CROI, For the First Time

Yvette is currently working at the Centre for Communication Impact (formerly JHHESA). She is a founding member of the new Advocacy for Prevention of HIV and AIDS (APHA) in South Africa, a former AVAC Advocacy Fellow and a leader in the country’s HIV prevention movement for young women. This blog is one in a series written by community scholars who attended CROI 2016.

My first CROI and it was not the science that was overwhelming…

When I was presented with the opportunity to apply for a scholarship to attend this very scientific meeting and conference as a community educator I was thrilled and most of all exited that I would be in the presence of all the scientists who’s work I have torn to shreds to get my communities in Mpumalanga, Limpopo and KwaZulu-Natal (KZN) to understand. As a community educator I have had to explain microbicides, PrEP, TasP, HIV vaccines and the BIG one: why we still don’t have a cure. Also, I have had to explain why it is important that we know the new research and why a lot of the HIV research happens in South Africa.

Upon my arrival I was overwhelmed by the beauty of the city; the buildings all looked old but they were a beautiful sight. When I left South Africa, the university students were burning old art and statues because it reminded them of our painful past. As I was driving from the airport upon my arrival in Boston, I saw a few homemade banners of Black Lives Matter in the city attached to these old buildings. They were not torn apart; they looked just like they belonged there. They were not threatening each other—the old building and the new feelings of we matter, black lives matter. I wish I had stopped my driver to take a picture.

I was invited to a pre-conference on cure research, on where we are. Because of my suspicions with cure and quacks, I thought I would only last 30 minutes at the most. How wrong I was. I was intrigued by how much research is happening and the amount of work that researchers were putting in trying to unlock this mystery. I was overwhelmed about how much of this research is happening in South Africa and that one study was actually happening in KZN. Research showed that even with focused interventions of counselling and empowerment skills, there were no differences in the new infection rates of young women in the program and those not in the program. Suffice it to say I was there the whole day and did not want to miss a presentation let alone a slide.

The next day was the first day of the conference and our day started at 7 am. I was jet lagged but did not want to miss anything. Not even the cold could keep me in bed. For the duration of the conference we had an opportunity to interact with the scientists, thanks to a great initiative by the BAI, AVAC and CROI Community Liaison Subcommittee. These morning meetings were a space where we as community advocates could come together and learn from each other. I realised that I knew about 30 percent of the community through our work and most of all our very vocal online presence on Facebook. I did not want to show my anxiety around the pending Ring and ASPIRE results so I would walk around meditating that it works. After all, my girls were hoping it does. The day the results were going to be announced I dressed like a winner—I wanted women to win.

When Dr Annalene Nel, lead researcher on the <Ring Study, mentioned a “significant” efficacy result, I did not know what to feel. I was overwhelmed by the word and I knew it worked. I knew our work was cut out for us as advocates. A lot of questions still remained unanswered for the young women but at least the ring works and we know that now. I was happy, very happy. I immediately announced it on my FB Page and I received so many inboxes from young women— both positive and negative—and most told me there is HOPE. Seeing Annalene made me very emotional because unlike the other researchers at CROI she did not see “subjects”— a word that made be shiver every time it was mentioned at sessions throughout the conference referring to research participants. She saw trial participants as young women, some of whom she had met throughout out the study period. I knew she was counting on support and I walked up to her and I told her what this means to the young women I worked with. Annalene received a standing ovation. I was happy—finally a woman for other women. For a feminist like me it mattered that Dr. Annalene was at the forefront. It mattered that she was OK. I was overwhelmed with pride to be South African at this conference and it mostly mattered that I was a woman at the conference too. The rectal microbicides trial results were also positive news for HIV prevention.

At this conference I learnt that there are more HIV prevention tools than there has ever been before. I was left wondering who these prevention tools are developed for. Why is it that if treatment is prevention are there not more visible TasP campaigns, despite UNAIDS’ 90-90-90 and MSF’s Getting to Undetectable? Why is it taking policy makers so long to implement early treatment when the benefits from the START study are so overwhelmingly positive? The benefits, especially for those living with HIV, are lowered risk of cancer, among other risks. This cannot be rocket science, especially seeing that women living with HIV are at such high risk of cervical cancer. Why is it that if being virally suppressed reduces the risk of passing the virus on to others, we are not including this in mass HIV communications? If PrEP works and can help defeat HIV, why are there only four countries that have approved the use of Truvada as PrEP? (Since CROI, two more countries have approved PrEP.) And why is South Africa not moving any faster with rolling out PrEP to those who need it?

I was also swayed in my initial stance against home testing, thinking pre- and post-testing might get lost in the process. However, if this is not the case and home testing will increase the number of men who test, I am now for it.

It was a week of late nights and early cold mornings, a week of appreciating the science. By including the community educators at CROI 2016 I hope the scientists will appreciate the work done by communities and most of all advocates. We will only appreciate your science if you appreciate our stories. And yes it does matter who delivers the news to whom: Male, Female Gay or Straight.

Thank you for the opportunity, the support and the guidance AVAC, BAI, CROI, Sister Love and all the other sponsors.

Push

Julie Patterson is an HIV prevention research advocate and public health professional who lives in Northeast Ohio. She is chair of the Case Western Reserve University/University Hospitals AIDS Clinical Trials Unit’s Community Advisory Board, a member of AVAC’s PxROAR program, and a member of the US Women and PrEP Working Group. This blog is one in a series written by community scholars who attended CROI 2016.

Being at CROI is like being inside a scientific tornado—data and results fly by, but they are difficult to catch. There is beauty in the force of it. Everyone is caught up, scientists and advocates alike. Once the dust settles, however, it is time to clean up and make sense of it all.

As I saw it, this year’s CROI was full of HIV prevention research victories.

It was incredibly moving to be a part of a standing ovation for the results of ASPIRE and the Ring study. A dapivirine vaginal ring used for HIV prevention has the potential to save the lives of millions of women around the globe. Also, new forms of PrEP and rectal microbicides are working their way through the research pipeline. They may eventually lead to even more options that increase pleasure during sex, are long-acting, give receptive partners control, and are designed to fit the different seasons of risk throughout one’s lifetime.

As advocates, however, these kinds of results are a beginning, not an endpoint.

Our job now—in light of the range of options noted above—is to demand further clinical research, open-label extensions, regulatory approval and rollout. For example, a ring cannot save a woman’s life if she cannot obtain it. Advocates must support the International Partnership for Microbicides (IPM) as they move forward for regulatory approval, and in the meantime, open-label studies should be funded to offer women who participated in the research the opportunity to continue to use the ring now that they know it’s safe and it works. It is unethical to do otherwise. Shall we tell women that a dapivirine vaginal ring can help to prevent HIV and then take it away? No. As the number of new HIV prevention methods expands, it’s important to keep our eyes on the prize: zero new transmissions.

Also at the conference, the US CDC released newly configured data that highlighted the situation in the US for gay/bisexual/same-gender-loving Black and Latino men who face a devastating lifetime risk for HIV. In the face of these data, we cannot rest. Systemic racism and structural violence are not predestined.

Noticeably, CDC didn’t run the numbers on trans* populations when they were calculating lifetime risk. If we don’t talk about trans* risk in these meetings, if we continue to make trans* people invisible in the data, who will act? We must continue to demand HIV prevention for transwomen, and especially transwomen of color, for whom the lifetime risk can be overwhelming. It was a step forward for the conference to host Dr. Tonia Poteat’s (Johns Hopkins University) brilliant plenary focused on Transgender Populations, but it is not enough. We must fight to keep trans* people in the forefront of prevention.

As AVAC, BAI and Community Educator Scholars, our job is to ask the hard questions, to dig deeper than the numbers, to contextualize the data. As a group, we bring history, anger, passion and wisdom to the research table. We voice the fears, the hopes, and the demands of our communities. Our strength is our presence and our collective effort.

Advocates are also tasked with translating what we’ve learned at CROI into information that people can use. We come home to our loved ones: people living with the virus; communities working to fight HIV; and vulnerable people who need this research and these results. As we share what we heard, we create consumer demand and the push that researchers need to move forward. Hope comes from this dialogue. The research to implementation cycle will continue, but only if we play our part.

CROI Round-Up; Post-Conference Webinar Series

News last week from the Conference on Retroviruses and Opportunistic Infections (CROI) in Boston was dominated by new efficacy data from two vaginal ring trials that have implications for HIV prevention for women. Our take on it is here, along with a special page with more background than we could squeeze into a blog post. But, the CROI buzz wasn’t all about vaginal rings, and this update provides some ways to hear more about what happened last week and what it all means.

Post-CROI Webinar Series

We will be convening a series of post-CROI webinars covering a range of topics over the next couple of months. The first webinar in our series explored the ring results with advocates and researchers. Slides, audio and the Flash animation of the webinar are available here. And stay tuned for details about the additional webinars in the series!

In-Depth Analysis

In addition to lots of media reports and publications, our colleagues at NAM/aidsmap, The Body and NATAP all provided in-depth coverage of the myriad studies presented in oral abstract sessions, posters and more. Check out the hyperlinks above for comprehensive coverage.

CROI Program and Webcast

CROI provides a number of ways to review what happened in Boston: check out the full program; taped playbacks of press conferences; webcasts of all sessions; and electronic posters will be available a week after the conference. There was a wealth of information on a wide range of topics, but here is a selection of sessions and presentations you might want to explore:

  • Lifetime HIV risk in the US: New data from the US Centers for Disease Control and Prevention (CDC) projected that 1 in 2 black gay men could be diagnosed with HIV in their lifetime. That number is 1 in 4 for Latino gay men and 1 in 49 for African American women. The figures for white men and women are far lower. These data highlight the ways that race impacts access to healthcare at every point in the treatment cascade. They suggest an urgent need to provide prevention including PrEP at a wider scale and with messages and programs that are community-designed and owned. They also provide another opportunity to examine the ways that alarming statistics do and do not advance a structural analysis of the problems and solutions to public health issues. As one article highlighted—individual risk calculations can lay the burden on individuals to change behavior when the drivers of risk are systemic, embedded and often out of individual control.
  • PrEP in the Real-er World: There was a lot of data on oral PrEP that, as expected, added layers to understanding of what the strategy is, and what it can and cannot do. It started with a presentation by Keith Green (University of Chicago) on Engaging Young Men of Color in Community HIV Prevention Studies and later Darrell Wheeler (SUNY Albany) presented an important PrEP study in Black MSM (HPTN 073), which showed that a culturally anchored “client-centered care coordination” model (C4) was important to getting men into and supported in a PrEP program. Other data gave some insight into additional components of PrEP programming and messaging. Presentations included findings that PrEP use can have a limited impact on renal function—as it can in people living with HIV who use TDF/FTC as part of treatment; an update from a New York City PrEP project where rates of sexually transmitted infections among PrEP users suggest that routine screening—at every clinic visit—should be the norm; and finally, a presentation of HIV infection in an adherent PrEP user who acquired TDF/FTC-resistant HIV. Each of these presentations raises concerns—and thebody.com has developed an excellent resource on the HIV-resistance data—but none are insurmountable or even surprising. Piloting PrEP in the real world is the only way to find out how best do deliver, message and monitor this new strategy to all populations at risk.
  • Long-Acting Injectables for Treatment—and Prevention: Antiretrotival treatment options took a step forward with the first injectable treatment option. 91 percent of patients in a study of the 8-week long-acting injectable cabotegravir and rilpivirine combination regimen maintained virological suppression and also expressed satisfaction with this new option in a new study. Both cabotegravir and rilpivirine are also being explored separately as PrEP agents. Marty Markowitz (Aaron Diamond AIDS Research Center) presented results from the Phase IIa ÉCLAIR study that examined the safety and pharmokinetics of cabotegravir in HIV-uninfected men, setting the stage for a future Phase III efficacy trial.
  • Turning Targets into Treatment: A full abstract-driven session was devoted to Getting to 90/90/90 and included Tendani Gaolathe (Botswana Harvard AIDS Institute Partnership) presenting on how Botswana is approaching the 90-90-90 goal, getting to 83 percent (testing), 87 percent (on treatment) and 96 percent (virally suppressed) representing an overall level of viral suppression of 70 percent as compared to the 73 percent goal of the 90-90-90 goals. Factors predictive of not being virally suppressed included youth, male gender, single status and, interestingly, higher education level. At the same time, there was a presentation on how Malawi is using its Option B+ rollout to prepare for universal treatment. The challenges of Option B+ could be seen in the 25 percent drop off in post-partum adherence by women after six months. And in a separate session, Helen Ayles (London School of Hygiene & Tropical Medicine) presented Missing But in Action: Where Are the Men? raising an emerging discussion of how to reach HIV-positive men with treatment programs. Strategies suggested include taking testing outside antenatal clinics and engagement through men’s clubs and even bars. While reaching these men is important, it remains critical that treatment for all who need it remain a focus.
  • Rectal Microbicides Well Received: Ross Cranston (MTN) presented data from MTN 017, the first Phase II rectal microbicide gel study—it showed no safety risk and both adherence and acceptability were high. The open-label trial looked at a rectal formulation of tenofovir gel inserted via vaginal applicator, comparing its daily use with event-driven (used before and after sex) use. A third study regimen included the use of daily oral Truvada as PrEP. All 195 MSM and transgender women cycled through each of the three regimens for eight weeks. Adherence feedback was provided to participants through daily texts, returned applicators and real-time drug levels reporting. This contributed to high adherence across all study regimens. Overall preference favors Truvada as PrEP slightly over event-driven tenofovir gel, but the difference is not statistically significant. Daily gel application came in a close third. Cranston concluded that due to these results, rectal tenofovir gel is worthy of further study. Research is already underway to expand the pipeline of rectal microbicide products in order to find the right product to move forward into an effectiveness study, said Ian McGowan (MTN), co-author of the study.
  • New Cure Work Discussed at CROI: On the day before CROI officially opened, the AIDS Treatment Activists Coalition, AVAC, European AIDS Treatment Group, Project Inform and TAG co-sponsored a community workshop on scientific, regulatory and community engagement issues in HIV cure research, which included an update on an exciting and emerging area using bNAbs for treatment and acute infection in the FRESH (Females Rising through Education, Support, and Health) cohort in South Africa. Presentations are posted online.

Finally, You Can Put a Ring On It!

Anna Miti, a 2015 AVAC fellow and Zimbabwean broadcast journalist, writes in her blog about the dapivirine vaginal ring results. She talks about next steps for the ring and how there is a need now to advocate for all stakeholders to call for the expedition of the process to make the ring available to those who need it.

I have to admit that the last few weeks have been a bit stressful, waiting anxiously for the results of a microbicide ring study- meant to prove its efficacy in HIV prevention. Well, finally the results are here! This is probably one of the biggest breakthroughs we have had in HIV prevention specifically for women in a while. Significant because we know women are more vulnerable to HIV infection than their male counterparts. I am glad to say that after the disappointing results of previous microbicides trials in Africa, the world has some news to share. And it is good news- well, mostly. The results of two phase 3 trials, ASPIRE study and Ring study, showed efficacy rates ranging from 27 to 61 percent. The trials showed that a monthly vaginal ring containing the antiretroviral drug (ARV) dapivirine can safely help prevent HIV infection in women. The Ring Study showed that the monthly dapivirine ring safely reduced HIV infection overall by 31 percent compared to a placebo. Similar results were seen in ASPIRE, which found that the ring safely reduced infection by 27 percent overall. The factors leading to the differences in efficacy are by age and consistency of ring use, or adherence, where older women (aged 25 and above) and those with the best adherence having the best protection. ASPIRE showed that the ring reduced HIV risk by 61 percent in women older than age 25, and 56 percent in women older than 21 (in a post-hoc analysis), who also appeared to use the ring more consistently. The Ring Study also showed higher efficacy (37 percent) for women over 21. However, little to no protection was seen in women ages 18-21 across both studies — 15 percent in The Ring Study and no protection in ASPIRE.

The good news is that the ring has the potential to prevent new HIV infections in one out of three women at worst and one out of two women at best, if used correctly and with high adherence. Besides pre-exposure prophylaxis and the male and female condom, the ring can be used as an additional tool for women to protect themselves from HIV infection. Significantly the Ring, when available, would be the only tool that women can use overtly or covertly for HIV prevention, removing the need to negotiate for safer sex. Negotiations for safer sex are not always successful as women find themselves vulnerable due to various socio-economic issues and therefore powerless to protect themselves from HIV by insisting on condom use or refusal to have sex.

The not-so-good-news is that this trial once again proved low levels of adherence in young women and subsequently low levels of protection for adolescent girls and young women, who are the most vulnerable to HIV infection. However some schools of thought suggest that other factors, such as biological differences might have played a role in low levels of protection in younger women.

The Ring Study enrolled 1,959 HIV-negative women ages 18-45 at seven sites in South Africa and Uganda, and ASPIRE enrolled 2,629 HIV-negative women ages 18-45 at 15 sites in Malawi, South Africa, Uganda and Zimbabwe. ASPIRE began in 2012 and ended in 2015. The Ring Study also began in 2012 and is reporting results early after its independent data safety and monitoring board recommended the study proceed to final analysis.

What Now

After all has been said and done the results of these two studies are positive. The microbicide ring is an additional tool that women can use to protect themselves from HIV. It can be used as part of a basket of HIV prevention methods including Pre-Exposure prophylaxis and the condom. There is need now to advocate for all stakeholders to call for the expedition of the process to make this ring available to those who need it. If we can prevent half of potential new HIV infections as proven by the two studies, then we have the potential to halt or reverse the HIV trajectory. The impact of such an occurrence would be phenomenal. Imagine the saving to public health if we stop new infections,which put a strain on health system in terms of costs, not to mention the impact on human development. On the other hand more needs to be done to investigate how to overcome barriers to HIV prevention for the youngest women. Efforts are already underway for studies to understand how ring use, and potential biological and other factors that may have influenced the different levels of protection seen by age in these studies. There is need to study what works for young women, and how we can further make HIV prevention tools work for them. We need to investigate barriers to adherence in young women, beyond the factors we already know such as low HIV risk perception.

The Future

There are still lots of potential to increase options for women, anchored on the success of the microbicides trials. Efforts are already underway to develop multi-purpose prevention technologies, which are basically products which will not only protect a woman from HIV, but protect her from pregnancy as well.

Conclusion

I believe that the swift move towards starting demonstration studies for the ring and the commencing of licensure processes can make HIV prevention in women happen faster. This will expedite the progress towards ending AIDS by 2030. Finally, as I finish this blog, I cannot pen off without thanking and appreciating the work done by research participants. These women are s/heroes and their dedication to the study will be beneficial to generations of women worldwide — WELL DONE!!

ASPIRE and The Ring Study Results — A Snapshot

Results from two Phase III multi-country trials (ASPIRE and Ring) studying the 4-week slow-release dapivirine vaginal ring were released at the 2016 Conference on Retroviruses and Opportunistic Infection. This chart details study design and enrollment, gives overall results and breaks results down by age.

AVAC’s take on ring trial results—breaking news in HIV prevention

Big news from two trials of HIV prevention for women was released today at the 2016 Conference on Retroviruses and Opportunistic Infections. Two trials of a vaginal ring containing the antiretroviral drug dapivirine announced their results. Both ASPIRE and The Ring Study found evidence of modest protection. The data were described at a CROI press conference and will be officially presented on Wednesday, February 24.

This update contains links to resources from the trials, AVAC’s press release, and a brief summary of key facts about, and AVAC’s take on, these important data. We will be updating our website in the coming days and working with partners to prepare a fuller analysis of the advocacy agenda for the ways forward. Please join the conversation—starting with our webinar on March to discuss the latest with researchers and advocates from around the globe. (Update: Recording now available.

At a glance:

  • Should I be excited about this? Yes. The two trials, which were independently conducted, had very similar results. This is good news for the field—in the past microbicide trials of the same product have had different findings. The data are clear that the dapivirine vaginal ring can work, and this should trigger regulatory action (see below).
  • What’s the bottom line? The data show that, as with daily oral PrEP and condoms, the product works when it is used correctly and consistently. But the trials also show that in a research setting, when women are told that they might be getting a placebo and that the product might or might not protect them, some participants—especially younger women—did not use the ring as prescribed.
  • When can I get the ring? The dapivirine ring is different from daily oral PrEP in that it is an experimental product (tenofovir-based oral PrEP used an existing, widely-used drug for HIV treatment). This means quantities are limited, and that the product can only be made available through research settings until it is approved. There is no opportunity for off-label use.
  • Well, then what do we do in the meantime? Younger women in both trials had lower rates of product use and lower rates of protection than older women. This, along with incidence rates of over 4 percent, is a reminder of the urgent need to deliver tools and programs that truly address young women and adolescent girls’ prevention needs now, while developing additional methods for the future.

AVAC’s priorities for action:

Demonstrate the ring’s role in prevention

  • The trials show that the dapivirine ring can be an effective prevention option for some women. The International Partnership for Microbicides should immediately proceed to submit a regulatory dossier for product licensure. If licensed, the ring could be piloted in “real world” settings, where approaches to improve consistent use can be explored.
  • Open-label extension trials for HIV-negative participants in the trials should be launched. Funders should not turn away from the evidence. The dapivirine ring works for some women and, now that safety and effectiveness has been established, it may work for more women—including those assigned to the placebo arms in the original trials. All participants should have access to open-label extension trials as originally planned by both trial sponsors.

Deliver daily oral PrEP

  • Even if the steps above are taken, it will be years before the dapivirine ring is available in public health programs designed to meet the needs of women in all their diversities. Daily oral PrEP is available today and must be explored via ambitious and innovative programs that provide safe, sustainable and community-supported access. This can include offering daily oral PrEP in open-label extension studies for the dapivirine ring.

Develop additional tools

  • Vaginal rings are already used to deliver contraception. They are a valuable platform for potential “multipurpose prevention technologies” (MPTs) that would provide both contraception and HIV prevention in a single product. MPT research must continue—for many women, including those at substantial risk of HIV, pregnancy prevention is a top priority. A combination tool is a critical goal for the field.
  • Additional prevention options remain necessary. Funders, researchers and civil society must remain resolute in sustaining the search for prevention options that women and men will want and use, including other long-acting ARV-based prevention options, vaccines and antibody-mediated prevention.

Please join us in congratulating both trial teams, the site staff and most especially the women who participated in the trials, whose contributions of time, information and trust have once again advanced the field.

We look forward to working with all stakeholders to understand and act on these results.

Press Release

Two clinical trials offer first evidence that vaginal ring may be important HIV prevention option for women

Contacts

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

AVAC says donors, researchers, regulators and communities must act swiftly to determine future of this approach

Boston, Massachusetts — Results of two large-scale clinical trials in Africa show promise for a potential new HIV prevention option for women but more work is needed before the vaginal ring containing the antiretroviral (ARV) drug dapivirine can be added to the very short list of HIV prevention options controlled or initiated by women.

“It’s clear that the dapivirine vaginal ring can be a viable option for women to protect themselves from HIV,” said Mitchell Warren, AVAC executive director. “These well conducted studies provide clear evidence that some women can reduce their risk of acquiring HIV by using the ring consistently, and they also raise critical questions about the level of use, benefit and future role in prevention that need to be answered. Researchers, donors, regulators and advocates now need to determine the best way forward to determine if and how the dapivirine ring could be used by women at risk of HIV infection.”

“Many women in sub-Saharan Africa – and notably younger women – remain at substantial risk of contracting HIV, and they need and deserve a range of options that they can control and comfortably use to protect themselves every time they have sex. Today, daily oral PrEP is the only truly discrete prevention option they can control. The dapivirine vaginal ring might become an additional option, as additional questions are answered and regulatory agencies consider these results. In the meantime, the incredibly high HIV infection rates among women in these trials tell us that we need to make oral PrEP more widely accessible and available with urgency.”

The results of the two studies, ASPIRE and The Ring Study, were previewed today by researchers at the Conference on Retroviruses and Opportunistic Infections (CROI) ahead of a scientific presentation later this week. Results from the ASPIRE study were also published today in the New England Journal of Medicine. The trials evaluated the safety and efficacy of a vaginal ring – which women placed themselves and replaced each month – containing the ARV dapivirine.

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. Both studies found the ring was safe to use.

In both trials, efficacy was substantially higher among the subset of women who were over 21 who appeared to keep the ring in consistently throughout the month. As with previous trials with other prevention methods, adherence to the prescribed use appeared higher among older women, which might explain higher levels of efficacy in these age groups. (For more information on the results see the table at the end of release).

“We congratulate the trial sponsors, scientific collaborators and partners for these well run and scientifically rigorous trials. We especially want to thank the more than 4,500 women whose altruism and commitment as trial participants made this effort possible,” Warren added.

The lack of protection seen among women in the trial between 18 and 21, likely because of lower adherence, is not unique to these two studies. Previous ARV-based prevention efficacy trials with both tenofovir gel and tenofovir-based oral PrEP also saw lower protection among younger male and female participants, likely due to lower adherence. With daily oral PrEP, however, adherence increased for younger participants in subsequent post-trial studies, in which participants knew that PrEP had already been proven effective and that they were receiving the active product.

“It is reasonable to believe that both adherence and efficacy can be increased for dapivirine ring use, just as we’ve seen it increase over time in PrEP studies,” Warren said. “A critical first step is to launch open label extension studies, with no placebo, among former ASPIRE and Ring Study participants. These studies results are needed to help guide decisions about regulatory approval and, perhaps, eventual rollout of a monthly dapivirine ring. In addition, we need to look at streamlining the process of developing a combination ring that would could protect against both HIV and pregnancy.”

As the product developer, IPM, along with the other trial sponsors and researchers, look at the path forward for the dapivirine ring, they can look to learn lessons from oral PrEP programs, female condoms and from the contraceptive field to understand how to better support adherence, improve product use and address special access needs of young women.

“HIV continues to be a public health crisis, especially for young African women who have few options for protecting themselves from HIV infection,” Warren said. “With each new prevention research result over the past six years show partial protection – for oral PrEP, microbicide gel and the RV 144 vaccine – AVAC said there was a global imperative to act on those results,” Warren said. “Today, there is a global imperative to act on these new vaginal ring results with a clear path to regulatory review and a fully funded, carefully prioritized research agenda to help answer the remaining questions about the dapivirine ring and how it might be added to prevention options for women.”

“While we need understand the path forward for rings and deliver existing HIV prevention and treatment options, we also need to press ahead with research and development of additional options. As long as women continue to be infected by HIV at high rates, we have a moral imperative to sustain the search for prevention options that women will want and use, including long-acting ARV-based prevention options, vaccines, antibody-mediated prevention and multipurpose prevention options that may combine HIV prevention with contraceptives,” Warren said.

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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 AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

New Px Wire: What to Watch in 2016

There are few, if any, quiet years in HIV prevention research and implementation. 2016 promises to be another year of big deal data, whether it’s findings from clinical trials, funding levels or readouts from PEPFAR’s first year of a geographically focused program plan. We write about this and a lot more to watch for in our new issue of Px Wire.

Click here to download the new issue.

We take a look at the bigger picture in our centerspread. Check it out for the most current version of AVAC’s classic timeline of biomedical HIV prevention research. But don’t get too attached—some of the trials mentioned in the timeline will have updates presented next week at the annual Conference on Retroviruses and Opportunistic Infections. We’ll always have an updated version in our Infographics Gallery—and save the date for a March 1 webinar to discuss the latest data and what’s next?

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.

As always, we welcome your questions and comments at avac@avac.org.

AVAC on World AIDS Day: We’re 20. We’re not giving up.

When AVAC was founded in 1995, we were called the AIDS Vaccine Advocacy Coalition. Our singular goal was to advance swift, ethical research for a vaccine that was then — and is today — essential to bring the epidemic to a conclusive end.

Twenty years later, AVAC is still focused on swift and ethical research, but our scope has expanded. Along with vaccines, we advocate for PrEP, microbicides, voluntary medical male circumcision and more.

Through it all, our message has been the same: prevention is the center of the AIDS response. Not just any prevention but smart, evidence-based, community-owned, rights-based strategies.

We do this work because it’s essential. We are able to do it because of our robust partnerships worldwide. We will keep doing it — with your help — until the epidemic has, finally, come to an end.

We’ve experienced 20 years of breakthroughs and disappointments in prevention research. A vaccine that many had given up on was the first to provide modest protection. One microbicide everyone hoped for didn’t pan out. Male circumcision and PrEP studies overcame skepticism and, together with antiretroviral therapy, paved the way for a prevention revolution.

Through it all, AVAC has worked with partners to maintain the field’s focus and press for continued research into an AIDS vaccine, a cure and more.

When AVAC was founded, the only biomedical HIV prevention options for adults were male and female condoms. The pathway for introducing any new strategy was largely unmapped. No one knew where the gaps would be—between trial result and country action, between guidance and financial support. Now we do.

Over two decades, AVAC has not only identified the gaps; we’ve worked to bridge them, so that products reach people in programs that work — without delay.

Twenty years ago, advocacy for HIV prevention hardly existed. So AVAC helped build a global network of advocates equipped with effective advocacy strategies and the latest evidence.

With our support, they are putting prevention on the agenda in countries and communities around the globe.

When the world lacked a plan for ending AIDS, we helped create one.

Now we’re holding global leaders accountable for results — demanding the resources, policies and evidence-based plans needed to deliver all of today’s prevention options to the people who need them, and to plan for the rapid rollout of new options as they emerge.

Communities’ support for prevention research can never be taken for granted — it has to be earned. For 20 years, we’ve helped build trust between researchers, funders and communities to speed the ethical development and rollout of new prevention options.

And when controversy threatened to derail those efforts, AVAC provided leadership and resources to help get them back on track.

Your gift to AVAC will support our efforts to accelerate the development and delivery of HIV prevention options to men and women worldwide. With your help, we can continue to convene, collaborate and communicate a strong, clear and cohesive vision for HIV prevention today, tomorrow and to end the epidemic.

It will take all of us working together to end AIDS. Please join us.

2015 Update on the Rectal Microbicide Pipeline: New Agents, New Formulations

The field has spent several intense years studying tenofovir gel as a rectal microbicide, and we all look forward to the results (due early 2016) of the world’s first Phase II rectal microbicide trial MTN 017 which tested a reduced glycerin formulation of tenofovir gel.

But there is a lot more going on than tenofovir gel!

In this webinar, hosted by IRMA and AVAC, we looked at new rectal agents in development, including the antiretroviral drug Dapivirine and Griffithsin, a potent, anti-HIV protein derived from red algae. We also discussed plans for developing new microbicide formulations like rectal douches.