A Leap Forward For the Dapivirine Vaginal Ring, the Next Steps Are Critical

After decades of research and advocacy, the Dapivirine Vaginal Ring is now one step closer to becoming available as a discreet, woman-initiated HIV prevention option. In July, the European Medicines Agency (EMA) issued a positive opinion for the ring, allowing the next steps in the regulatory process to go forward. Download this podcast to hear five different perspectives on the ring, how it expands HIV prevention options for women, and the most important next steps to bring the ring to women who need it.

New Resources on AVAC.org! The ring, long-acting PrEP and more

In the midst of harrowing trends in COVID-19 and growing concerns about its impact on HIV, HIV research has brought welcome good news. From a positive opinion on the Dapivirine Vaginal Ring, efficacy data on long-acting injectable cabotegravir (although limited to MSM and transgender women), and advocacy opportunities to demand the integration of HIV services with sexual and reproductive health, HIV prevention is making important strides in 2020. This round-up of new resources on AVAC.org and PrEPWatch.org features tools and information to advance prevention advocacy right now.

A Giant Step for the Dapivirine Vaginal Ring, What’s Next?

Understanding the EMA Opinion and Next Steps for the Dapivirine Vaginal, AVAC’s primer on the status of the ring after the EMA’s positive opinion, background on the relevant research and advocacy for what must happen next.

A webinar on Wednesday, July 29 brought together leading advocates and representatives from the ring’s developer (IPM) and WHO to talk about next steps on the regulatory process and implications for rollout.

On AVAC.org’s dedicated page for the dapivirine vaginal ring find links to key resources for advocacy.

AVAC’s debut episode of Research Fundamentals, on our podcast Px Pulse, explores the concept of partial protection. What is Partial Protection, an 11-minute episode on how and why an intervention can offer imperfect but still useful protection.

CAB-LA Shows Efficacy in One Trial, Results Coming Soon in Another

On AVAC.org’s page on long-acting injectable cabotegravir find a background on the research to date, including two trials testing this long-acting PrEP option, HPTN 083 & 084. Put the research in context with a host of additional resources found there.

An Advocates’ Primer on Long-Acting Injectable Cabotegravir for PrEP, AVAC’s primer for understanding the results of HPTN 083 and the status of HPTN 084, explores unanswered questions and next steps for advocacy.

A Conversation About Long-Acting PrEP for Cisgender Women, this discussion between Sinead Delany-Moretlwe, HPTN 084 Study Chair and Awelani Neluonde, CAB Member, was part of AVAC’s Research Literacy Networking Zone at AIDS 2020.

A Conversation About Long-Acting PrEP for MSM & Transgender Women, this discussion between Raphael Landovitz, HPTN 083 Study Chair and AVAC’s Jessica Salzwedel was part of AVAC’s Research Literacy Networking Zone at AIDS 2020.

Priorities for Advancing HIV/SRH Integration

Visit www.srhintegration.org, a joint initiative between AVAC and FP2020, which features a video series One Expert, One Question, One Minute, with key stakeholders framing the priorities for integration. There’s also a recording of a July 30th webinar, One Year After ECHO: Innovation in the time of COVID. And find links to a host of resources to inform your advocacy.

Thinking About Better PrEP Rollout?

Easier and Equitable Access to PrEP: How DSD Can Help Get Us There, by AVAC’s Jessica Rodrigues, Director of Product Introduction and Access, and published on the IAS blog devoted to differentiated service delivery (DSD), makes the case for expanding PrEP access with this user-centered approach, and using DSD for PrEP as a model for future prevention products.

See data on PrEP uptake in a whole new way with AVAC’s Global PrEP Tracker, showing dynamic trends over time. Download the Excel version of the Tracker for additional information on targets, programs, drug registration status, all sortable by country. Updated quarterly.

A Look at the Pipeline

The Years Ahead in Biomedical HIV Prevention Research provides an updated snapshot of the status of key biomedical HIV prevention strategies in research and development.

At this moment in the epidemic of COVID-19, many people who need HIV prevention products and services are struggling, and the stakes are high—will the world lose hard-won gains against HIV? But stakeholders in research are persevering with success and advocates are leveraging the day-to-day challenges to continue to demand the products people need today and in the future. We hope you’ll use these resources to tell the story, protect the global gains against HIV and push for more at this critical time.

Major Milestone for Women’s HIV Prevention: EMA recommends Dapivirine Vaginal Ring

AVAC welcomes today’s opinion from the European Medicines Agency (EMA) that recommends the Dapivirine Vaginal Ring as an additional HIV prevention option for cisgender women 18 and older. The EMA action moves a much-needed woman-initiated HIV prevention option one step closer to reaching women who need it. To help advocates understand this key development, AVAC has created a new ‘primer’ on the issue with everything advocates need to know about what’s happened and must happen next.

Read on for more information, links to new resources, next steps for advocates, and registration details for a webinar on Wednesday, July 29 at 10am EDT to discuss this welcome development.

Every day brings fresh news of the ways that the pandemics of HIV, COVID and gender-based violence are harming women and adolescents—along with many other groups. In this context of rising risk, giving women options to choose from is essential. This includes options for HIV prevention, contraception and overall health that work within their lives.

The EMA opinion came from its Human Medicines Committee, which reviewed the existing data under a mechanism that allows the EMA to provide regulatory views on products that are intended for use outside the European Union. The opinion states that the “Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis (PrEP) is not used, cannot be used or is not available.” It also calls for further safety and efficacy data to be collected in younger women, and for monitoring of women who acquire HIV while using the ring, to understand if drug resistance arises.

AVAC’s partners have been at the forefront, informing conversations about the Dapivirine Vaginal Ring trials and their results. As Manju Chatani-Gada, AVAC Director of Partnerships & Capacity Strengthening said in AVAC’s press release earlier today, “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 two decades. Women have been waiting for an HIV prevention option that they can use discreetly and easily, and for many the ring could be that product,” Click here to see more of the women-led, youth-centered activism on this issue to date.

Advocates, the International Partnership for Microbicides (IPM) which developed the ring, implementers, policy makers and other stakeholders are gearing up for the next stage in securing access to this product. The ring is the first biomedical strategy designed expressly for reducing risk through receptive vaginal sex to receive a positive regulatory opinion since the female condom in 1993.

Join us for a webinar on Wednesday, July 29 at 10am EDT to hear about next steps on the regulatory process and implications for rollout from advocates, IPM and the WHO.

And use these resources to deepen your knowledge of the ring, its implications for cisgender women’s HIV prevention, and the essential next steps to translate positive research and regulatory opinion into impact:

As public health indicators continue to show unacceptably high rates of HIV among adolescent girls and young women, this positive regulatory opinion is a source of hope and a call to action. Now is the time for accelerated work on evidence-based implementation, funding and the political commitment needed to both scale up a choice-based platform of HIV prevention that includes the ring, oral PrEP and the female condom.

Join us in the work ahead, watch for webinars, calls, podcasts and more.

Press Release

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.

The latest on AVAC.org

Check out the resources below for the latest AVAC material, including our just-released AVAC Report 2019: Now What?, our opinion piece on Devex highlighting priorities for 2020 and beyond, and several new resources and publications!!

AVAC Report 2019: Now What?

Our November publication of our annual report asks Now What? as we look ahead to 2020 and the certainty of missing HIV prevention targets set by UNAIDS. In answer, we issue a call to action: enact bold, activist, visible leadership on HIV; sustain investment; use today’s evidence to guide tomorrow’s prevention targets; and double down on multilayered prevention approaches.

Check out these additional resources in the report:

The Global Development Community is Listening

On December 3rd, Devex published AVAC’s opinion piece exploring the critical challenges and opportunities we laid out in Now What? Read on for the actions we think will make the difference from leaders and communities at every level.

Youth Leadership Will Turn the Tide Against HIV

We commemorated World AIDS Day 2019 with the launch of a series of blogs from the new generation of leaders who must carry the torch to end the epidemic. Learn why we call these leaders Generation Now and have pledged our support to their remarkable efforts. And read the blogs to see their responses, framing the challenges ahead.

Abuja Commitments for Spending on Health Put in Context

To coincide with the recent ICASA conference Accountability International published, with support from the AVAC-led Coalition to Accelerate & Support Prevention Research (CASPR), Mind the Gap: African HIV Financing Scorecard. This report tracks current African domestic investments in HIV treatment and prevention. The report also makes the case for the importance of considering other indicators, beyond the 2001 Abuja pledge of 15 percent of annual budget investments into the health sectors, when evaluating political will and opportunities to increase investment and access to health.

Learning from “Like” Products to Accelerate the Introduction of New Prevention Options

As part of the OPTIONS Consortium, which AVAC co-leads, we published The Dapivirine Ring: Key learnings from like-product introductions, which examines historical experiences introducing products that share characteristics with the dapivirine vaginal ring, specifically, products that were vaginally inserted or partially efficacious.

The Complex Challenges of HIV Vaccine Development Require Renewed and Expanded Global Commitment

Several AVAC staff and partners contributed to a new viewpoint in The Lancet journal describing what it will take to develop and deliver an HIV vaccine. In The Complex Challenges of HIV Vaccine Development Require Renewed and Expanded Global Commitment, the authors highlight the need to plan now for regulatory review, procurement, and implementation of a potential HIV vaccine to speed its availability. Additionally, drawing on our Resource Tracking Working Group data, the authors call for increased funding for HIV prevention research and the need for strengthening the pipeline of early stage HIV vaccine candidates.

Support AVAC

As the end of the year approaches, we hope you’ll remember AVAC in your charitable giving. Help us sustain this essential work with your support in one or more of the following ways:

Learning from “Like” Products to Accelerate the Introduction of New Prevention Options

As part of an analysis funded by the OPTIONS Consortium (of which AVAC is a part), AVAC examined historical experiences introducing products that share characteristics with the dapivirine vaginal ring, specifically, products that were vaginally inserted and/or partially efficacious. Both are characteristics of the dapivirine vaginal ring and can represent a challenge to acceptance and use. However, products ranging from the rotavirus vaccine to the contraceptive ring have overcome these challenges. In our analysis – entitled The Dapivirine Ring: Key learnings from like-product introductions – we interrogate what facilitated their success and uptake, and conclude that with adequate planning and education, it is possible for products such as these to make an impact.

Developed by the International Partnership for Microbicides (IPM), the dapivirine vaginal ring is a silicone ring which looks similar to a contraceptive ring, but releases dapivirine (an antiretroviral drug) slowly over the course of one month. The ring is vaginally inserted, rests high inside of the vagina, and a woman can remove and reinsert the ring herself if she wants to. Also, its effect is localized (limited to the vagina) rather than systemic (affecting the whole body). The ring can give women control over their HIV prevention choices, without need to negotiate with or disclose to her partner.

Final results of the open-label studies HOPE and DREAM found the ring to be partially efficacious (with participants seeing a 39 percent and 63 percent reduction in HIV-risk respectively). These results were an improvement over the results of previous phase III trials ASPIRE and The Ring Study, in which the ring was demonstrated to reduce women’s risk of acquiring HIV by only 27 percent and 31 percent respectively.

Partially efficacious products and procedures have played a pivotal role in public health interventions for decades, and have been an important component of the HIV response for many years. For example, voluntary medical male circumcision (VMMC) is a well-known and effective tool for HIV prevention, and reduces the risk of HIV acquisition by 60-75 percent. The malaria vaccine and rotavirus vaccine are two other partially efficacious products that have become staples in prevention efforts.

In order to address concerns about partial efficacy, providers and implementers have employed a few key strategies. By focusing on interpersonal communication and using small groups to discuss the nuances of the products with both end-users and providers, it is possible to build confidence in a partially effective product. Product champions can also help drive up demand and acceptability of something like the ring. Integrating the ring with other health services may also draw new clients in and support uptake.

Researchers have noted that vaginal insertion of the ring has proven to be a barrier for some women, particularly due to lack of experience with these types of products in the African context and cultural norms which stigmatize female genitals.

The introduction of vaginally inserted products like the female condom, the progesterone contraceptive vaginal ring, tampons and the menstrual cup provide valuable lessons when considering how the dapivirine ring might be introduced. For example, peer-to-peer communications that include a product user can be effective in recruiting new users. Additionally, encouraging providers to try the ring themselves can help overcome provider bias. Acceptability of the ring among even a small group of vocal providers can influence uptake nationally, so those providers need to be found, encouraged and given a platform.

Finally, empowering women to explain the ring to partners, by promoting body awareness and knowledge of sexual and reproductive health, will be an essential component to ring introduction. To this end, education & communication (IEC) materials demonstrating how the ring fits in a woman’s body can alleviate concerns about the ring getting stuck or causing infertility.

With these strategies in mind, the HIV prevention field can better prepare for possible introduction of the dapivirine ring and ultimately help policy makers, health care providers and women interested in a new HIV prevention option make informed decisions about the ring. By clearly articulating the value of the ring as one component of the HIV prevention portfolio, and educating women and their providers about the benefits of a discreet and female-controlled prevention option, it is possible to accelerate the impact of the dapivirine ring in improving women’s health and reducing HIV incidence.

AVAC’s “3D” View of the World: 2019 and beyond

This infographic lays out AVAC’s top-line recommendations from AVAC Report 2019: Now What? The recommendations fall into three categories: deliver — prevention programs whose impact is well-measured and -defined; demonstrate — next-generation engagement for next-generation trials; develop — new targets for the post-2020 world.

AVAC Report 2019: With 2020 targets sure to be missed, we ask Now What?

Report cover

Today, AVAC released Now What?, our 2019 annual report on the state of the HIV prevention field. Each year, the AVAC Report frames the most pressing advocacy issues facing the HIV response. At the threshold of 2020, it’s clear that global goals for HIV prevention will miss the mark by a long shot.

Though important progress has been made, the crisis UNAIDS called out in 2016 persists today with new infections around 1.7 million annually, a far cry from the 2020 target of fewer than 500,000.

So, we asked ourselves, Now What?, and answered with cross-cutting analysis and an advocacy agenda to match.

FIRST, we call for leadership that is bold, visible and activist, from the new head of UNAIDS, to houses of parliament to civil society coalitions: take uncompromising stances, demand accountability, speak out for intersectional issues of race, gender, class and climate. This work needs to be funded, full-throttle and fearless.

SECOND, we call for the use of today’s most recent evidence to guide new prevention targets that will pave the way for epidemic control. Clear milestones for the prevention research pipeline must be set. Investments over the past decades have provided us with the prevention options we have today, and much-needed new strategies are under now investigation. The field needs targets for prevention research that people can understand and influence.

THIRD, we call for multilayered prevention approaches that are centered around the person, not the virus. Since last World AIDS Day, we’ve learned again, perhaps most strikingly from the ECHO trial, about the dynamic needs of women for HIV and pregnancy prevention. The complexity of translating results into policy, bring renewed urgency to the need for comprehensive HIV prevention and reproductive health approaches. Multilayered prevention incorporates multipurpose strategies (i.e., products that prevent both pregnancy and HIV) within programs designed to address structural barriers (i.e., policy reform, transforming community norms, facilitating educational empowerment).

2020 will be a pivotal year—join us in calling on leaders, from the grassroots to global capitals, to make 2020 a turning point, when siloes come down, crises are transformed by innovation, and prevention is center stage in the fight against HIV.

Happy reading, and we’d love to hear how you answer Now What?

The Dapivirine Ring: Key learnings from like-product introductions

Vaginal insertion and partial efficacy are two challenges that could affect the uptake and continued use of the dapivirine ring. Analyses of the introductions of other products that share similar characteristics provide useful lessons to inform planning for rollout of the dapivirine ring. This paper provides information for planners, implementers, funders, researchers, trainers, providers of technical assistance and others to build an agenda for introducing the dapivirine ring that addresses these two challenges.

What’s New on AVAC.org and PrEPWatch.org

We don’t want you to miss a host of resources posted in recent weeks on AVAC.org and PrEPWatch. In case you missed them, these tools and resources will sharpen your take on the field.

Reporting on Global HIV Prevention

Check out these reports—recently published by AVAC and partners—for updates on funding trends in prevention and cure R&D, as well as a fresh look at places that have beaten back HIV with existing interventions:

Smarter Rollout

These articles and tools support advocates, implementers and decision-makers working on PrEP rollout today with an eye on future interventions tomorrow:

  • Reaching and Targeting More Effectivley: The application of market segmentation to improve HIV prevention programmes, by AVAC’s Anabel Gomez and others, and published in the Journal of the International AIDS Society, explores how to leverage the power of market segmentation for the promotion and uptake of primary prevention.
  • Just updated in July, AVAC’s Global PrEP Tracker on PrEPWatch.org provides the latest data on programs, number of enrollments by country, regulatory status and more.
  • A User’s Guide to PrEP Tools offers a handy table to navigate the many tools produced by different organizations to support policy makers, implementers, providers and others on PrEP access, uptake and continuation. Use this table to learn more about these tools, who they’re designed for, and when to use them.
  • The PrEP4Youth video series of public service announcements encourages adolescent girls and young women in South Africa to consider PrEP as an HIV prevention method. Created by the OPTIONS Consortium in collaboration with the South African National Department of Health, these videos feature popular actresses and put young women at the center with short empowering messages.

Apply to be an AVAC Fellow in 2020

AVAC would like to remind you that our call for applications for the 2020 class of AVAC Fellows is open until September 20. We encourage you to learn more about the program and share this information with your network!