A new long-acting vaginal ring that women themselves can insert into their own bodies is giving new hope to reducing the risk of HIV, according to a report at a recent HIV research conference in Madrid.
The intra-vaginal dapivirine ring has been found highly effective in reducing the risk of infection, according to Zeda Rosenberg, founder and CEO of the International Partnership for Microbicides (IPM).
"IPM developed this monthly dapivirine ring - the first long-acting microbicide product clinically shown to reduce HIV risk,” Rosenberg told Citizen News Service. “It is a flexible silicon ring that slowly releases the drug dapivirine, which is an HIV prevention drug. More importantly, its use is under the control of women who can use it discreetly, if they want to, without their partner’s knowledge.
Women at risk of acquiring the infection from their partners can “put the ring in her vagina, leave it in place for 1 month and then replace it by herself,” Rosenberg said. “The drug is slowly released into the target cells and substantially reduces the risk of her HIV infection."
The ring is similar to vaginal rings commonly used by women for contraception except that it contains dapivirine, which belongs to a class of antiretrovirals (ARVs) called non-nucleoside reverse transcriptase inhibitors (NNRTIs) that prevent HIV from replicating itself.
The long-acting ring sits high inside the vagina, where it slowly releases the drug directly at the site of potential infection, with low systemic absorption, over the course of one month the ring is worn. Women can insert and replace the ring themselves once every month.
Despite substantial progress in combating HIV, after decades of intensive research an AIDS vaccine is still somewhere in the future. With HIV-related deaths falling by 38 percent between 2000 and 2017 according ot the World Health Organizations, and new infections falling by 38 percent during the period, nonetheless 940,000 people still died from HIV-related causes in 2017. Some 32 people are living with the virus in developing countries, particularly sub-Saharan Africa, the Caribbean and Southeast Asia.
The spread to submissive sexual partners in these countries is a factor. The dapivirine ring combats this by being easy to use and comfortable, woman-initiated and controlled and doesn’t interrupt womens’ daily activities. Sustemic drug absorption is low and there is no interaction with conception or related resistance. Manufacturing costs are low, the rings can be stored and room temperature and they are scalable.
"We know that women like choices,” Rosenberg said. “It is not just one product that all women may want to or can use. We already have a highly effective HIV prevention option – the male and the female condom – that can protect against unintended pregnancy as well as HIV. But its uptake is not very high. We also have the daily oral HIV prevention or PrEP (pre-exposure prophylaxis) pill - Truvada - which is highly effective in preventing HIV infection in women if used consistently.
“But we know that there are women who cannot adhere to taking a pill every day and/or fear the stigma of taking PrEP as prevention and being misperceived as being HIV infected rather than uninfected. Yet others may not want the HIV drug to be circulating in their body. So for all these women, a ring that provides a high dose of drug locally where the infection occurs (and hardly any systemic drug in the blood stream) might be a perfect option."
When will it be available?
The ring is currently under review by the European Medicines Agency (EMA) for regulatory approval, based upon the interim open-label study results, Rosenberg said, with the possibility of scientific approval from the EMA by mid-2019. The International Partnership for Microbicides will then seek WHO pre-qualification.
“Our goal is to have the ring be accessible by women in developing countries,” Rosenberg continued. “So one of the critical factors is to have a positive approval, getting WHO to pre-qualify the product, put it on its essential medicines list, so that other governments see WHO’s recommendations and then process their own approvals. This will help facilitate approvals in regions where women face the highest HIV risk. Even though it is difficult to predict, but I would hope that we could see the ring in the market in 2020”.
If approved, the dapivirine ring would be the first biomedical HIV prevention method developed specifically for women.
Multipurpose Prevention Technologies
“We believe in the promise of multipurpose prevention,” Rosenberg said. “We already have in development a combination HIV prevention and contraception three-month long-acting ring, with dapivirine and hormone levonorgestrel, in collaboration with MTN (Microbicides Trial Network) and if that proves successful, we could be moving that product.”
The first clinical study results of the dual-purpose vaginal ring, which releases the antiretroviral drug dapivirine as well as a contraceptive hormone, showed that the ring was well-tolerated and there were no safety concerns. A second phase 1 study has already been launched.
Likewise, Second Phase I study of another polyurethane, dual-reservoir 3 month acting ring for prevention of HIV + HSV-2 (genital herpes) + contraception is also ongoing.
Multipurpose prevention tools not only have the potential to be more cost-effective and convenient but will also go a long way to address women’s health needs in tandem, protecting them against HIV, unintended pregnancy and/or other STIs.
Kay Marshall, Senior communications Advisor at AVAC, told CNS (Citizen News Service) that MPTs can indeed help turn the tide against HIV, especially for women, as they combine contraception and HIV prevention and so women can achieve multiple objectives with one device and also get them at one go, avoiding multiple clinic visits. This is especially true for young women, who often worry about unintended pregnancy and are also at increased risk of acquiring HIV. So HIV prevention could be an added benefit to them in addition to protecting themselves from pregnancy. Ending the HIV/AIDS epidemic will be possible when women can choose from multiple options that meet their needs, which may change throughout their lives.
Shobha Shukla is the Managing Editor at Citizen News Service. Follow her on Twitter @Shobha1Shukla or visit www.citizen-news.org)