AVAC Applauds Positive Opinion from EMA on Woman-initiated Prevention Option

Calls for accelerated implementation research, WHO guidance and regulatory review for Dapivirine Vaginal Ring

Contact

Mitchell Warren, +1 (914) 661-1536, mitchell@avac.org
Kay Marshall, +1 (347) 249-6375, kay@avac.org

New York City, July 24, 2020 – AVAC applauded the positive opinion adopted today by the European Medicines Agency (EMA) on the use of the Dapivirine Vaginal Ring as an HIV prevention option for cisgender women 18 and older. The International Partnership for Microbicides (IPM), the developer of the ring, announced that it will be moving swiftly toward the next steps needed to get this critical prevention option into the hands of women who want and need it. AVAC congratulates IPM, welcomes this commitment to bringing a much-needed woman-initiated HIV prevention option to women, especially in Eastern and Southern Africa, and calls for an integrated introduction plan that lifts up the voices of women, speeds regulatory approvals and is fully funded.

The Dapivirine Vaginal Ring is a flexible, silicone ring that a woman can insert in the vagina for monthly protection against HIV. It contains the antiretroviral drug dapivirine and is designed to provide women with a discreet and long-acting option for HIV prevention. The ring was shown to be modestly effective in two large efficacy studies and open-label extension studies showed a trend toward higher efficacy when women knew the product they were using contained the active drug.

The EMA’s positive opinion recommends the Dapiviring Vaginal Ring “in combination with safer sex practices when oral pre-exposure prophylaxis (PrEP) is not used, cannot be used or is not available.” This regulatory opinion, generated through a mechanism that allows review of medicines intended for use outside of the EU, triggers critical actions from WHO, including reviewing its HIV treatment and prevention guidelines for possible inclusion of the ring and beginning the pre-qualification process that would help ensure countries are able to approve and procure rings for their programs.

“This is a long-awaited day for the thousands of women in Africa, Europe and the US, who participated in clinical trials of the ring and those of us who have advocated for access to the ring and other women-initiated prevention options for over two decades. Women have been waiting for additional HIV prevention options that they can use discreetly and easily, and for many the ring could be that product,” said Manju Chatani-Gada, AVAC’s Director of Partnerships & Capacity Strengthening. “We’re looking forward to ensuring that women guide and lead the next steps, working with IPM, WHO and country stakeholders to ensure that former trial participants, future users of the ring and women’s health advocates are included in decision-making processes for research and introduction going forward.”

“As a young woman and a youth advocate, I’m so excited by this news. We need diverse prevention options that will meet our needs where we are in our lives. The ring gives us another choice and that’s so important," said Cleopatra Sheilla Makura, Youth Prevention Advocate and former AVAC Fellow from Zimbabwe. “I can’t wait to share this news with other young women and help plan for the introduction of this new prevention option in our communities.

As part of the opinion, the EMA asked that additional data from cisgender women ages 18-25 be collected to better understand the ring’s efficacy overall and among this group that is often at a higher risk for HIV. They have also asked for more data to be gathered on potential drug resistance among ring users who might become infected. These additional data would complement information from introduction activities that will help program implementers and policy makers better understand how the ring can be effectively provided to women. These early introduction activities will also provide critical data to support integrating the ring into existing HIV prevention programs and sexual and reproductive health programs.

“The positive EMA opinion is a critically important step that helps move the Dapivirine Vaginal Ring from a research product to a reality in women’s lives, and ultimately to public health impact.” said Mitchell Warren, AVAC Executive Director. “AVAC has been proudly working with IPM and a range of other partners to develop a robust plan for ring introduction and scale-up. Now is the time to design and fund strategic introduction of the ring in communities where we know women have been waiting for new HIV prevention options.”

Despite years of expanded treatment and prevention options for HIV, women – especially young women – in many communities remain at substantial risk of HIV infection. Incidence rates in women have remained persistently high at four percent as seen in the MIRA trial thirteen years ago to the ECHO study in 2019 and the recently stopped HVTN 702 vaccine trial earlier this year. Women need and deserve more options from which to choose to protect themselves from HIV.

“The high rates of HIV infection in many communities in East and Southern Africa are a reminder that we have no time to lose,” Warren added. “The US government, several European governments and the Bill & Melinda Gates Foundation have made critical long-term investments in IPM to develop the ring; now these and additional funders need to double down on this initial support to work with IPM and others in the field to ensure the ultimate return on these investments: HIV infections averted. This includes investing in a suite of access activities as well as supporting plans for rapid regulatory review and integration of the ring into existing HIV prevention and SRH programs.”

IPM estimates that the ring could become available in 2021 in some countries in East and Southern Africa. AVAC will continue to work with IPM and other partners through a new consortium - PROMISE - that is supported by USAID and PEPFAR to ensure that the critical next steps, including pilot introduction initiatives that will help guide eventual rollout plans for the ring, continue at pace with plans adapted to meet the current challenges presented by the COVID-19 pandemic.

Additional studies that are ongoing or planned are looking at the safety and acceptability of the ring among young women ages 16 to 21 and women who are pregnant or breastfeeding. The COVID-19 pandemic has slowed some of these studies, but are critical to provide data to help ensure more women will soon have access to the ring

“While the ring is not yet available, we must not forget that highly effective prevention options for women already exist and must be made available: daily oral PrEP and the female condom. Work must continue to expand these options today to strengthen programmatic platforms so that the ring and other future options are rapidly and seamlessly integrated into SRHR services and to enable women to have informed choice among an array of options,” added Chatani-Gada.

In addition, research for additional women-initiated HIV prevention options must be prioritized. Results may come later this year or in 2021 from a trial looking at long-acting injectable PrEP for women and there are multiple other products, some combined with pregnancy prevention, in the pipeline. IPM and partners are testing a Dapivirine Vaginal Ring that would last three months and early stage research of multiple combination HIV prevention and contraceptive products are underway. It is critical that this research continue to be prioritized and fully funded.

More information on the Dapivirine Vaginal Ring is here and here.

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of HIV prevention options as part of a comprehensive response to the pandemic.