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]  

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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.” 

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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]

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Px Wire April-June 2010, Vol. 3, No. 2

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy. Highlights in this issue include: next steps in AIDS vaccine trials in the post-Thai vaccine trial (RV144) era; “test and treat” approach for prevention presented at CROI; a preview of AVAC Report 2010; information on the Microbicides 2010 Pre-Conference Advocacy Workshop; new funding for advocacy related to MSM and prevention research; six new clinical trials looking at enhanced prevention strategies.

Px Wire January-March 2010, Vol. 3, No. 1

PxWire is AVAC’s quarterly update covering the latest in the field of biomedical HIV prevention research, implementation and advocacy. Highlights in this issue of PxWire include updates on: the results from MDP 301, a trial of the microbicide PRO 2000, which lay to rest its prospect as a viable microbicide; CDC’s newly modified PrEP trial (TDF2 in Botswana), which changed its status as an efficacy trial to a safety and behavioral study; the evolving effort to understand the Thai prime-boost AIDS vaccine results; recent NIH grants that nearly double global spending on rectal microbicides; and a timeline of 2010 trial milestones—what trial results are expected and what new studies are scheduled to commence?

Press Release

AVAC Praises Thai AIDS Vaccine Trial Collaborators and Volunteers for Historic Study

New York, NY, September 24, 2009 , “Today marks an historic milestone in the search for an AIDS vaccine; we now have evidence that it is possible to reduce the risk HIV infection with a vaccine,” said AVAC executive director Mitchell Warren, reacting to the results of the first AIDS vaccine trial to ever show efficacy at preventing HIV. “It will take time and resources to fully analyze, understand and validate the data, but there is little doubt that this finding will energize and redirect the AIDS vaccine field as all of us begin the hard work to translate this landmark result into true public health benefit.”

“We congratulate the trial sponsors, scientific collaborators and partners who conducted this trial, and especially want to thank the more than 16,400 Thai men and women whose altruism and commitment as trial volunteers made this effort possible. These volunteers and their communities have made an inestimable contribution to HIV prevention research. We all owe them a debt of gratitude,” Warren said. “As we move forward in our search for vaccines and other new HIV prevention interventions, researchers will need the collaboration of tens of thousands more volunteers around the world in additional trials. We are confident that many more communities and individuals will follow in their footsteps.”

As the trial team reported in Bangkok today, the Thai prime-boost trial found that rates of HIV infection were roughly 30 percent lower among volunteers who received the vaccine versus those who received the placebo. This is the first evidence of an AIDS vaccine providing any level of protection against HIV infection. Statistical analyses presented as part of this initial announcement support the validity of the finding. It is important to remember that the trial was a “test of concept” study designed to identify initial signs of promise in a product. The trial sponsors and implementers, led by the US Military HIV Research Program and funded by the National Institutes of Allergy and Infectious Diseases (NIAID), have been clear that additional studies would be needed to further understand any positive result. There is now an imperative on the trial team and the field as a whole to determine what those steps will be and to implement them with all due haste. Additional analysis of the trial data are expected to be presented at the annual AIDS vaccine meeting that will take place in October.

The trial looked at vaccine impact on risk of infection and on viral load among vaccine and placebo recipients who received the vaccine and went on to acquire HIV. The vaccines themselves are not capable of causing infection. There was no evidence of an impact on viral load, a goal that has been embraced by many vaccine stakeholders as more realistic and attainable than an impact on risk of infection.

“These results move us one step further along in the marathon journey of AIDS vaccine research that continues. They also demonstrate that the scientific process is remarkable and unpredictable, and underscores the need for testing strategies in human efficacy trials. We look forward to more data from the trial in the coming weeks that will help guide the decisions about the design of additional trials of this strategy, and the impact of this finding on broader AIDS vaccine research,” Warren said.

“AVAC calls on the trial sponsors, vaccine manufacturers, researchers, funders and others in the field to work quickly, cooperatively and boldly to translate these results into development of a scientific action plan, a plan for community engagement in Thailand and around the world, and a broader communication effort to convey both the promise and limitations of this result. Above all, we must ensure that all stakeholders, including private industry, which played a critical role in this trial, reaffirm their commitments to work that will lead to eventual access to an effective vaccine for people around the world, ” Warren said.

The trial team and Thai collaborators held extensive consultations to determine next steps in various scenarios and determined that a vaccine effect of 50% or higher would trigger a licensure application in Thailand. This finding does not reach this threshold. The same consultations determined that a modest effect, such as was reported today, would trigger additional discussions about the way forward. These new consultations are an essential next step and should include a range of stakeholders including members of communities that might use such a vaccine.

Stakeholders within Thailand and around the world must recognize and rise to the challenge of explaining the promise of this proof of concept as well as the rationale for proceeding with a thorough consultative process and data analysis before making any decisions about future access.

It is important to note that the two vaccines tested in the Thai trial contain synthetic fragments of subtype E, one of the most common HIV strains circulating in Thailand and Southeast Asia. The regimen also contains subtype B, which is most common in North America and Europe. Therefore this result estimates the level of protection conferred by a vaccine that includes genetic fragments matched to the common circulating subtype. Scientists do not know whether a vaccine that is effective against the strains that are found in a given geographical area will also be effective in other areas and against other strains of HIV. The trial collaborators and other experts are already planning follow-up studies to confirm and elaborate on this and other findings from this trial.

“This is an astonishing scientific achievement, well beyond the expectations of many scientists. It starts a new chapter in the search for an HIV vaccine: to make highly protective vaccines that can be made available to all who need them. There is a great deal of work to be done on many fronts at once, and AVAC is fully committed to hastening that day. We need to enlist a larger number of new vaccine advocates to keep the process moving productively as quickly as feasible,” said Bill Snow, an AIDS vaccine activist since 1991, and a co-founder of AVAC in 1995.

There are also still other HIV vaccine strategies in laboratory and human testing. Furthermore, other HIV prevention options, particularly microbicides and pre-exposure prophylaxis, or PrEP, are being tested in efficacy trials which will yield results in the next few years. In the last few years, clinical trials have also shown that medical male circumcision can be effective at reducing the risk of HIV infection in heterosexual men.

“This step adds immensely to the drive for comprehensive HIV prevention,” Warren added.  “That means perfecting methods and ensuring access for all who need it to existing HIV prevention and treatment options, including male and female condoms, behavior change counseling, male circumcision, clean needles, harm reduction and antiretroviral drugs; ensuring continued research to find effective new options, including vaccines, microbicides, and PrEP; and planning for integrating these new interventions into combination programs.”

More information about the Thai trial results is available on the AVAC website at http://www.avac.org/thaitrial.htm. Additional information will be added as it becomes available.

  Contact: Mitchell Warren, +1 (914) 661-1536, [email protected]; Kay Marshall, +1 (347) 249-6375

Anticipating the Results of the Phase III AIDS Vaccine Trial in Thailand

A 2009 document discussing the RV144 vaccine trial in advance of efficacy data. It provides background information on the vaccine candidate and trial design, and explores potential scenarios for the results.

Press Release

Shifting Scientific, Health Priorities and Global Economic Downturn Impact Investment in HIV Prevention R&D

Cape Town — A new report on investment in HIV prevention research in 2008 finds that HIV vaccine research funding levels decreased for the first time since investment trends have been tracked. This may have been influenced by shifts in scientific priorities, the declining economy and competing priorities in the larger global health agenda. Despite this decrease, the overall trend since 2000 has been of increasing investment for experimental biomedical prevention strategies.

The report, Adapting to Realities: Trends in HIV Prevention Research Funding 2000 to 2008, was released at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention in Cape Town South Africa by the HIV Vaccine and Microbicide Resource Tracking Working Group. It is available online at http://hivresourcetracking.org/.

The report identified investments of almost $1.2 billion in HIV prevention research in 2008, of which $868 million supported vaccine R&D, and $244 million supported microbicide R&D, while other HIV prevention R&D received much lower levels of funding. AIDS vaccine research declined for the first time since 2000, falling by ten percent from 2007 levels. At the same time, funding for both microbicides and preexposure prophylaxis (PrEP) increased by eight and 13 percent, respectively.

Funding for HIV prevention research remains a relatively small percentage of the overall response to HIV/AIDS. A recent report released by the Kaiser Family Foundation and UNAIDS documented commitments from the developed world for HIV/AIDS treatment and prevention programs in developing countries of $8.7 billion in 2008, up from $6.6 billion the previous year.

“Research to develop new HIV prevention tools and strategies is essential to prevent new infections, and an HIV vaccine still holds the greatest hope to ending the epidemic,” said Michel Sidib�, Executive Director of UNAIDS “It is vitally important that investments into research for HIV prevention be sustained and increased for as long as it takes to reach those goals.”

The Resource Tracking Working Group identified a critical need in this time of shifting budget priorities and economic uncertainty for the HIV prevention research field to identify funding needs and put in place scientific plans to help guide research decisions. These steps will ensure that there is no duplication of efforts and that funding can be linked efficiently to scientific priorities.

“Support and interest in HIV prevention research from public, private and philanthropic funders over the last decade has supported key R&D priorities, moved the field forward and brought us closer to new HIV prevention options,” said Mitchell Warren, executive director of AVAC. “We face tremendous challenges — both scientific and economic — over the coming years, but we must not lose the momentum we have gained. The field needs sustained support from a range of funders. The AIDS epidemic shows no signs of slowing, and the desperate need for new HIV prevention options will not change.”

Levels of funding in 2008 reflected key shifts in the HIV prevention research field. The halting in late 2007 of the Step and Phambili vaccine trials, which were testing a candidate vaccine developed by Merck, ended one of the only pharmaceutical company partnerships for HIV vaccine R&D. This slowing in industry involvement is reflected by a decline in industry funding levels in 2008. Pharmaceuticals and biotech companies in 2008 accounted for only four percent of HIV vaccine research funding. Levels were even lower across other HIV prevention research priorities. Nevertheless, the commercial sector contributes to the development of HIV prevention research in a number of ways through pharmaceutical company support. A number of companies have provided ARV compounds for development as potential microbicides, and as oral PrEP, along with technical support to microbicide product developers.

“The worldwide economic crisis has fueled debate about the best way to invest in global health, with some arguing that AIDS takes up resources at the expense of efforts to deal with other diseases and to improve health systems in the developing world. But given that AIDS is the number one killer in sub-Saharan Africa, and number four in the world, it is imperative that we reverse this pandemic, and that can only be done through improved methods of prevention, including a vaccine. If we can conquer AIDS, we will be able to invest resources in other pressing priorities,” said Seth Berkley, President and CEO of the International AIDS Vaccine Initiative.

It is important to note that HIV vaccine research and development is continuing to move forward. Just today, the South African AIDS Vaccine Initiative announced the start of a trial to study a vaccine candidate developed by local South African scientists. Results are also expected later this year from the largest vaccine trial ever, which successfully enrolled more than 16,000 participants. In addition, researchers around the world are developing new vaccine approaches and conducting basic research to inform vaccine development.

The report notes that increased investment in microbicide R&D may reflect increased interest in research on antiretroviral (ARV)-based candidates. Investment increased in microbicides overall at the same time that the field intensified its focus on ARV-based approaches to microbicide development.

“Increased funding for microbicide R&D over the past decade has fostered a major expansion for the field; clinical trials of microbicide candidates have been conducted in 27 countries around the world; and pre-clinical research has yielded important scientific information. Support from public, private and philanthropic funders is essential to increase R&D for new microbicide candidates,” said Polly Harrison, Director of the Alliance for Microbicide Development.

The U.S. government was once again the primary funder for HIV prevention research, supporting 71 percent of HIV vaccine R&D, 63 percent of microbicide R&D, and providing 46 percent of funding for PrEP prevention research in 2008. A decrease in investment from the U.S. National Institutes of Health contributed to the overall decline of funding for HIV vaccine R&D. The U.S. government investment fell by $39 million, a six percent decrease. Other governments also decreased funding for HIV vaccine research in 2008: European government funding fell by 13 percent and total funding from other countries (including Brazil, Canada, India, South Africa, and Thailand) fell by 16 percent.

The report authors caution that while it is too early to attribute all of the funding decreases to the financial crisis, there is concern that a prolonged global recession could have a major impact on public investment in all HIV/AIDS programs. A recent report from UNAIDS and the World Bank found that the economic crisis has already affected levels of funding for treatment and prevention programs in some developing countries.

The Working Group also reported on investment in operational research related to proven biomedical HIV prevention research interventions — medical male circumcision and ARVs for prevention of vertical transmission of HIV from mother to child. These efforts are being funded at much lower levels that other HIV prevention research, with $11 million supporting research related to rollout of male circumcision and $21 million supporting operations research for prevention of vertical transmission. 

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Press Release

Piecing Together the HIV Prevention Puzzle: AVAC Report Assesses Progress in AIDS Vaccine, Microbicide and PrEP Research and Calls for Urgent Coordination and Leadership in Advance of Upcoming Results

New York, NY — “It’s an exciting time in HIV prevention research. We will see results from a number of critically important HIV prevention research trials this year, as well as see the start of new trials around the world that will yield important answers in the years to come,” said Mitchell Warren, AVAC executive director, at the release of AVAC’s 13th annual report of the field.

“But scientific, community and political leaders must act now to plan for continued research and implementation of effective strategies, or this excitement will be wasted.”

The report — Piecing Together the HIV Prevention Puzzle — looks at AIDS vaccine research, where there is an energized focus on discovery, innovation and basic science and looks at the broader HIV prevention field, particularly the implications of pre-exposure prophylaxis (PrEP) and other strategies in efficacy trials today.

This analysis of the HIV prevention field comes in a year that has already brought disappointment as well as intriguing results from various prevention studies. At the same time, even trials that failed to show overall benefit, such as the Step Study of the Merck HIV vaccine candidate, have continued to generate new, valuable information and questions that would not otherwise exist.

These trials have succeeded as a result of increasingly robust partnerships between researchers and communities grappling with HIV, including gay men around the world and heterosexual women in Africa. These partnerships, along with the persistently high rates of new infections, are a continual reminder of the global commitment to and need for continuing the search for new prevention for as long as it takes.

“We hope to have new prevention intervention pieces to add to the puzzle in the next few years,” said Warren. “But as the slow implementation of male circumcision to reduce heterosexual men’s risk of HIV infection reminds us, we need extensive planning and guidance to ensure research results are translated into real impact against the epidemic. We can’t afford to wait for efficacy results before we begin to plan. We must anticipate and tackle the major hurdles for implementation now.”

The Report identifies major issues for implementation of new prevention options, including:
–    Ongoing global failures to scale up access to HIV testing and counseling services.
–    Persistent inattention to the needs of gay men and other men who have sex with men around the world.
–    Gaps in health care infrastructure that will complicate introduction of any new strategy.

In the Report, AVAC also underscores the importance of WHO and UNAIDS getting involved in planning for the results from PrEP trials before data are available.
“WHO and UNAIDS, along with other stakeholders, need to combine their strengths now to provide leadership and coordination so that the world is ready to work with results from the many ongoing PrEP trials,” said Warren.

Positive results from current vaccine, PrEP and microbicide trials will also present challenges and opportunities for other ongoing and planned HIV prevention trials.

“There has been concern that positive results from PrEP trials would require vaccine or microbicide trials to become larger, longer and more expensive, as PrEP could become a standard of prevention in these trials,” said Warren. “But we believe that success in one trial will open up possibilities and options for research that could combine AIDS vaccines and other interventions as they emerge.”

To help guide efforts in new areas of research and sustain ongoing research, AVAC calls for researchers and trial sponsors to begin planning on how combination strategies can be evaluated.

As the field looks to fit the puzzle pieces together, the AVAC Report also identifies a number of big questions in AIDS vaccine research for 2009 and beyond, focusing on issues such as cell-mediated viral control, HIV genetic diversity, the role of animal models, immune activation, antibodies and adjuvants.

In its analysis of the vaccine field, AVAC also assesses the progress and future potential of the Global HIV Vaccine Enterprise and considers the impact of results from the Thai prime-boost vaccine trial that are expected in September. With over 16,400 participants, this is the largest AIDS vaccine trial ever undertaken.

“In AIDS vaccine and HIV prevention research today, we see a fertile mix of big science and individual efforts, of product-oriented work and of slow and steady basic science,” Warren added.

“What we need now is a quick, strategic, scientific analysis of all the efforts underway, with a goal of identifying gaps and opportunities for synergy both within the AIDS vaccine field and across the vaccine, PrEP, and microbicide fields. AVAC is excited to help move the HIV prevention field toward a collaborative agenda and to prepare now for implementing potential new prevention options.”

Piecing Together the HIV Prevention Puzzle is available at http://www.avac.org/reports.htm. 

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