The Px Wire centerspread from January-March Volume 7, No. 1 lays out the “research-to-rollout” continuum of steps between initial evaluations of a novel concept for HIV prevention and the ultimate introduction of new tool offered in an effective public health program.
A Three-Part Agenda for Ending AIDS 2014
The HIV Prevention Research-to-Rollout Continuum
AVAC Playbook 2013–2014: Global goals and priorities
The AVAC’s Playbook is a concise look at global goals related to ten areas that are critical to ending the AIDS epidemic. The squares contain long-term goals; in the circles we have laid out priorities for 2014. Working with our partners, we develop and implement advocacy strategies to get us closer to these goals.
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, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375
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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. The full report, AVAC Report 2013: Research and Reality, is available at www.avac.org/report2013.
Tratamiento como Prevencion
A basic fact sheet explaining what treatment as prevention means.
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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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, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375
Exploring Treatment as Prevention in South Africa
AVAC 2013 Advocacy Fellow, Mickey Meji, has been speaking with South African community members to better understand how treatment as prevention might work for key populations in the country.
The South African government is working to reduce the number of new HIV infections in the country, setting specific targets, but none of these discuss how treatment as prevention (TasP) approaches might impact key populations or address their needs. That is why I chose to gather information about these populations’ experiences and opinions with respect to treatment as prevention and educate individuals living with HIV about TasP so they are able to engage in discussions on the topic and its impact on their communities.
As part of my Fellows project, I spoke with men who have sex with men, sex workers and transgendered people in four provinces in South Africa. They were HIV-positive, negative or unaware of their status. I was nervous at first, not knowing what to expect, but I quickly got the hang of it. I got more comfortable and those speaking with me more readily shared their stories. I found that those taking treatment primarily took medicine for their own health but a few did to reduce transmission to others. Only one person in our consultations mentioned taking PrEP. Feelings were mixed among HIV-negative participants over whether they would use PrEP or not were it available to them.
Over the coming month, I will conclude my community consultations. Then I will work with other AVAC Fellows in South Africa to analyze the information. These findings will guide my future work advocating for the health and rights of these populations.
AVAC is please to announce the call for 2014 Advocacy Fellowship applications. Much more information on the program, including a three-minute informational video, and application details are available at www.avac.org/2014fellowsapps.
Press Release
New report on global HIV treatment research and development investments in 2010 and 2011
Public-sector funding streams are flatlining, jeopardizing scientific innovation
New York, NY – Today, Treatment Action Group (TAG) released its latest report, Funding Scientific Innovation: Global Investments in HIV Treatment Research and Development in 2010 and 2011. For this report, TAG submitted surveys to 171 public, private, and philanthropic funders from around the world; of these 41 responded to TAG, reporting investments of US$2.6 billion in HIV treatment research and development (R&D) in 2011. The TAG report documents an 11.8% increase in funding from the baseline year of 2009, when 46 global funders were surveyed, but only a 6.9% increase from 2010, when 34 funders reported investing US$2.5 billion.
While investments recorded between 2009 and 2011 demonstrate a steady—albeit low—increase in funding, inflation and flatlining of public-sector budgets could put HIV treatment discovery in jeopardy. Simpler, more effective ART formulations are in the pipeline and more effective diagnostic tools are moving towards the market, but to ensure that these lifesaving tools are widely accessible, further commitment to HIV treatment R&D is necessary.
Funders from 18 countries participated in the yearly resource-tracking exercise. The US National Institutes of Health (NIH) was responsible for 62% of the total reported amount in 2011. This level of investment will decline with the impact of sequestration, the automatic across-the-board cuts to U.S. government spending, created in the Budget Control Act of 2011, which began last week on March 1.
The largest share of HIV treatment R&D funding, 51.8% (or US$1.4 billion) was directed to the development of new medications. Though the private sector is the leading funder of HIV treatment R&D, its participation in this resource-tracking effort was paltry, with only 8 of 41 institutions providing their investment figures for 2010 and 2011. As a result, private-sector participation is underrepresented here, giving the lead to the public sector, with 69.2% of the recorded 2011 total originating from public and international development agencies.
“We are disappointed that industry continues to be reluctant to report their investments in HIV treatment R&D,” said TAG’s executive director, Mark Harrington, “when we believe that their contribution to the research effort is significant, yet badly underreported.”
“TAG is concerned that public-sector investment is flat when the world needs to reach 15 million HIV positive people with treatment by 2015,” said Harrington. “This is particularly troubling in the United States—since the government funds 63% or nearly two-thirds of the global reported total of HIV treatment research—where the current sequestration of federal funding will cost the NIH $1.5 billion (5%) of its current-year budget, directly threatening urgently needed progress in research to develop more effective treatments for HIV, a cure, and a vaccine to end the epidemic,” he added.
“For the first time, the end of the AIDS epidemic is within reach if we act,” said Mitchell Warren, executive director of AVAC. “Research into better treatment regimens and ways to narrow the gaps in the treatment cascade have the potential to expand treatment access to improve health outcomes for people living with HIV/AIDS and will play a critical role in reducing the cycle of new infections. The past three years have been a period of modest growth investment in HIV treatment R&D. With greater sustained and flexible funding, the future of HIV treatment research will be even more promising.”
Along with drug development, TAG records investments in basic science; applied/infrastructure/unspecified research; HIV diagnostics; therapeutic vaccines; treatment as prevention; and operational and implementation science. “The goal of this report is to provide evidence-based data on investments in HIV treatment research. We urge more HIV research funders to participate in this project and help us create an accurate account of the world’s response to curbing and ultimately ending the epidemic with innovative tools,” said Marina Smelyanskaya, the report author. “With better data, the report can serve as a roadmap for activists, policy makers, and funders to identify key resources and gaps in HIV treatment R&D funding,” she added.
The report called for greater transparency of pharmaceutical research investments, multisectorial collaboration, and support from global advocates in its resource-tracking efforts.
The HIV Treatment Research and Development Resource Tracking Project is a collaborative initiative of TAG and AVAC, directed and managed by TAG, with financial support from the Joint United Nations Programme on HIV/AIDS (UNAIDS).
Contact:
Marina Smelyanskaya, +1-347-301-4955
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About TAG: Treatment Action Group is an independent AIDS research and policy think tank fighting for better treatment, a vaccine, and a cure for AIDS.
TAG works to ensure that all people with HIV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions. TAG catalyzes open collective action by all affected communities, scientists, and policy makers to end AIDS.
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.
Achieving the End: One Year and Counting
In AVAC Report 2012, Achieving the End: One Year and Counting we’ve identified five priorities for action.
Achieving the End
Recent breakthroughs in HIV prevention research have created unprecedented opportunities to curb new HIV infections, save lives and set the world on a path towards eliminating HIV transmission.