This graphics shows a family tree representing HIV research in the United States. It appears in AVAC Report 2017: Mixed messages and how to untangle them.
US HIV Research: A family tree
HIV Cure Research Strategy for Women: Where are we?
This blog post first appeared on Positively Aware. It represents a report taken from a session presentation summary at this year’s US Conference on AIDS (USCA), a community-based event which was held in September in Washington, DC.
The authors are Danielle Campbell, Julie Patterson, David Evans, Pedro Goicochea, Moisés Agosto, Dawn Averitt, Catalina Ramirez, and Karine Dubé Danielle Campbell, Julie Patterson, David Evans, Pedro Goicochea, Moisés Agosto, Dawn Averitt, Catalina Ramirez, and Karine Dubé.
The need for a cure is critical, but will the search for HIV cure strategies include women? Women are drastically underrepresented in HIV cure research studies. A review of 159 studies showed that only 18 percent of HIV cure study participants were women. Women have a high willingness to participate in research, although they are in general less willing than men to take risks related to HIV cure research interventions. Research is in the works to better understand the differences in willingness, but studies outside of the HIV cure arena suggest that if structural barriers to participation are diminished, and more effort is made to establish trusting relationships between investigators and participants, more women will participate.
Currently, there is no cure for HIV. Only one person has been cured, Timothy Ray Brown, after receiving two bone marrow transplants that simultaneously rid his body of HIV infected cells and gave him new cells that are resistant to HIV. Scientists are trying to replicate his cure. The transplant of stem cells is a central HIV cure strategy being investigated, particularly to eliminate nearly all traces of the virus from a person’s body (e.g., an eradicating, or sterilizing, cure). Other methods include the early administration of antiretroviral treatment, combined with a variety of strategies that make HIV more visible to infection-fighting immune cells, improving the immune system’s ability to detect and eliminate infected cells, and possibly rendering immune cells impervious to HIV infection.
Scientists suspect that there are gender-based differences that affect how these investigational interventions might work inside the body. For example, two studies have suggested that the presence of female hormones and hormone receptors on immune cells might make it more difficult to flush HIV out of hiding. In addition, cis-gender women who have female chromosomes are genetically primed for stronger immune responses to infection and to vaccines. They might, perhaps, have an advantage if vaccines or other approaches to prime the immune system’s response to HIV are used.
While studies of all diseases have traditionally lagged far behind in terms of participation by women, HIV has more recently had a better track record in terms of prevention and treatment trials, and improvements in recruitment and retention guided in part by the efforts of the Women’s Interagency HIV Study (WIHS), which is an NIH-funded cohort (or group) that studies the impact and progression of HIV infection among women in the United States. It is the largest and longest running HIV cohort focused on women. In total, 4,982 women at nine sites have participated in the cohort to date. The WIHS cohort is also uniquely diverse in that it is reflective of the US epidemic among women. The WIHS cohort is a great platform to advance HIV cure-related research in the United States. WIHS participants volunteer in studies that measure the HIV reservoir in the blood, genital tract, and other tissues, that study the role of sex hormones on HIV reservoirs and that examine the relationship with ART pharmacology.
The WIHS cohort has been creative in overcoming challenges to women’s participation in HIV cure research. For example, if women are asked to come in fasting for a lab test, the study site provides a substantive meal after the procedure. Providing mileage reimbursements, metro vouchers, and taxi rides are critically important, since transportation issues are a main deterrent to participation in research. Other strategies to improve sex equity in HIV cure-related research include addressing eligibility criteria, adapting recruitment strategies, and engaging community members as early as possible in the process. For this reason, WIHS could serve not only as a model for successful recruitment and retention of women living with HIV into research, but also as a source of participants who might be inspired to participate in HIV cure-oriented research.
Including women in HIV cure research means:
- Thinking about what they need: different types of recruitment strategies and study coordination which may benefit from partnerships with different organizations or advocacy groups
- Listening to what they want: information and a chance to participate, fair reimbursement and compensation, assistance with logistical barriers
- Designing studies that reflect them: re-thinking eligibility criteria to balance participant risk with exclusions that disproportionally affect women
- Prioritizing their involvement: a few women or a single study is not enough, we need to advocate for representation of all women, including transwomen
More Resources on Women and HIV Cure-Related Research
The Well Project/Women’s HIV/AIDS Research Initiative
The Well Project is a non-profit organization whose mission is to change the course of the HIV/AIDS pandemic through a unique and comprehensive focus on women and girls.
Treatment Action Group
A great resource for articles, reports and other information related to HIV cure research efforts.
Advocacy resources: treatmentactiongroup.org/CURE/advocacy
Media monitor which tracks cure research related news, places stories in context and addresses inaccuracies:
treatmentactiongroup.org/cure/media-monitor
A listing of clinical trials and observational studies related to the research effort to cure HIV infection:
treatmentactiongroup.org/cure/trials
AVAC
AVAC’s work includes a range of activities aimed at addressing: ethical issues, including community involvement in research; standards of prevention and care in trials; and community engagement and research literacy outside the context of a specific clinical trial or intervention.
HIV Cure Research Glossary
This glossary is designed for the media and laypersons interested in understanding the issues involved in HIV cure-related research.
CUREiculum
The CUREiculum is a suite of tools that provides simple, accessible information on HIV cure research, organizing into a systematic format for ongoing or issue-specific learning.
Social and Ethical Aspects of HIV Cure Research (searcHIV)
searcHIV is a multi-site, multi-disciplinary working group focusing on investigating the biosocial implications of HIV cure research.
Women’s Interagency HIV Study (WIHS)
The Women’s Interagency HIV Study (WIHS) is a large, comprehensive prospective cohort study designed to investigate the progression of HIV disease in women.
New Report: Investment trends for HIV prevention and cure R&D
It is said success breeds success. 2016 was a year of encouraging progress, indeed success, on a number of HIV prevention fronts. Two trials of the dapivirine vaginal ring showed efficacy, a spate of new vaccine and antibody trials began, and a trial of long-acting injectable PrEP launched.
Those developments are successes by any measure, and yet this year’s funding report from the Resource Tracking for HIV Prevention Research & Development Working Group (Working Group) shows that prevention funding continues to slowly decline overall. Over the same time, cure research got a big bump from global funders. A separate cure-focused brief from the Working Group, developed in partnership with the International AIDS Society (IAS), showed investment in cure research tripled since 2012.
Released today, the Working Group’s latest annual report on global investment in biomedical HIV prevention shows that overall funding for HIV prevention research and development (R&D) has fallen to its lowest level in a decade.
- Download HIV Prevention Research & Development Investments, 2016: Investment priorities to fund innovation in a challenging global health landscape
- Download graphics from the report
- Download the press release
- Download Global Investment in HIV Cure Research and Development in 2016: Funding for a cure remains a priority
The prevention research report notes that funding for preventive vaccine research constituted the bulk of all investments, followed by investments in cure, microbicides, prevention of mother-to child transmission (PMTCT), PrEP, medical male circumcision (VMMC), treatment as prevention (TasP) and female condoms. Over half of the 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 PrEP, VMMC and TasP, research in this area can be expected to slow down. Nevertheless, the overall trends bear close watching and strong advocacy to ensure that research continues. The progress of this research in the context of flat funding should not be misconstrued. Flat funding will not get us where we need to go next.
Taking stock of all that’s been accomplished with a decade of flat funding, it’s important to note that two million people continue to be infected each year. To achieve control of the epidemic, the field must also take stock of what could be achieved with the right priorities.
The right products need to be tested in the populations who need them most, and research does not always connect well to the people who are most at risk. The report explores the demographic breakdown of almost 700,000 participants in ongoing HIV prevention trials in 2016, with the majority of these volunteers residing in sub-Saharan Africa, most notably in treatment as prevention trials in Botswana, Uganda, Kenya and South Africa. Only one in eight trial participants in 2016 belonged to a population most affected by HIV, including MSM and transgender women, injection drug users and cisgender women.
An intensifying trend towards a small number of large investors is concerning. Together, the US public sector and the Bill & Melinda Gates Foundation (BMGF) represented 88 percent of the total global investment in 2016, compared to 81 percent in 2015. Simply put, for every dollar spent on HIV prevention R&D in 2016, 88 cents came from just two donors.
On a hopeful note, global investment in research toward an HIV cure increased to US$268 million, a 33 percent increase over 2015 levels, with a number of new funders, and an expanded research portfolio at the US National Institutes of Health. The majority of investments (US$253.2 million) came from the public sector with US$13.8 million invested by philanthropies such as Aids Fonds, amfAR, CANFAR, the Bill and Melinda Gates Foundation, Sidaction and Wellcome Trust.
This is a vigorous period in research and development, reflecting a growing recognition from the global community that research has to be part of the long-term fight to end the HIV epidemic. Now is the time to support continued progress with additional, well-targeted resources.
The Resource Tracking Working Group hopes these reports will serve as tools for advocacy and be used to develop public policy that accelerates 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
Declining Funding and Shrinking Donor Base Imperils Continued Success of HIV Prevention Research; European Countries Called to Renew Support
Contacts
AVAC: Kay Marshall, kay@avac.org, +1-347-249-6375
IAVI: Rose Catlos, rcatlos@iavi.org, +1-212-847-1049
New York and Paris —
A new report released today ahead of the 9th IAS Conference on HIV Science documents 2016 funding and highlights a continuing trend of flat or declining funding and its potential impact on further innovation in HIV prevention research and development (R&D).
The Resource Tracking for HIV Prevention R&D Working Group’s (RTWG) 13th annual report, HIV Prevention Research & Development Investments, 2016: Investment priorities to fund innovation in a challenging global health landscape, documents the lowest annual investment in HIV prevention R&D in more than a decade. In 2016, funding for HIV prevention R&D decreased by three percent (US$35 million) from the previous year, falling to US$1.17 billion.
At a time when the field is moving towards a new slate of efficacy trials across the prevention pipeline and follow-on research for successful antiretroviral-based prevention options is underway or planned this trend is worrisome, particularly in light of uncertainties around the sustainability of public sector support from the US and other funders. Even small declines in funding can delay or sideline promising new HIV prevention options that are needed to end the HIV epidemic.
The US continued to be the major funder of HIV prevention research. In fact, 88 cents of every dollar spent on HIV prevention R&D in 2016, came from just two donors: the US public sector and the Bill & Melinda Gates Foundation. In contrast, European public sector funding fell by US$10 million from 2015, and at US$59 million, accounted for just six percent of all public sector investment. This is the lowest European funding recorded in the last decade and marks a 52 percent decrease from the peak funding (US$124 million) in 2009. In addition, the number of philanthropic donors fell sharply from a total of 27 in 2015 to just 12 in 2016.
The RTWG renewed a call for a greater range of donors to increase the stability of R&D financing and cushion potential impact if any of the major funders were to reduce their investments. Noting increases in public sector funding from the Netherlands and Sweden, the RTWG called on other European countries to increase investment in critical HIV prevention tools to help end the epidemic.
The past year has seen one new HIV vaccine efficacy trial begin and another planned to begin later in 2017; a novel proof-of-concept trial of antibody-mediated prevention underway; a monthly vaginal ring with the antiretroviral (ARV) drug dapivirine proven effective and under review by the European Medicines Agency; a multipurpose technology combining dapivirine and a contraceptive has launched early-stage trials; a long-acting ARV-based injectable PrEP formulation is beginning efficacy trials; and, finally, daily oral PrEP delivery programs are being scaled up in multiple countries. And behind these more advanced R&D activities come many other different HIV prevention modalities poised to prove themselves in early-stage research.
“The latest figures from UNAIDS show us that there has been progress toward meeting the 90 90 90 treatment goals, but there has been less progress – and less reporting – on meeting the prevention goals that are critical to epidemic control,” said Mitchell Warren, AVAC executive director. “We need to not only vastly accelerate roll out of HIV treatment and existing prevention options, we need continued and sustained investment to keep HIV prevention research on track to provide the new tools that will move the world closer to ending AIDS.”
The RTWG has tracked more than US$17 billion in investment towards biomedical HIV prevention since 2000 and warned that the greatest impact of this investment could be lost without continued and sustained support to move promising prevention options from laboratories and clinics into the lives of those who most need them.
“We are at an incredibly exciting time in the field of HIV prevention research and development with more life saving innovations, science and technology coming to the forefront than ever before,” said Luiz Loures, Deputy Executive Director of UNAIDS. “We cannot allow a lack of funding to set back progress. Invest now and we can end AIDS by 2030.”
The report documents some critical increases in funding, including the highest annual investment in preventive HIV vaccines since 2007, which includes the highest investment by the US public sector in preventive vaccine research since 2000, in part because of the start of the first vaccine efficacy trial in almost a decade. Yet European public sector investment in vaccine research was the lowest since 2001. The increase in support for vaccine research comes at a critical time in vaccine R&D and is an example of funders responding to the need for investment to keep promising research moving forward. The RTWG noted this level of investment should be occurring across the field to support the broadest possible pipeline of promising new HIV prevention options.
“A true end to AIDS will only be possible if we can develop and deploy an effective HIV vaccine and other innovative biomedical products for HIV prevention” said Mark Feinberg, President and CEO of the International AIDS Vaccine Initiative (IAVI). “With growing risk of increasing rates of HIV infection due to demographic trends and incomplete reach of HIV treatment programs, advances being made in HIV R&D needs support and acceleration. Progress can only happen with sustained public and private sector investment in HIV prevention R&D.”
The HIV field comes together in Paris next week at IAS2017 at a time when there is both much to be optimistic about in HIV science and in the accumulated knowledge of what and how we need to deliver treatment, prevention and care to the people who need it most. Yet, as the title of the report notes, this optimism faces a volatile global health landscape. Funding constraints, policy changes, shifting donor priorities and shifting demographics will all play a role in the world’s ability to respond to the continued challenges that HIV presents.
“After years of prudent and increasingly high-impact investment in HIV prevention and treatment, we have seen amazing dividends in lives saved, families kept together, communities revitalized and economies boosted,” added Warren. “We cannot lose that momentum. We have the innovative science. Now we need an expanded cadre of innovative funders who will work with us to ensure a continued return on investment in more lives saved and more infections averted.”
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 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.
CROI 2017: A View from My Seat at the Table
The annual Conference on Retroviruses and Opportunistic Infections (CROI) is an annual gathering where advocates and researchers learn where the science on HIV is taking us. The findings can be both grand and granular. They answer questions, raise new ones or both. And not all of those questions are strictly about science. Two of AVAC’s partners have been reflecting on what they took away from the conference, insights that inform our thinking long after the sessions end and results are published.
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.
There are conferences that I attend where I can be “Rob Newells, Executive Director for AIDS Project of the East Bay (APEB).” The Conference on Retroviruses and Opportunistic Infections, more commonly known as CROI, is not one of those conferences. At CROI, the ED hat comes off, and I’m purely a community advocate again. This year, that was even more true than in previous years. As I looked around the room of Community Educator Scholars (a program that supports advocates attending CROI) as we gathered for our first early morning breakfast of the week, I immediately noticed that I was the only African American man at the table. There were two African American women (one Scholar and one member of the Community Liaison Subcommittee) and several Africans (shout out to my brothers Ntando, Simon and Supercharger), but no other Black men from the United States. It wasn’t the first time that I’ve been the only one, and I know it won’t be the last, but—if I’m being honest—I was both disappointed and stressed by it. I felt a lot of pressure to be the eyes and ears for my community in a way that I hadn’t felt in previous years.
From a community perspective, CROI is the most boring meeting I attend. It’s 4,000 science and research geeks talking to each other about what they’ve been doing locked away in their labs for the last few years. Most of the news that gets reported after CROI is for science and research geeks, and those reports usually miss the things that I find interesting or that I think my community would find interesting, useful, and relevant. So, in an attempt to rectify that shortcoming, I attended all of the plenary sessions and a bunch of the oral abstract sessions and even took my time to talk to presenters during the poster sessions. I took lots of notes and pictures of slides, and when I returned home (after another conference the following week) I talked it all through with my staff. It took a while longer for me to organize my thoughts into a coherent presentation that I could use for the community report-back I coordinated at the Alameda County Public Health Department on National Women and Girls’ HIV/AIDS Awareness Day. This is some of what I shared.
CDC’s oral presentation on HIV Incidence, Prevalence and Undiagnosed Infection in Men Who Have Sex with Men gave us good news and bad news. The good news is that the percentage of undiagnosed HIV infections decreased for all racial/ethnic groups between 2008 and 2014. (That tells me we’ve been doing a better job of testing.) The bad news is that there was an increase in HIV incidence among Latino MSM and MSM between the ages of 25 and 34. (Annual infections among Black MSM dropped from 10,100 in 2008 to 10,000 in 2014. I don’t see that as anything to write home about, but a decrease is a decrease, right?)
Anal Cancer
I had my third or fourth high resolution anoscopy (HRA) just before CROI, so I was particularly interested in a few of the abstracts related to anal cancer. (There were seven posters and four oral abstract presentations on anal cancer this year, so I wasn’t the only one interested.) While anal cancer is fairly rare overall, men living with HIV who have sex with men are 60-190 times more likely to get anal cancer than the general population. We know that certain types of HPV are responsible for most anal cancers, and most MSM living with HIV have HPV of one type or another. What we didn’t know was what we should be doing about it. What I took away from CROI 2017 was that anal cancer screening should start at 30 to 35 years old for MSM living with HIV. Insured folks like me should get an annual HRA. Unfortunately, HRA is not the most cost-effective prevention tool, and resources to perform the test are limited worldwide. Additionally, patients who rely on the Ryan White AIDS Program or Medicare for coverage have to settle for a digital rectal exam (exams where the doctor inserts a gloved, lubricated finger into the anus to feel for unusual lumps or growths) to detect anal cancer because an HRA isn’t covered. As fun as a digital rectal exam may sound, it’s not that effective. HRA detects the most cancers. (I know from personal experience. I asked my primary care physician to refer me for an anal pap smear and HRA a few years ago. He didn’t find anything suspicious with the digital rectal exam, but he gave me the referral anyway. The HRA found a stage 4 pre-cancerous lesion which was removed during the procedure. Thank you, Kaiser Permanente.)
Antibodies
Bridge HIV in San Francisco is one of the sites for the AMP (antibody mediated prevention) Study, and I know people in my community who are enrolled so I paid attention. Antibodies are a big deal in HIV research. My takeaway from CROI was that the current study won’t produce a home run that will work for everyone. Researchers hope to have an understanding about whether or not antibodies can work for prevention, but as public health intervention it is cumbersome, involving monthly clinic visits and transfusions. And no matter the results from AMP, vaccines based on neutralizing antibodies are still a long way off.
Cure Research
There were two things I found interesting in the cure research presented this year. The first was that people on effective antiretroviral therapy are not producing new HIV-infected cells. Cells proliferate before they die off. That means that earlier detection and treatment results in fewer proliferating cells with less diversity and smaller reservoirs. That might make HIV easier to target and cure. The other thing that caught my attention was that estrogen blocks RNA replication. That discovery leads to at least two pathways to cure: Can we block estrogen to bring latent cells out of hiding (the “flush and kill” strategy), or can we increase estrogen to keep RNA blocked (the anti-proliferation model)?
Drug Use and MSM
Over the past few years, I have heard from friends in Oakland and Atlanta that there was an increasing problem with crystal meth use among Black MSM. I’ve had conversations with many of my colleagues about the increasing mention of PnP (Party and Play) on dating/hook-up app profiles. For years, the common assumption has been that meth is for white boys, but apparently more and more black men are going that route. There were a couple of posters about drug use and MSM that I totally expected to confirm that for me. The first, from CDC, looked at drug use by MSM in 20 cities across the United States. Surprisingly, they didn’t see an increase in meth use. They saw an increase in prescription opioid use among Black MSM between 2008 and 2014. But just two steps away, the very next poster from George Washington University noted a drastic increase in crystal meth use among Black MSM in Washington, DC, over the same time period. I totally expect to see more research in this area.
Pre-Exposure Prophylaxis (PrEP)
What I heard coming from Seattle about pharmacist-managed PrEP was intriguing. Being able to avoid the cost of a clinic visit could greatly increase access and uptake. I contacted my agency’s pharmacy partner when I got home to find out if they had the ability to order labs and prescribe Truvada for PrEP without patients having a clinic visit. (They can, and we will.)
And there was good news for women. Apparently, there was some confusion after all of the talk about good and bad bacteria in the vaginal microbiome at AIDS 2016. That was in relation to vaginal microbicides. Oral PrEP doesn’t go through the vagina, so the vaginal microbiome has no effect on blood and tissue levels of the drug. Oral PrEP works for women. Period.
There were a few other abstracts dealing with community cohort care for adolescents, HIV testing incentives, and text messaging interventions for PrEP users that were interesting enough for me to mention to the folks at home, but if I’m being honest, I was looking for something else.
CROI 2017 was the first conference in an entire year where I didn’t hear anything from the HPTN-073 team. Instead we heard from a team at Emory University, but what I heard only annoyed me. I don’t need another study that tells me how Black MSM don’t use PrEP. The study led by black men for black men (HPTN-073) showed us what works. Emory presented yet another study that showed us what doesn’t work. They studied Black MSM aged 16 to 29 in Atlanta. Participants were offered risk reduction counseling, condoms and lube, and non-incentivized oral PrEP. After viewing a brief education video from WhatIsPrEP.org, the men who expressed interest were scheduled to see a study clinician to initiate PrEP.
The study results indicated that 56 percent of the men expressed interest but 39 percent of those never showed up for the initiation visit with the clinician. Of the ones that did come back, only 35 percent initiated PrEP. The study team’s conclusion was that, “even after amelioration of structural barriers that can limit PrEP use,” PrEP uptake was suboptimal. What structural barriers, you ask? Only lack of health insurance was addressed. (As if that’s the most pressing structural barrier Black MSM face in the United States.) When I asked about what else was done to engage these men based on what we know from HPTN-073, I was told that there is really “no hard, a priori evidence that more aggressive interventions are needed” for Black MSM.
I sat down so that I wouldn’t come off as the angry Black man, but when 79 percent of the participants in HPTN-073 accepted PrEP after a series of counseling sessions that combined service referral, linkage and follow-up strategies to address unmet psychosocial needs (part of what that team calls C4, or client-centered care coordination), I would argue that the need for more aggressive interventions is obvious. A study led by black men told us how to work with black men. Apparently, someone needs to fund more “For Us, By Us” studies so that we have a body of evidence showing what works because I’m tired of hearing what doesn’t work.
There were no exciting results from large efficacy trials at this year’s CROI like there have been for the last several years. It was back to basic science. That means the conference was even more boring than it normally is. But when I returned to Oakland and put my E.D. hat back on, I realized that I had the power to implement some of what I learned without waiting for studies to be published or government agencies to catch up to the science which could take years. I had the power.
In addition to client-centered care coordination and pharmacist-managed PrEP, we are in the process of adding an optional SMS intervention to the PrEP program at APEB, and we’ve started working with La Clinica de la Raza—a local community-based organization that prioritizes Latino populations—to support efforts to address the increasing HIV infection among Latino MSM. That’s why I go to CROI. That’s why I’m grateful to the scholarship committee for supporting my attendance and to AVAC for always providing what I need in order to stay on top of new developments in biomedical HIV prevention research. That’s why I wish I wasn’t the only African American man at those daily 7am breakfast meetings.
…cue Solange’s “F.U.B.U.”
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.
- Read the letter here—organizational sign-ons accepted until November 30, 2016.
- Download this factsheet, explaining the trial in plain language.
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.
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.
- Click here to download the full Report and here for a one-page summary
- Click here for the press release
- Click here for an infographic from AVAC’s new issue of Px Wire
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.
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.