Press Release

2014 Omololu Falobi Award For Excellence In HIV Prevention Research Community Advocacy Presented Posthumously to Nigerian Advocate Oyelakin Taiwo Oladayo

Contacts

AVAC: Manju Chatani, [email protected], +1-413-923-8674
Kay Marshall, [email protected], +1-347-249-6375 or +27-76-867-0818

Award honors passionate young advocate lost too soon

Press Release

New report finds missing and incomplete data imperils the global HIV/AIDS response

Contacts

AVAC: Kay Marshall, [email protected], +1-347-249-6375
Mitchell Warren, [email protected], +1-914-661-1536
amfAR: Joana Casas, [email protected], +1-212-806-1602

amfAR and AVAC call for improved, transparent and timely data collection

New York – A new report from amfAR, The Foundation for AIDS Research, and AVAC outlines the need for a new approach to tracking data to guide the key decisions that shape the response to the HIV/AIDS epidemic. Critical and expensive decisions made with incomplete data are undermining the response—even as the systems for collecting this data continue to improve, the report found. Data Watch: Closing a Persistent Gap in the AIDS Response outlines corrective steps to sustain and expand the progress made in the past few years in the AIDS response and lays out key areas where better, more complete data is needed, including:

What proportion of people with HIV globally who are taking antiretroviral drugs remain connected to a clinical provider and have their virus fully suppressed, enabling them to remain healthy and avoid transmitting HIV to others?
What proportions of those communities most impacted by HIV (e.g., young women in Africa, gay men and other men who have sex with men, transgender individuals, sex workers, people who inject drugs) do not have access to effective HIV prevention tools due to pervasive stigma or discrimination?
Is global AIDS funding focused on those programs that will have the greatest impact in reducing transmission and disease burden worldwide?

The report, supported in part by the M•A•C AIDS Fund, makes the case that if we are to achieve ambitious new targets aimed at ending the epidemic by 2030, we must improve our data systems for the HIV response now. Data Watch updates amfAR’s and AVAC’s 2012 Action Agenda to End AIDS, which made the case for a more businesslike approach to ending the epidemic and proposed a multi-year plan with concrete strategies, targets and timelines.

“There is no doubt that the data we have shows that we are making progress in the fight against HIV/AIDS. Importantly, we are moving toward a ‘tipping point,’ when for the first time the number of people with access to HIV treatment will exceed the number of people who become infected,” said Mitchell Warren, AVAC executive director. “But to keep up the momentum, we must improve data systems and identify specific milestones that we need to meet over the next one to three years to ensure we get on – and stay on – target to achieve these ambitious goals.”

The report documents many cases where data is incomplete or missing, finding that sometimes necessary data collection systems are not in place. For example, in most low- and middle- income countries there is very little tracking of viral load—a measure of the amount of HIV in a person’s bloodstream—among people being treated for HIV. In many cases, data exists but is incomplete or not being optimally analyzed. Poor or missing data limits our ability to drive strategic action and accelerate progress toward ending AIDS.

“Good information is critical for making good decisions, and when resources are limited, data matters even more,” said Greg Millett, amfAR’s vice president and director of public policy. “With global AIDS funding falling far short of what is needed, we must maximize the impact of every dollar. The bottom line is clear: more complete and timely data will help save more lives.”

The report calls on UNAIDS, the US-funded PEPFAR program, and the Global Fund to Fight AIDS, Tuberculosis and Malaria to dramatically improve their collection, analysis and reporting of HIV/AIDS information. It outlines which data matters the most, including:

Coverage of core interventions including HIV testing, antiretroviral therapy, voluntary medical male circumcision, prevention of vertical transmission, male and female condom availability, and harm reduction programs.
Disaggregated information by gender, age, key population status, and other key factors. Overall numbers are insufficient.
Indicators of service quality including percentage of people on ART with undetectable viral load tests, retention in care data and more.
Impact data on incidence, HIV prevalence and AIDS-related deaths are the ultimate indicators of success.
Results-linked expenditure data sheds light on where programs are achieving results and on how reallocation of resources could improve program impact.

As part of the Action Agenda to End AIDS, amfAR and AVAC launched Data Watch to help advocates track progress—and to hold the key sources of global HIV information accountable for timely, accurate reports. An Action Agenda to End AIDS, launched by amfAR and AVAC at the 2012 International AIDS Conference, outlined key actions that need to be taken in 2012–2016 to lay the foundation to end the AIDS pandemic. For more information, visit endingaids.org.

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About amfAR: amfAR, The Foundation for AIDS Research, is one of the world’s leading nonprofit organizations dedicated to the support of AIDS research, HIV prevention, treatment education, and the advocacy of sound AIDS-related public policy. Since 1985, amfAR has invested more than $388 million in its programs and has awarded more than 3,300 grants to research teams worldwide.

About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

Press Release

Declining Investment Could Slow Research and Rollout of New HIV Prevention Options

Contacts:
AVAC: Mitchell Warren (in Melbourne) [email protected],
+1‐914‐661‐1536; Kay Marshall, [email protected], +1-347-249-6375
IAVI: Arne Naeveke (in Melbourne), [email protected], +1.646.623.4785; Barbara Rosen, [email protected], +1-212-847-1056
UNAIDS: Sophie Barton‐Knott, [email protected], +41 79 514 6894

Report shows prevention R&D funding falls 4% due to public sector research budget reductions in US, Europe

Melbourne, Australia, 18 July 2014 – Investment in HIV prevention research fell 4 percent in 2013, due to a combination of factors including declining investments by the United States and European donors, changes in the international development landscape and changes in the pipeline of HIV prevention products being tested, according to a new report from the HIV Vaccines and Microbicides Resource Tracking Working Group. In 2013, total investment in prevention research was US $1.26 billion, down US$50 million from 2012.

HIV Prevention Research & Development Investment in 2013: In a changing global development, economic, and human rights landscape is the tenth annual report by the Working Group, a collaboration between AVAC, UNAIDS, and IAVI. The report summarizes investment in HIV prevention research across nine prevention options. The report was released today ahead of the 20th International AIDS Conference (AIDS 2014) in Melbourne, Australia. Breakdowns by prevention modality are available in the full report at www.hivresourcetracking.org.

Despite US budget cuts in 2013 and a decline in support for HIV prevention research, the US government remains the single largest funder of prevention research, accounting for more than 70 percent of total investment over the past five years. The US contribution decreased US $44 million to US $881 million in 2013, largely due to automatic, across-the-board cuts to all federally funded programs. Funding from European government donors was also reduced due to shifting paradigms and policies in the international development landscape with reduced support for HIV prevention R&D. Without increased and sustained funding, new prevention options will likely be unable to progress efficiently toward efficacy trials and eventual rollout.

“Research and development has produced a valuable range of medicines, diagnostics and devices to prevent and treat HIV which have to be made more widely available. However, funding is declining at a time when services need to be expanded and better treatments and additional HIV prevention options are needed,” said Luiz Loures, Deputy Executive Director, UNAIDS. “Now is not the time to pull back from science, but rather to push forward towards ending the AIDS epidemic.”

Investment declined in research & development related to voluntary medical adult male circumcision (VMMC) and female condoms, both options that have long been proven effective and are now being scaled-up as part of broader HIV prevention programs. Investment increased for R&D related to treatment as prevention (TasP) and pre-exposure prophylaxis (PrEP), which have more recently proven effective and now require additional implementation science to support wide scale implementation. Declining funding for vaccines and microbicides in 2013, both in various phases of product development, presents a challenge for the revitalization of their respective pipelines in the wake of the completion of several large efficacy trials in the last few years.

“There is a growing consensus that we can end the AIDS epidemic if we develop and deploy the right tools and reach those most at risk,” said Mitchell Warren, AVAC Executive Director. “But we won’t be able to make a sustained impact on the cycle of new infections without development and aggressive rollout of new prevention options – voluntary medical male circumcision, PrEP, treatment as prevention, microbicides and eventually vaccines. We need sustained and flexible funding to ensure that we efficiently develop new options, demonstrate how proven options can be rolled out and deliver what we know works.”

This decline in prevention funding comes during a changing and very challenging human rights environment, as harsh new anti-homosexuality laws and other legislation criminalize those most at risk from HIV/AIDS and make it increasingly difficult to answer critical questions about how the prevention needs of gay men, men who have sex with men, transgender people, sex workers, people who inject drugs and other populations most affected by HIV can be met. This will continue to have an impact on how those trials are funded and where they can be conducted.

“A combination of long-term vision, scientific innovation and generous funding has eradicated smallpox, is close to eradicating polio, and has brought us to an era in which a positive HIV test is no longer an automatic death sentence,” said Margie McGlynn, IAVI President & CEO. “A vaccine will be essential to the global, comprehensive response that can end AIDS once and for all, and sustained and broadened support will be crucial to its development.”

The report and additional infographics on prevention research investment are online at www.hivresourcetracking.org.

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The HIV Vaccines and Microbicides Resource Tracking Working Group is composed of AVAC, the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). The Working Group has been tracking investment in HIV prevention research since 2004.

Press Release

AVAC applauds confirmation of Dr. Deborah Birx as US Global AIDS Coordinator

New York – AVAC today applauds Dr. Deborah Birx on her official confirmation as the new US Global AIDS Coordinator. Dr. Birx will lead the 10 year old President’s Emergency Plan for AIDS Relief (PEPFAR) which plays a critical role in the global fight against AIDS.

“We at AVAC are extremely excited that President Obama nominated and the Senate unanimously confirmed such an innovative and visionary person to lead this global effort. We are at a critical juncture in the global fight against AIDS, and Dr. Birx is the ideal leader for the work that lies ahead,” said Mitchell Warren, AVAC executive director.

“Dr. Birx’s sterling career in both HIV prevention research and service delivery has always been characterized by passionate commitment to ambitious, innovative responses to the epidemic,” Warren added. Dr. Birx focused her early career on AIDS vaccine research, ultimately serving as Director of the US Military HIV Research Program as it initiated the RV 144 vaccine trial that showed in 2009 through modest efficacy that an AIDS vaccine was possible. Dr. Birx is committed to the promise of combination prevention including the need for new tools such as an AIDS vaccine. More recently, as director of the Global AIDS Program at the US Centers for Disease Control and Prevention, she has helped keep the focus on setting and attaining ambitious prevention and treatment goals in communities around the world hard hit by the HIV epidemic.

“As a member of AVAC’s board of directors, Dr. Birx lent her experience and wisdom to our global advocacy work, and we know her as a keen advocate for a comprehensive response to the HIV/AIDS epidemic. We congratulate her on this confirmation and look forward to continuing to work with her in the global fight to end AIDS,” Warren said.

Dr. Birx is assuming this role at a critical time for PEPFAR. Her leadership will be essential in achieving the goals laid out in the PEPFAR Blueprint for Creating an AIDS-Free Generation.

Last year, PEPFAR met an ambitious target for scaling up voluntary medical male circumcision, and it is continuing to expand available treatment slots for people living with HIV. But there is difficult work ahead for Dr. Birx and her team—specifically, it is essential to ensure that planned transitions from direct US aid to country ownership of programs do not proceed at the expense of quality services. PEPFAR must demonstrate leadership in ensuring that people not only start AIDS treatment, but remain on it, reaping the full benefits of effective viral suppression.

It is also critical that PEPFAR continue to engage with civil society as it drafts and implements its plans for country-level work. Dr. Birx, with her established commitment to working with civil society, will be a an important ally for this work going forward. Finally, the PEPFAR program needs a strong advocate at home, and we look to Dr. Birx to ensure that PEPFAR remains fully funded and ambitious in its targets for the next five years and beyond.

Dr. Birx assumes this role at a time when new anti-gay laws in Uganda and Nigeria coupled with existing laws that criminalize homosexuality in many countries around the world endanger a comprehensive response to HIV and the human rights of many men and women. She and her team will need to find ways to continue supporting essential HIV prevention and treatment services for people in these countries while also ensuring that organizations and individuals which promulgate homophobic policies and support discriminatory laws are identified and isolated from service provision. This is a key immediate step as the US and the global community works to secure human rights for all people, regardless of sexual orientation, worldwide.

“Dr. Birx follows in the footsteps of two previous leaders who helped to create and mold a truly transformational global health program that the US can be proud of. We now look forward to this next chapter of one of the greatest stories in public health,” Warren added.

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About AVAC: Founded in 1995, AVAC is a non-profit organization that uses education, policy analysis, advocacy and a network of global collaborations to accelerate the ethical development and global delivery of AIDS vaccines, male circumcision, microbicides, PrEP and other emerging HIV prevention options as part of a comprehensive response to the pandemic.

Contact:

Mitchell Warren, [email protected], +1-914-661-1536

Kay Marshall, [email protected], +1-347-249-6375

Press Release

AVAC applauds nomination of Dr. Deborah Birx as US Global AIDS Coordinator

New York – AVAC today issued the following statement from AVAC Executive Director Mitchell Warren on the nomination of Dr. Deborah Birx as the new Ambassador and US Global Coordinator:

“We at AVAC are extremely excited that President Obama has nominated an innovative and visionary person to lead the U.S. government’s fight against HIV/AIDS. The program, now 10 years old, is at a critical juncture, and Dr. Deborah Birx is the ideal leader for the work that lies ahead.

“Dr. Birx’s sterling career in both HIV prevention research and service delivery has always been characterized by passionate commitment to ambitious, innovative responses to the epidemic. Dr. Birx focused her early career on AIDS vaccine research, ultimately serving as Director of the US Military HIV Research Program as it initiated the RV 144 vaccine trial that showed in 2009 through modest efficacy that an AIDS vaccine was possible. We know that she is committed to the promise of combination prevention including the need for new tools such as an AIDS vaccine. More recently, as director of the Global AIDS Program at the US Centers for Disease Control and Prevention, she has helped keep the focus on setting and attaining ambitious prevention and treatment goals in communities around the world hard hit by the HIV epidemic.

“As a member of AVAC’s board of directors, Dr. Birx has lent her experience and wisdom to our global advocacy work, and we know her as a keen advocate for a comprehensive response to the HIV/AIDS epidemic. We congratulate her on this nomination and look forward to continuing to work with her in the global fight to end AIDS.

“Dr. Birx will be assuming this role at a critical time for the President’s Emergency Plan for AIDS Relief (PEPFAR). Her leadership will be essential in achieving the goals laid out in the PEPFAR Blueprint for Creating an AIDS-Free Generation.

“PEPFAR recently met an ambitious target for scaling up voluntary medical male circumcision, and it is continuing to expand available treatment slots for people living with HIV. But there is difficult work ahead for Dr. Birx and her team—specifically, it is essential to ensure that planned transitions from direct US aid to country ownership of programs do not proceed at the expense of quality services. PEPFAR must demonstrate leadership in ensuring that people not only start AIDS treatment, but remain on it, reaping the full benefits of effective viral suppression.

“It is also critical that PEPFAR continue to engage with civil society as it drafts and implements its plans for country-level work. Dr. Birx, with her established commitment to working with civil society, will be a terrific ally for this work going forward. Finally, the PEPFAR program needs a strong advocate at home, and looks to Dr. Birx to ensure that PEPFAR remains fully funded and ambitious in its targets for the next five years and beyond.

“Dr. Birx follows in the footsteps of two previous leaders who helped to create and mold a truly transformational global health program that the U.S. can be proud of, and we thank Ambassadors Mark Dybul and Eric Goosby for their leadership—and look forward to this next chapter of one of the greatest stories in public health.”

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

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Press Release

AVAC urges HIV prevention research “reality check” in new report

Cape Town, South Africa, December 9, 2013 – In a report released today, AVAC calls on funders and researchers to capitalize on lessons learned from a range of recent HIV prevention trials with better problem solving, more critical thinking and coordinated action around large-scale human trials, faster roll out of proven options and ongoing research for new advances that women and men will want to use.

This year’s AVAC Report, entitled Research and Reality, pays particular attention to the needs of women and girls. Citing recent trials that failed to provide conclusive answers due to low use of products in the studies, the report lays out a broad and ambitious development agenda for female-initiated prevention options including vaginal gels, rings and other emerging biomedical strategies.

The new report also urges researchers, donors and implementers to step up plans for large-scale delivery of recently proven methods for women and men, including pre-exposure prophylaxis (PrEP) and non-surgical male circumcision devices. While pilot studies of these options are in progress, a lack of longer-range plans for program scale-up and roll out means that valuable time, and lives, could be lost.

“Prevention research has had both rough times and revolutionary breakthroughs in the past few years. It’s time to apply lessons from these experiences to work faster and smarter going forward,” said Mitchell Warren, AVAC executive director. “As advocates, we’re looking to make sure that new HIV prevention developments are turned into action—whether that’s delivering new options that work to the people who need them, or revising past assumptions based on trials that didn’t go as planned.”

“We need to keep focused on HIV prevention that’s effective, available and meets the needs of men and women throughout their lives,” Warren said.

Refocusing the Search for New Methods for Women

Research and Reality, released at the 17th International Conference on AIDS and STIs in Africa (ICASA), takes an in-depth, critical look at prevention research for women. There has been a positive, proof of concept finding that a vaginal gel can reduce women’s risk of HIV, as well as positive data on daily oral tenofovir-based PrEP in women. However, there have also been two trials in which participants did not actually use the options being tested regularly enough to answer the study questions.

In the report, AVAC offers recommendations and analysis to move beyond competing interpretations of these data. This is the first advocacy document to provide a full picture of what the trials do and do not reveal about the future of female-initiated prevention. It identifies clear steps to take to address issues from past trials and a core set of questions that need to be answered through strategic research going forward.

“It would be completely unacceptable to throw up our hands and say we don’t know what women want,” said Warren. “With women representing half of the global HIV epidemic, it’s both a practical and a moral imperative to keep up the search for new methods that women can control and want to use.”

“Recent trial results may be puzzling, but one thing we know for sure is that many women at risk want and need new ways to protect themselves from HIV,” said Nono Eland, chairperson of the Women’s Sector of the South African National AIDS Council (SANAC). “The prevention revolution continues. Earlier this year, participants at the SANAC Women’s Sector biennial summit called for better investment in prevention for women. We called for women to be meaningfully involved at all stages—from planning to distribution of HIV prevention products that are developed for us and reiterated the need for prevention research literacy for communities.”

To help resolve questions and challenges about women’s prevention options, Research and Reality recommends that researchers and trial sponsors:

Continue to explore and measure methods to improve adherence.
Conduct additional qualitative research to better understand women’s reasons for enrolling in a trial and using (or not using) a study product.
Use innovative trial designs that would select trial participants who are most likely to adhere to a product regimen so efficacy can be determined – if the trial shows efficacy, bridging studies should be designed to examine how the strategy might work among more diverse populations

“When conventional approaches to science are not working, it’s time to break with convention,” said Dr. Helen Rees, Executive Director of the Wits Reproductive Health and HIV Institute in South Africa and a member of AVAC’s board of directors. “We urgently need to identify a range of prevention options that can work for women – and then we need to know which options will work best for which women.”

Research and Reality also provides four overarching recommendations on issues that lie at the intersection of research goals and real-world conditions.

Launch complex trials to answer complex questions – Clinical trials remain the only way to answer the most important scientific questions in HIV prevention. Researchers and funders must continue to launch new trials despite the challenges, complexities and costs. This is especially true for AIDS vaccines, as well as to clarify the effect of hormonal contraception on HIV risk, where research is critical and must proceed.
Plan for roll out beyond pilot projects – Pilot projects are an important first step toward ensuring that promising research results translate into real impact on people’s lives, but pilot projects alone will not end the AIDS epidemic. To realize their full potential, interventions such as daily oral PrEP and non-surgical devices for voluntary medical male circumcision need to be adequately resourced, ramped up, and included in national HIV/AIDS implementation plans.
Invest and innovate in virologic suppression – In addition to the life-saving benefits of antiretroviral therapy as treatment for people living with HIV, research shows that ARV treatment can dramatically reduce the risk of HIV transmission to others. But treatment works in this way only when it effectively suppresses virus in the body to very low levels. To achieve and sustain HIV suppression and realize the full preventive potential of treatment, it is critical to invest in treatment adherence programs, new antiretroviral therapies, therapeutic vaccines and a cure.
Align programs, models and funding to stay on track to end AIDS – Countries are developing HIV prevention plans and targets based on modeling that does not fully account for realities on the ground. Models are essential, but they need to be designed with built-in feedback loops – pulling in surveillance data and other information about the impact of prevention programs, so that results can be improved quickly over time.

The new Research and Reality recommendations build on the AVAC Playbook, a long-term agenda for global HIV prevention efforts first issued in 2011. AVAC assesses and reports on the most critical next steps for the development and delivery of new prevention options each year.

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

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Press Release

AVAC applauds new WHO ARV guidelines as critical step; must be paired with equally bold HIV prevention to end AIDS

New York, NY – New World Health Organization (WHO) guidelines that will greatly expand the number of people eligible for antiretroviral (ARV) treatment around the world are critical and must be implemented with comprehensive programs to curb new HIV infections in order to stay on the road to ending AIDS, AVAC said today.

“These guidelines are a landmark in the fight against AIDS,” said Mitchell Warren, AVAC executive director. “But guidelines alone don’t save lives – money, pills and smart programs save lives. Investment and effective implementation will be critical.”

“Expanding HIV treatment is a global imperative, but it can’t be done in isolation,” Warren added. “To reach the tipping point against AIDS, we need to dramatically slow new HIV infections. The prevention benefits of treatment will get us part of the way there, but not all the way. We have to scale up every prevention option we have, including male circumcision, PrEP, male and female condoms and clean injecting equipment, while pressing ahead in the development of microbicides, vaccines and other new prevention strategies.”

“Different people need different options. While these guidelines are based on a broad range of evidence, earlier HIV treatment may not be right for everyone. Individuals must make their own choices about when they are ready to start HIV therapy,” Warren said.

AVAC, together with amfAR, has called on policymakers, funders, governments and civil society to achieve a “tipping point” in the global AIDS epidemic, at which the rate of treatment initiation (expansion of people gaining access to treatment) exceeds the number of people becoming newly infected. This goal and other long-term shifts in rates of new HIV infections and deaths are only possible with a surge of investment and implementation in the short-term. AVAC urges immediate action on this critical issue. With aggressive investment, a tipping point could be reached in a number of countries in the next three years. For more, visit www.endingaids.org.

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

Press Release

New global report released at IAS 2013 highlights funding trends, opportunities and challenges for HIV prevention R&D

Kuala Lumpur – Recent breakthroughs in HIV prevention research have confirmed the promise of new options to help end the AIDS epidemic and highlight the urgent need for ongoing research to develop additional prevention options and support rapid rollout of proven ones. However, continued progress requires a broader base of funders committed to sustained support according to the new report From Research to Reality: Investing in HIV Prevention Research in a Challenging Environment released today at 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013) in Kuala Lumpur.

Steady progress in research and development for HIV vaccines, pre-exposure prophylaxis using antiretroviral drugs (PrEP), and treatment as prevention have confirmed the critical role science has to play in providing solutions to end the AIDS epidemic, yet the ninth annual report from the HIV Vaccines and Microbicides Resource Tracking Working Group shows that funding has essentially plateaued.

In 2012, funders invested a total of US $1.31 billion across R&D for six key prevention areas: preventive HIV vaccines, microbicides, PrEP (pre-exposure prophylaxis) using antiretroviral drugs, treatment as prevention, operations research related to voluntary medical male circumcision and prevention of vertical transmission. This is a six percent increase over funding in 2011. However, a significant portion of this increase is likely due to improved reporting by several donors.

“Science has a critical role to play in ending the AIDS epidemic,” said Luiz Loures, Deputy Executive Director, Programme, UNAIDS. “The potential returns on investments are hugely important and I strongly urge donors to make funding for research and development a top priority.”

This report comes as new guidelines are being released from the World Health Organization (WHO) on when to start taking antiretroviral therapy (ART) for HIV. These new guidelines recognize recent advances made in HIV prevention R&D and will help countries maximize the impact of antiretroviral therapy on keeping people alive and well ad helping prevent new infections. It is too early to tell what additional resources will be needed to support countries and programs in adopting the new WHO guidelines and effectively rolling out these proven prevention options, which represents an investment opportunity for countries heavily impacted by HIV, particularly emerging economies.

According to the report, the United States remained the largest public sector funder of HIV prevention research, spending a total of US$925 million in 2012—70 percent of the total investment in HIV prevention R&D—and underscoring the importance of fostering broader commitments by additional global partners.

“As the report highlights, the HIV vaccine field has been a leader in catalyzing innovative partnerships across the public, private, philanthropic and academic sectors. Such partnerships can help integrate new funders and help enhance the information exchange and collaboration that is required as we tackle remaining critical questions in immunology as we move forward to develop even more effective prevention options,” said Margaret McGlynn, President and CEO of the International AIDS Vaccine Initiative, IAVI.

For the first time this year, the report includes the critical investment made by HIV prevention research trial participants. In 2012, there were 99,931 participants in HIV prevention research trials, primarily based in sites with high HIV burden in South Africa, Uganda and the United States. As more efficacy trials are planned, tens of thousands more women and men in the communities hardest hit by HIV will take time from their daily lives to participate in clinical trials and to help end the epidemic, representing a significant, ongoing investment in prevention R&D.

Following the scientific breakthroughs of 2011, during which preventive HIV vaccines, PrEP, and treatment as prevention all advanced faster and further along the scientific path, 2012 was largely a year of follow-up research seeking to confirm results of past studies, move forward with new clinical research and roll out proven new prevention modalities. Even though 2012 brought steady progress, it also brought results that have both challenged the resiliency of the HIV prevention research field and raised new questions that the field is compelled to answer.

Additional data from the RV144 vaccine trial in Thailand has provided new clues about why and how the vaccine worked and has helped to pave the way for trials set to begin in Thailand and South Africa in 2016. At the same time, researchers are developing other vaccine candidates and also learning more about broadly neutralizing antibodies, which may form the basis of future clinical trials.
2012 saw intensified focus on faster rollout of adult male circumcision for maximum prevention impact. Funding for R&D and operations research increased, with an emphasis on research that would better inform delivery and demand and enhance understanding of current constraints.
Planning for demonstration projects of daily oral PrEP among a range of populations moved forward in 2012, following the US Federal Drug Administration (FDA) approval of Gilead Science Inc.’s daily oral TDF/FTC as PrEP and World Health Organization (WHO) guidance for PrEP demonstration research trials.
Large-scale trials of treatment as prevention are now taking place in more than 40 countries around the world, demonstrating a global commitment to explore the potential of this intervention. At the same time, implementers and normative agencies continued their efforts to add treatment as prevention to HIV prevention agendas and the national strategies.
Following flat results from the VOICE (MTN 003), which was testing daily oral tenofovir, daily oral TDF/FTC and daily 1% tenofovir gel, data from the trial are being examined, and preliminary results suggest that too few women in the trial adhered to prescribed use of the trial products to allow for evaluation of their effectiveness. The ongoing FACTS trial of 1% tenofovir gel as well as microbicide ring trials are working to incorporate lessons learned from the VOICE trial around understanding and supporting participant adherence.

There is a growing consensus that we can begin to end the AIDS epidemic if we develop and deploy the right tools,” said Mitchell Warren, executive director of AVAC. “But we won’t be able to make a sustained impact on the cycle of new infections without aggressive roll out of new prevention options—voluntary medical male circumcision, PrEP, treatment as prevention, microbicides and eventually vaccines. We need sustained and flexible funding to ensure that we efficiently deliver what we know works, demonstrate how proven options can be rolled out, and develop new options.”

The report is available online at: www.hivresourcetracking.org.

Contacts:
AVAC: Kay Marshall, [email protected], +1 347 249 6375 or Mitchell Warren (in Kuala Lumpur), [email protected], +1 914 661 1536
IAVI: Arne Naeveke, +31 63 882 4367, [email protected]
UNAIDS: Sophie Barton-Knott, +41 22 791 1697, [email protected]

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Financial support for this project was provided by AVAC: Global Advocacy for HIV Prevention (AVAC), the International AIDS Vaccine Initiative (IAVI), and the Joint United National Programme on HIV/AIDS (UNAIDS). In prior years, support was also provided by the Alliance for Microbicide Development (AMD) and the International Partnership for Microbicides (IPM).

Press Release

New PrEP trial results among injecting drug users underscore that PrEP works when taken consistently; AVAC calls for accelerated action to get PrEP to those who can benefit from it

New York, NY – Results from the Bangkok Tenofovir Study published online today in The Lancet provide additional evidence that daily oral tenofovir-based pre-exposure prophylaxis (PrEP) reduces HIV infection risk when taken consistently. The results from the study—the first conducted among people who inject drugs—are consistent with previous studies among men and women primarily at risk of acquiring HIV through sex. They provide additional support for moving forward to ensure that people who can benefit from PrEP have access to it.

“These results underscore what we’ve learned in a range of studies—daily tenofovir-based PrEP works when you take it,” said Mitchell Warren, AVAC executive director. “Although there is more to learn about how this or other PrEP strategies work in men and women who inject drugs, this study offers the first indication that oral PrEP may reduce the risk of HIV infection via needle exposure. Comprehensive harm reduction, along with human rights protections, are the fundamental HIV prevention tools for injecting drug users. We need to continue to roll out proven prevention and find out more about how this oral PrEP strategy might work in a group that is at very high risk for HIV infection and has too often been ignored.”

“We now need to get serious about making PrEP available to those who can benefit. More than two and a half years after the first positive results from a PrEP trial, little has been done to answer critical questions about the best ways to roll out daily oral PrEP to key populations worldwide. Within the next year, a comprehensive package of demonstration projects should be planned, funded and launched in countries around the world,” Warren said.

Data from previous oral PrEP studies showed varying levels of effectiveness of tenofovir-based prevention for heterosexual men and women, and for men and transgender women who have sex with men. In July 2012, the US Food and Drug Administration (FDA) approved daily oral TDF/FTC (marketed as Truvada) for HIV prevention for all adults at risk of HIV from sexual transmission based on data from several PrEP trials that evaluated TDF/FTC for PrEP. Only one other PrEP study—Partners PrEP, which enrolled serodiscordant couples—evaluated daily oral tenofovir disoproxyl fumarate (TDF, marketed as Viread), as well TDF/FTC. It will be critical to examine the cost and feasibility of both daily TDF and TDF/FTC in light of these new data.

The Bangkok Tenofovir Study, which was conducted by the US Centers for Disease Control and Prevention (CDC), the Bangkok Metropolitan Administration and the Thailand Ministry of Public Health, found that a daily dose of the drug tenofovir reduced the risk of HIV infection by 49 percent overall and at a higher rate (up to 74 percent) among trial participants who had detectable tenofovir in their blood, an indication that they were taking the drug consistently. The study, which began in 2005, enrolled more than 2,400 men and women who were part of a drug treatment program run by the city of Bangkok.

The trial team states the conclusion that the HIV infections that occurred were primarily the result of injection drug use, rather than sexual exposure. The team also reports consistent decreases in reported risk behaviors including injection drug use, needle sharing and unprotected sex in both study arms; also of note, the preventive benefit was only observed after the first three years of follow-up.

“People who use drugs also have sex, and there is no way of distinguishing between infection acquired via sex versus drug use. This is one reason why this PrEP strategy cannot be viewed as a replacement for proven prevention such as syringe exchange and drug substitution programs that specifically reduce risk of HIV via drug use. All countries need to offer these services without criminalizing, stigmatizing or infringing on the rights of those who need them,” Warren said. “However, this is the first trial to provide evidence for a prevention option that could protect against HIV infection through both sexual contact and injecting drug use—and this is an exciting finding that must be followed up. PrEP could be a powerful additional tool for some people who inject drugs,” Warren added.

CDC’s new interim guidelines also released Wednesday include important guidance for how PrEP can best be used to help people who inject drugs protect themselves. Consolidated US Public Health Service Guidelines on PrEP use for all risk groups, which will include more detailed guidance on PrEP use for injecting drug users, are expected to be released later this year.

“We commend the CDC for acting quickly to put these interim guidelines in place to help individuals and their health care providers make informed decisions about PrEP use in the context of comprehensive HIV prevention. PrEP is not a silver bullet or a simple solution, but it is an option that can be life-saving for some individuals,” Warren added.

“PrEP using tenofovir-based drugs is a niche product that cannot and will not replace other options that are part of combination prevention. Yet it is an intervention with the real possibility of preventing infections, especially where other prevention options aren’t enough,” Warren said.

“Now, policy makers, regulators, advocates, WHO, UNAIDS and Gilead Sciences—the manufacturer of both TDF and TDF/FTC—must work together to determine how best to move forward to ensure that PrEP is included where appropriate in comprehensive harm reduction programs for people who inject drugs. PrEP must complement, not replace, harm reduction programs everywhere, and especially in countries and communities with significant HIV epidemics driven by injecting drugs,” Warren added.

“AVAC recognizes the altruism and commitment of the more than 2,400 trial volunteers who made this effort possible,” Warren said. “These volunteers and their communities have made an inestimable contribution to HIV prevention research and to the eventual development of new ways for men and women to protect themselves from HIV.”

More information about PrEP is available at www.avac.org/prep and www.prepwatch.org.

Contact:

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

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Press Release

WHO prequalification of PrePex medical male circumcision device has potential to help countries accelerate key HIV prevention program

New York, NY – The announcement last week that the World Health Organization (WHO) prequalified the PrePex device for non-surgical voluntary medical male circumcision (VMMC) offers another important option for expansion of VMMC programs in countries hard hit by the HIV epidemic. VMMC, as part of comprehensive HIV prevention programs, is starting to make an impact on the HIV epidemic in many communities and countries.

The impact of PrePex, and other non-surgical devices that could also be prequalified, will depend on several factors including the cost of the devices, the quality and scope of data available to guide decisions about product introduction, and sustained investment in product introduction including pilot projects and social marketing.

“PrePex and other devices could help expand VMMC programs to meet the HIV prevention needs of more men in Africa. But without strong programs, even the best products have little or no impact,” said Mitchell Warren, AVAC executive director. “Importantly, WHO’s prequalification paves the way for countries and international donors to procure the device and expand HIV prevention options. Evidence has shown that expanded VMMC programs can have a profound impact on rates of new HIV infections in men and women for years to come.”

“Now, national policy makers, civil society, traditional practitioners, and health providers need to understand the different roles for both surgical and non-surgical procedures and make decisions about whether it makes sense to use PrePex in local programs. If the decision is, ‘yes,’ the product needs to be strategically introduced in programs that have clear messages, committed financing and integration with surgery-based programs. We need action now to ensure these conditions are met,” Warren added.

“For PrePex to make a difference in VMMC scale-up, it has to be affordable,” Warren said. “AVAC and other advocates look forward to working with governments, donors and the manufacturer to help ensure that cost is not a barrier to the use of PrePex where it can make a difference.”

The cost of the device, at least at first, is reported to be around $20, which may be a barrier for widespread use. Bulk purchasing, the prequalification and introduction of additional devices, or a decision by the manufacturer could lead to a lower price. AVAC welcomes today’s statement from UNITAID, which finances the WHO prequalification program, stating that PrePex must be affordably priced.

Landmark clinical trials in three African countries showed that voluntary medical male circumcision (a term used to indicate the specific procedures used in the context of HIV prevention, versus traditional practices in initiation rites) reduced HIV-negative men’s risk of HIV infection by at least 60 percent and long-term follow-up has shown that VMMC is a highly effective and inexpensive intervention.

“International donors have indicated a willingness to fund pilot studies and introduction of PrePex for VMMC programs, but African governments, health care providers and local communities will need to decide how PrePex might best be used to expand VMMC programs. Governments must move swiftly to evaluate whether PrePex is a good additional option and develop policies and budgets to match. Most importantly, governments should continue allocating resources for this HIV prevention strategy overall,” said Angelo Kaggwa, program coordinator at AVAC and a co-coordinator of the Africans Telling the Truth about VMMC campaign.

“This initial prequalification of PrePex is only for men 18 and older. One of the key next steps for PrePex must be to gather data on safety and effectiveness among younger men and adolescents,” Kaggwa added. “Many men seeking surgical procedures are under 18, and we need to provide them with the range of options.”

“WHO prequalification of the PrePex device is most exciting and very welcome. Policy makers, health care providers, donors and civil society must now work together to find the best ways to add non-surgical devices to broader circumcision programs so that we can reach more men with VMMC – with a method that is relatively simple and convenient. I know, because I myself have been circumcised with the PrePex device. So when I add my voice to the PrePex conversations, it is from the perspective of the personal experience of a satisfied client,” said Dr. Mannasseh Phiri, a leading VMMC and HIV/AIDS activist in Zambian. “Circumcision, like HIV, is often difficult for us to discuss openly. And in many of our communities, medical circumcision of adult men is a relatively new concept that now exists alongside traditional circumcisions of young boys. We must continue to speak out about the great benefits of medical male circumcision for men and for women in our communities. We must encourage more and more men of all ages to come forward and get circumcised.”

Current modeling data project that, if 80 percent of adult men in 14 priority African countries (with high HIV incidence and low rates of VMMC) were to undergo the procedure by 2015, 20 percent of all new infections in men and women would be averted by 2025 in those countries. Non-surgical circumcision devices, like PrePex, provide more options to achieve these targets.

WHO prequalification is a process to ensure that medicines, diagnostics and medical devices meet international standards of quality, safety and efficacy. Prequalification helps donors and countries that do not have adequate regulatory capacity to review all products make informed decisions about purchasing medicines and devices. PrePex is the first male circumcision device prequalified by WHO. Other devices are also under development. Manufacturers apply for prequalification and must provide extensive information about the product’s quality, safety and efficacy, which is evaluated by staff from WHO and experts from national regulatory authorities worldwide. More information on devices and the prequalification process is available at www.who.int/diagnostics_laboratory/evaluations/prequalification_status/en/index.html.

For more information on voluntary medical male circumcision, VMMC devices and programs, visit www.avac.org/vmmc, truthaboutvmmc.org and www.malecircumcision.org.

Contact:

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

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