About the Dapivirine Ring
What is the Dapivirine Vaginal Ring?
The first topical HIV prevention method to be submitted for regulatory approval, it is an intravaginal silicone ring, developed by the International Partnership for Microbicides (IPM) for HIV prevention.
The ring delivers an antiretroviral drug called dapivirine. It’s released slowly over the course of one month directly to vaginal tissue to help protect against HIV at the site of potential infection. Little of the drug is absorbed elsewhere in the body resulting in low systemic uptake.
This means that the drug is unlikely to be found in high concentrations in the bloodstream and other body tissues, which may reduce side effects as well the risk of development of HIV resistance. Data from Phase III studies of the ring show no evidence that the ring increased resistance to NNRTIs, the class of ARV drug to which dapivirine belongs and which is also used in some treatment regimens.
The Dapivirine Ring reduces the risk of HIV-infection, and offers a discreet and long-acting alternative to daily oral PrEP.
Although access to daily oral PrEP is increasing around the world, a daily pill is not a suitable or desirable prevention method for everyone. Today, women account for more than half of all people living with HIV globally, and face persistently high HIV-infection rates. Experience introducing oral PrEP in many countries has revealed that women face unique challenges when it comes to adhering to a daily pill due to gender inequity, social norms and other structural barriers.
Efficacy data shows that the ring reduces HIV risk by 35 percent, with recent data from open label extension studies suggesting a greater reduction in HIV risk by about half. Modelling has shown that even a partially effective prevention option can have an important protective impact for women and their communities as part of a comprehensive HIV prevention strategy.
Like oral PrEP, the Dapivirine Ring does not protect against other STIs or unwanted pregnancy.
The ring does not reduce risk of chlamydia, gonorrhea, syphilis or herpes, or unwanted pregnancy. There are studies underway examining the safety of a combined dapivirine-levonorgestrel ring that would protect against both HIV infection and unwanted pregnancy, as well as different vaginal rings that combine antiretrovirals and other medications to prevent STIs.
IPM Ring Backgrounder
A two-page overview of the Dapivirine Ring, including trial results, current status and next steps curated by IPM (updated regularly).
What is the status of the dapivirine vaginal ring’s approval?
In early 2021, The WHO included the ring in its guidelines on HIV treatment and prevention. In November 2020, WHO prequalified the ring. Prequalification involves evaluating whether a medicine meets global standards for quality, safety and efficacy. Many African national regulatory agencies consider WHO prequalification as they review new products.
In July 2020, the European Medicines Agency (EMA) gave a positive opinion on the use of the ring by women in low- and middle-income countries outside of the European Union.
IPM, the ring’s developer, submitted the ring to the EMA for review under Article 58. This procedure allows the EMA, in cooperation with the World Health Organization (WHO), to apply European Union (EU) standards to provide a scientific opinion on the safety, efficacy and quality of medicines that would be marketed exclusively outside of the EU—specifically in low- and middle-income countries—for diseases of major public health interest.
The positive opinion also recommended a post-authorization efficacy study to better understand efficacy among cisgender women aged 18-25, and to complement existing data on potential drug resistance. The EMA’s positive opinion helps advance the ring from an investigational product to a real tool that women can use.
Next, IPM is actively applying for the ring to be reviewed by countries in sub-Saharan Africa, where women face persistently high HIV risk. Initial submissions are planned for Eswatini, Kenya, Lesotho, Malawi, Rwanda, South Africa, Tanzania, Uganda, Zambia and Zimbabwe. IPM submitted the ring to the US FDA in early 2021. For the latest information, visit IPM's website.
Planning for Introduction
A comprehensive plan for introduction is in place. Initial regulatory submissions are planned for countries in Africa where the need is greatest, including: Eswatini, Kenya, Lesotho, Malawi, Rwanda, South Africa, Tanzania, Uganda, Zambia and Zimbabwe.
Ensuring the voices of women and people with vaginas are heard is an essential component of ring introduction, just as it has been critical during clinical trials.
Additional resources and planning tools can be found on the PrEP Planning A-Z pages For a one-page overview of ring resources, click here. For more, here's the latest issue of the Dapivirine Ring Quarterly Newsletter.