World.- Despite advances in the fight against HIV, women continue to face a very high risk of contagion, especially in sub-Saharan Africa. A new monthly vaginal ring that they can use privately and on their own terms has the potential to expand their prevention portfolio and for a long time. The European Medicines Agency has just given the positive opinion on its use.
Nearly 1,400 women get HIV every day in sub-Saharan Africa, representing nearly 60% of new infections in sub-Saharan Africa. Current prevention strategies are essential, but not sufficient, to stop the high rates of contagion in them as they still lack the range of methods needed to protect their own health.
Existing prevention products include the daily oral antiretroviral pill, known as pre-exposure prophylaxis or PrEP, increasingly available in Africa, as well as condoms. Although PrEP is highly effective, not all women can take a pill daily. Condoms are also highly effective, but are often impractical for women who cannot negotiate their use with male partners or who are at risk of sexual or intimate partner violence.
On July 24, the Europe Medicines Agency (EMA) announced a long-awaited news: the positive scientific opinion on the dapivirine vaginal ring for use among cisgender women aged 18 years and over in developing countries, with the aim of reducing their risk of HIV infection.
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Our hope is that we can make the ring available in 2021 in some communities in Africa, waiting for several critical steps, such as strong political will and funding
The announcement marked a milestone for our International Microbicides Association (IPM) – a non-profit product development partnership established in 2002 with the aim of preventing transmission of the virus by accelerating the development and availability of a safe and effective microbicide for use by women in developing countries – which has developed this product.
The monthly dapivirine ring might be a long-acting option that a woman could use privately, on her own terms, to reduce the risk of HIV during vaginal sex. While this week’s positive EMA review is a historic step, it’s not an endorsement, and our work now focuses on ensuring that the ring reaches women. Our hope is that we can make the ring available in 2021 in some communities in Africa, awaiting several critical steps, such as strong political will and funding.
In parallel, the World Health Organization (WHO) will review the evidence on the ring as part of its guidelines process and consider the prequalification product, a process that facilitates access to medicines that meet global quality, safety and efficacy requirements.
At the same time, additional studies are being conducted and planned in Africa to help better understand how the product could meet women’s sexual and reproductive health needs at different times in their lives. This includes studying its use and safety among groups facing a particularly high risk of HIV, including adolescent girls and pregnant and nursing women.
Proven device security
Ring research has been overseen for 16 years in 16 clinical trials in Africa, Europe and the United States. Two Phase III studies found that the ring reduced the risk of HIV-1 infection in women, with no safety issues with its long-term use.
The Ring Study, conducted between 2012 and 2016, found that the ring reduced overall risk by 35%, and ASPIRE, led by the Microbicides Testing Network (MTN), found that the ring reduced overall risk by 27%. Together, the two studies assessed monthly ring use in nearly 4,600 women aged between 18 and 45 in Malawi, South Africa, Uganda and Zimbabwe.
Two other subsequent open-extension (OLE) follow-up studies showed increased ring use compared to previous Phase III studies, suggesting that once women know that a product has been shown to work in trials without safety issues, they are more likely to use it.
Providing safe and effective HIV prevention options for the most at-risk women promises to be one of the great public health achievements of our generation
The DREAM study found that 95% of enrolled women wore the ring at least part of the time. In addition, the data suggested further risk reduction in the two studies, by more than 50%. Although this finding is based on statistical models and is therefore limited, it is an encouraging trend that we hope to observe in further research.
It was also shown that the ring has a favorable safety profile in all clinical trials to date, including more than 20 studies analyzing the safety of dapivirine in a variety of formulations. In addition, the acceptability of the ring for women has been examined since the beginning of the product development process.
Finally, IPM is working on the development of other products such as a dapivirine vaginal ring that lasts three months, which would increase its benefit and reduce costs; it is also developing a contraceptive ring with dapivirine to respond to two threats to the health of different but often overlapping women: HIV and involuntary pregnancies.
Providing safe and effective HIV prevention options for the most at-risk women promises to be one of our generation’s great public health achievements. But we must be aware that this potential requires continued financial and political investment. The ring’s promise to help control the AIDS epidemic will only come true if we can make it affordable and accessible to them.