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WHO recommends dapivirine vaginal ring as a new choice for HIV prevention for women at high risk of HIV infection

WHO recommends dapivirine vaginal ring as a new choice for HIV prevention for women at high risk of HIV infection

 


WHO recommended it today dapivirine vaginal ring (DPV-VR) may be offered as an additional prevention option for high-risk women[1] HIV infections as part of a combined approach to prevention.

DPV-VR is an option initiated by a woman to reduce the risk of HIV infection. To use the ring properly, it must be worn inside the vagina for 28 days, after which it should be replaced with 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 randomized controlled phase III studies found that the use of DPV-VR reduced the risk of HIV infection in women and that long-term use was well tolerated. The Ring study showed a 35% reduction in HIV among women using DPV-VR, and the ASPIRE study showed a 27% reduction in risk.

The results of open-label extension studies in the trials showed an increase in ring use, and modeling data indicate a greater reduction in risk – by more than 50% in both studies – compared to phase III trials. Secondary analyzes of study data also suggest a greater reduction in risk among women who have consistently used DPV-VR.

The purpose of DPV-VR is to reduce the risk of HIV infection during vaginal sex for women who are at significant risk of HIV as a complementary approach to prevention, in addition to other safer sex practices. It can be offered with oral PrEP as an option for women who do not want or cannot take a daily oral tablet. Although contraceptive vaginal rings have been available for several years, DPV-VR is the first vaginal HIV prevention product. Research into the development of the vaginal ring, which includes contraception and HIV prevention, is underway.

As of November 2020, DPV-VR has been included in the WHO Prequalification List of Medicines. This followed a positive scientific opinion from the European Medicines Agency (EMA) under Article 58 on the use of DPV-VR for HIV prevention, which was approved in July 2020.

At a recent meeting of the WHO Guidelines Development Group, the Group formulated a conditional recommendation supporting the DPV-VR offer. The group estimated that the benefits of DPV-VR outweighed the harm based on a systematic review and meta-analysis of the scientific evidence presented to them. This evidence included the cost-effectiveness of the vapivirine vaginal ring, acceptability, proven feasibility, and potential to increase ownership as additional prevention choices, noting that some variability in efficacy in younger age groups and limited data on use among pregnant and lactating women.

The guideline development group set out application considerations and research gaps to be considered when introducing this product. This included addressing the provisions of the DPV-VR as part comprehensive services; Ensuring that women are offered complete information in order to informed choice about the benefits and potential risks when thinking about using a ring; adolescent girls and young women they may need more support during initiation and to continue; acceptability among women from key population groups; additional compliance support and demand generation; training and support to service providers understand and be able to offer this new product; further information on safety in pregnancy and lactation and cost-effectiveness.

WHO emphasizes the importance of providing HIV prevention services to women in conjunction with other services, including offering other choices for HIV prevention, diagnosis and treatment of sexually transmitted diseases, offering voluntary partner services, HIV testing, and links to antiretroviral drugs. therapy for all women who have a positive test and through contraceptive options. Services must also be provided to women who are exposed to violence in intimate partners, and health professionals need training to provide services that respect and include women in all their diversity.


[1] Significant risk of HIV infection was defined as an incidence of HIV greater than 3 per 100 person-years.

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