Press Release

A Decade of Flat Funding Could Imperil Progress of the HIV Prevention Research Pipeline

Contacts

AVAC: Kay Marshall, [email protected], +1-347-249-6375
IAVI: Arne Naeveke, [email protected], +1-212-847-1055

A PDF version of this press release is also available.

Report released at HIV Research for Prevention Conference highlights funding trends, opportunities and challenges for HIV prevention R&D

Chicago – A new report released today at the second HIV Research for Prevention Conference in Chicago documents 2015 funding, highlighting a decade of flat funding and its potential impact on continued innovation in the HIV prevention research and development (R&D) field.

The Resource Tracking for HIV Prevention R&D Working Group’s (RTWG) 12th annual report, HIV Prevention Research & Development Investments, 2000-2015 Investment priorities to fund innovation in a challenging global health landscape, finds that funding for R&D of new and emerging prevention options decreased slightly in 2015. This was due in part to decreases from the US public sector and a downswing in global philanthropic funding.

Steady progress in R&D for AIDS vaccines, microbicides, pre-exposure prophylaxis using antiretroviral drugs (PrEP) and treatment as prevention (TasP) confirms science’s critical role in providing solutions to end the HIV/AIDS epidemic. Yet research for these badly-needed solutions is in danger of being slowed or even sidelined by inadequate funding.

“It is critical that investments into HIV prevention innovations, science and technology are scaled up to put us firmly on the Fast-Track to ending AIDS by 2030,” said Luiz Loures, Deputy Executive Director, UNAIDS.

In 2015, funders invested a total of US $1.20 billion across R&D, down from US $1.25 billion in 2014, across eight key areas: preventive AIDS vaccines, microbicides, PrEP using antiretroviral drugs, TasP, HSV-2 vaccines and operations research related to voluntary medical male circumcision, female condoms and prevention of vertical transmission.

The report also finds that investment is being made along all phases of the research pipeline but remains concentrated among a few large investors. A more diverse base of funders would increase the stability of R&D financing and cushion the impact if any of the major funders were to reduce their investments. To improve continuity, RTWG calls for a more balanced funding base, especially through support of new investment by European and low- and middle-income countries. The US public sector (primarily via the National Institutes of Health) remained the largest global contributor at US$850 million, accounting for 70 percent of total funding. Together the US government and the Bill & Melinda Gates Foundation, the largest philanthropic funder, accounted for 81 percent of all funding in 2015.

“There is now very strong momentum in research and development, and we need to expedite the development of vaccine strategies and other new, biomedical prevention options that promise to be safe, accessible and effective for use throughout the world,” said Mark Feinberg, President and CEO of IAVI. “There must be adequate and sustained investment at all stages from early laboratory research and to clinical testing if we are to truly be able to contain the HIV pandemic and approach and end to AIDS.”

This is indeed a time of great optimism for HIV prevention research. Daily oral PrEP is gaining traction as a new prevention option in an increasing number of countries; an antiretroviral-based microbicide ring that showed modest efficacy earlier in 2016 will be further evaluated to determine its viability as a prevention option for women; large-scale efficacy trials of an AIDS vaccine candidate and an injectable form of PrEP are slated to begin soon and a novel proof-of-concept trial of antibody-mediated prevention is underway in several countries. Many more promising candidates in earlier stages are progressing toward pre-clinical and clinical evaluation.

Importantly, 2015 saw increasing investment in the science of delivery – or implementation research – primarily focused on delivery of TasP interventions. Such investments will become even more important to help ensure new prevention options move quickly and efficiently into prevention programs and begin to have an impact on HIV infection rates. There is also an increasing understanding that research must understand and integrate the needs and desires of people who will eventually use new prevention options. Ensuring that the perspective of those for whom new prevention options are being developed is included from the beginning of the research process can help ensure that safe and effective products can be rolled out swiftly and be more fully accepted.

“Innovative science needs innovative funding,” said Mitchell Warren, AVAC Executive Director. “We need an expanded and more diverse global cadre of funders who will be involved in and dedicated to advancing HIV prevention R&D, including product delivery. And these investments need to ensure that new options like daily oral PrEP, and potentially the dapivirine vaginal ring, do not sit on the shelf unused because we don’t know how to effectively deliver them, and that future R&D better meets the needs and wants of those for whom products are developed.”

The report and infographics on prevention research investment are online at www.hivresourcetracking.org and on social media with #HIVPxinvestment.

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Since 2000, the Resource Tracking for HIV Prevention R&D Working Group (formerly the HIV Vaccines & Microbicides Resource Tracking Working Group) has employed a comprehensive methodology to track trends in research and development (R&D) investments and expenditures for biomedical HIV prevention options. AVAC leads the secretariat of the Working Group, that also includes the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). This year’s report is additionally made possible by the support of several donors, including IAVI, UNAIDS, the Bill & Melinda Gates Foundation and the American people through the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the US Agency for International Development (USAID). The contents are the responsibility of AVAC and the Working Group and do not necessarily reflect the views of PEPFAR, USAID or the United States Government.

Making Sense of Recent Cure Headlines—People Living with HIV and Advocates Speak Out

Recent headlines touting that “a cure for HIV is near” have popped up on media platforms across the globe this week. These came after a trial in the UK reported treatment of the study’s first patient with a new therapy. Like many headlines, they’re not the truth—not even close. The trial won’t have final results until 2018. It’s only then that researchers will know whether the intervention had an effect. But this didn’t stop the mainstream media from trumpeting an early victory against the virus.

Coverage originated in the UK, but the hyped media coverage continues to ripple through mainstream and social media. In response to this flurry of hype, long-time activist and TheBody.com editor JD Davids’ penned an excellent opinion piece, ‘Infuriating’: People With HIV, Doctors, Advocates Speak Out on Bad ‘HIV Cure’ Reporting.

In the piece, JD points out that, “these stories aren’t just inaccurate. They’re harmful. People feel hopeful, then their hope is dashed. They learn to ignore HIV research news, including that which is responsible and accurate. Providers and advocates have to spend time sensitively debunking the misinformation and supporting those who are disappointed. All this takes time and spirit and energy that then can’t go toward proactive efforts to, well, cure HIV for real, while doing the hard work to honor and improve and save our own and other people’s lives in the here and now.” Read the whole piece here.

For those in search of accurate information, TheBody has an explainer piece on the study making headlines. Check out the AVAC cure page for basic materials and resources. And our CUREiculum is a suite of tools that provide simple, accessible information on HIV cure research in a module-based format. Each module was developed by a community-scientific partnership to help ensure that materials covering quite complex basic science are both accurate and accessible. The CUREiculum grew out of a recognition for the need among members of the community to increase literacy around the growing HIV cure research field—a need for which was reiterated this week.

Prevention, Treatment and Human Rights

AVAC Executive Director Mitchell Warren and international gay rights activist Bisi Alimi dig into the tough realities of fighting HIV in 2016 in this interview, originally livestreamed from the AIDS 2016 conference in Durban.

Alimi asks Warren to make sense of scientific advances and new discoveries that are answering big questions and raising others. And Warren shows the imperative connection between prevention, treatment and human rights. Click to view.

Ighodaro spars with Bisi over some provocative questions about the role of Africa’s activists and an agenda for the future. View the video here.

New! AVAC Report 2016 Big Data, Real People: The annual state of prevention advocacy

If you’re packing for Durban, we hope you’ll pause right now and add to your bag AVAC’s annual state of the field, Big Data Real People. The full PDF, Executive Summary and graphics are available here.

As always, AVAC Report is our annual advocacy analysis, with an agenda that spans the next 12 months—and beyond. We’ve designed it be a clear, succinct, actionable statement of the strengths and weakness of HIV prevention data today—and we hope you’ll join us in amplifying these messages at next week’s gathering.

Even if you’re not heading to Durban, we hope that this year’s Report will top your packing list for the journey through the next 12 months of advocacy and action.

In the Report, we argue that the state of HIV prevention data collection in 2016 is poor. One part of the solution lies in the adoption of “HIV Prevention Data Dashboards”. This tracking tool could bring the same specificity and accountability to non-ART prevention services that the “treatment cascade” of diagnosis, initiation, retention and virologic suppression does for antiretrovirals for people living with HIV.

The world cannot even pretend that ending AIDS is possible without action on non-ART prevention. We need to roll out what we have, continue R&D on what we still need, as well as scale up ART for all people living with HIV. That’s what the new UNAIDS Prevention Gap report says. That’s what AVAC has said for years. That’s what we hope you’ll say in Durban and over the coming year.

Here’s the Report, a roadmap for the coming year. Please read it, join us on the journey, let us know what you think!

Press Release

Data gaps hinder global efforts to reduce HIV infections, AVAC report warns; improved data collection and reporting needed to meet looming global AIDS targets

Contacts

Mitchell Warren, [email protected], +1-914-661-1536
Kay Marshall, [email protected], +1-347-249-6375

In a report issued today, AVAC warned that major gaps in global HIV/AIDS data stand in the way of delivering HIV prevention advances to millions of people who need them most. The report identifies several critical weaknesses of today’s HIV prevention data collection and monitoring systems and offers a concrete roadmap for closing these gaps. The report, Big Data, Real People, was issued ahead of next week’s International AIDS Conference in Durban, South Africa (July 18-22), where advocates will demand action to speed HIV prevention research and delivery.

“In an era in which big data are expected to improve essentially every part of our lives, there’s no excuse for HIV prevention data systems to be so uneven, incomplete and inefficient,” said Mitchell Warren, AVAC’s executive director. “To have any chance of ending the epidemic by 2030, we need to be collecting and accounting for every bit of useful information from every person living with or at risk for HIV.”

The need for improved HIV prevention data systems is particularly pressing given the UNAIDS “fast-track” goal to reduce new annual diagnoses to no more than 500,000 by 2020. Earlier this month, UNAIDS reported that the number of new HIV infections has remained near 2 million per year for the past decade.

Report identifies specific HIV data gaps, recommends solutions

AVAC’s report focuses on four critical data gaps that must be addressed to effectively prioritize, target and measure the impact of efforts to develop and deliver HIV prevention advances.

Specifically, today’s HIV prevention data are:

  • Not sufficiently broken down by age, gender, income status, key population status and other vital categories
  • Missing or incomplete for key populations most in need of prevention, including adolescent girls and young women, men who have sex with men, transgender women, and others
  • Not tied to useful HIV prevention metrics and indicators, so that it is impossible to know whether prevention programs are actually averting infections and improving health
  • Not effectively informing the HIV prevention research agenda

To overcome these weaknesses, the report outlines three critical strategies that should be pursued most urgently:

1. Standardize and systemize data collection and reporting for HIV prevention

Understand, measure and report on the risk level of people testing HIV-negative; create and measure linkages to evidence-based prevention for people at substantial risk; and use a standardized “Prevention Data Dashboard” to continually evaluate progress. Such dashboards would consolidate and arrange available data to illuminate critical prevention gaps and help the global community, governments and funders better conceptualize their HIV prevention programming and evaluation. AVAC’s report provides a model dashboard for decision-makers to adopt.

2. Improve use of data for adolescent girls and young women

Ensure that a growing volume of available data can be applied in a meaningful way. As a first step, funders, implementers and governments need to do a better job of defining and segmenting this population; map who is investing in what and where; put adolescent girls and young women in control of core aspects of the data-collection enterprise; and adopt gender-specific indicators tailored to girls and women.

3. Put research on the “fast-track” and countries at the center

Fit biomedical HIV prevention research into comprehensive prevention plans tied to national targets for incidence reduction. Countries and research institutions must invest time and resources in stakeholder engagement; ensure that research priorities are informed by epidemiological and other quality HIV data; and develop national research plans for meeting the prevention needs of specific, affected populations.

The new report and related resources, including downloadable graphics, are available now at www.avac.org/report2016.

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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.

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.

Register Now for June 6 Webinar on Basics of HIV Cure Research!

In July, thousands of advocates, researchers and educators will arrive in Durban excited to hear the latest news in the HIV field. To get ready for the upcoming developments in HIV cure research, AVAC is thrilled to announce the first webinar in a six-part series preparing advocates and cure-enthusiasts alike for the HIV cure research agenda being presented at Durban. The webinar series will provide accessible, essential information for advocates who want to understand the HIV cure research updates being presented in Durban, and provide a space to engage with leading researchers and advocates before AIDS 2016.

CUREiculum Webinar: HIV – The Basics What You Need To Know, And Want to Know About HIV Cure Research led by Nicolas Chomont, a leading researcher at the University of Montreal.

Join us Monday, June 6 at 9am ET (see www.timeanddate.com for the time in your area).

  • What are researchers talking about when they say “cure”?
  • What kind of progress is being made toward a cure for HIV?
  • How can we talk about HIV cure to our communities?
  • What do we need to know before AIDS 2016?

Register here.

A FRESH Look at Basic HIV Cure Research

The Female Rising through Education, Support and Health cohort, or FRESH, located in the Umlazi Township outside of Durban, South Africa, is showing how basic science research can do more than just collect blood samples. Updates on work with FRESH are highlighted in other advocates’ reflections on CROI 2016.

The FRESH cohort—presented at CROI 2016—is a population of young women enrolled in a longitudinal study conducted by the Ragon Institute in Boston, MA and the University of KwaZulu-Natal in Durban South Africa. The purpose of the study is to identify young women (ages 18-23) in very early HIV infection—also known as “acute infection”—to study the innate, or primary, immune system and to address gaps in HIV prevention within this population.

In addition to biweekly clinic visits to draw blood, vaginal and cervical swabs, the women take part in an intensive training and education program to prepare them for jobs, entrepreneurship or reentry into the school system. The women attend two, three-hour classes per week over the course of 12 months. This intensive skills-building program was put in place to combat poverty in the population, a known driver of the epidemic, and help retain young women in the study.

The cohort began enrollment in 2013 and as of September 29, 2015, 699 women have been enrolled. Over 24 months 32 women were diagnosed soon after infection.

At the pre-CROI Community Cure Workshop, Zaza Mtime Ndhlovu (University of KwaZulu Natal) presented his research on HIV specific CD8 T cell responses in early infection. A subset of the cohort’s acutely infected women contributed to Dr. Ndhlovu’s research looking at T-cells directly before and after infection. Dr. Ndhlovu’s work shows that during the acute infection phase, HIV-specific CD8 cells develop very quickly and in high numbers. The number of HIV-specific CD8 T cells varies from person to person and contributes to the viral set point of the individual.

This means as soon as HIV enters the body, within the first few days, these HIV-specific CD8 cells can immediately begin fighting the virus. This is why the more HIV-specific CD8 responses an individual has the lower their viral set point. These HIV-specific CD8 T cells are prone to dying, so they don’t last long in the body.

This is significant because it offers a potential strategy toward HIV remission. If researchers can preserve these CD8 cells, either by preventing their death, by using a drug to enhance the immune system, or by priming the body to make more HIV-specific CD8 cells through a vaccine, they could potentially develop a “kill” component of a “kick and kill” curative strategy. The FRESH cohort is providing researchers with a new model of working with communities to prevent new HIV infections and conduct basic research toward a cure.

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.

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.