A Steady Hand of Advocacy in Uncertain Times: HIV Vaccine Awareness Day 2017

[UPDATED] This post now includes recordings of previously held webinars.

This year will mark the 20th anniversary of HIV Vaccine Awareness Day (HVAD). On this May 18, as HIV prevention advocates we find ourselves in new terrain when it comes to vaccine research—both in terms of scientific progress and the challenging political environment. We’ll be highlighting these important issues in an HVAD webinar series leading up to and ending on May 18—read on for full information and to register.

As we look back on the 20 years since President Bill Clinton called for accelerating HIV vaccine development, AVAC recognizes that, now more than ever, we need steady hands and supportive voices to back this long-term, challenging, essential endeavor. Can you help us identify the next HIV vaccine champions? Are you one of them?

This year we are celebrating HVAD, not only on May 18, but throughout the month leading up to it (and beyond). We promise not to inundate you! But we recognize the “breadth and potency” of the current research landscape and the many events that will happen around the globe to mark the momentous day. We want to keep you in the loop.

We’ll provide research literacy tools; share AVAC’s take on developments in the field; and host a series of webinars to discuss key issues in vaccine research and advocacy. Please register, mark your calendars, and have your questions ready.

Recordings of previous webinars available here:

  • Ad26 Mosaic Program—Janssen’s Maria Pau discusses preparations for the next efficacy trial
    April 28 – YouTube / Audio / Slides
  • The History—and Future—of the NIH’s Vaccine Research Center with Barney Graham
    May 4 – YouTube / Audio / Slides
  • Building on (and Building!) Success—Status of HVTN 702 with Fatima Laher
    May 8 – YouTube / Audio / Slides
  • “Plan B”-NAb? An Overview of Antibody Research with Lynn Morris
    May 11 – YouTube / Audio / Slides
  • An Overview of Vaccine Development with Julie Ake of MHRP
    May 18 – YouTube / Audio / Slides

We hope you’re looking forward to the month ahead as much as we are! Talk soon.

HVTN Regional Meeting – A View from the Outside

This blog is the first in a series of reflections from AVAC staff and members of the Vaccine Advocacy Resource Group (VARG) on the regional meeting of the HIV Vaccine Trials Network (HVTN), which took place in Johannesburg from February 28 to 1 March 2017.

AMP. Licensure. Enrollment targets. Success.

These were a few of the buzz words from the HIV Vaccine Trials Network (HVTN) regional meeting last month. This meeting, the first of three the network will convene in 2017, was held in Johannesburg, highlighting the HVTN’s build out of programs in sub-Saharan Africa—and the significance of an HIV vaccine for this region.

As network meetings go, the audience for this meeting was largely internal; a chance for HVTN core staff and leadership to celebrate key milestones, particularly around the network’s two large efficacy studies—HVTN 702 and the Antibody Mediated Prevention Trials (AMP)—with their clinical site partners.

While advocates are not the primary audience, the HVTN allows us to attend plenaries and other open sessions. AVAC and civil society partners look to these meetings to hear updates, interact with research teams, and continue to build our research literacy and our translation and liaison roles in the HIV vaccine field.

To advocates—both from AVAC and the Vaccine Advocacy Resource Group (VARG), a global team of HIV prevention advocates—looking in from the outside, this meeting underscored the intensity of resources necessary to make clinical trials happen and allowed us to get a sense of how the vaccine field sees itself.

What follows are impressions from AVAC and a few VARG members from our times in meeting rooms—and in hallways.

AMP. The AMP trials are in an exciting place—exceeding enrollment targets across all sites, both in the Americas and Southern Africa, and maintaining high retention and adherence. While we are thrilled about the trials’ current success, and intrigued by passive immunization as a potential prevention strategy, we felt a gap in communication from the trial’s architects about how to situate it in the broader field. AMP is testing a 30-60 minute infusion of an antibody called VRC01 that is administered every two months for just under two years. While there was much discussion about this particular antibody and others in development, it’s not yet clear how researchers will build on the AMP results to deliver a feasible prevention option. We were left with questions about what will happen with VRC01 if the trial shows efficacy, as its dosing schedule makes it hard to imagine as a real world tool. There are also more powerful antibodies and easier methods of administering them that are being explored. We want to be sure that the goals and follow up steps of AMP are well articulated and understood. Watch this space—it is sure to evolve quickly!

HVTN 702. The first vaccine efficacy trial in seven years is now in its 22nd week of enrollment. As 702 sites continue to get started and data from the precursor trials, RV 144 and HVTN 100, continue to provide more clarity on mechanisms of improving immunogenicity, we note a need for cautious optimism. While 702 presents a possibility for moving toward a licensed vaccine, we were a bit concerned about the hopes being raised about this trial, and feel strongly that the messages should convey realistic expectations. Licensure is the ultimate goal, but we have to closely watch, and accurately translate, the data for ourselves and to our communities. If we’ve learned one thing from HIV vaccine research, it’s that we never know what to expect!

PrEP Access. Finally, let’s talk about oral PrEP—researchers certainly did at this meeting. Access to PrEP is (slowly) becoming a reality in trial communities all over the world—and the HVTN, and all trialists, are grappling with how to incorporate PrEP into trials, especially as this context evolves at national, community, and individual levels. As research advocates, we know that the trial context rarely reflects the real world. While we commend the AMP and 702 teams for exploring ways to connect trial participants to mechanisms for PrEP access, we see a necessity for a more rigorous and urgent commitment to link national and local PrEP programs to participants who need and want it.

Note: This is a crucial area that advocates are watching, and where they can and need to help research teams. Without taking PrEP into account and ensuring that communities have input, clinical trials run the risk of being viewed as skirting larger community needs as well as ethical and human rights obligations.

Now that the meeting is wrapped, and we’ve had a couple of weeks to reflect, we’re left with the feeling that the field appears too siloed. The conversations around antibodies and vaccine candidates seem to be happening in isolation from larger dynamism in the field and the very communities where trials are taking place. The rich and rapidly iterating prevention research environment needs an HIV vaccine—and an HIV vaccine needs this exciting environment.

What’s New on AVAC.org

AVAC.org has a host of new resources providing concise updates, informed perspective and handy tools. Take a look at the highlights below and get up to speed on a range of strategic issues.

New Resources

  • AVAC, in partnership with the Clinton Health Access Initiative (CHAI), is taking on new work focused on supporting innovation in the prevention “market”—including the programs that deliver new products and the pipeline of products in trials. This two-page intro to the “HIV Prevention Market Manager” gives an overview of this new body of work.
  • To get a flavor of the work the Prevention Market Manager team is focused on, check out this new resource: End-User Research Landscape Mapping and Findings. The term “end user” is used by people who work on developing and marketing products. It refers to the individual who’s ultimately going to make the decision to seek out and use a given product or intervention. This resource gives a sense of the range of efforts trying to understand what is and isn’t known about one key set of “end users” for new prevention options—adolescent girls and young women in sub-Saharan Africa.

From the Infographics Gallery

  • Introduction to Long-Acting Injectables is an updated graphic to guide you through the basics of antiretrovirals that are being developed as long-acting injectables for both treatment and prevention.

Strong Voices in P-Values

  • Progress and justice for women and girls has come under attack by the new US administration via the reinstatement and proposed expansion of the Global Gag Rule. In Standing Together Against the Global Gag Rule the AVAC team reaffirms its commitment to the fight for bodily autonomy, for justice, for choice and voice for women and girls.
  • In New and Touted HIV bNAb: Big deal or news blip?, veteran science writer and HIV journalist Mark Mascolini delves into the nuances of vaccine research using broadly neutralizing antibodies. You will learn more than just what these are; Mascolini looks at the big promises and the small print.
  • Lindsay Roth, a long-time organizer and advocate for sex workers’ rights, gives any lay reader on the subject of sex work an opportunity to gain a deeper understanding of the issues at stake in Getting Set to Defend and Advance Sex Workers’ Rights in 2017 and Beyond. Roth’s reporting shows how HIV prevention, human rights and economic justice can only succeed together.

Px Wire’s Take on 2017: #Onwards #UntilTheEpidemicIsOver

2017 promises to be a year of big changes, but how the political winds will touch the field of HIV is still unknown. Amidst the uncertainty, long hard work advancing HIV prevention is pushing frontiers all over the world from the lab to the clinic to the household medicine cabinet.

This issue of Px Wire, AVAC’s quarterly update on HIV prevention research, looks ahead at a host of issues we are watching in 2017. Are we confronting “Fast Track” goals with the sober analysis they demand? Will oral PrEP guidelines translate into programs and will programs meet people’s needs? What progress can we expect from studies on the dapivirine vaginal ring, various vaccine candidates or on broadly neutralizing antibodies, which are garnering so much press attention of late? Will global leaders embrace policies that ensure data gaps on key populations will finally be filled?

Check out AVAC’s round-up of these and other questions that we think will define the state of HIV prevention in 2017. And this issue’s centerspread extends the story beyond 2017 with an infographic showing the status of large-scale prevention trials through 2020.

What’s New and What’s Needed: Updates in research results and advocacy

Welcome to our first post-US election update! Many of us, in the US and around the globe, continue to be moved, activated and concerned by the recent US election. We have been grateful for forums exploring how our work may be affected by various political scenarios, including this call on the future of Global AIDS Funding, hosted by GNP+. At the same time, we want to restate our long-standing and vigorous commitment to our ongoing work, which will continue with the same rigor as ever, in pursuit of our mission.

In that spirit, this update highlights recent developments in biomedical prevention research. Together they serve as a great example for why a pro-science, pro-research, pro-stakeholder engagement agenda is a non-negotiable necessity, irrespective of politics and political parties.

New basic science provides clues on cure and vaccines. Earlier in the month, two papers were published regarding new innovations in HIV prevention and cure.

A paper authored by Katharine Bar at UPenn and colleagues reported on the effect of the antibody VCR01 in people living with HIV. In these trials, people living with HIV stopped their antiretroviral treatment (ART) while receiving infusions of VRC01, a broadly neutralizing antibody that blocks the activity of many strains of HIV. The study measured the safety of VRC01 and sought to determine if it helped people control their virus while off treatment. Researchers compared viral “rebound” (the reappearance of virus in the body after ART is stopped) between people who received VRC01 and people who did not. Findings show VRC01 only slightly delayed viral rebound. This shows the value of the scientific research field in action, testing and narrowing the field of solutions until we hit the bullseye. VRC01 is also under study as a tool for HIV prevention in the ongoing AMP trials (HVTN 703/HPTN 081 and HVTN 704/HPTN 085), and a number of other antibodies are in various stages of both prevention and therapeutic research.

A paper authored by Dan Barouch of the Ragon Institute and colleagues looked at a strategy for a cure that combines a therapeutic vaccine with a TLR7-agonist. TLR7 is a protein that controls and activates human immune responses. This study looked at non-human primates (NHP) with SIV (the simian version of HIV). The study used the vaccine vector Ad26/MVA from Janssen Pharmaceuticals to instruct immune cells to recognize SIV, and the TLR7-agonist to activate those immune cells. This strategy tested whether the Ad26/MVA/TLR-7 combination would be able to marshal immune cells to eradicate SIV. In the study, non-human primates were put on ART immediately after infection. One group of NHPs received the vaccine alone, another received only TLR7, a third received a placebo and the last received a combination of Ad26/MVA and TLR7. All were then taken off of ART. Those that received the combination had the largest drop in SIV and the longest delay in viral rebound. There are a lot of caveats with animal models, but this finding could add to optimism for the scientific pursuit of an HIV cure. The Ad26/MVA vaccine vector is also being tested as a preventative vaccine, and a large-scale efficacy study of the regimen could begin in 2017.

Community mobilization on the DISCOVER trial of Gilead’s F/TAF as oral PrEP.

An article published on TheBody.com by long-time advocates Anna Forbes and Marc-André LeBlanc outlined the latest developments related to Gilead’s Phase III trial of the drug F/TAF for oral PrEP. The trial, known as DISCOVER, has raised concerns among advocates that stakeholder engagement has been insufficient. The study plans to enroll 5,000 participants from 92 sites across the US and Europe. Participants will be randomized to receive either daily TDF/FTC (Truvada), which is a proven prevention option approved by the US FDA for PrEP in 2012, or daily F/TAF, which is a different version of the drug combination that has been approved for treatment but the efficacy for prevention is unproven. Given the complex messaging of this trial—one that compares an approved option with an experimental one—community engagement over the course of trial planning and execution is imperative. The standards for stakeholder engagement, outlined in the Good Participatory Practice Guidelines, are designed to address this type of trial and should be met. While Gilead has engaged a limited subset of community stakeholders, a group of advocates, representing a range of organizations, submitted a public letter to Gilead on November 16 demanding substantial and meaningful improvements to the process of community engagement. This is the right thing to do and history has shown this process improves the chances for the trial’s success.

Decades of testing and research reflected in studies like these are doing the painstaking, instrumental work it takes to move us toward our goal, the end of AIDS. Let’s keep our eyes on the prize.

HIVR4P: “Where Are the African Americans?”

Rob Newells is an Associate Minister at the Imani Community Church in Oakland, California, and serves as Executive Director for AIDS Project of the East Bay—a community-based organization serving the most vulnerable and marginalized communities in Alameda County since 1983. He was a 2011 Fellow of the Black AIDS Institute’s African American HIV University Community Mobilization College and has been a biomedical HIV prevention research advocate with AVAC’s US PxROAR group since 2012.

I looked around a conference room at HIVR4P and said to myself (and my Facebook friends), “Where are the African Americans?” Chicago has lots of African Americans, but this research-heavy conference was lacking in community representation. (Shout out to the folks like Matthew Rose from NMAC and Noël Gordon from HRC, and also an R4P plenary speaker, doing the very necessary national and international policy and advocacy work, but as one colleague put it, “Who represents black and brown men in the US?”) African biomedical HIV prevention research advocacy is strong. African American research advocacy could use a boost.

It’s natural for black men working in HIV to attend conferences geared towards community like National African American MSM Leadership Conference on HIV/AIDS and Other Health Disparities (NAESM) and the United States Conference on AIDS (USCA), but we also need be in those spaces that are geared towards the researchers who are developing new strategies that will eventually be implemented in our communities. There’s no reason for the disparities in PrEP awareness between black people and white people that exist today.

Advocates like those I joined in being honored with receiving the 2016 Omololu Falobi Award for Excellence in Biomedical HIV Prevention Research Community Advocacy, have been trying to get the word to our communities since before the US FDA approved Truvada for PrEP in 2012. We’ve got to stay ahead of the curve.

After a few years of relative calm on the HIV prevention research front, the San Francisco Bay Area is now looking at four major studies, which will be recruiting participants at the same time (more info below). The HIV epidemic in the US disproportionately affects black MSM, which means they are also targeted for enrollment in these studies. And the way gentrification has affected demographics in San Francisco (black people made up 13.4 percent of the population in 1970, down to less than 6 percent today), black men 15 minutes across the bay in my hometown of Oakland which is still about 27.3 percent African American (down from 46 percent in 1980) will be heavily recruited to participate in these studies. And the data keep telling us that black men have lower health literacy than other groups – not only in the community, but also on the front lines of the HIV workforce as noted in the Black AIDS Institute’s 2015 “When We Know Better, We Do Better” report.

Black men need to be in the rooms where scientists are discussing their research because it affects us directly. As advocates, it’s our responsibility to help our communities understand sometimes hard-to-understand clinical trial results and their implications. We can’t wait to get to 1-in-2 black MSM diagnosed with HIV before we start taking HIV in black communities seriously.

On a community level, we have to talk about sex and sexuality. The young people who shared their experiences during the symposium “How to Talk to Me About Sex” told us that they learn from their friends and social media and the Internet. Not talking about sex responsibly in community is not helping prevent STIs, pregnancy, or HIV infections.

HIVR4P is focused on HIV prevention research, and black men from the United States were vastly underrepresented. The things being studied today may be the new prevention tools we’re rolling out in our communities in a few years. We have to be talking about them now. And for those of us who act as resources for clients and friends, we need to be able to answer (and ask) questions about these studies. Who should participate? Why would anyone participate? Which study might be the right study for you?

Locally, we have the AMP Study and Gilead’s F/TAF for PrEP study recruiting now. A long-acting injectable study is ready to start recruiting. And we expect to see a new vaccine trial start up in 2017. And California is a Medicaid expansion state, so most people already (theoretically) have access to Truvada for PrEP covered by their health insurance plans. You don’t have questions?

Conferences like HIVR4P are where advocates can engage in conversations with colleagues and researchers from around the world. It’s where we come to understand the issues around various biomedical HIV prevention methods and start to think about how to share what we learn with our communities. (Dennis Burton’s plenary presentation on “Progress in Neutralizing Antibody-based HIV Vaccine Design” helped me understand bNAbs for the first time since I started paying attention to them at HIVR4P2014 in Cape Town.)

I recognize my privilege. Not everyone gets awarded scholarships to attend meetings like HIVR4P. Fortunately, the conference sessions are available online for everyone to access. The Chicago Black Treatment Advocates Network hosted an AIDS2016 Report Back on the South Side at the same time as HIVR4P. (I missed a symposium session to Uber over for a couple of hours.) However we get the information, we have to improve our health literacy in general, and our biomedical HIV prevention research literacy specifically. Sharon Hillier’s plenary talk on “Rings and Things” is a reminder that Truvada for oral PrEP is just the tip of the iceberg. There are new options coming. We have to be ready. It’s past time for more African Americans to get with Solange and pull up “A Seat at the Table.”

“This sh*t is for us… Sometimes we don’t trust… This sh*t is for us.”

Debate This: What do HIV prevention and elections have in common?

In a baseball-obsessed town (see Monday’s round-up) there was competition for TV viewers last night in Chicago as millions of people, including many conference-goers, watched the third and final debate between the two candidates vying to become the next US President. What do political campaigns and HIV prevention have in common? Read on for our (non-partisan) thoughts!

Lesson One: Tell a story, make it personal.

Politicians, advocates and parents—these are all groups that know the power of storytelling. Wednesday’s plenary session featured Noël Gordon Jr. (Human Rights Campaign) who told his unique story of getting on PrEP. He also shared his observations from working with gay men and transgender women, he talked about how their attitude toward HIV prevention, the threats to uptake and what opportunities we have to succeed. In advocacy, the best stories are the ones that (re)connect people to the issues. Gordon showed statistics on who is using PrEP in America—and the racial, age and gender demographics of PrEP users do not match those of people most at risk. Stigma also remains a huge issue.

Also in this plenary session, and available via webcast: two excellent research updates—Dennis Burton (Scripps Research Institute) on broadly neutralizing antibody-based vaccine design and Sharon Hillier (Microbicide Trials Network) on the state of the microbicide field.

Later that morning in the Advocates’ Corner, four advocates—Chilufya Kasanda, current AVAC Fellow at the Treatment Advocacy and Literacy Campaign (Zambia), Chamunorwa Mashoko, a leader of the Advocacy Core Team in Zimbabwe, Morenike Upkong, founder and leader of the Nigerian HIV New HIV Vaccine and Microbicide Advocacy Society and Amaka Enemo, current AVAC Fellow at the Heartland Alliance in Nigeria—shared personal stories about empowerment, advocacy and being human. All participated in a training for advocates earlier this year conducted by The Moth, a US-based organization focused on the art and craft of storytelling. Check back at avac.org to see video from their stories later this year.

Lesson Two: Exercise choice, give consent, show zero tolerance for sexual violence.

Some of the story lines in the American election have been a potent reminder of the fundamental right that all people, women and men, have to exercise choice about their bodies. In her plenary, Sharon Hillier (MTN) showed data that underscored the importance of full, free choice. Among women under 21 in the ASPIRE trial of the dapivirine ring, overall use was very low. But among women in this age range who were invested in using it—indicated by the amount of dapivirine still remaining in used rings, drug levels in samples, and self-report—use levels were stronger. And when they did use it, they were protected. Hillier reported analysis from the ASPIRE data indicating that the ring, used consistently, reduced risk by up to 84 percent compared to women under 25 using a placebo ring. This information complemented findings, also from ASPIRE, presented by Thesla Palanee-Phillips (WHRI) at the Tuesday press conference (and on the conference program today) that found that intimate partner violence—which can be physical and psychological—impeded adherence among ASPIRE trial participants. In this election and prevention season, it bears repeating: no biomedical prevention strategy will eliminate the need to prevent and address sexual, psychological and physical violence against women, sexual minorities and all people under threat because of how they live or what they do.

Lesson Three: Look who’s talking (or being talked about).

Sometimes the candidate who seizes the spotlight is campaigning for the next election. HIV prevention, like American politics, can gravitate towards the next big thing, be it a vaccine candidate or a presidential hopeful. The relatively untested is also relatively untarnished—and it can inspire hope for major change. Much of the vaccine discussion was not on the candidates now in efficacy trials but rather on candidates in earlier phases of development. On Tuesday, Chris Parks (IAVI) discussed the results of a trial in non-human primates of a vaccine that uses Vesicular Stomatitis Virus (VSV) as a vector. VSV is a replicating vector: a virus that has been disabled so that it doesn’t cause disease or carry risk but does have the ability to copy itself. It is thought that replicating vectors could prompt strong and sustained immune responses.

Later on Tuesday, Hanneke Schuitemaker from Janssen said that a decision is expected as early as the 4th quarter of 2016 about whether to move forward with a three-part vaccine strategy known as Ad26/gp140/MVA, which is currently under development in collaboration with a number of organizations including the HIV Vaccine Trials Network (HVTN), International AIDS Vaccine Initiative (IAVI), the US Military HIV Research Program (USMHRP) and Beth Israel Deaconess Center.

Interest in next-generation candidates also showed up in discussions of long-acting antiretrovirals, which could be used for both treatment and prevention. Data were shown on a new compound known as EFdA, which is in early animal studies, and on cabotegravir, the candidate moving toward possible efficacy trials in 2017. Politics remind us—don’t discount or count on any single candidate to get the job done!

Lesson Four: Money talks.

At an afternoon session, we heard that money for HIV prevention R&D has remained essentially flat for over a decade. These data come from a new report, HIV Prevention Research & Development Investments, 2000–2015: Investment priorities to fund innovation in a challenging global health landscape, from the Resource Tracking for HIV Prevention R&D Working Group, which AVAC leads. Read more on the new data in our blog post here.

Lesson Five: People in power can and must listen to and be guided by people “on the ground”.

Who are politicians or trial site staff responsible to—and dependent on—for success? The people in the communities in which they work. Without collaboration, there is no change. No engagement, no chance of making real progress. This is recognized across the field—and there’s expanding data on just how to engage. This contribution to the field is coming from widespread use of the Good Participatory Practice Guidelines (GPP) framework, which has been mentioned throughout the conference. In a presentation by Kenyan researcher Jane Ng’ang’a from the KAVI Institute of Clinical Research, she described how KAVI evaluated and improved its engagement plans using GPP. She credits the GPP framework for fostering community understanding and genuine support for the research. AVAC is proud to be the home of an online course on GPP—be sure to subscribe to the Advocates’ Network for announcements of when the next course will run.

When scientists work with (or as) advocates, or when politicians serve as (or team up with) activists, great things can happen. So one of our favorite moments of yesterday’s dialogues came at a “Meet the Experts Session”. Discussing their respective presentations, antibody expert Dennis Burton, and Noël Gordon, expert on the real world experience of people whose lives are affected by HIV in the US, realized they needed to connect. Business cards were exchanged—and perhaps the next prevention revolution was born.

For those on-site today, be sure to check out the final sessions at the Advocates’ Corner and grab some extra materials to take home! Thursday’s sessions include:

  • 10:00am – 10:30am: PrEP implementation in Chicago’s STI clinics
  • 12:00pm – 1:00pm: “It’s too complicated for them”: Service providers as gatekeepers to PrEP information and access

For the latest from the conference follow in real-time on Twitter and check out meeting coverage on aidsmap. The daily rapporteur summaries also provide report-backs on the conference. Missed a session? Visit here to see the webcasts as they become available.

Not To Be Missed: New report on funding for prevention research

The span of a decade—that interval that’s neither too long nor too short to bring innovation—is one that’s often used in the HIV prevention research space, usually to convey optimism. Back in 1997, then President Bill Clinton called for a national commitment to develop an AIDS vaccine within ten years. Just this week, Bill Gates said, “With the right leadership and investments over the next decade, we can discover and deliver a vaccine for HIV.”

The success of these forward-looking claims has always depended on sustained funding. Note, in both cases, the emphasis on commitment and leadership. No one is promising a vaccine with anything less. A look back at the last ten years provides a warning on this front. Released today, the Resource Tracking for HIV prevention R&D Working Group’s latest annual report on global investment into biomedical HIV prevention reports that overall funding for HIV prevention research and development (R&D) has remained essentially flat for over a decade.

Close followers of the annual “RT” report take note—a preliminary version was released at AIDS 2016 in Durban in July. The final version contains slightly updated data and the same overall messages: with a slight fall from US$1.25 billion in 2014 to US$1.20 billion in 2015, overall funding for HIV prevention research and development (R&D) has been more or less level for the past ten years.

And what a decade it’s been! Consider the developments in PrEP, the pipeline of injectable ARVs for prevention and treatment, the continued advance of the ARV-containing vaginal dapivirine ring, and the insights and advances that have come from sustained scientific inquiry related to the search for an HIV vaccine. These are exciting times. And the fact that all of this happened in the context of flat funding for research doesn’t mean that flat funding will get us where we need to go next. As Tom Hope, PhD (Northwestern University) stressed at an opening plenary of the HIV R4P conference where the report was launched, the fact that funding is declining concurrent with new discoveries is a major challenge for the field.

The report notes that preventive vaccine research funding constituted the bulk of all investments, followed by investments in microbicides, TasP, PMTCT, PrEP, VMMC and female condoms. With the exception of vaccines and female condoms, every other HIV prevention option tracked by the working group experienced a decline. These trends are somewhat reflective of the cyclical nature of large-scale clinical trials—when trials end, funding drops off. Likewise, as some interventions enter full scale rollout, like VMMC and TasP, research in this arena can be expected to slow down. Nevertheless, the overall trends bear close watching and strong advocacy to ensure that research continues.

The right products need to be tested in the populations who need them most. The report is also a powerful reminder that this isn’t necessarily how research works. It provides information on the demographic breakdown of almost 900,000 participants in ongoing HIV prevention trials in 2015, with the majority of these volunteers residing in sub-Saharan Africa, most notably Uganda, Kenya, and South Africa. Only one in eight trial participants in 2015 belonged to a population most affected by HIV, including MSM and transgender women, injection drug users, and cisgender women.

These sobering facts come in the context of a vigorous period in research and development. It’s a time of growing recognition from the global community that research has to be part of the long-term fight to end the HIV epidemic. Taking stock of all that’s been accomplished with ten years of flat funding, now is the time to support continued progress with additional, well-targeted resources.

The Resource Tracking Working Group hopes that this tool provides strong facts for advocacy and supports efforts to assess public policy and its role in accelerating scientific progress. We thank all of the individuals who contributed data to the report and who gave time and effort as trial participants.

Check out the report, share it with your fellow advocates, and be sure to let us know if your organization is either a funder or recipient of HIV prevention grants or if you have further questions or information about resource tracking at all!

Press Release

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

Contacts

AVAC: Kay Marshall, kay@avac.org, +1-347-249-6375
IAVI: Arne Naeveke, anaeveke@iavi.org, +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.

Trial Participants by Prevention Research Area, 2015

Given the higher rates of acquisition seen across so-called key populations—members of highly burdened and underserved groups—it is critical to provide access to the research process such that they can participate and reap more immediate benefit of scientific progress. Greater efforts must be made to include key populations in this crucial process for the HIV prevention response to be truly impactful.