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

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, kay@avac.org, +1 347 249 6375 or Mitchell Warren (in Kuala Lumpur), mitchell@avac.org, +1 914 661 1536
IAVI: Arne Naeveke, +31 63 882 4367, anaeveke@iavi.org
UNAIDS: Sophie Barton-Knott, +41 22 791 1697, bartonknotts@unaids.org

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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, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +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, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375

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Press Release

AIDS vaccine trial results, while disappointing, must guide continuing search; research for vaccine and other new HIV prevention options must continue

New York, NY – The announcement today that immunizations in a large-scale HIV vaccine trial have been stopped early after an independent scientific review board determined that the vaccine being tested is not effective is a reminder of how challenging it is to develop an effective AIDS vaccine, AVAC said. AIDS vaccine research is in its most promising period in decades with breakthroughs in a number of approaches different from that studied in 505. Even though the trial showed no benefit, analysis of these data will help refine the vaccine research pipeline.

The US National Institute of Allergy and Infectious Diseases (NIAID) announced today that the independent Data Safety and Monitoring Board for HVTN 505, a trial testing a two-part vaccine among 2,500 men who have sex with men and transgender women in the United States, recommended that the immunizations be stopped since the data showed that the trial would not be able to show vaccine efficacy. Follow-up of participants will continue.

“This trial has provided a clear, swift answer about a specific vaccine strategy. It’s not the answer we hoped for, but the search doesn’t end here. There are other approaches that must be pursued without delay, and this result will help to focus and guide research efforts,” said Mitchell Warren, AVAC executive director. “Researchers need to unpack the data from this trial to understand more about why this strategy didn’t prevent infection.”

HVTN 505 tested a two-part vaccine strategy including a series of DNA “prime” shots with a vaccine “boost” using a vector based on adenovirus type 5 (Ad5), a common cold virus. While a similar but distinct Ad5-vectored candidate failed to show efficacy in two previous trials, the vaccine tested in HVTN 505 had key differences that researchers hoped would overcome the limitations of earlier candidates.

The adenovirus-based vaccine in HVTN 505 is one of several AIDS vaccine approaches being studied. Vaccine concepts based on the successful RV144 vaccine strategy that showed modest efficacy in a large trial in Thailand in 2009 are moving toward efficacy trials in Thailand and South Africa. Researchers have also recently discovered a number of highly potent neutralizing antibodies and are working to translate these into future vaccine strategies.

“While today’s result is disappointing, we need to look at the bigger picture of AIDS vaccine science. Now more than ever, it is critical to maintain robust funding and establish clear timelines and milestones for the development of an HIV vaccine and other HIV prevention options that can help end the AIDS epidemic,” Warren said.

“At the same time, these results highlight that we must also ensure that all available existing prevention options are offered to those who want and can benefit from them – including male and female condoms, HIV treatment, voluntary medical male circumcision, and daily oral pre-exposure prophylaxis, or PrEP.” Warren said. “While a vaccine remains essential in the long-term fight to end AIDS, we can achieve substantial reductions in new HIV infections in the meantime with fully funded implementation of proven prevention and treatment strategies.”

“There will be many questions and concerns from trial participants, researchers, communities, advocates and others about what the data from HVTN 505 tell us,” Warren said. “NIAID, the trial’s sponsor, has specifically noted the need to understand the finding of slightly higher numbers of infections among vaccine recipients. This finding does not have statistical significance and does not mean that the vaccine increased the risk of HIV. But we do need to understand these data and communicate them clearly. The levels of transparency, urgency and concern that we have seen already from NIAID and HVTN remain crucial as the trial team examines the data and continues to closely monitor trial participants.”

“AVAC also recognizes the enormous contributions of the more than 2,500 volunteers in this trial. Their altruistic involvement makes HIV vaccine research possible. We owe it to them to understand and build on what has been learned here and proceed with further research as rapidly and strategically as possible. The trial staff have also done a huge amount of work and are to be credited for running such a good trial and getting us to an answer.”

“The news today about the halting the trial deeply saddens me as both an HIV vaccine advocate and 505 trial participant,” said Matthew Rose, a member of AVAC’s PxROAR HIV prevention advocacy program. “But I remain hopeful in our search for a vaccine, as this trial showed how researchers and communities can work together to recruit under-represented populations that have not been engaged in AIDS vaccine research. The trial offers a model for how research can be more reflective of the communities that carry the highest burden of HIV and could most benefit from an effective vaccine.”

“These results do not change the fundamental view that an AIDS vaccine remains critical to any long-term strategy to end the AIDS epidemic,” said Rose.

Contact:

Mitchell Warren, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375

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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).

Download report here.

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.

Press Release

VOICE trial results underscore need to accelerate development of additional HIV prevention options for women; PrEP strategies remain valuable prevention tool

New York, NY – Results from a large-scale HIV prevention trial among African women known as VOICE (Vaginal and Oral Interventions to Control the Epidemic) provide an urgent reminder that products must meet the needs of the people using them. While disappointing, the results lend new urgency and direction to the search for additional safe and effective HIV prevention options for women, AVAC said today.

Researchers announced today that none of three pre-exposure prophylaxis (PrEP) and microbicide interventions tested in VOICE—daily oral tenofovir, daily oral TDF/FTC (Truvada), and daily 1% vaginal tenofovir gel—provided additional protection against HIV in the study, likely because few of the women in the trial used the products as directed. This low adherence explains the lack of benefit and is consistent with data from other antiretroviral (ARV)-based prevention trials that found a correlation between higher levels of adherence and protection from HIV. The new results were presented in Atlanta at the 20th Conference on Retroviruses and Opportunistic Infections (CROI).

“The VOICE results reinforce what we already know from previous trials—these interventions work when they are used, and they don’t work when they are not used,” said Mitchell Warren, AVAC Executive Director. “PrEP is still a valuable option for many women, and men, who recognize their risk and can take PrEP consistently. Now we have a dual responsibility to understand who might benefit from daily PrEP and ensure that they can access it, and to accelerate the development of additional options that can meet the urgent needs of others.”

A range of trials has shown varying levels of effectiveness of tenofovir-based prevention for heterosexual men and women, and for men and transgender women who have sex with men. The VOICE data do not invalidate the prior trial results, including the finding that daily oral tenofovir-based PrEP provided high levels of protection for women in stable relationships where one partner was HIV-positive, and that 1% vaginal tenofovir gel was modestly effective on a different dosing schedule.

“Previous trials of tenofovir-based gel and pills have shown that biologically this approach can work, but only if the product is used. HIV prevention is never just biomedical—behavior is key. What we’ve learned from VOICE and other trials is that adherence to the prescribed dose—the behavioral component—is the variable that determines effectiveness,” Warren added.

“Biomedical tools do not work in a vacuum but rather in the complex realities of women’s and girls’ lives. The women of VOICE and other prevention trials have much to tell us. Now we need to listen to what they are saying and design prevention options based on a better understanding of their reproductive and sexual health needs and desires, their perceptions of personal risk for HIV infection, and their interest in and ability to use the products offered in those trials,” Warren said.

VOICE showed a very high incidence of HIV in the trial—5.7 percent among all the women in the trial and 8.8 percent among unmarried women under the age of 25 in South Africa.

“The high rates of new HIV infections among women, especially young women, are the most shocking and disturbing data from this trial. They are a sobering reminder of how desperately women need new prevention options that they can and will use to protect themselves from HIV,” said Elizabeth Bukusi, Deputy Director (Research and Training) of the Kenya Medical Research Institute (KEMRI) and an AVAC Board Member. “The VOICE results teach us again that an urgent need for new prevention options does not mean women will automatically demand or use those products.”

Following the 2012 US Food and Drug Administration (FDA) approval of Truvada as PrEP for adults at risk of HIV, AVAC called for a comprehensive package of PrEP demonstration projects for all populations—including young women—that could benefit from the proven option of daily oral TDF/FTC. Demonstration projects and other studies in which participants know that they are taking an intervention that has been proven to work will provide important information about how adherence can be supported in real-world situations. AVAC is also working with advocacy partners in the US and internationally to push national health agencies to systematically determine how PrEP can be delivered to the women and men who will benefit from it. This includes a statement released today from a coalition of HIV and women’s health advocates calling on US agencies to coordinate a PrEP agenda to quickly and accurately answer questions about how PrEP can be made available to women in the US.

At the same time, AVAC calls for accelerated research and development of additional HIV prevention options that are less dependent on adherence and may be easier and more desirable for women to use. These include different delivery mechanisms, such as long-acting rings and injections, and less-than-daily dosing schedules, such as that being tested in the FACTS 001 trial, which is looking at 1% tenofovir vaginal gel used around the time of sex. Renewed commitment and resources are also urgently needed for research to develop HIV vaccines, which would overcome many of the issues around adherence, and combined contraceptive and HIV prevention methods, which would address many women’s needs more comprehensively.

“The data presented today are only the beginning of what we will learn from VOICE. We need to make sure that we get all of the information we can from the VOICE participants to help us understand why women were dedicated to the trial and yet were not willing or able to use the products consistently. These women are at such high risk for HIV, we owe it to them to work with them to find the options that they can and will use to protect themselves,” Warren said.

For more information about the VOICE results and ARV-based prevention visit www.avac.org/prep and www.avac.org/microbicides. The Working Group on US Women and PrEP Statement is online at www.prepwatch.org/#women.

Contact:

Mitchell Warren, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375

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Press Release

AVAC statement on PEPFAR Blueprint

New York, NY – PEPFAR’s blueprint has enormous potential to accelerate global HIV prevention efforts. It rightly emphasizes that we need to ‘follow the science’ if we intend to deliver life-saving HIV prevention and treatment breakthroughs to millions of people worldwide. The blueprint underscores that success depends on scaling up combinations of effective strategies. It also places much-needed emphasis on voluntary medical male circumcision, which could prevent millions of HIV infections and do so more affordably than almost any other method today.

It’s particularly encouraging that the blueprint focuses on translating scientific breakthroughs into lives saved. Powerful new HIV prevention options could together lead to dramatic reductions in HIV infections, but we don’t have all the information we need to scale them up in the right combinations for various communities. Urgent questions about the real-world use of new prevention tools in combination have been clear for months or even years, yet the work to answer them is barely under way. That’s as unconscionable as it is unnecessary.

The blueprint also recognizes that ending AIDS will not be easy or quick. While current options can have a tremendous impact, continued science and innovation are essential to ultimately halt new HIV infections and deaths from AIDS.

The US has shown great leadership, and now it’s time for the rest of the global community to step up. Frankly, we are not on pace to end AIDS – but we could be. Global agencies, governments, donors and advocates need to work with PEPFAR now to agree on the most urgent priorities, set specific goals and demonstrate real progress within the next year.

A PDF version of this is available for download.

Contact:

Mitchell Warren, mitchell@avac.org, +1-914-661-1536

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Press Release

AVAC report finds that world is already falling behind pace to end AIDS epidemic; five essential actions needed in 2013 to avoid historic missed opportunity

New York, NY – AVAC today issued a “top five” list of global actions needed in 2013 to accelerate HIV prevention efforts and preserve the opportunity to end the AIDS epidemic. The recommendations address urgent, unresolved challenges that threaten the delivery of powerful new HIV prevention methods that could help dramatically reduce the 2.5 million new HIV infections that occur worldwide every year. They include critical actions to speed access to HIV treatment, voluntary medical male circumcision (VMMC) and pre-exposure prophylaxis (PrEP), and to safeguard vital new research on vaccines, microbicides, other HIV prevention options and a cure.

“Recent scientific breakthroughs give us reason to be optimistic like never before, but our chances of success are already imperiled,” said Mitchell Warren, AVAC executive director. “Right now, the world isn’t moving as fast as it should be to begin ending the epidemic. There is still time to get back on a winning pace but only with focused, aggressive action now. This can be the year that HIV prevention begins to achieve its potential – in fact, it has to be.”

The priorities are featured in a new report, Achieving the End: One Year and Counting, which offers AVAC’s critical assessment of progress achieved since global leaders began to discuss the opportunity to “begin to end AIDS” in late 2011. The report reflects input from HIV prevention leaders across a broad spectrum.

“We have a narrow window to translate the past year’s excitement into life-saving changes on the ground,” said Dr. Helen Rees, Executive Director of the Wits Reproductive Health and HIV Institute (WRHI) in South Africa and a member of AVAC’s board of directors. “The possibility of ending AIDS is very much alive but depends on much bolder leadership, increased coordination and agreement on a clear set of short-term priorities.”

“The world needs immediate answers to the question, ‘What now?’, and then it needs to act on them,” said Warren. “We’ve identified what we believe are the five HIV prevention priorities that can make the greatest possible difference in the coming year. Whether we’re on pace to end AIDS in a year’s time will depend in large part on our success in these areas.”

AVAC’s priority recommendations for 2013 are as follows:

End confusion about “combination prevention” – In 2012, there was long-overdue recognition that different countries will need to implement different combinations of HIV prevention interventions for different populations at risk. But the hard work of defining those combinations and establishing priorities has not been done. In 2013, donors, policy makers and civil society need to be held accountable for choosing, implementing and evaluating the right packages of interventions for specific circumstances.
Close the gaps in the HIV “treatment cascade” – Antiretroviral treatment not only improves and prolongs the lives of those infected, it is among the most powerful HIV prevention strategies available, reducing the risk that an infected person will pass on HIV by up to 96 percent. But only a small proportion of people diagnosed with HIV are linked to antiretroviral treatment and an even smaller share stay on treatment and have their HIV infection suppressed to levels low enough to prevent transmission to others. A range of studies is looking at ways to narrow this gap, but these efforts are uncoordinated and incomplete. In 2013, researchers and funders need to convene and establish a clear research and implementation agenda to close the gaps in the treatment cascade.
Prepare for new non-surgical male circumcision devices – In 2013, the World Health Organization (WHO) is expected to approve new male circumcision devices that could eliminate the need for surgery, speed recovery and lower costs in many of the 14 priority African countries where VMMC could reduce HIV infections by 20 percent. While the new devices may not be right for every country or setting, there could be months or years of lost opportunities unless national health leaders immediately take action to evaluate their benefits, costs and optimal uses.
Define and roll out needed PrEP demonstration projects – Global health agencies including WHO and UNAIDS have said they are awaiting the results of real-world demonstration projects before they can provide guidance on the use of PrEP – yet there is no clarity on what range of studies is needed, and few are under way. By the end of 2013, a core set of studies must be defined and moving ahead.
Safeguard HIV prevention research funding – New momentum on research into HIV vaccines, microbicides and other new tools is threatened due to the possibility of federal budget sequestration in the US and similar pressures in other countries. The potential cuts could slow or halt progress on some of the most promising HIV prevention research in many years. Policy makers must have the courage to preserve this vital research in 2013.

“The most urgent questions about new prevention tools have been clear for months or even years, and yet the work to answer them is barely under way,” said Warren. “That’s as unconscionable as it is unnecessary. Millions of lives depend on our ability to pick up the pace.”

The new recommendations build on AVAC’s long-term agenda for global HIV prevention efforts, issued in late 2011. That report, titled simply The End?, established near-, medium- and long-term goals for delivering available prevention interventions, demonstrating potential impact of emerging tools such as PrEP and microbicides, and developing essential new tools, including AIDS vaccines. In addition to the five key priorities for 2013, AVAC’s new report includes key updates to the long-term agenda for global HIV prevention.

A PDF version of this press release is available.

Contact:

Mitchell Warren, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375

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Press Release

AVAC welcomes CDC guidance on PrEP for heterosexual men and women; calls for more demonstration projects to help guide optimal PrEP use

New York, NY — AVAC today welcomed the US Centers for Disease Control and Prevention (CDC) guidelines on the use of the antiretroviral drug emtricitabine/tenofovir disoproxil fumarate (TDF/FTC or Truvada) as pre-exposure prophylaxis (PrEP) among sexually active heterosexual men and women.

“These guidelines are another essential building block as we look at the ways PrEP can be used as an effective prevention option for men and women,” said Mitchell Warren, executive director of AVAC. “For the US, CDC guidance is a crucial step in a long process of ensuring that TDF/FTC as PrEP is made available to those who need it. Together with CDC’s initial guidance on PrEP use among gay and bisexual men, released in early 2011, these guidelines will help ensure that that individuals and health care providers have the information they need to make informed decisions about PrEP use.”

“We know that daily oral PrEP using TDF/FTC is not a magic bullet. It provides partial protection and is not a replacement for other prevention strategies like the male and female condom. It will not be right for everyone. As the CDC guidance notes, use of PrEP requires adherence, a confirmed HIV-negative diagnosis and ongoing monitoring. But for some people, some of the time, oral PrEP with TFD/FTC will be a powerful prevention option.”

“We also need real-world projects now to answer important questions about how best to implement PrEP, especially among those most at risk of HIV infection, including many women and young gay men. It is essential that a range of PrEP demonstration projects be fully funded and implemented as quickly as possible.”

PrEP demonstration projects will tell us who can benefit most; how to provide PrEP safely and efficiently; how to integrate PrEP with other essential prevention methods such as condoms; and how to ensure high levels of adherence, which research has shown to be essential for PrEP to work. Currently, only a limited number of demonstration projects are planned or underway in the United States and even fewer globally.

“With more than 50,000 new HIV infections in the US each year and millions of new infections globally, we clearly need new ways to prevent HIV infections,” Warren added. “PrEP is an important option for some people here in the US and around the world. We must all work together to ensure that PrEP is integrated into HIV prevention programs in communities where it can prevent infections and save lives.”

This press release is available as a PDF.

Contact:

Mitchell Warren, mitchell@avac.org, +1-914-661-1536
Kay Marshall, kay@avac.org, +1-347-249-6375

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For more information about PrEP and the steps needed to make it available to people in need, visit www.prepwatch.org and www.avac.org/prep.

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