Press Release

Global AIDS Policy Partnership Statement in Support of Heroes Act 2020

Contact

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

The Global AIDS Policy Partners (GAPP) issued the following statement regarding the Health and Economic Recovery Omnibus Emergency Solutions Act, or Heroes Act, released today:

The Global AIDS Policy Partnership (GAPP) applauds and strongly supports the provision of much-needed funding to global health efforts as part of the next COVID-19 relief package, led by the House Appropriations Committee Chairwoman Nita Lowey and House Speaker Nancy Pelosi.

Including at least $3.5 billion for the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFTAM) to support low to middle income countries to bolster health systems and respond to the outbreak, and $1 billion for the President’s Emergency Plan For AIDS Relief (PEPFAR), will be essential to advance COVID-19-related support for these programs and to resume pre-pandemic work addressing the full array of challenges that these programs now face.

The COVID-19 pandemic has harmed efforts to control HIV and other global health programs and could reverse a decade of progress. In fact, according to UNAIDS, just a six-month disruption in HIV treatment access could lead to an additional 500,000 HIV-related deaths in sub-Saharan Africa alone. We are in the early stages of this new pandemic but have already seen the effects on these other long-standing epidemics. TB case detection programs have stalled in many countries; PEPFAR programs have had to adapt or have halted prevention programming; a number of HIV treatment centers have reported fewer people are accessing antiretroviral treatment raising the threat of greater mortality and HIV infection; and some malaria campaigns have been suspended.

Years of sustained PEPFAR and GFTAM investment has strengthened supported countries’ laboratory networks, surveillance capacity, health care workers and supply chains, allowing them to respond efficiently and effectively to COVID-19. But capacity has become strained as the need to fight both epidemics simultaneously takes hold. While this represents a critical investment in addressing the primary and secondary effects of the COVID-19 pandemic and the resulting recession, much more is and will be needed in the months to come in order to preserve decades of US investments in global health and economic development globally.

Funding allocated in the Heroes Act would allow us to safeguard decades of progress against HIV, TB and malaria and save millions more people from these diseases. This additional funding for the global response to COVID-19 will protect the more than $80 billion investment United States taxpayers have made in stopping three of the world’s most pernicious killers, while allowing the programs designed to combat HIV, TB and malaria to support the response to COVID-19.

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The GAPP is a coalition of over 60 advocacy and implementing organizations committed to expanding and improving global HIV/AIDS programming.

Press Release

AVAC Applauds Positive Opinion from EMA on Woman-initiated Prevention Option

Calls for accelerated implementation research, WHO guidance and
regulatory review for Dapivirine Vaginal Ring

Contact

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

New York City, July 24, 2020 – AVAC applauded the positive opinion adopted today by the European Medicines Agency (EMA) on the use of the Dapivirine Vaginal Ring as an HIV prevention option for cisgender women 18 and older. The International Partnership for Microbicides (IPM), the developer of the ring, announced that it will be moving swiftly toward the next steps needed to get this critical prevention option into the hands of women who want and need it. AVAC congratulates IPM, welcomes this commitment to bringing a much-needed woman-initiated HIV prevention option to women, especially in Eastern and Southern Africa, and calls for an integrated introduction plan that lifts up the voices of women, speeds regulatory approvals and is fully funded.

The Dapivirine Vaginal Ring is a flexible, silicone ring that a woman can insert in the vagina for monthly protection against HIV. It contains the antiretroviral drug dapivirine and is designed to provide women with a discreet and long-acting option for HIV prevention. The ring was shown to be modestly effective in two large efficacy studies and open-label extension studies showed a trend toward higher efficacy when women knew the product they were using contained the active drug.

The EMA’s positive opinion recommends the Dapiviring Vaginal Ring “in combination with safer sex practices when oral pre-exposure prophylaxis (PrEP) is not used, cannot be used or is not available.” This regulatory opinion, generated through a mechanism that allows review of medicines intended for use outside of the EU, triggers critical actions from WHO, including reviewing its HIV treatment and prevention guidelines for possible inclusion of the ring and beginning the pre-qualification process that would help ensure countries are able to approve and procure rings for their programs.

“This is a long-awaited day for the thousands of women in Africa, Europe and the US, who participated in clinical trials of the ring and those of us who have advocated for access to the ring and other women-initiated prevention options for over two decades. Women have been waiting for additional HIV prevention options that they can use discreetly and easily, and for many the ring could be that product,” said Manju Chatani-Gada, AVAC’s Director of Partnerships & Capacity Strengthening. “We’re looking forward to ensuring that women guide and lead the next steps, working with IPM, WHO and country stakeholders to ensure that former trial participants, future users of the ring and women’s health advocates are included in decision-making processes for research and introduction going forward.”

“As a young woman and a youth advocate, I’m so excited by this news. We need diverse prevention options that will meet our needs where we are in our lives. The ring gives us another choice and that’s so important,” said Cleopatra Sheilla Makura, Youth Prevention Advocate and former AVAC Fellow from Zimbabwe. “I can’t wait to share this news with other young women and help plan for the introduction of this new prevention option in our communities.

As part of the opinion, the EMA asked that additional data from cisgender women ages 18-25 be collected to better understand the ring’s efficacy overall and among this group that is often at a higher risk for HIV. They have also asked for more data to be gathered on potential drug resistance among ring users who might become infected. These additional data would complement information from introduction activities that will help program implementers and policy makers better understand how the ring can be effectively provided to women. These early introduction activities will also provide critical data to support integrating the ring into existing HIV prevention programs and sexual and reproductive health programs.

“The positive EMA opinion is a critically important step that helps move the Dapivirine Vaginal Ring from a research product to a reality in women’s lives, and ultimately to public health impact.” said Mitchell Warren, AVAC Executive Director. “AVAC has been proudly working with IPM and a range of other partners to develop a robust plan for ring introduction and scale-up. Now is the time to design and fund strategic introduction of the ring in communities where we know women have been waiting for new HIV prevention options.”

Despite years of expanded treatment and prevention options for HIV, women – especially young women – in many communities remain at substantial risk of HIV infection. Incidence rates in women have remained persistently high at four percent as seen in the MIRA trial thirteen years ago to the ECHO study in 2019 and the recently stopped HVTN 702 vaccine trial earlier this year. Women need and deserve more options from which to choose to protect themselves from HIV.

“The high rates of HIV infection in many communities in East and Southern Africa are a reminder that we have no time to lose,” Warren added. “The US government, several European governments and the Bill & Melinda Gates Foundation have made critical long-term investments in IPM to develop the ring; now these and additional funders need to double down on this initial support to work with IPM and others in the field to ensure the ultimate return on these investments: HIV infections averted. This includes investing in a suite of access activities as well as supporting plans for rapid regulatory review and integration of the ring into existing HIV prevention and SRH programs.”

IPM estimates that the ring could become available in 2021 in some countries in East and Southern Africa. AVAC will continue to work with IPM and other partners through a new consortium – PROMISE – that is supported by USAID and PEPFAR to ensure that the critical next steps, including pilot introduction initiatives that will help guide eventual rollout plans for the ring, continue at pace with plans adapted to meet the current challenges presented by the COVID-19 pandemic.

Additional studies that are ongoing or planned are looking at the safety and acceptability of the ring among young women ages 16 to 21 and women who are pregnant or breastfeeding. The COVID-19 pandemic has slowed some of these studies, but are critical to provide data to help ensure more women will soon have access to the ring

“While the ring is not yet available, we must not forget that highly effective prevention options for women already exist and must be made available: daily oral PrEP and the female condom. Work must continue to expand these options today to strengthen programmatic platforms so that the ring and other future options are rapidly and seamlessly integrated into SRHR services and to enable women to have informed choice among an array of options,” added Chatani-Gada.

In addition, research for additional women-initiated HIV prevention options must be prioritized. Results may come later this year or in 2021 from a trial looking at long-acting injectable PrEP for women and there are multiple other products, some combined with pregnancy prevention, in the pipeline. IPM and partners are testing a Dapivirine Vaginal Ring that would last three months and early stage research of multiple combination HIV prevention and contraceptive products are underway. It is critical that this research continue to be prioritized and fully funded.

More information on the Dapivirine Vaginal Ring is here and here.

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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 HIV prevention options as part of a comprehensive response to the pandemic.

Press Release

Injectable PrEP is Highly Effective for Some Populations and Must Move Forward as Quickly as Possible

AVAC calls for intensified efforts to increase access to daily oral PrEP

Contact

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

New York City, July 7, 2020 – AVAC welcomes new, additional data that shows an injectable antiretroviral for HIV pre-exposure prophylaxis (PrEP) is safe and highly effective in reducing HIV risk cisgender men and transgender women who have sex with men. At the 23rd International AIDS Conference today researchers from the HIV Prevention Trials Network (HPTN) released data comparing rates of HIV among trial participants who received the bi-monthly injection, and those who received daily oral tenofovir/emtricitabine (TDF/FTC). While both strategies reduced HIV risk among participants, the injectable strategy was more effective compared to oral PrEP.

The overall number of infections in both arms of the study was very low, underscoring the high efficacy of both interventions. Importantly, daily oral PrEP is licensed and available now for men, women and adolescents in many communities around the world.

“It’s great to see such a high level of efficacy in a potential additional HIV prevention option and to see the high level of efficacy for an already available option, daily oral PrEP,” said Mitchell Warren, AVAC Executive Director. “As we celebrate this exciting new data, we also must ensure that the companion HPTN 084 study of the same product in cisgender women finishes as quickly as possible and simultaneously work to ensure broader access and support for daily oral PrEP in communities where it is needed now.”

These data add insight to the May 2020 announcement from HPTN 083 that injectable PrEP was highly-effective. Importantly, investigators shared data on adherence among participants taking oral PrEP and found that 76 percent of a random sample had blood levels consistent with daily use. While additional work to understand the results is ongoing, this suggests that the difference in impact might be due to the products. Use of the injection requires an oral “lead-in” phase, and 48 weeks of oral PrEP use after discontinuation. Learning more about preferences and feasibility of both injectable and oral PrEP among people at risk of HIV is a critical next step.

“We need options that will work in people’s lives, we need existing daily PrEP delivered at scale now, and we need multiple additional PrEP options to address diverse needs. CAB-LA, the dapivirine vaginal ring, and future products that show efficacy must be brought to market as quickly as possible,” added Warren.

Given that current data show efficacy in men who have sex with men and transgender women, but not in cisgender women, where rates in adolescent girls and young women are persistently high, messages, licensure and introduction plans need to be swift, clear and strategic with respect to the growing array of PrEP options available for different groups. ViiV, the manufacturer of CAB-LA, must now move quickly to work with regulatory agencies, to share, for community review and input, its plans for seeking review and the timeline for incorporating data from the ongoing HPTN 084 study, while WHO must simultaneously launch a parallel consultative process to support guidance for CAB-LA, so there will be no delay in rolling the drug out.

In 2018, AVAC and the Clinton Health Access Initiative (CHAI) established the Biomedical Prevention Implementation Collaborative (BioPIC) to work with a wide range of stakeholders to develop an introduction plan for long-acting injectables and other next-generation HIV prevention options. Today’s announcement makes planning all the more important if promising research results are to be translated into public health impact.

“Planning for health systems to meet future demands for a drug delivered by injection every two months must also be prioritized,” said Jessica Rodrigues, AVAC’s Director of Product Introduction and Access. “Daily oral PrEP was proven effective more than a decade ago, yet people who want and need this vital prevention option are still unable to access it in many communities. We must not repeat that cycle with new prevention options like CAB-LA and the monthly dapivirine vaginal ring for women, which is currently under regulatory review.”

These clinical trials are an important step in the process, but much additional work is needed. Every product has unique attributes and challenges, and there is much more to be understood about CAB-LA and the way in which it might be effectively delivered in communities and among populations where it is most needed. The HPTN 083 team is still analyzing the safety data on the oral lead-in period as well as the potential need for oral PrEP to “cover the tail” of participants who wish to stop receiving CAB-LA. The research to date suggests that stopping CAB-LA and clearing the drug from the body may not be as easy as stopping daily oral PrEP, since traces of CAB-LA can linger in the body well after discontinuing injections. It will be essential to understand how this can be addressed outside of a clinical trial setting.

“Understanding the potential risk of drug resistance, user preferences, health system capacity needs, the price of the product and the programs to deliver it and support use, amongst other issues, are necessary to move forward as quickly as possible if the product is ultimately approved for use,” said Rodrigues. “AVAC and our partners have already begun this work and have valuable insights; it now needs to accelerate with global collaboration so that the delays that have slowed the rollout of daily oral PrEP do not recur again.”

Also at AIDS 2020, the SEARCH study presented additional information on the impact of oral PrEP in the context of a comprehensive “health-fair” based approach. SEARCH previously found that this approach, which provided ‘universal testing’ and same-day antiretroviral treatment, reduced incidence by about 30 percent. In the latest data, the SEARCH team found that once daily-oral PrEP was offered to SEARCH participants, new HIV infections dropped by about 75 percent, compared to the period when PrEP was not yet available. This underscores the feasibility and urgency of making oral PrEP a part of comprehensive programs, anchored in a universal testing approach.

“The UNAIDS report and much of the news at this conference is reminding us that the world was failing at HIV prevention before the COVID-19 pandemic hit. SEARCH shows us the possibilities for PrEP success in some of the hardest hit communities in East Africa,” Warren said. “It’s critical that we find ways to scale up innovative daily oral PrEP programs even as we plan for access to new HIV prevention options. We can’t afford any more delays.”

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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 HIV prevention options as part of a comprehensive response to the pandemic.

Press Release

Global Health and Human Rights Organizations Say US Withdrawal from WHO is Reckless Act that Could Delay Americans’ Access to COVID-19 Solutions and Prolong Global Pandemic

Contact

New York City, July 7, 2020 – AVAC, Health GAP and the Treatment Action Group (TAG) strongly condemn the Trump Administration’s withdrawal from the World Health Organization (WHO). Today’s announcement formalizing the President’s threats from earlier this year is short-sighted and dangerous, and will cost more lives and deepen economic devastation in the United States and around the world, which are already reeling from the ongoing COVID-19 pandemic.

“This virus respects no borders; COVID-19 anywhere can quickly become COVID-19 everywhere. Global health emergencies require global leadership, and that requires a strong and supported World Health Organization,” said Mitchell Warren, AVAC’s Executive Director. “The Administration is playing politics with people’s lives here in the US and around the world. We will be left behind as the world comes together to collaborate and coordinate science as the best strategy to counter the pandemic, and we will lose ground in our historical investments to end HIV, TB, hepatitis C and other health issues.”

The COVID-19 pandemic has brought unprecedented global cooperation among researchers and funders, with WHO playing a critical role in coordinating both the overall global response and many of the global research initiatives. Global cooperation on public health policy, science, data and information sharing is needed more urgently than ever before. The Trump administration makes a dangerous gamble in thinking that the US can act alone in the response to COVID-19.

“We are seeing the disastrous effects of the US federal government’s lack of strategy playing out every day in increased COVID cases and deaths of Americans, particularly in the Black community,” says Suraj Madoori, TAG’s US and Global Health Policy Director. “Withdrawal from WHO will only compound the issues for our nation and for the world by further retreating on shared responsibilities in public health governance.”

The COVID-19 epidemic is devastating already constrained health systems in low- and middle-income countries where COVID-19 is surging, and has further weakened the US healthcare system as well. At the same time, this new pandemic is already having profound implications on responses to HIV/AIDS, TB, viral hepatitis, malaria, vaccination and contraceptive programs and all other public health responses.

WHO plays a key role in coordination, guidance development and mobilization of these public health responses in countries struggling with COVID-19 in addition to limited resources, conflict and other humanitarian and ecological disaster-related crises. As governments and stakeholders position resources against COVID-19, the WHO has taken the lead in forming the Access to COVID-19 Tools (ACT) Accelerator, a new and needed global collaboration to accelerate development, production and equitable access to COVID-19 tests, treatments and vaccines.

The US, as a historic leader and funder of global public health initiatives, and the largest funder of WHO, has a moral responsibility to help ensure an equitable global response to the COVID-19 pandemic. Terminating the US relationship with WHO starves the organization of funding, US staff and US expertise. It likely prolongs the pandemic and will force WHO to cut critical funding and support for other health programs, including those responding to HIV/AIDS, TB, viral hepatitis, and sexual and reproductive health.

“The Trump administration is shameless in its extreme nationalism at the expense of people’s lives. The WHO performs a vital role in getting new HIV treatments to people around the world safely and quickly and providing key technical assistance to strengthen health systems in vulnerable countries. Trump pulling the US out of the WHO is yet another demonstration of his disregard for people living with HIV around the world,” said Matthew Rose, Director of US Policy and Advocacy for Health GAP.

AVAC, Health GAP and TAG call for the Trump Administration to immediately reverse this disastrous decision, restore and protect funding to WHO and work to ensure global cooperation in the pandemic response.

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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 HIV prevention options as part of a comprehensive response to the pandemic.

About TAG: Treatment Action Group (TAG) is an independent, activist and community-based research and policy think tank fighting for better treatment, prevention, a vaccine and a cure for HIV, tuberculosis and hepatitis C virus. TAG works to ensure that all people with HIV, TB and HCV 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.

About Health GAP: Health GAP is an international advocacy organization dedicated to ensuring that all people living with HIV have access to affordable life sustaining medicines. Our team pairs pragmatic policy work with audacious grassroots action to win equitable access to treatment, care and prevention for people living with and affected by HIV worldwide. We are dedicated to eliminating barriers to universal access to affordable life sustaining medicines for people living with HIV/AIDS as key to a comprehensive strategy to confront and ultimately stop the AIDS pandemic. We believe that the human right to life and to health must prevail over the pharmaceutical industry’s excessive profits and expanding patent rights.

logos for the participating organizations

Press Release

Trial Finds Long-Acting Injectable Antiviral Safe and Effective HIV Prevention for Some Populations

AVAC calls for trial among women to continue with urgency and to accelerate planning for possible introduction of new option to prevent HIV

Contact

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

New York City, May 18, 2020 – AVAC welcomes the news that an injectable antiretroviral for HIV pre-exposure prophylaxis (PrEP) has demonstrated initial safety and efficacy in cisgender men and transgender women who have sex with men. The US National Institute of Allergy and Infectious Diseases (NIAID), the HIV Prevention Trials Network (HPTN) and ViiV announced today that a bi-monthly injection of cabotegravir (CAB-LA) appears to be at least as effective as daily oral TDF/FTC (brand-name Truvada) at preventing HIV acquisition in HIV-uninfected cisgender men and transgender women who have sex with men. The data come from HPTN 083, one of two ongoing HIV prevention safety and efficacy trials of CAB-LA. The announcement was based on a scheduled review by an independent data and safety monitoring board (DSMB) that found that CAB-LA was providing significant protection.

“This is encouraging news for the HIV prevention field. We need additional prevention options to help people protect themselves from HIV,” said Mitchell Warren, AVAC executive director. “We now know that for men and transgender women who have sex with men, CAB-LA appears safe and effective. We look forward to the peer review publication of these data, as well as the results from the ongoing, companion trial in cisgender women, HPTN 084, in hopes that this might be a safe and effective option for all people at risk of HIV infection.”

As reported today, the DSMB recommended that all HPTN 083 trial participants be told which active drug (CAB-LA or oral TDF/FTC) they were receiving and that placebos be dropped from the study. The study will continue to completion with all participants receiving their preferred product. The DSMB also recommended that the HPTN 084 companion study continue with both active and placebo products. Both HPTN 083 and HPTN 084 are designed as double dummy, double blind studies with participants receiving both an active product and a placebo.

“Data on safety and efficacy among women, expected from HPTN 084, remain an urgent priority,” Warren added. “In many communities, women are at very high risk for HIV and have few options for HIV prevention. We cannot allow women to be left behind in the search for safe, effective and licensed HIV prevention options.”

“In addition, there is urgent work to be done to understand what HIV prevention programs and health systems need to do now in order to meet future demands of delivering a drug by injection every two months,” Warren added. “In 2018, AVAC and the Clinton Health Access Initiative (CHAI) established the Biomedical Prevention Implementation Collaborative (BioPIC) to work with a wide range of stakeholders to develop an introduction plan for long-acting injectables and other next-generation HIV prevention options. Today’s announcement makes planning all the more important if promising research results are to be translated into public health impact.”

These clinical trials are an important step in the process, but much additional work is needed. Every product has unique attributes and challenges, and there is much more to be understood about CAB-LA and the way in which it might be effectively delivered in communities and among populations where it is most needed. Understanding user preferences, health system capacity needs, the price of the product and the programs to deliver it, and the potential risk of drug resistance, amongst other issues, is necessary to move forward as quickly as possible.

“Operational research to find out how communities and individuals can best be supported to access the drug and how health systems can be strengthened to deliver it, should it be approved for use, is a critical next step while we await complete data from all populations that would inform a regulatory submission,” said Warren. “This is essential work that can and must begin now so that we don’t repeat the same kind of delays that have slowed daily oral PrEP rollout over the past eight years.”

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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 HIV prevention options as part of a comprehensive response to the pandemic.

Press Release

AVAC and TAG Statement on Ethical Conduct of SARS-CoV-2 Vaccine Challenge Studies

Organizations will partner to establish a global community advisory mechanism and also call on WHO to empanel a globally representative standing committee to address ethics and review protocols

Contact

Kay Marshall, +1-347-249-6375, [email protected]
Richard Jefferys, +1-646-243-8370, [email protected]

New York City, May 7, 2020 – The COVID-19 pandemic is a global health emergency that may demand new, safe, and expedited ways of conducting ethical research to find the solutions we need, including a safe and effective vaccine. With most of the world’s population pinning hopes of a return to work and life outside of isolation on the development and delivery of a SARS-CoV-2 vaccine, research is moving at unprecedented speed. As researchers look for ways to shave off a few months in the time to discovery, development, expedited approval, manufacture to scale and equitable delivery of a COVID-19 vaccine, controlled human infection studies (or “human challenge trials”) are now being discussed as a way to possibly shorten the timeline for vaccine efficacy studies.

On Wednesday, May 6, 2020, the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 released a report which stated that well designed challenge studies could accelerate COVID-19 vaccine development. The WHO Working Group lays out eight criteria for SARS-CoV-2 challenge studies that would need to be satisfied for studies to be ethically acceptable.

The WHO Working Group has articulated important criteria for assessing a challenge study, but we believe that they left out the most important one: Until there is an approved treatment, a challenge trial with a potentially fatal and as-yet untreatable pathogen is unacceptable.

In recent times, live pathogen challenge trials have been conducted in diseases where a safe, effective approved treatment is available, or for which pathogenesis and risks are reasonably well characterized. That is not the case for COVID-19, which means that adequately communicating about and assessing potential risks and benefits of participating in a challenge study and ensuring appropriate informed consent may be impossible.

Challenge trials are also most useful when it is difficult to recruit enough participants at high risk of measurable incidence to carry out a regular placebo-control study. As COVID-19 cases grow exponentially in communities around the world, it is clear that researchers will be able to enroll placebo-controlled efficacy trials among participants at high risk of SARS-CoV-2 acquisition who will be able to understand the risks and benefits and give true informed consent. Moreover, in this case, a placebo is highly likely to be safer than a live challenge for a significant number of those at risk in a disease with a currently estimated case fatality rate (CFR) greater than 1 percent.

While there has been increased coverage of the potential for live virus challenge vaccine studies in SARS-CoV-2, we do not believe that individuals’ expressed willingness to participate in such a trial is an adequate or appropriate measure of informed consent. The current discussion in scientific journals and in social and mainstream media cannot substitute for the needed stakeholder engagement to ensure that individuals and communities have input into what amounts to a radical and potentially dangerous, destructive and distracting change in the way research is done.

Moreover, before any challenge studies can be designed and conducted, researchers will need to develop and validate a challenge virus, a time-consuming process in its own right. During that time, it is possible that treatment(s) will emerge that will change the equation. But that is not guaranteed. If researchers move to develop a challenge model for SARS-CoV-2 vaccines, there must be a parallel process of rigorous ethical review and stakeholder engagement that addresses community and individual concerns and questions about this research.

Stakeholder engagement, as guided by Good Participatory Practice Guidelines, is a cornerstone of biomedical research. Expedited research timelines cannot short change robust engagement across a broad range of stakeholders. It is possible and necessary to ensure stakeholder input in plans for potential challenge studies.

Since the early days of the HIV epidemic, TAG and AVAC have each engaged with and advocated for accelerated research timelines, innovative trial designs, and meaningful community engagement for HIV, TB and health research. We are working with our global partners representing communities severely impacted and at risk for COVID-19 and other community and stakeholder representatives to develop a global community advisory mechanism that could work with WHO, vaccine developers and researchers, and research sponsors to ensure SARS-CoV-2 vaccine research happens to the highest possible scientific, ethical and public health standards and in the fastest possible way.

We call for the WHO to empanel a standing committee that includes researchers and ethicists involved in the WHO working group along with community representatives, policy makers, regulators, vaccinologists, infectious disease and public health experts to address the ethics of live SARS-CoV-2 challenge trials and review protocols. We must all work to ensure no unnecessary delays, but also no short-cuts which place participants at unacceptable risk of illness and death.

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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 HIV prevention options as part of a comprehensive response to the pandemic. For more information, visit www.avac.org.

About TAG: Treatment Action Group (TAG) is an independent, activist and community-based research and policy think tank fighting for better treatment, prevention, a vaccine and a cure for HIV, tuberculosis and hepatitis C virus. TAG works to ensure that all people with HIV, TB and HCV 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. For more information, visit www.treatmentactiongroup.org.

Press Release

Global Health and Human Rights Organizations Denounce Trump Administration Decision to Pull Commitments to WHO during COVID-19 Crisis

Contact

Kay Marshall, +1-347-249-6375, [email protected]
Suraj Madoori, +1-917-530-5996, [email protected]

AVAC, Health GAP, KEI and TAG

AVAC, Health GAP, Knowledge Ecology International (KEI) and Treatment Action Group (TAG) strongly condemn the Trump Administration’s decision to halt funding to the World Health Organization (WHO) in the midst of the urgent COVID-19 global health crisis.

“In a time where international cooperation on public health strategy, science, data and information sharing is more urgently needed than ever before, the Trump Administration has made an incredibly shortsighted decision to pull critical commitments to the WHO,” commented Mark Harrington, Executive Director of TAG. “Cutting global health funding in the middle of a pandemic will only prolong the devastating loss of life and economic damage in the US and across the world, and undermine the response to other infectious diseases, including HIV, tuberculosis and hepatitis C.”

WHO plays a central role in developing normative guidance, and coordinating data and best practices in public health for its member states to implement through national programs and policy. This ensures in-country public health responses on-the-ground are backed by data and science, particularly in countries where COVID-19 continues to surge.

“WHO coordination, guidance and mobilization of the public health response is tremendously important for supporting countries with struggling with limited resources, conflict and other humanitarian and ecological disaster-related crises,” explains Suraj Madoori, TAG’s US and Global Health Policy Director. “The COVID-19 epidemic will devastate already constrained health systems without the good global governance, cooperation, transparency, protection of human rights, access to health technologies for all—principles embodied by the WHO.”

The US contributes $893 million to WHO over two-years, accounting for nearly 15 percent of the agency’s budget. According to the WHO, funding contributions from the US government support a range of pandemic response activities, including prevention and control of outbreaks, emergency operations, strengthening surveillance and early warning management. Moreover, roughly $89 million (10 percent) of US funding to WHO supports tuberculosis (TB), HIV and hepatitis programming at the agency – placing even more pressure on the global response to these diseases, which has been significantly impacted by COVID-19 and the COVID-19 response in many countries.

“The Trump administration’s efforts to deflect and distract will be deadly for people living with HIV, particularly in countries that are in desperate need of increased emergency funding to bolster health systems that could be pushed to their limit by COVID-19,” said Asia Russell, Executive Director of the Health Global Access Project (Health GAP). “Defunding the WHO shows the administration’s callous disregard for human life. Congress should take immediate steps to protect and in fact increase the US investment in global health.”

Developing the guidance, surveillance, treatments, diagnostics and vaccines needed to curb the COVID-19 pandemic requires increased resources and international cooperation. To date, in the US there are an over 600,000 confirmed cases, and an estimated 26,000 deaths.

“Even with a perfect response to COVID-19 in the US, which is far from the case, we would still need WHO’s global efforts to help ensure that the pandemic is brought under control across the globe,” said Mitchell Warren, AVAC’s Executive Director. “Without robust international cooperation and WHO leadership, we cannot end this pandemic.”

This virus respects no borders. COVID-19 anywhere can quickly become COVID-19 everywhere. The US government must immediately restore and protect funding to WHO and work to ensure global cooperation in the pandemic response.

“The WHO needs to be fully operational and Trump’s comments are a massive distraction. The US already has enormous influence on WHO policies, but Trump’s comments and actions will reduce this, and breed deep and lasting resentment to the US around the world,” warned James Love, Executive Director for KEI.

AVAC, Health GAP, KEI and TAG urgently calls on Congress to take action to ensure that no appropriated funding to the WHO and global health partners is withheld in a time of critical need to address the growing COVID-19 crisis.

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Press Release

HIV Vaccine Trial HVTN 702 Stopped Early for Non-Efficacy

Contact

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

Other Vaccine Trials Not Affected; AVAC Calls for Ongoing Support to Vaccine Research

New York City – Today the US National Institute of Allergy and Infectious Diseases (NIAID) announced that HVTN 702, a large-scale HIV vaccine efficacy trial of a canary pox-based vaccine candidate, has been stopped because the vaccine does not prevent HIV.

HVTN 702 (also known as Uhambo) was stopped following a scheduled review by an independent data and safety monitoring board that showed no significant difference between the vaccine and placebo arms of the trial. The review identified no safety concerns. Trial participants are being informed of the stop and will remain in the study for follow-up.

“We always hope that efficacy trials will show positive results that lead to new prevention options,” said Mitchell Warren, Executive Director of AVAC. “It is very disappointing that this vaccine candidate does not work, but the trial was well-conducted and got an answer as quickly as possible. Over the last decade, the HIV vaccine field has made unprecedented progress in working together to tackle the tough questions that need to be answered to move research forward intelligently, share important findings, and avoid duplicative endeavors. The HIV vaccine field is more coordinated than ever before, which means it can take the answers this trial has provided and move the research agenda forward in new directions.”

“South Africa and South Africans have made enormous contributions to HIV vaccine and prevention research, as researchers, clinicians and trial participants,” Warren said. “AVAC recognizes the significant contribution of the 5,400 volunteers in this trial. Their involvement makes HIV prevention research possible. AVAC commends the trial staff and the global research team for their hard work in conducting this trial, getting an answer fast, and prioritizing participants throughout the process. We are glad the funders for this and other research recognize the imperative to work together to sustain investment.”

HVTN 702 evaluated whether an investigational HIV vaccine regimen is safe, tolerable, and effective at preventing HIV infection among 5,400 South African adult women and men. The Phase 2b/3 study, the largest and most advanced HIV vaccine trial to take place in South Africa, and was adapted from the vaccine strategy tested in the RV144 Thai vaccine trial, which showed roughly 30 percent lower infection rate among volunteers who received the vaccine versus those who received the placebo.

The vaccine approach in HVTN 702 is different from that being tested in other large-scale vaccine efficacy studies HVTN 705/HPX2008 (the Imbokodo Study) and HVTN 706/HPX3002 (the Mosaico study). It is also different from the planned PrEPVacc Study, which will test yet another vaccine strategy along with oral PrEP. The stop of HVTN 702 does not affect these trials or any other HIV prevention efficacy trials taking place globally.

“A vaccine is absolutely essential to achieving a durable end to the HIV epidemic,” said Warren. “It will be important for the HVTN 702 partners to share data from the study as quickly as possible, and for the field to come together as it did after RV144 to ensure that what can be learned from this trial is fed back into the research pipeline expeditiously. Other ongoing HIV prevention efficacy studies, including three vaccine efficacy trials, two antibody-mediated prevention trials and two long-acting injectable ARV studies will yield results in the coming years; and the earlier stage research pipeline is diverse and promising. It is critical that funding for HIV vaccine and other prevention research – as well as industry involvement – continue as part of a comprehensive agenda to end the epidemic.”

For more information, learn about the HIV vaccine research pipeline and about HVTN 702.

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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. For more information, visit www.avac.org.

Press Release

Modest Increase in HIV Prevention Research & Development Funding Encouraging

More Robust Investment Needed to Fully Fund Prevention Research to Help End the Epidemic

Mexico City — Investment in HIV prevention research and development ticked up modestly in 2018, following five years of steady declines in funding according to a new report released today at the 10th IAS Conference on HIV Science. The modest increase in funding, while encouraging, is not enough to fully fund the needed research to develop new prevention options to help meet ambitious goals of curbing and eventually ending the HIV epidemic.

The Resource Tracking for HIV Prevention R&D Working Group’s (RTWG) 15th annual report, HIV Prevention Research & Development Investments, 2018: Investing to End the Epidemic, documents an overall increase of 1.2 percent or US$13 million from the previous year, bringing the total funding for the year to US$1.14 billion.

This increase in funding comes at a time of great promise in the field, with the largest slate of preventive HIV vaccine trials in history underway or planned and key antiretroviral-based prevention options in efficacy trials (long-acting injectable PrEP) and under regulatory review (monthly dapivirine vaginal ring). In addition, many other promising HIV prevention options are in early-stage human trials or in pre-clinical development. Adequate funding to keep the pipeline of potential new prevention options moving swiftly is critical.

As in previous years, the US continued to be the major funder of HIV prevention research, with 87 cents of every dollar spent on HIV prevention R&D coming from just two donors: the US public sector contributed almost three-fourths of all global funding (US$829 million out of US$1.14 billion), while the Bill and Melinda Gates Foundation remained the principal philanthropic donor, accounting for 91 percent (US$149.7 million out of US$164 million) of all sector investment.

Overall European public sector funding was the lowest seen in more than a decade, with an 0.7 percent dip from 2017 levels to a total of US$57.5 million. There were, however, key increases from non-US public sector donors, including a 54 percent increase by the UK, a 73 percent increase from Germany and nine percent from Canada. In addition, funding from the European Commission increased by 25 percent.

The RTWG was encouraged by the overall increase in funding and noted the important increases from these key public sector donors, but renewed a call for increased funding from a greater range of donors to help guarantee the stability of R&D financing and cushion potential impact if any of the major funders were to reduce their investments.

Just nine philanthropic donors contributed to HIV prevention R&D in 2018, down from a high of 27 in 2015. While philanthropic donors account for a small percentage of overall funding, this low number of donors is concerning.

“We know what we need to do to end the epidemic. We need universal testing and treatment; we need to scale up existing prevention options; and we need to invest in research and development for new prevention choices that will meet the various needs of people at risk of HV infection. No one approach on its own will ever be enough,” said Mitchell Warren, executive director of AVAC. “There has never been a more important time to invest in HIV prevention R&D. Current donors must sustain and increase their commitments and we need new donors to invest in promising research that is necessary to bring this epidemic to an end.”

The RTWG has tracked more than US$19 billion in investment towards biomedical HIV prevention since 2000 and warned that the greatest impact of this investment could be lost without continued and sustained support to move promising prevention options from laboratories and clinics into the lives of those who most need them.

“Bringing HIV prevention programs to scale requires strengthened research, sustained investments and the political will and program leadership to ensure the rapid translation of research into programs,” said Dr. Shannon Hader, deputy executive director of UNAIDS. “The global agenda to end AIDS by 2030 will not be possible without the convergence of service delivery and research. The investments in the AIDS response will have far-reaching consequences.”

The report and infographics on prevention research investment are online at www.hivresourcetracking.org and on social media with #HIVPxinvestment.

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Since 2000, the Resource Tracking for HIV Prevention R&D Working Group (formerly the HIV Vaccines & Microbicides Resource Tracking Working Group) has employed a comprehensive methodology to track trends in research and development (R&D) investments and expenditures for biomedical HIV prevention options. AVAC leads the secretariat of the Working Group, that also includes the International AIDS Vaccine Initiative (IAVI) and the Joint United Nations Programme on HIV/AIDS (UNAIDS). This year’s report is additionally made possible by the support of several donors, including the Bill & Melinda Gates Foundation and the American people through the US President’s Emergency Plan for AIDS Relief (PEPFAR) and the US Agency for International Development (USAID). The contents are the responsibility of AVAC and the Working Group and do not necessarily reflect the views of PEPFAR, USAID or the United States Government. AVAC does not accept funding from the pharmaceutical industry.

Press Release

The Future of the HIV Response

New report provides first-time analysis of success across six locations

Mexico City — For the first time, AIDS experts have brought together new assessments from six locations around the world that have made impressive progress fighting the epidemic, identifying the common contributors to success and providing a roadmap to ending the epidemic globally.

In a new report released today at IAS 2019 and on EndAIDS.org, amfAR, AVAC and Friends of the Global Fight Against AIDS, Tuberculosis and Malaria demonstrate how dramatic reductions in HIV incidence and mortality have been accomplished in six very different settings around the world: Thailand; Malawi; Rakai, Uganda; New South Wales, Australia; London, England; and San Francisco, United States.

The report provides a graph for each location, illustrating declining HIV rates and deaths, as well as policy decisions that drove advances against the epidemic. The report also maps out the future, showing how the required policy, structural and research advances can propel dramatic progress.

“This report highlights the reality that progress toward ending HIV shouldn’t be limited by geography or demographics,” Greg Millett, Vice President and Director of Public Policy at amfAR, said. “It also highlights how much easier we can achieve our goal by continuing to invest in scientific research, as well as policies that promote human rights.”

Common contributors to lowering HIV incidence and mortality across the six locations include:

  • Campaigns to encourage HIV testing, particularly among groups that are most affected
  • Free and easy access to treatment at the time of diagnosis with HIV
  • Scale up of evidence-based HIV prevention, such as voluntary medical male circumcision, pre-exposure prophylaxis and harm reduction
  • Concerted efforts to provide human rights-based services and social supports alongside programmes to fight stigma and discrimination

“There is nothing easy about achieving epidemic control, but in Malawi, a country with few resources, we have found that innovation and early adoption of new guidelines is key to rapid scale up of treatment and prevention,” said Maureen Luba, Africa Regional Advocacy Advisor for AVAC. “With 91% of people who are aware of their status on HIV treatment, Malawi is beginning to show progress on the way to ending the epidemic. But we can’t declare success too soon; we can’t step back now in Malawi or anywhere else.”

Chris Collins, President of Friends of the Global Fight Against AIDS, Tuberculosis and Malaria, said, “This report provides a new narrative. Ending the epidemic isn’t an insurmountable challenge but a question of putting the evidence to work and scaling access, particularly for those most at risk. It won’t be easy anywhere, but it is possible everywhere.”

The six locations profiled in the report were selected based on their progress in response to the epidemic and the availability of data and information about local policy interventions. The report authors also aimed to assess a mix of types of epidemics – some among key populations and others impacting broader populations.

“To eliminate HIV worldwide, we need not just great prevention tools, but also strategic and impactful investments and policies,” Adeeba Kamarulzaman, International AIDS Society President-Elect, said. “The report provides important new analysis of what has worked and what can be scaled to build on this success.”

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About amfAR, The Foundation for AIDS Research: amfAR is one of the world’s leading non-profit organizations dedicated to the support of AIDS research, HIV prevention, treatment education and advocacy. Since 1985, amfAR has invested nearly US$550 million in its programmes and has awarded more than 3,300 grants to research teams worldwide. For more information, visit www.amfar.org.

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. For more information, visit www.avac.org.

About Friends of the Global Fight Against AIDS, Tuberculosis and Malaria: Friends of the Global Fight Against AIDS, Tuberculosis and Malaria advocates for US support of the Global Fund and the goal to end the epidemics of AIDS, tuberculosis and malaria. For more information about Friends of the Global Fight, visit www.theglobalfight.org.

The International AIDS Society (IAS) leads collective action on every front of the global HIV response through its membership base, scientific authority and convening power. Founded in 1988, the IAS is the world’s largest association of HIV professionals, with members in more than 170 countries. Working with its members, the IAS advocates and drives urgent action to reduce the impact of HIV. The IAS is also the steward of the world’s most prestigious HIV conferences: the International AIDS Conference, the IAS Conference on HIV Science, and the HIV Research for Prevention Conference. For more information, visit www.iasociety.org.

The IAS Conference on HIV Science is the world’s most influential meeting on HIV research and its applications. This biennial conference presents the most critical advances in basic, clinical and operational research that moves science into policy and practice. Through its open and inclusive programme development, the meeting sets the gold standard of HIV research featuring highly diverse and cutting-edge studies. The 10th IAS Conference on HIV Science – known as IAS 2019 – is taking place in Mexico City, Mexico, on 21-24 July 2019. For more information, visit www.ias2019.org.