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.

Conducting Research With a Heart: The stories of CROI 2016 Award Recipients

Morenike Ukpong, Associate Professor at Obafemi Awolowo University and Coordinator of the New HIV Vaccine and Microbicide Advocacy Society in Ife, Nigeria, writes why she believes CROI 2016 made strides in taking community concerns into consideration. This blog is one in a series written by community scholars who attended CROI 2016.

One of the struggles in the field of biomedical HIV prevention research for years has been the need for research teams to truly make people and communities a central theme in their work: think less about the data, publications, conference presentations and think more of the people you work with and work for. At 2016 CROI, I sincerely felt we have made significant positive strides in that area—not token forms of community engagement, but true consideration of concerns and interests of the people and communities through whom data for change are generated.

It started with Monday’s Workshop for New Investigators and Trainees where Sharon Hillier (MTN) clearly highlighted the significant role of community in changing the landscape of HIV prevention. At the same preconference meeting, Laurel Sprague (Sero Project), Sethembiso Mthembu (ICW) and Keith Green (University of Chicago) all brilliantly highlighted how the social context of the lives of people—our history, stress, experienced trauma, stigma people living with HIV and other vulnerable communities face—impact the way we as community members respond to research implementation. They discussed how this social context impacts on the truth generated through the data collected, and how research outcomes are translated and used by all of us in the community. And then, at the Clinical Trial Design workshop, Patrick Sullivan (Emory) reiterated the need to look for the human faces behind the big data you may want to use for making heroic public health changes—look for the faces in the data and ask their permission for the use of their data.

For me, the three speakers recognized for their work and who gave opening lectures at the 2016 conference were embodiments of this message of making people central to the theme of the research. We must conduct research to address human needs. “Think, plan and conduct it with them for them” was the clear message I heard.

Bruce Walker (Ragon Institute) discussed the FRESH study ongoing in South Africa where women undertook capacity-building programs, got empowered to get employment, yet contributed to a study that enabled researchers to detect acute infection and understand more about T-cell control for HIV vaccine and cure research. Of course, all HIV-positive persons got treatment immediately following diagnosis so that they could benefit from the outcome of the START study (which showed that starting HIV treatment immediately after diagnosis reduced the risk for HIV-associated diseases). Gerald Friedland (Yale) also discussed how he identified with the epidemic of HIV and tuberculosis in Bronx, USA and Tugela Ferry, South Africa where epidemics of poverty arising from neglect of people and their basic needs—health, housing, transport. Kenneth Cole also narrated how the concern for people, their lives and the need for HIV cure was central to his work at amfAR though he is a fashion designer. Clearly, we can all do something irrespective of our profession.

As I reflected on these great people, their talks, their programs and their passion, I conclude that my years of advocacy with many, many, many other brilliant advocates, to make people and communities central to the heart of research was (and still is) a worthy cause. Helping young investigators understand how the social context of people’s life need to inform the design and implementation of HIV treatment, prevention and cure research will truly get us to the end of the HIV epidemic sooner rather than later.

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.

Anatomy of a Target – Treatment

In Px Wire, our quarterly newsletter, we looked at the strengths and limitations of new PEPFAR targets, new UNAIDS targets, new guidelines on ART and PrEP from the WHO and new Sustainable Development Goals.

In this excerpt from our centerspread graphic, we take a closer look at antiretroviral therapy and treatment.

A December Reading List

It’s the holiday season and in many parts of the world that means lists: of gifts, things to be thankful for, things that are needed and, sometimes, things to read. This week, which began with World AIDS Day, brought more reading material than we can possibly plow through between now and New Year’s Eve. So, in the holiday spirit, here’s a guide to some of the highlights from the new releases and who in your life might enjoy them most.

For the Walk-the-Talk Activist: As described in this post from AVAC’s P-values blog, this week’s International Conference on AIDS and STIs in Africa (ICASA) in Zimbabwe has brought bold advocacy and activism from women’s groups, sex workers, gay men and other men who have sex with men, trans-diverse people, women living with HIV and many other groups. Unfortunately, there have also been rights violations and harassment of people, including many individuals from “key populations”. Our blog provides first-hand accounts and info on how UNAIDS responded.

For Anyone with a “Wonder Woman” in their Lives: An AVAC blog on the new Innovation Challenge for the DREAMS Initiative, a program aimed at adolescent girls and young women. The Innovation Fund is designed to infuse additional money into bold programs—and bring in new private-sector partners.

For the Implementation Advocate (who can live without photo captions): The new World Health Organization policy brief on what’s new in the second edition of the Consolidated Guidelines on the Use of Antiretrovirals (ARVs). If you feel like you’ve missed the second edition (the first, issued in 2013, can be found here), fear not. The full guideline still isn’t out—WHO has said to watch for it in 2016. But this policy brief gives important highlights and expands on the early release guideline on PrEP and when to start ART, which came out in September.

The newest document highlights what’s truly new. In the ART section, WHO, for the first time, advances a “differentiated care” approach that sees people living with HIV in categories other than CD4 cell count, and pregnant or not. The document begins to map what it would take to deliver services in a world where people who are unstable on ART receive one type of intervention, those who are healthy and newly diagnosed, and so on. It won’t be easy—but it wouldn’t be possible without this type of detail.

If you’re looking for captioned photos, this is a document to avoid: pictures of people apparently from low- and middle-income countries abound, but with no identifiers, and it’s hard to tell when, where or why the pictures were taken. In a document that recommends looking closely at each individual and his or her reality, the illustrations would be a great place to start.

For the Two-Briefs-Are-Always-Better-Than-One Advocate and the PrEP-Curious Reader: A two-page policy brief on PrEP from WHO that’s short and to-the-point. This is a great handout to show to people who want just the facts on why WHO now states “#offerprep” as a strong recommendation.

For the Number Cruncher (who likes photo captions): Volume Four of the One Campaign’s “Unfinished Business” report on global financing for HIV manages to be both clear, simple and comprehensive about who is spending what—at the country level and in the private sector. It also features country-specific pages and recommendations, trend analyses and clear advocacy “asks” for the Global Fund, African countries—and more. Fans of captions will be happy to see that every picture has an explanation of who is shown, where they are from and what they do.

For the Unsatisfied Realist: Treatment on Demand for All, a policy analysis paper by Health GAP and partners that maps the gaps between policy and reality when it comes to ART access worldwide. Noting that fewer than 1 out of 10 people living with HIV worldwide live in a country where immediate ART (as recommended by the WHO) is current policy, the report describes the state of, and remedies for, this great global divide.

For the Precision-Minded PrEPster: The full New England Journal of Medicine article presenting the findings from the IPERGAY trial that evaluated “on-demand” PrEP in gay men in France and Canada. Steer clear of the press release and subsequent media which suggests that the study found evidence that coitally-related dosing is effective and head straight for the discussion section which clearly states that the only conclusion IPERGAY can draw is that four pills per week provides high levels of protection in this study population.

Evaluation of the levels of drug needed to provide protection in the context of anal sex back up this conclusion—which, for now, is clear evidence that a daily PrEP regimen can be forgiving of a few missed doses for gay men and transwomen. Now is not the time to shift from the message that a pill a day provides protection. For more on PrEP’s pipeline and interpretation of the IPERGAY results, check out the two articles in POZ magazine.

Pour les Francais et leurs Amis: For the French and those who love them, lift a glass for resilience in the face of terror and another for the announcement from French Minister of Health, Marisol Touraine that will bring government-subsidized PrEP to those who need and want it.

For the Speed Readers: Ending the HIV-AIDS Pandemic—Follow the Science, an editorial in the New England Journal of Medicine. In it, Anthony Fauci and Hilary Marston of the US NIH need just over 1,000 words to summarize the science that has defined progress in the epidemic.

Happy reading—and let us know what’s on your list!

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.

Anatomy of a Target – Treatment U=U

In Px Wire, our quarterly newsletter, we looked at the strengths and limitations of new PEPFAR targets, new UNAIDS targets, new guidelines on ART and PrEP from the WHO and new Sustainable Development Goals.

In this excerpt from our centerspread graphic, we take a closer look at antiretroviral therapy and Treatment U=U.

The New Context for HIV Prevention: Is the world on target?

The new issue of Px Wire, AVAC’s quarterly newsletter on HIV prevention research and implementation, is now available. In this issue, we decipher the strengths and limitations of the multiple recent developments impacting HIV prevention: new PEPFAR targets, new UNAIDS targets, new guidelines on ART and PrEP from the WHO and new Sustainable Development Goals. What does each development mean, and how do advocates tailor their advocacy accordingly?

We’re especially excited about our centerspread graphic (see below) which looks at the sum total of the new targets and guidelines and gives our “take” on whether the current context is on target.

Click here to download.

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.

Px Wire October-December 2015, Vol. 8, No. 4

In this issue of Px Wire, our quarterly newsletter, we decipher the strengths and limitations of the multiple recent developments impacting HIV prevention: new PEPFAR targets, new UNAIDS targets, new guidelines on ART and PrEP from the WHO and new Sustainable Development Goals. What does each development mean, and how do advocates tailor their advocacy accordingly?

The New Context for HIV Prevention: Is the world on target?

In this issue of Px Wire, our centerspread graphic looks at the sum total of the new targets and guidelines and gives our “take” on whether the current context is on target.