The term “microbicide” refers to substances being studied that could be used in the vagina and/or rectum to reduce the risk of HIV infection via sexual exposure. There are no licensed microbicides available today. Simple, easy-to-use microbicides would help these individuals take control of their own health—while offering people everywhere an additional, needed option. The graphics below represent key facts about the microbicide field.
Microbicides by the Numbers: Science, products, money and more
What Should the Next US President Do? Advice for Hillary and Donald.
On behalf of IFARA, thebodypro.com recently posted two videos. In the first, Jim Pickett, director of Prevention Advocacy and Gay Men’s Health at the AIDS Foundation of Chicago, spoke with Robert Grant, MD, MPH, Mike Cohen, MD, Ian McGowan, MD, PhD, FRCP, and Mitchell Warren about HIV prevention research presented at this year’s Conference on Retroviruses and Opportunistic Infections (CROI).
New prevention tools, such as a safe and effective vaginal ring and the prospect of long-acting injectable agents are exciting news, panelists agreed. However, these tools are only as good as their implementation — as is the case with already approved methods, such as oral pre-exposure prophylaxis (PrEP). This includes finding and effectively treating people living with HIV, because those with an undetectable viral load do not transmit the virus.
Panelists would advise the next US President to invest in long-term research, including the search for a vaccine, cure, fund open-label studies of the vaginal ring, and provide treatment and prevention services to as many people as possible — especially women and men of color.
Watch the video on thebodypro.com.
In the second video, AVAC Policy Director Kevin Fisher spoke with Steven Wakefield and Ntando Yola about the development of a vaccine for HIV.
Wakefield called antibody-mediated prevention “the next holy grail.” Trials of broadly neutralizing antibodies that are infused every two months will start enrollment across the globe by mid-year, he said. However, a potential vaccine is just one component in a set of HIV prevention methods. Yola described HIV prevention as “a track field where products are racing each other.” Communities pin their hopes on each new prevention modality, but the focus needs to be moved from specific methods to overall prevention science, he believes. To that end, the science behind vaccine research needs to be explained in a way that people in the community can understand.
This video is also available at thebodypro.com.
Women’s Prevention Works If Women’s Realities Are Appreciated and Prioritized
Seventy-five advocates from across Africa—friends, allies, researchers—came together for a one-day meeting in Johannesburg on April 14 to discuss the recent dapivirine ring results, what they mean in the broader context of women’s HIV prevention, what comes next and key milestones to plan for.
The recently released results of the dapivirine vaginal ring for HIV prevention demonstrated, for the first time, that an ARV-containing vaginal ring could prevent HIV acquisition. The trial data caused celebration and immediate conversation about what would happen next given that the trial showed both that the ring works and that there may be real challenges with adherence, particularly in younger women.
With new programs, funding initiatives and research specifically targeted for women and girls, this workshop convening was an important juncture to pause, take stock, consider the next few years and plan key advocacy priorities. The discussions highlighted the exciting and complicated road ahead for rings and for prevention options for women generally.
This meeting provided an opportunity to unpack and interpret the dapivirine ring results, understand and interrogate next steps, situate the next two years for women’s HIV prevention (research, implementation and funding), and identify advocacy opportunities and areas for further engagement.
Two young women living with HIV set the stage for the day with their personal stories and perspectives on where HIV prevention sits in the context of the lives of young African women. Their stories became a frame for the day—recognizing the special needs young people have for contextualized education about HIV and sexuality, but more importantly that young women are the most powerful champions and MUST be involved in designing and delivering any interventions and decision-making processes that impact their lives.
There was rich discussion on advocacy priorities for the next year or so and what is needed to ensure that women’s prevention is prioritized. Two of the issues raised underpin the way forward for women’s HIV prevention and serve as a call to action for those attending this meeting and other communities across Africa: (1) the need to roll out PrEP now as we wait for rings; and (2) the need to revive activism in the HIV prevention movement.
One of the most important takeaways was that as we consider the exciting biomedical prevention interventions to change the trajectory of the epidemic—race, gender and the unique aspects of women’s lives will continue to affect access to care and prevention. It is critical to situate the research and access in the realities of women’s, and especially young women’s lives, and that context is always important.
Please visit www.avac.org/ring-results-and-next-steps to access meeting presentations and materials.
Px Wire April-June 2016, Vol. 9, No. 2
Px Wire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy. This issue is an advocate’s guide to the past, present and future of the dapivirine ring for HIV prevention. Featuring a timeline of key milestones that could lead to licensure, a simple comprehensive Q & A, and a closer look at where sub-Saharan African women will have access to daily oral PrEP and/or the Ring via open-label extension studies.
Patchwork of Prevention for Women: Oral PrEP and the Dapivirine Ring
Participants in the ring efficacy studies will get extended access to the ring via open-label studies. But will they have access to PrEP? This map shows which sites will provide PrEP and which will not. Excerpted from Px Wire.
Dapivirine Ring Results—A snapshot
This infographic provides detailed study design and result information from The Ring Study (IPM 027) and ASPIRE (MTN-020). The lower portion of the infographic charts additional, related studies and the regulatory process before the ring’s earliest possible introduction. Excerpted from Px Wire.
Dapivirine Ring—Past, Present and Future
AVAC’s new issue of Px Wire is an advocate’s guide to the past, present and future of the dapivirine ring for HIV prevention. It features a timeline of key milestones that could lead to licensure, a simple comprehensive Q & A, and a closer look at where sub-Saharan African women will have access to daily oral PrEP and/or the Ring via open-label extension studies. We hope this resource will be used to spark discussion and guide plans for further engagement.
Click to download the new issue of Px Wire.
The full issue of Px Wire, as well as our archive of old issues and information on ordering print copies, can be found at www.avac.org/pxwire.
New Resources at AVAC.org and Our Webinar Series Continues
There’s lots to digest from the recent 2016 Conference on Retroviruses and Opportunistic Infections, but we’ve got you covered. Here are some new resources on our website. Also our post-CROI webinar series continues. See below for details.
Read — Advocates’ Voices from CROI
CROI was about more than the ring results. In our blog series, read perspectives directly from from advocates and activists in attendance. You won’t want to miss advocates’ frank takes on which scientists walk the walk in community engagement, why research results are just the beginning and what the ring results means to African women.
Listen — Webinar: Exploring Dapivirine Trial Results
In the first of a series, Jared Baeten of the Microbicide Trials Network and Zeda Rosenberg of the International Partnership for Microbicides spoke about the dapivirine ring trial results announced at the conference and fielded questions from webinar participants. (More post-CROI webinars to come!)
Look — Infographic: Evidence for HIV Prevention Options
Given these results, what’s the big picture of ARV-based prevention trial results? This graphic shows the levels of efficacy from each major trial with the confidence intervals around the finding. (Not sure what a confidence interval is? See our one-page Advocates' Guide to Statistical Terms.)
Read — Dapivirine Ring Results
Two trials of a vaginal ring containing the antiretroviral drug dapivirine announced their results at the conference. We compiled press releases, media reaction, provided background materials, linked to the conference webcasts with the results and more.
Post-CROI Webinars Series
Upcoming Webinars
Community Perspectives from CROI 2016
April 6 at 2:30pm EDT
The Well Project and AVAC are proud to present this webinar highlighting findings from the annual conference through community voices. We will be joined by:
- Kate Borloglou, The Well Project
- JD Davids, TheBody.com
- Jessica Salzwedel, AVAC
- Lisa Diane White, SisterLove
Please join to learn about these important clinical, research and advocacy-related updates as well as a Q&A session. Register here!
Past Webinars
Long-Acting Injectable Antiretrovirals for Treatment and Prevention
March 24, 2016
David Margolis (ViiV Healthcare) and Marty Markowitz (Aaron Diamond AIDS Research Center) spoke about long-acting injectable antiretrovirals for treatment and prevention.
At CROI, Margolis presented findings from the LATTE 2 trial, which tested a pair of long-acting injectables—cabotegravir (from ViiV Healthcare) and rilpivarine (from Janssen)—for HIV maintenance therapy, and Markowitz presented findings from the ÉCLAIR paste 2A study of cabotegravir in HIV-uninfected men.
Harnessing Antibodies for HIV Prevention and Treatment
March 17, 2016
John Mascola of the NIH Vaccine Research Center spoke about harnessing antibodies for HIV prevention and treatment. The recording includes discussion with webinar participants. For more background, click here to view his CROI plenary session.
Exploring Dapivirine Ring Results
March 1, 2016
In the first webinar of our post-CROI webinar series, Jared Baeten (MTN) and Zeda Rosenberg (IPM) spoke about the dapivirine ring trial results announced at the conference and fielded questions from webinar participants.
Move On Down the Road: The vaginal dapivirine ring will enter open-label extension trial
Over the weekend, the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), announced that it would move forward with an open-label extension (OLE) study of a vaginal ring for HIV prevention. This welcome development is the latest step in the journey of a unique, woman-controlled prevention option.
It’s been almost exactly three weeks since the world got its first look at data from the ASPIRE trial and The Ring Study, both of which found that a vaginal ring containing the antiretroviral dapivirine provided women in the trial with a modest level of protection against HIV. Both trials had similar results: among all women in the ASPIRE study, the ring reduced the risk of transmission by 27 percent; in the Ring Study, the overall reduction was 31 percent; and effectiveness varied by age—with higher levels of protection seen in older women, possibly because of more consistent use in this age group.
The trial data caused celebration and immediate conversation about what would happen next given that the trial showed both that the ring works and that there may be real challenges with adherence, particularly in younger women. These are the kinds of questions that open-label trials are meant to answer (for a description of the types of studies that follow efficacy results, click here). By definition, in an open-label extension (OLE) study, everyone knows that they are receiving the product, and they receive information learned from the previous clinical trials of the product. Women participants in the open-label extension study of ASPIRE, known as HOPE, will be told that the product reduces risk of HIV if it is used correctly and consistently—worn in the vagina for roughly a month at a time. This type of information may lead more women to use the product versus the trial, where they are told at every study visit that they may have received the placebo, and that there is no evidence that the experimental product provides protection.
NIAID reached its decision to move forward after last week’s consultation with a panel of outside experts that included physicians, scientists, advocates, ethicists and statisticians – including two AVAC Advocacy Fellows from Malawi and Zimbabwe.
NIAID announced that they will also fund additional studies to help answer additional questions that the OLE is not designed to answer. One of these is a study with adolescents and young women (ages 16-21) to look at safety, adherence and acceptability of the dapivirine ring and oral PrEP. This is an important development, and one that will help ensure that the world has the information it needs about the ring should it receive regulatory approval. This regulatory approval process, which is being pursued in tandem with the open-label extensions, involves preparation and submission of an extensive dossier of information on the product from the clinical trials. The International Partnership for Microbicides (IPM), the ring’s developer, is expected to submit for approval in about one year’s time.
Now that NIAID has agreed to fund HOPE, the extension of ASPIRE, it is essential that IPM’s donors similarly support the Ring Study’s proposed open-label extension, DREAM. AVAC and our advocacy partners will be working with urgency in the coming weeks to amplify demand for this study, as well as additional research needed to understand the potential role of the ring in women’s lives. At the same time, we continue to emphasize the urgent need to roll out daily oral PrEP as a tool that can be used right now to reduce risk for women and men and to maintain a robust prevention research pipeline of additional options that will, over time, provide a wider range of options from which women and men can choose.
CROI for the Community
Rob Newells is the newly appointed Executive Director of AIDS Project of the East Bay. He is minister and founder of the the HIV program at Imani Community Church in Oakland and has been an AVAC PxROAR member since 2012. This blog is one in a series written by community scholars who attended CROI 2016.
I have a love-hate relationship with the annual Conference on Retroviruses and Opportunistic Infections (CROI). The 12-hour days of high science can be overwhelming, and even after being deliberate about building down time into my schedule, I still crashed and burned before the end of Day 3. (It took the entire week to adjust to the time difference between East and West coasts, and after the daily 7 am Community Educator Breakfast Updates, I struggled to stay awake and alert for the morning plenary sessions.) But I survived!
There are always major headlines coming out of meetings like CROI. As a biomedical research advocate, my inner nerd gets super-excited about things like Phase 2 study results from MTN 017 (a rectal microbicide study), but at CROI I’m a community educator. I try my best to take off my research nerd hat for a few days and tune my ears to hear what members of my community will find useful right now. (I’ll have plenty of time and dozens of webinars to help me grasp all of the high-level science presented at CROI so that my inner nerd will be ready for additional updates during the International AIDS Conference in July.)
The week after returning to Oakland from Boston, I shared information with the staff working at AIDS Project of the East Bay (APEB) and with community members participating in a series of breakfast discussions coordinated through my ministry at the Imani Community Church in partnership with the East Bay HIV Faith Collaborative. This is what I told them:
- Vaginal microbicide rings look like they’ll work. Don’t be frightened when you hear that the HIV infection rate was only reduced by about 30 percent. Remember that old 44 percent reduction in the HIV infection rate for pre-exposure prophylaxis (PrEP) when the first iPrEx study results were released just over five years ago? It gets better! With PrEP we saw that when people know the product actually works, they use it more and risk goes down. It works when you use it! Will the same thing hold true for the vaginal ring? There’s a need for open-label studies to see if women will use it more when they know it works.
- There’s reason to think injectable PrEP might work, but there are questions about how to deal with the “tail” — the period of time after injectable PrEP is terminated but there still may be low (non-protective) levels of drug in the system.
- People who use oral PrEP are generally people who are already at-risk for STIs, and they should be tested more often than every six months as is currently recommended by the CDC. (Our Medical Director at AIDS Project of the East Bay already screens PrEP clients for STIs quarterly as suggested by the research presented at CROI.)
- We talked a little about the PrEP failure case from Canada, which occurred when the PrEP user was infected with tenofovir- and emtricitibine-resistant virus. But staff and community members alike were more interested in the HPTN-073 study results showing that, with a little client-centered care coordination (C4), it’s really not so difficult to spark black men’s interest in PrEP. This was the silver lining in the cloud hovering over the community after CDC presented lifetime risk estimates indicating that half of all gay black men in the US will test positive for HIV if we don’t do something about it now. (If my community needed a wake-up call… a new reason for a sense of urgency around this HIV epidemic… a fire lit under its collective ass… This has to be it.)
Then we spent a little time talking about things I heard at CROI that probably won’t make headlines:
- Did you know that fat may stimulate HIV replication and act as a reservoir for HIV cells? How do we talk to our clients about obesity and weight loss?
- Do you really understand how much smoking while living with HIV increases risk for opportunistic infections, cardiovascular disease, lung disease and some cancers while decreasing life expectancy? What are we saying to our clients living with HIV about smoking that’s different from what we say to clients not living with HIV? (After checking in with our Medical Director, APEB will be implementing a smoking cessation program through our primary care clinic.)
- When researchers looked at people’s “Perception of Infectiousness,” the takeaway for me was that black people still don’t believe having an undetectable viral load prevents the transmission of HIV. (There are lots of conversations about medical distrust among African Americans begging to be had over and over and over again until someone figures out how to effectively address the issue.)
Another CROI is in the books (and on webcast). It will likely take months for my inner research advocacy nerd to wrap my head around all of the science, but now that my sleep pattern and weather conditions are closer to California-normal, the community educator in me is very happy.