“We need to use modeling to communicate what the possibilities are and what’s been gained from investments to date.” This was the consensus of a small group of advocates, activists, public health leaders and modelers gathered on September 9 by AVAC and amfAR to take a closer look at the state of epidemiological modeling as it relates to the goal of ending the AIDS epidemic. There is scientific evidence for a range of potent prevention strategies including treatment as prevention, male circumcision in the immediate term and, in the future, microbicides, PrEP and vaccines. But decision makers face real challenges about determining priorities and budgets. Models can’t provide the answers, but they can give a sense of the benefits and trade-offs for different scenarios. On October 3, Tim Hallett, a modeler and epidemiologist from Imperial College London, met in Nairobi with AVAC and a small group of East African advocates including several of our Fellows, to discuss how advocates can be what Hallett calls “informed consumers” of HIV models. In the coming weeks and months, AVAC and its allies will be working to help frame the questions and modeling the needs critical to ending AIDS. Watch this space.
Modeling the End of the Epidemic
A New Tool for Laypeople Serving on Institutional Review Boards
The New HIV Vaccine and Microbicide Advocacy Society (NHVMAS), a partner in AVAC’s work on Good participatory practice for biomedical prevention research, recently published two new training manuals: one for training laypersons serving on ethics committees on how to read and give feedback on protocols, and one on the basics of research ethics. The training manuals and a PowerPoint presentation for training laypersons serving on ethics committees are available for download here. If you have trouble downloading the files or require printed copies, contact us at [email protected].
Press Release
Government Incentives Should Extend to AIDS Vaccine Development
NEW YORK — The AIDS Vaccine Advocacy Coalition (AVAC) today hailed new federal legislation that provides financial incentives for private industry to develop vaccines and other antidotes to protect people in the event of biological or chemical weapon attacks.
But AVAC called on Congress and the administration to extend the same kind of incentives as those provided under Project Bioshield to spur private investment in a vaccine to combat AIDS.
“Every day, 8,000 people die of AIDS-related illness and 14,000 become newly infected with HIV,” said Mitchell Warren, AVAC executive director. “By tearing apart the fabric of entire societies in the developing world and destabilizing governments, AIDS is as much of a national security threat as various agents of biological and chemical warfare.”
Of the estimated $540-$570 million spent for global AIDS vaccine research in 2002, less than 25 percent came from private industry, Warren said. Most of the work was financed by governments and other public-sector sources.
“If we are to find an AIDS vaccine, we must establish new incentives for private industry to greatly accelerate its involvement,” Warren said.
Project Bioshield, signed into law by President Bush on Wednesday, will give private companies $5.6 billion in incentives over the next 10 years to develop and stockpile vaccines and other antidotes to chemical and germ warfare. Among the carrots are guaranteed government purchase of the products and accelerated regulatory approval.
“These are exactly the kind of incentives we need to get the private sector, with its wealth of expertise, more involved in developing a vaccine against the worst plague of modern times,” Warren said. He said similar efforts should be undertaken to spur private investment in vaccines to combat two other killers in the developing world – TB and malaria.
AVAC is a non-profit and non-partisan group that works to speed the ethical development of an AIDS vaccine. It is funded by the Bill & Melinda Gates Foundation, the Ford Foundation and other philanthropic groups.
Press Release
Report on HIV Prevention Research Funding Says New Investment Critical to Capitalize on HIV Prevention Research Breakthroughs
Rome – In the last year, promising trial results and critical scientific breakthroughs have changed the HIV prevention landscape, providing new opportunities for both a broader response to the epidemic with new prevention options and broader clinical and laboratory agendas with new research targets. At the same time, investment in biomedical HIV prevention research remained stable despite the effects of the recent global economic downturn, according to a new report released today in Rome at the 6th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention.
Capitalizing on Scientific Progress: Investment in HIV Prevention R&D in 2010 is the seventh annual report from the HIV Vaccines and Microbicides Resource Tracking Working Group documenting investments in biomedical HIV prevention research from public, philanthropic and commercial sectors. This year’s report argues that capitalizing on recent promising scientific breakthroughs will require substantial additional and sustained investment from a broader set of donors.
The major, and surprising finding of the report, given the global funding environment, is that overall investment in HIV prevention R&D had actually increased, with the modest exception of a one percent decline in vaccine R&D. The report documented a total US$1.19 billion investment in research and development (R&D) for four key HIV prevention options: preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) using antiretroviral drugs, and operations research related to medical male circumcision. Even in the aftermath of a global recession, this investment approached the previous historical high of US$1.23 billion reached in 2007 for these four prevention technologies.
Yet to capitalize on the recent exciting prevention breakthroughs being discussed at the IAS conference, more investment will be needed across prevention technologies and from bench research to operational and implementation research.
“Certainly in this era of economic restraint it is good news that donors continue to see the value of investing in prevention research,” said Paul DeLay, Deputy Executive Director, Programme, UNAIDS, the Joint United Nations Programme on HIV/AIDS. “But as we capitalize on the recent breakthroughs and move quickly to make new forms of prevention available to those who need them most, we need donors to also move quickly to ensure that funding shortfalls do not become roadblocks.”
There is an urgent need to direct resources to accelerate promise into progress. Yet the report recognized that funders continue to confront budgetary constraints, with some having reduced or eliminated their HIV prevention research programs altogether. Funding for HIV prevention research also remains highly concentrated among relatively few funders, and the Working Group warns that this narrow base of funding will threaten the sustainable research effort required at this critical time and highlights the need for broadening that base, importantly including emerging economies.
“The recent promising results of PrEP and treatment as prevention trials tell us that thirty years into the epidemic we may finally be on the path to ending AIDS,” said Mitchell Warren, AVAC executive director. “New prevention options—medical male circumcision, PrEP, microbicides and eventually vaccines—will play a critical role in reducing the cycle of new infections. As we look toward the next 30 years of AIDS, investment in prevention research has never been more important. Going forward we need funding structures that are flexible, agile, and generous enough to adapt rapidly to new opportunities.”
“We have seen tremendous progress in HIV prevention research over the last two years,” said Margaret McGlynn, President and CEO of the International AIDS Vaccine Initiative (IAVI). “Sustaining the momentum built through these advances depends on access to stable funding that can be flexibly applied to the most promising areas of research. This will allow us to build upon the field’s successes and to move promising concepts from the pipeline into clinical trials as swiftly as possible.”
“The recent exciting results in the PrEP and microbicide fields are proof that investment in HIV prevention research is bringing women and men around the world much closer to having a broad range of effective HIV prevention options,” said Zeda Rosenberg, CEO of the International Partnership for Microbicides (IPM). “Wise investments now in laboratory and clinical research, and in efforts to roll out new interventions will pay off as HIV infections decline significantly in the coming decades.”
The report is available online at: www.hivresourcetracking.org.
Kay Marshall (AVAC), [email protected], +1-347-249-6375
Sophie Barton-Knott (UNAIDS), [email protected], +41 79 514 6896/
+41 22 791 1697
Lauren Wesolowski (IAVI), [email protected], +1-212-328-7420
###
The Working Group is composed of AVAC, the International AIDS Vaccine Initiative (IAVI), the International Partnership for Microbicides (IPM), and the Joint United Nations Programme on HIV/AIDS (UNAIDS).
Px Wire July-September 2011, Vol. 4, No. 3
PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy. This edition of PxWire includes a feature on the new momentum to end the AIDS epidemic in light of the recent HPTN 052 results; an exploration of the progress in AIDS vaccine research and the need for evolving trial designs to accommodate new trial results such as those from HPTN 052 and iPrEx; and, as always, a centerspread with an updated timeline of biomedical HIV prevention efficacy trials and a world map showing where various strategies are being tested.
PxWire January-March 2011, Vol. 4, No. 1
PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy. This issue of PxWire takes inventory of the regulatory, trial-planning and scientific agenda-setting steps that are being taken with respect to recent positive trial results. It reviews ongoing and proposed next steps that have been triggered by the Thai prime-boost AIDS vaccine trial, the CAPRISA 004 microbicide trial and the iPrEx trial of once-daily TDF/FTC for pre-exposure prophylaxis.
2010 AVAC Report: Turning the Page (Thai translation)
The AVAC 2010 Report, Turning the Page, highlights that the biomedical prevention field is entering the next chapter of its development. The past year brought the first evidence, from the Thai Prime-Boost trial, that an AIDS vaccine could prevent HIV in humans, as well as significant preclinical findings around potent, HIV-specific neutralizing antibodies.
At the same time, two microbicide trials testing the candidate PRO 2000 yielded seemingly different, but ultimately disappointing results, and the field now prepares for the release of results from CAPRISA 004, the first ARV-based microbicide effectiveness trial.
Press Release
AVAC Calls for AIDS Vaccine Field to Implement New Scientific Strategic Plan Released by Global HIV Vaccine Enterprise
New York, NY, – AVAC welcomes the new Global HIV Vaccine Enterprise Scientific Strategic Plan, released today, as a critical document that the field must implement as part of ongoing efforts to improve coordination, efficiency and transparency to quickly capitalize on recent advances in AIDS vaccine research.
The Plan comes at a crucial time in the field. In the last year, the RV144 Thai vaccine trial proved that an AIDS vaccine is possible, which along with the identification of new potent, HIV-specific neutralizing antibodies have re-energized AIDS vaccine researchers, advocates and funders.
“This is the most exciting period in HIV vaccine research in the last three decades. As we enter this new era in vaccine and HIV prevention research, scientists, funders and advocates are grappling with both the excitement of scientific breakthroughs and the realities of funding shortfalls. This plan has the potential to help meet the current challenges in the field,” said Mitchell Warren, AVAC executive director. “But a plan is only as good as its execution, and AVAC will be watching and reporting on how the field comes together to capitalize both on the consensus of the plan and the promise of the science.”
The new Scientific Strategic Plan provides important signposts for the way forward, but the field must also be willing to be flexible and adaptable to quickly react to the changing realities of the AIDS epidemic and biomedical research.
“This plan proposes a comprehensive strategy that goes beyond the scientific activities of any single funder or organization,” said Bill Snow, a co-founder of AVAC, who was involved in the planning process. “There is now an urgent need to broaden international participation in the work that is necessary to build on the recent developments that have made HIV vaccine design and development as exciting and essential as it has ever been.”
AVAC recommends the following actions to realize the potential of the Plan:
- The Enterprise, through the secretariat and its governing Council, develop a comprehensive and ambitious resource mobilization strategy that identifies key gaps, new funding sources and opportunities to make the best use of already committed funds.
- The Enterprise secretariat, with guidance and input from its scientific working groups, identify priority, time-sensitive issues that could be resolved or refined through immediate, Enterprise-led action.
- Each Enterprise member articulate how their funding and/or scientific decisions are aligned with the Plan, or articulate why not.
AVAC believes it is crucial that the Global HIV Vaccine Enterprise Council, Director and Secretariat drive execution of the plan. Collectively, they should hold themselves and the full range of stakeholders, including donors, scientists and organizations, accountable for matching their work to the plan’s priorities with urgency.
“Now more than ever, HIV vaccine research must also be seen in the context of the overall research agenda for HIV prevention,” Warren added. “Even as this plan is executed, the AIDS vaccine field must adapt to emerging results from other biomedical prevention trials, such as microbicides and pre-exposure prophylaxis (PrEP), by preparing for positive data with new ideas for trial design and combination prevention.”
AVAC’s annual state of the field report on vaccines and HIV prevention research, which provides more information about the way forward for prevention research and more detail about our expectations of the Global HIV Vaccine Enterprise, is available online at www.avac.org/avacreport. The Global HIV Vaccine Enterprise Scientific Strategic Plan is being published open access today by Nature Medicine and available at www.vaccineenterprise.org.
Contact:
Mitchell Warren, +1-914-661-1536, [email protected]
Kay Marshall, +1-347-249-6375, [email protected]
###
Press Release
Report Warns Flat Funding for HIV Prevention Research May Limit Ability of Researchers to Move Promising Approaches Forward
VIENNA (21 July, 2010) – Following significant advances in vaccine and microbicide research, importantly including results presented today of 39% efficacy in the CAPRISA 004 microbicide gel trial among women in South Africa, a new report released today warns that flat funding for HIV prevention research may limit researchers’ ability to quickly move promising approaches forward.
The report examines investment in HIV prevention research in 2009 and finds that the onset of a global recession did not immediately impact funding levels for biomedical HIV prevention research. Total funding remained stable at approximately US$1.165 billion for preventive vaccines, microbicides, pre-exposure prophylaxis (PrEP) and operations research related to male circumcision.
In the face of an economic crisis that has deeply affected the economies and public-sector budgets of HIV prevention research funders, level funding for HIV prevention is cause for cautious optimism. Yet much of the 2009 funding was likely reflective of resources committed when the global economy was far healthier. As current funding commitments come to an end, the concern will be whether funders will be able to renew commitments at existing funding levels. Furthermore, the report authors argue that flat funding of HIV prevention research could have serious consequences for the field as results from critical prevention trials move the research agenda forward. They warn that researchers could have insufficient resources to advance important opportunities to prevent HIV.
Advancing the Science in a Time of Fiscal Constraint: Funding for HIV Prevention Technologies in 2009, the sixth annual report from the HIV Vaccines and Microbicides Resource Tracking Working Group, was released today at the XVIII International AIDS Conference in Vienna, Austria. It documents investments in biomedical HIV prevention research from public, philanthropic and commercial sectors in 2009. HIV vaccines continued to receive the majority of funding, with a total of US$868 million, which was equal to 2008 funding levels. Investment in microbicides was US$236 million, a decline of 3 percent from 2008 levels. Funding for oral pre-exposure prophylaxis (PrEP) increased by 18 percent over 2008 levels to US$52 million.
The stability in funding is encouraging, given a 10 percent decrease in funding for AIDS vaccine research seen in 2008, but the Working Group identified several areas of concern if funding remains flat, including escalating costs of late-stage clinical research, dependency on a small group of funders and a lack of diversity in funders. In addition, the Working Group stresses that the CAPRISA 004 results, while tremendously exciting, are by no means the definitive answer about antiretroviral-based microbicides and appropriately resourced confirmatory and exploratory research will be needed.
The Working Group has documented an overall trend since 2000 toward increased funding of new funders joining in the effort to support HIV prevention research. Yet in 2009, this funding stability was largely the result of increased or sustained funding by the U.S. National Institutes of Health and the Bill & Melinda Gates Foundation, which together accounted for 79 percent of vaccine funding, 59 percent of microbicide funding and 70 percent of PrEP funding.
“With five new infections, for every two people newly on treatment we cannot give up our quest for new HIV prevention tools,” said Michel Sidibé, Executive Director of UNAIDS. “Investments for HIV prevention must be enhanced and sustained.”
“As we push for expanded funding and political commitments for HIV prevention research and the overall AIDS response, we must also work to find smart and innovative ways to make the best use of available funding to continue to scale up delivery of existing interventions and to look for new ones,” said Mitchell Warren executive director of AVAC. “HIV prevention researchers, advocates and donors must all commit to working together to ensure that we make the best and smartest use of limited resources, while also ensuring that the most promising interventions continue to move forward.”
Recent and upcoming results from several major studies could radically change the trajectory of HIV prevention research and increase the need for funding. These include the results of the RV144 Thai AIDS vaccine trial, which showed modest protection against HIV and scientifically demonstrated for the first time that an AIDS vaccine was possible, results from an important proof of concept microbicide trial CAPRISA 004, released yesterday at the Vienna AIDS conference, and anticipated results from two PrEP trials in the coming year.
“This is a very exciting time in HIV prevention research,” said Seth Berkley, President and CEO of the International AIDS Vaccine Initiative. “As the prevention research field is primed to exploit scientific advances availability and flexibility of funding will be critically important. Our ability to move discoveries into and to undertake even the most critical of these large-scale trials is at risk in the current funding environment.”
“We must work to continuously ensure resources are available to fulfill the promise of new scientific advances that could save millions of lives,” said Dr. Zeda Rosenberg, CEO of the International Partnership for Microbicides. “Microbicides, PrEP, vaccines and treatment-as-prevention are just beginning to show great promise for HIV prevention in large-scale trials. As we work together to develop these tools and transform our global health goals into reality, our success depends on having sufficient resources to keep pace with research developments in the field.”
###
Press Release
Turning the Page to a New Era in HIV Prevention Research: AVAC Report warns promising developments in biomedical HIV prevention could be undermined by current conditions of the global AIDS response
New York, NY, 14 July 2010 – A new report from AVAC surveys the state of biomedical HIV prevention research, including the first evidence of vaccine-induced protection in humans and the emergence of ARV-based prevention—and provides strategic recommendations for moving forward in a time of constrained resources and faltering commitment to ending AIDS.
Turning the Page, AVAC’s 13th annual report on the state of the HIV prevention research field, offers unique context and a timely critique for issues that will be center stage at the upcoming AIDS 2010 Conference in Vienna. These issues are also central to the AIDS response outlined in the first ever US National HIV/AIDS Strategy, released Tuesday.
As the report describes, scientific developments in several arenas of biomedical prevention research have re-energized the search for additional strategies. In the vaccine field this includes the first evidence of vaccine-induced protection and strides in identification of new potent, HIV-specific neutralizing antibodies. Antiretroviral-based prevention also shows potential, and the report provides context for the upcoming results of the CAPRISA 004 microbicide trial, the first effectiveness trial of an ARV-based prevention strategy in HIV-negative people.
The biomedical prevention research field must now develop strategies for pursuing new scientific leads and following through on promising developments without the guarantee of expanded financial resources. In addition, the implications of recent breakthroughs need to be explained clearly to diverse audiences. As the report describes, the next phase of human clinical trials will involve complex designs and questions, and their success will depend on the support of all stakeholder groups. It will be difficult to execute this ambitious research agenda in the context of fiscal constraint—and the field needs to address this head on.
“We face yawning gaps in funding for proven prevention and treatment and a crisis in financial and political will,” said Mitchell Warren, AVAC Executive Director. “There is skepticism about whether disease-specific funding for AIDS is cost effective and skepticism about whether limited funds for AIDS should include funding for AIDS prevention research.”
“The recent report from UNAIDS that proven HIV prevention is having a demonstrable impact on the epidemic in many African countries is good news. But to really have an impact on the epidemic we need additional funding and political commitments for AIDS treatment and prevention programs AND more funding for HIV prevention research,” Warren added.
“The AVAC Report makes the critical point that to capitalize on recent breakthroughs in HIV prevention, we must find smart and innovative ways to make the best use of available funding,” said Chris Collins, AVAC Board Member and Vice President and Director, Public Policy at amfAR, The Foundation for AIDS Research.
The HIV prevention research field has been buoyed by major breakthroughs in recent months and Turning the Page calls for researchers, funders and others to prioritize collaboration and nimble and adaptive planning for replenishing the pipeline with new products and designing clinical trials that will yield the most information to move the field forward.
In recent years, the HIV prevention research agenda has broadened beyond vaccines and microbicides to include antiretroviral-based prevention, including pre-exposure prophylaxis, and, more recently, efforts to understand the role of treatment as prevention. At the same time, HIV treatment programs—once thought to be impossible to implement in developing countries—have expanded to reach millions of people around the world.
“The HIV prevention research agenda must take into account the new realities of the fight against AIDS. We believe that new prevention programs cannot be built while current treatment programs are faltering,” Warren said. “To reach the goal of universal access to healthcare—which includes comprehensive AIDS treatment and prevention—advocates, researchers, health care providers, funders and policy makers must speak with one voice.”
Turning the Page lays out the critical components of a response to AIDS that unites treatment and prevention, including:
- Sustain and expand current treatment and care programs: Funding restrictions are beginning to take a damaging toll on AIDS treatment programs at the precise moment that data are emerging to show that ARV treatment prevents deaths, lowers health care costs and can reduce the risk of HIV transmission. Donors and policy makers must take the critical steps needed to forestall further damage and put treatment programs back on track.
- Actively explore treatment as prevention: There is compelling evidence that earlier initiation of antiretrovirals in HIV-positive people can reduce the risk that they will infect sexual partners with HIV. Additional data will come from an ongoing clinical trial, but the world should begin exploring the practical approaches and implications of scaling up HIV treatment as prevention that can help guide policy makers’ decision-making about potential introduction of treatment as prevention when the data become available.
- Plan for ARV-based prevention: Neither oral PrEP nor topical ARV-based microbicides have yet been proven to have benefit. But, if they do, they will need to be delivered strategically, in programs that provide clear, integrated messages about the risks and benefits of ARVs for prevention in HIV-negative people. Results from CAPRISA 004, the first ARV-based microbicide effectiveness trial, will be delivered next week at AIDS 2010 and results from initial PrEP effectiveness trials are expected in the next 12 months. The field needs to be prepared to address the many questions that will emerge from these results and develop rational plans for ensuring the best use of the potential new options.
“We must also be ready to be surprised. The greatest advances in the fight against AIDS have come about because people and institutions refused to accept conventional wisdom about what was possible,” Warren said. “In 15 years of advocating for AIDS vaccines, we at AVAC have witnessed many moments when an AIDS vaccine was deemed a scientific impossibility. Yet, a trial that had been all but discounted by many provided evidence that a preventive AIDS vaccine is possible. And AIDS treatment programs and their clients have flourished in every possible context around the globe in the face of those who said it was impossible.”
“Now is the best time to invest in an expanded response to the AIDS epidemic. AVAC stands with the global community of advocates for HIV prevention, treatment, research and implementation to expect and demand an extraordinary response to this unprecedented epidemic—our only hope of closing the book on AIDS,” Warren added.
Turning the Page and other AVAC publications, including an upcoming report on anticipating the results of ARV-based prevention trials are available online at www.avac.org.
Contacts: Mitchell Warren, +1 (914) 661-1536, [email protected] / Kay Marshall, +1-347-249-6375, [email protected]
###