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, mitchell@avac.org
Kay Marshall, +1 (347) 249-6375, kay@avac.org

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, kay@avac.org
Richard Jefferys, +1-646-243-8370, richard.jefferys@treatmentactionngroup.org

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, kay@avac.org
Suraj Madoori, +1-917-530-5996, suraj.madoori@treatmentactiongroup.org

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, mitchell@avac.org
Kay Marshall, +1 (347) 249-6375, kay@avac.org

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.

Press Release

Pivotal ECHO Study Provides Reassuring Evidence on HIV Risk and Contraceptives

High Rates of HIV Infection in East and Southern Africa Remain a Public Health Crisis for Women

Download this statement as a PDF.

Contacts

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

Durban and New York – Results of a pivotal clinical trial among 7,829 women ages 16-35 in East and Southern Africa provide important evidence to help inform women’s choices for contraception and HIV prevention. The Evidence for Contraceptive Options and HIV Outcomes (ECHO) Study found no substantial difference in HIV risk among women using the three methods of contraception in the study – the copper-releasing intrauterine device (Cu-IUD), a levonorgestrel (LNG) implant (Jadelle) and depot medroxyprogesterone acetate-intramuscular (DMPA-IM), also known as Depo-Provera.

The data, released today at the South African AIDS Conference, also sound an alarm about rates of HIV infection among women in East and Southern Africa. Overall, HIV infection rates among the study population were almost 4 percent – underscoring the need to integrate HIV and sexual and reproductive health programs and to dramatically and quickly expand HIV prevention information and services.

“These highly anticipated results contain good news and bad news: on the one hand, a well-run randomized clinical trial has demonstrated no difference in HIV risk among three highly effective family planning methods that are safe and effective. On the other hand, the trial delivered a sobering reminder that women and girls in East and Southern Africa are still at very high risk of HIV infection. An overall HIV infection rate of almost 4 percent in the study points to a public health crisis for women in the region,” said Mitchell Warren, AVAC Executive Director. “ECHO provides the data needed to help guide clear policy decisions that support programs that give women fully integrated HIV and pregnancy prevention information and choice.”

Previous trials of HIV prevention options in the region have often shown very high rates of HIV infection among participants, but the eligibility criteria for those trials usually include characteristics that are associated with HIV risk, such as transactional sex, history of sexually transmitted infections or self- reported high-risk behaviors. In the ECHO study, the only sexual behavioral eligibility criterion was being sexually active. This makes the high rates of HIV infection seen in this general population alarming; the World Health Organization guidelines for oral PrEP say that a 3 percent rate of new infections is the definition of “substantial risk”.

“The women in this trial are our sisters and daughters and mothers who were simply seeking contraception,” says Lillian Mworeko, Executive Director of the International Community of Women Living with HIV/AIDS Eastern Africa and co-chair, with AVAC, of the Civil Society HC-HIV Advocacy working group, an Africa-based network of women and allies working on HIV and sexual and reproductive health and rights in the context of ECHO and beyond. “It is a wake-up call to put HIV prevention on-site at every family planning clinic including PrEP and female condoms with peer support and trained providers.”

“Women urgently need access to information about contraception and HIV prevention, and they need expanded access to the full range of proven contraceptives and HIV prevention options, including female condoms and daily oral PrEP,” Warren added. “And we need to accelerate the development of and access to additional women-controlled HIV prevention options like the monthly dapivirine vaginal ring (currently pending regulatory approvals), and other long-acting methods, including vaccines. At the same time, ECHO provides added urgency to the development of methods that combine HIV prevention and contraception.”

The announcement of the ECHO results is an important step for women’s health as it provides evidence that WHO and national Ministries of Health will use to make decisions that will have impact on policies, programs and women’s lives. “Policy makers, funders and program implementers must urgently work to provide women with access to all sexual and reproductive health options in the same place at the same time, delivered with accurate and adequate information and without judgement,” Warren said.

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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.

Press Release

Mitchell Warren Elected President of TB Alliance Stakeholders Association, Joins Board of Directors

Global health and HIV/AIDS leader brings extensive experience in advancing critical global health innovations

New York—TB Alliance, a not-for-profit organization leading the development of new, improved and affordable tuberculosis (TB) treatments, today announced that its Stakeholders Association (SHA) has elected Mitchell Warren as its president, a position that entails a seat on TB Alliance’s Board of Directors. An accomplished leader and advocate, Warren brings extensive experience in accelerating the development and introduction of critical global health innovations.

Warren is the Executive Director of AVAC, 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 HIV/AIDS pandemic. TB is the leading killer of people living with HIV, responsible for about one-third of the total 940,000 global HIV deaths in 2017. Warren was previously Senior Director for Vaccine Preparedness at the International AIDS Vaccine Initiative (IAVI).

“I’m honored to lead the SHA and especially excited to connect the efforts of the TB and HIV communities in accelerating innovation in product development and delivery. We’re at critical junctures in advancing against both diseases, and collaborations between scientists, product developers and communities have never been more important if we are to succeed,” said Warren. The SHA is an informal association of organizations that provides an advisory role in support of TB Alliance’s strategic decision-making. It has provided guidance to TB Alliance since both groups were founded at the Meeting on TB Drug Development in Cape Town, South Africa in 2000.

SHA Members include representatives from TB-affected communities, governments, non-governmental organizations, academia, foundations and industry. Because the SHA president has a seat on the TB Alliance Board, the perspectives of the SHA and the communities they represent are represented at the highest levels of the organization. As president, Warren will serve for a three-year term.
“The Stakeholders Association plays an integral role in shaping the work of TB Alliance,” said Mel Spigelman, MD, President and CEO of TB Alliance. “We are pleased to welcome Mitchell’s leadership as SHA president and the invaluable experience he will bring to our Board of Directors.”

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About TB Alliance: TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia’s Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Cystic Fibrosis Foundation, European & Developing Countries Clinical Trials Partnership, Germany’s Federal Ministry of Education and Research through KfW, Global Health Innovative Technology Fund, Indonesia Health Fund, Irish Aid, Medical Research Council (United Kingdom), National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, United Kingdom Department for International Development and the United States Agency for International Development.

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

Press Release

Continued declines in HIV research funding put global prevention targets at great risk

Contacts

AVAC: Kay Marshall, kay@avac.org, +1-347-249-6375
IAVI: Anita Kawatra, akawatra@iavi.org, +1 212-847-1055

Madrid – HIV prevention research funding continued to decline in 2017 for the fifth consecutive year, driven largely by a five-year low in US public sector funding, according to a report released today at the HIV Research for Prevention (HIVR4P 2018) conference in Madrid, Spain.

The Resource Tracking for HIV Prevention R&D Working Group’s 14th annual report, Investing to End the Epidemic, documents funding that fell to the lowest level in more than a decade: In 2017, funding for HIV prevention research and development (R&D) decreased by 3.5 percent (US$40 million) from the previous year, falling to US$1.13 billion.

This declining funding comes at a time of great optimism for research, with a slate of efficacy trials across the prevention pipeline – including major HIV vaccine, passive antibody and next generation PrEP efficacy trials – and critical follow-on research for proven antiretroviral-based prevention options, notably the dapivirine vaginal ring. But it also comes a time when the broader HIV field is grappling with a prevention crisis that is exacerbated by decreased funding for the overall HIV response and a lack of political will to adequately fund a response that will ensure the world meets the ambitious prevention targets to end the epidemic.

The Working Group warns that getting to zero new infections will not only require the expansion of existing options like voluntary medical male circumcision (VMMC) and oral pre-exposure prophylaxis (PrEP), but also the development of innovative new products, including long-acting, antiretroviral-based prevention options and a vaccine. Sustained funding is critical to keep the full gamut of HIV prevention research moving forward in a timely manner. Even small declines in funding can delay or sideline promising, new HIV prevention options that are needed to end the HIV epidemic.

“Make no mistake. We are in a prevention crisis and we cannot afford a further funding crisis,” said Mitchell Warren, AVAC executive director. “It is unacceptable that donor funding for HIV prevention research continues to fall year after year even as research is moving new options closer to reality. We need continued and sustained investment to keep HIV prevention research on track to provide the additional tools that are required for sustainable, durable control of the HIV epidemic.”

The US government continued to be the major funder of HIV prevention research, contributing almost three-fourths of overall funding. A decrease of almost six percent, though, brought funding to a five-year low of US$830 million. The Working Group noted that sharp declines in US government funding have a major impact on the biomedical HIV prevention R&D field. With uncertainty around continued political will to fund the HIV response, this trend is extremely worrying.

Together, the US public sector and the Bill & Melinda Gates Foundation (BMGF) represented 87 percent of the total global investment in 2017, an imbalance that has continued for several years. The Working Group in this year’s report cautioned against the disproportionate impact of shifting donor priorities by these two donors on cutting-edge research, noting that a US$50 million decrease in vaccine R&D in 2017 was largely attributed to cuts from the US government, while a 67 percent increase in VMMC funding in 2017 is due largely to enhanced investment from BMGF. The Working Group renewed a call to diversify the funding base to ensure both the sustainability of the field and that decades of gains made in scientific innovation are not lost to fluctuating investment.

The Working Group noted with concern that funding by the European Commission (EC) dropped by almost half from 2016 to 2017 (US$14.4 million in 2016 to US$7.6 million). Noting increases in public sector funding from Canada, Brazil and the Netherlands, the Working Group called on other European countries to increase investment in critical HIV prevention tools to help end the epidemic and to offset the drop in EC funding.

“A true end to AIDS will only be possible if we can develop and deploy an effective, accessible HIV vaccine and other biomedical innovations to prevent HIV infection,” said Mark Feinberg, M.D., Ph.D., President and CEO of the International AIDS Vaccine Initiative. “Decades of research are paying off with the most exciting advances we’ve seen to date. But progress can only continue with sustained public and private sector investment in HIV prevention R&D.”

As researchers, implementers, advocates and funders gather this week in Madrid to review progress in HIV prevention research, there is much to be optimistic about in HIV science and in the accumulated knowledge of how to end the epidemic. At the same time, sobering changes in the funding and policy environment could imperil future progress and wipe out the progress made. Funding constraints, policy changes, shifting donor priorities and shifting demographics will all play a role in the world’s ability to respond to the continued challenges that HIV presents.

“With 5000 people becoming infected with HIV every day it is critical that we both scale up the effective HIV prevention programmes we currently have and invest in new technologies and solutions so that they can become a reality for the populations most affected by HIV,” said Tim Martineau, Deputy Executive Director, Programme a.i. UNAIDS. “Doing both will avert new infections, save lives and reduce the rising costs of life-long antiretroviral treatment.”

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

2018 Omololu Falobi Award for Excellence in HIV Prevention Researc

Media Contacts

Kay Marshall
AVAC Senior Communications Advisor
kay@avac.org

2018 Omololu Falobi Award for Excellence in HIV Prevention Research: Community Advocacy Celebrates a “Real Powerhouse” Young PrEP Advocate

Madrid – Gcobisa Madlolo, an activist, a writer, a proud mother of twins and a fresh, inspiring and powerful voice for young women in her native South Africa and beyond is the recipient of the fifth Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy. Madlolo will accept the award at the opening session of the third HIV Research for Prevention (HIVR4P) Conference in Madrid, Spain on Monday, October 22, 2018. Madlolo was an early adopter of daily oral pre-exposure prophylaxis (PrEP) and is a powerful advocate for young women’s sexual health rights.

The award is given by a group of Advocacy Organizations that focus on HIV prevention in memory of Nigerian activist Omololu Falobi, who is remembered by friends and fellow advocates as a talented journalist, an activist for social justice, an advocate for prevention research and a son of Africa who worked tirelessly to ensure Africans were taking ownership of their own HIV care and prevention.

In 2018 the award committee sought to recognize, appreciate and honor courageous and inspiring young people who have chosen to participate in clinical trials and/or use new biomedical HIV prevention options and to bravely discuss their experiences, and inspire others in the process.

In her nomination of Madlolo, Professor Sinead Delany-Moretlwe of the Wits Reproductive Health and HIV Institute (Wits RHI) said, “She’s a real powerhouse, and truly the present and future of women’s HIV prevention advocacy. Gcobisa grabs every opportunity to share her PrEP journey, the importance of support, how she is able to adhere to PrEP and how going on PrEP was a life changing decision for her.”

Madlolo participated in the EMPOWER (Enhancing Methods of Prevention and Options for Women Exposed to Risk) study which aimed at development of simple, scalable evidence-informed interventions, adapted for local use in Africa. Her commitment to finding interventions that work for herself and communities is so deep that when EMPOWER ended in 2017, she transitioned into another demonstration project, POWER (Prevention Options for Women Evaluation Research), which is helping to inform the introduction of oral PrEP among African women.

“I am grateful to be honored with the Omololu Falobi award, said Madlolo. “This recognition means that I must go out there even more, more especially to the communities where young women have very limited resources to share, and inspire and encourage them to make the right health choices.”

“I am more determined than ever to be the face of PrEP. I want to go out there to every village, every town, every city and talk to other young people about the importance of protecting themselves. For me, I take PrEP because I cannot put the keys to my own health in someone else’s pocket – I want young women and men everywhere to realise that they have to take control of their health,” she added.

Manju Chatani-Gada, Director of Partnerships & Capacity Strengthening at AVAC said, “Omololu was a visionary leader, journalist and HIV prevention activist, who accomplished much in his too-short life. He dedicated himself to HIV prevention research advocacy in Nigeria, Africa and worldwide and to championing the voices of civil society. Omololu would be so proud of Gcobisa and her fierce advocacy on behalf of herself and other young women. And that the award is celebrating the contributions of trial participants.”

In addition to Madlolo, the award committee honored two other young women advocates:

  • Ruth Nahurira, a former participant in the ASPIRE (A Study to Prevent Infection with a Ring for Extended Use) trial and the HOPE (HIV Open Label Prevention Extension), two studies of the dapivirine vaginal ring. Ruth has used her personal story and experience to help sensitize communities – those close to her home in Kampala, Uganda and even globally – about the importance of HIV prevention research, particularly for women. Within the trials themselves, she mentored other study participants, encouraging them to use their assigned rings and to comply with study procedures.
  • Mercy Mutonyi Wafula is a passionate advocate and one of the earliest adopters of oral PrEP in Kenya. Mercy has been part of the PrEP journey from trial phase to someone who has chosen PrEP as her intervention of choice for HIV prevention. Her work with sex workers earned her an opportunity to not only work as a lead PrEP Ambassador, but also as a co-investigator of a PrEP demonstration project. She is also the coordinator of a DREAMS Innovations Challenge project at the Bar Hostess Empowerment & Support Programme (BHESP) that is focusing on creating awareness and demand for PrEP among sex workers in Nairobi.

Since 2008, the Omololu Falobi award has been presented as ongoing legacy that recognizes his commitment and lasting contributions to HIV prevention research advocacy and honors those who follow in his footsteps. Madlolo received support to attend HIVR4P along with a cash award to help advance her advocacy work for prevention options for young people. The runners up also received a cash award.

The Omololu Falobi Award for Excellence in HIV Prevention Research Community Advocacy was established in 2008 by the African Microbicides Advocacy Group (AMAG) and partner organizations to recognize advocates’ contribution to the HIV prevention research field through advocacy. Today the award is presented by AMAG, AVAC, International Rectal Microbicides Advocates (IRMA), Journalists Against AIDS Nigeria (JAAIDS), and the New HIV Vaccine and Microbicides Advocacy Society (NHVMAS).

Profiles of Madlolo and the two runners up as well as more information about the award, Falobi, and previous recipients are online at www.avac.org/falobi.