You guessed it right. I am talking about the dapivirine vaginal ring (DPV-VR), which is one of the top advances happening in the field of microbicides. It is the first long acting prevention product whose Phase-3 randomised controlled studies have shown that using the dapivirine vaginal ring reduced the risk of HIV infection in women and long-term use was well-tolerated.
The World Health Organization (WHO) has just recommended it as a new prevention choice for women at substantial risk of HIV infection as part of combination prevention approaches. The European Medicine Agency has already given a positive scientific opinion on its use, and it has been submitted for regulatory approvals in many countries of Africa and in the USA.
Patriarchal norms have long forced women’s sexual health needs to remain on the blind spot. The economic, social and cultural barriers faced by women often disempower them to exercise their right to negotiate use of prevention options for HIV (and other STIs and unintended pregnancy) with their partners. If we are to end AIDS and achieve zero new HIV infection goal, then it is vital to have more women initiated methods to prevent transmission of all STIs including HIV, and unintended pregnancies. That is why dapivirine vaginal ring provides the much needed ray of hope.
WHAT IS THE RING?
The dapivirine vaginal ring is a female-initiated option to reduce the risk of HIV infection. It is a silicon ring impregnated with 25mg of the drug dapivirine (a non-nucleoside reverse transcriptase inhibitor). It is easy to bend and insert in the vagina, where it must be worn for a period of 28 days, after which it should be replaced by a new ring. The ring works by releasing the antiretroviral drug dapivirine from the ring into the vagina slowly over a period of 28 days.
This is indeed a revolution in the field of new innovations for HIV prevention, which is now more than just distribution of condoms and pills. And this is just the beginning, with newer technologies in the offing.
“In my own view this is going to be a product that could have real utility because it is extremely safe and because it is such a tiny amount of drug so it would not require a lot of medical monitoring. So it is not going to be very medicalized. All you really need is a rapid test and a dispensation”, said Dr Sharon Hillier, Professor, Department of Obstetrics, Gynaecology & Reproductive Sciences and Microbiology and Molecular Genetics, University of Pittsburgh, during an interaction with a group of select global journalists ahead of the ongoing virtual 4th HIV Research for Prevention (HIVR4P) International Conference.
“When the ring is rolled out, it will be critically important to figure out where to promote it most efficiently. For example, as very little drug comes out of the ring, it might make it a very attractive choice for a woman who is breastfeeding as not much drug will get into the breastmilk. We are doing a study of testing this vaginal ring in breastfeeding women which will be over by September 2021. Another study is also currently underway on pregnant women”, she shared.
Prof Hillier also spoke about next generation rings and approaches to new formulations of delivering drugs for HIV prevention.
The next generation ring (currently under research) has 200mg of dapivirine and can be left in the vagina for 3 months at a time. The first studies, showing that it is safe, have been completed.
MULTIPURPOSE PREVENTION TECHNOLOGY
There is also a 90 day multipurpose dapivirine vaginal ring currently-under-research that aims to provide dual protection against both HIV and unwanted pregnancy. It contains 200mg of dapivirine and 320mg of levonorgestrel to allow for extended release of the two drugs over 3 months. Results of phase-1 clinical studies, presented at the ongoing fourth HIVR4P Conference, show that it is safe and delivers sustained levels of each drug when used continuously for 90 days- levels likely sufficient to serve its dual purpose for protecting against both HIV and unintended pregnancy. This is going to be a game changer by giving a woman a simple and very safe product in her hands that she can insert in her vagina that could provide both family planning and HIV prevention.
ACCEPTABILITY AND ACCESS
There has been great progress in getting HIV prevention products into women’s hands and in having more sustained delivery options. If we create a broad menu of options, people can choose what works best for them, said Prof Hillier. However she concedes that more community education and understanding has to be generated around the utility and use of the dapivirine ring. She said that while a lot of acceptability work has been done in many African countries and in USA, less work has been done in Asia and South America. It was basically designed to address women’s needs in Africa and has been highly acceptable to women there.
