The World Health Organization (WHO) has recommended the use a silicone vaginal ring containing the antiretroviral known as dapivirine as a new method for preventing HIV among women at substantial risk of contracting the virus.
The product, which was added to the WHO’s list of prequalified medicines last November, is a discreet, long-acting, HIV-prevention product designed specifically for women.
Currently, people without HIV but who are at very high risk of contracting the disease take a pill called pre-exposure prophylaxis (PrEP) that contains two anti-HIV drugs every day to lower their chances of contracting HIV.
PrEP is only effective when taken daily as prescribed. However, studies have shown that the pill is much less effective if consistency is interrupted.
To create better adherence and provide people with a variety of acceptable, discreet, and convenient choices, researchers have been studying new long-lasting forms of HIV prevention methods that can be inserted, injected, infused, or implanted in a person’s body from once a month to once a year to provide sustained protection from acquiring the virus.
According to the WHO’s guideline, the dapivirine vaginal ring (DPV-VR) will be offered as part of combination prevention approaches.
The United Nations agency, however, issued a conditional recommendation noting some variability in effectiveness of the ring in younger age groups and limited data regarding use among pregnant and breastfeeding women.Advertisement
“The WHO Guideline Development Group assessed that the benefits of the DPV-VR outweigh the harms based on a systematic review and meta-analysis of the scientific evidence presented to them,” said the WHO.
This evidence included the cost-effectiveness of the ring, acceptability, demonstrated feasibility, and the potential to increase equity as an additional prevention choice.
In some parts of the world, particularly in sub-Saharan Africa, women are especially vulnerable to HIV exposure, because they cannot negotiate safer sex due cultural, social and gender barriers, among other reasons hence putting them at a heightened risk of unintended pregnancies, STIs and HIV.
According to the UNAids, nearly 870,000 new HIV infections occur globally among women and girls every year – three every four minutes.
In sub-Saharan Africa, three in four new infections among 15–19-year-olds are among girls.
In Kenya, about 970,000 girls and women are estimated to be living with HIV.
The antiretroviral dapivirine in the ring is released slowly to reduce the woman’s risk of acquiring HIV infection locally in the vagina with few effects elsewhere in the body.
The ring is seen as a method for cisgender women (people whose gender identity matches their sex assigned at birth) in sub-Saharan Africa, who despite being the face of the epidemic, have few options for protecting themselves against getting infected.
In addition to other safer sex practices, the use of DPV-VR is intended as a complementary prevention approach and can be offered alongside oral PrEP as a choice for women who do not want or are unable to take a daily oral tablet, said the WHO.
The ring is made of silicone, which gives it flexibility to bend and insert. It works by releasing dapivirine into the vagina slowly over a period of 28 days, after which it is replaced with a new one.
Over the last decade, a number of studies in different settings have tested the ring’s safety, effectiveness and acceptability.
These studies were first conducted in Belgium and the United States, followed by Kenya, Malawi, South Africa and Tanzania
The initial research included women aged 18 to 45, with additional safety studies among post-menopausal women and adolescent girls aged 15 to 17 in the US.
While contraceptive vaginal rings have been available for several years, the DPV-VR is the first vaginal HIV prevention product.
Original Press Release
WHO today recommended that the dapivirine vaginal ring (DPV-VR) may be offered as an additional prevention choice for women at substantial risk of HIV infection as part of combination prevention approaches.
The DPV-VR is a female-initiated option to reduce the risk of HIV infection. To properly use the ring, it must be worn inside the vagina for a period of 28 days, after which it should be replaced by a new ring. The ring is made of silicone and is easy to bend and insert. The ring works by releasing the antiretroviral drug dapivirine from the ring into the vagina slowly over 28 days.
Two Phase III randomized controlled trials found that using the DPV-VR reduced the risk of HIV infection in women and long-term use was well-tolerated. The Ring Study demonstrated an HIV reduction of 35% among women using DPV-VR, and the ASPIRE study a 27% reduction in risk.
Results from the open-label extension studies of the trials showed increases in ring use and modeling data suggest greater risk reduction — by over 50% across both studies — compared to the Phase III trials. Secondary analyses of the trial data also suggest higher risk reduction among women who consistently used the DPV-VR.
The DPV-VR is intended to reduce the risk of acquiring HIV during vaginal sex for women who are at substantial HIV risk as a complementary prevention approach in addition to other safer sex practices. It can be offered alongside oral PrEP as a choice for women who do not want or are unable to take a daily oral tablet. While contraceptive vaginal rings have been available for several years, the DPV-VR is the first vaginal HIV prevention product. Research is under way to develop a vaginal ring that includes both contraception and HIV prevention.
Since November 2020, the DPV-VR has been included on the WHO’s prequalification list of medicines. This followed the positive scientific opinion from the European Medicines Agency (EMA) under Article 58 on the use of the DPV-VR for HIV prevention, which was granted in July 2020.
At a recent WHO Guideline Development Group meeting, the Group formulated a conditional recommendation supporting offer of the DPV-VR. The Group assessed that the benefits of the DPV-VR outweigh the harms based on a systematic review and meta-analysis of the scientific evidence presented to them. This evidence included the cost–effectiveness of the dapivirine vaginal ring, acceptability, demonstrated feasibility, and the potential to increase equity as an additional prevention choice, noting some variability in effectiveness in younger age groups and limited data regarding use among pregnant and breastfeeding women.
The Guideline Development Group outlined implementation considerations and research gaps to be considered in rollout of this product. These included addressing the provision of the DPV-VR as part of comprehensive services; ensuring women are offered full information in order to make an informed choice about the benefits and potential riskswhen considering to use the ring; adolescent girls and young women may need more support during initiation and for continuation; acceptability among women fromkey population groups; additional adherence support and demand creation; training and support for providers to understand and be able to offer this new product; further information on safety in pregnancy and breastfeeding and cost-effectiveness.
WHO stresses that when providing HIV prevention services for women it is important to provide these alongside other services including the offer of other HIV prevention choices, STI diagnosis and treatment, the offer of voluntary partner services, HIV testing and links to antiretroviral therapy for all women who test positive, and a range of contraception options. Services must also be provided for women who experience intimate partner violence and health care workers need training to provide services that are respectful and inclusive of women in all their diversity.