention option for people with vaginas.

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Article Sources
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  1. International Partnership For Microbicides. IPM’s dapivirine ring for women’s HIV prevention receives WHO prequalification. Updated November 24, 2020.

  2. Centers for Disease Control and Prevention (CDC). About HIV/AIDS. Updated November 3, 2020.

  3. World Health Organization (WHO). HIV/AIDS. Updated November 30, 2020.

  4. International Partnership For Microbicides. Dapivirine ring. Updated March 3, 2016.

  5. Centers for Disease Control and Prevention (CDC). About PrEP. Updated November 3, 2020.

  6. Nel A, van Niekerk N, Kapiga S, Bekker LG, Gama C, Gill K, Kamli A, et al. Safety and efficacy of a dapivirine vaginal ring for hiv prevention in womenN Engl J Med. 2016;375(22):2133-2143.

  7. Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, et al. Use of a vaginal ring containing dapivirine for hiv-1 prevention in womenN Engl J Med. 2016;375(22):2121-2132.