JUST IN: WHO gives thumbs up to dapivirine vaginal ring
Roselyne Sachiti Features, Health and Society Editor
The World Health Organisation (WHO) has 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 works by releasing the antiretroviral drug dapivirine from the ring into the vagina slowly over 28 days.
In a statement, WHO said Two Phase III randomised controlled trials found that using the DPV-VR reduced the risk of HIV infection in women and long-term use was well-tolerated.
According to WHO, the ring study demonstrated an HIV reduction of 35 percent among women using DPV-VR, and the ASPIRE study a 27 percent reduction in risk.
Furthermore, 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 percent across both studies — compared to the Phase III trials, WHO said.
Secondary analyses of the trial data also suggest higher risk reduction among women who consistently used the DPV-VR.
In Zimbabwe women are excited by the latest developments.
Speaking to The Herald today following yesterday’s announcement, one of the randomised trial participants Tariro Kutadza, a TB Champion for StopTB Partnership Zimbabwe, said women have been awaiting this.
“I participated in the research giving a voice to communities. Number one, there were no girls and women options for HIV Prevention as with condoms man have an upper hand.
“This is empowering for us. I can take control of the ring and there is no need for patriarchy like in condoms,” said Kutadza who is also a Global Goodwill Ambassador, representing people living with diseases and Communities Rep GF. CCM.
She further applauded the vaginal ring saying “it results in stigma reduction as it is inserted in my body and that is a great step. The ring is for me by me. My body; my health.”
Chairperson of the Zimbabwe Women Living with HIV National Forum, Catherine Murombedzi, welcomed the latest news saying the dapivirine vaginal ring is an option and a choice for women that are at risk.
“Women at risk faced violence when they were forced not to use protection during intercourse. The ring brings that moment when I as a woman have that power to decide, the power not to ask partner to protect you, that power where it is within you.”
She said while the female condom offered protection, it was not well received.
“I am not sure whether it was because of its shape and it was visible from the outside. The dapivirine vaginal ring is inserted in a woman’s private parts and lasts for 28 days,” said Murombedzi.
She added: “It is a milestone for women and girls. It is a milestone for women and girls at risk. It is again a milestone that we celebrate. It is an option for women.”
She applauded scientists for continuing to give women power from violence.
“Women were violated sexually. Even condoms would sometimes be removed during the act whether male or female. This dapivirine vaginal ring is empowerment for women. We are all pleased for 2020 for all the strides that have been made in HIV research, it liberates women. The power to be free from HIV. I am excited by this ring,” she explained.
Reacting to the news, Community Working Group on Health (CWGH) Executive Director Itai Rusike said numerous efforts, investments of resources as well as research and development have led to immense progress in prevention, treatment and care to defeat HIV.
He said the positive recommendation and endorsement by WHO on the effectiveness of the Dapivirine to reduce the risk of HIV infection for women is a welcome development and something worth celebrating as it adds to the progress made towards defeating the disease.
“According to UNAIDS, globally, increased access to HIV treatment has averted around 12.1 million AIDS-related deaths since 2010. This victory calls for celebration as it will lead to significant reduction of HIV transmission and related deaths,” he said.
WHO said 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 risks when considering to use the ring; adolescent girls and young women may need more support during initiation and for continuation; acceptability among women from key 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.
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