New Issue of Px Wire: Action on Oral PrEP and Updates on Antibodies

The new issue of Px Wire, AVAC’s quarterly newsletter on HIV prevention research and implementation, is now available.

Click here to download.

In this issue, you’ll find:

  • Updates on how WHO is approaching broader guidance on oral PrEP—and what advocates think should happen next.
  • A closer look at passive immunization, an expanding area of research referring to the administration of laboratory-generated antibodies. Passive immunization is being explored in people living with HIV in attempts to help control viral replication and/or serve as part of a cure strategy. It is also being explored for HIV prevention.
  • And this issue’s centerspread provides a quick primer on passive immunization with HIV-specific antibodies, long-acting antiretroviral injectables, and preventive vaccines, including a new, informative table reviewing the pipelines in research and development for all three research avenues.

New Overview of Cure and Vaccine Research from TAG

Richard Jefferys of Treatment Action Group, whose incredibly clear and detailed updates on immunology, virology and pathogensis (a.k.a. what immune system does, how the virus evolves, and what the virus does to the immune system) can be found on the Michael Palm Basic Science Blog, has just published an overview of vaccine and cure research in the TAG newsletter. The piece is a great introduction and update to a critical topic—and to learn more register for an upcoming AVAC webinar.

And for more on cure research, visit our CUREiculum page.

Thailand National Community Advisory Board

Amidst the 80-plus participants at AVAC’s African Partners’ Forum, one face may have stood out more than any other. The one participant from Thailand, an AVAC partner of almost eight years, brought into the room a global perspective and a wealth of research advocacy expertise— that, despite his solitary role and his sometimes quiet demeanor, was palpable throughout the three days.

Udom is a consultant for AVAC working on community engagement in HIV research, and a consultant for the Retrovirology Department of Armed Forces Research Institute of Medical Sciences (AFRIMS) on CAB constitution since 2010. His work at AVAC is to promote community participation in HIV research and Good Participatory Practice (GPP) implementation in the country. Udom is also a member of the National Subcommittee on HIV Vaccine Development and the National Subcommittee on Biomedical HIV Prevention representing the Thai civil society involving in HIV/AIDS. One of the founders of Thailand National Community Advisory Boards (NCAB) on HIV research.

Through the Thai NGO Coalition on AIDS, he has championed the AVAC/UNAIDS Good Participatory Practices—both with research entities and national bodies—and has helped move the dial on stakeholders’ roles in the research process in Thailand. We asked him to share his experiences with the group, in particular development of a National Community Advisory Board. Here are some of his words:

Community participation in HIV research in Thailand can be divided roughly into two stages – before RV144 stage, and RV144 (and beyond) stage. RV144 was the world’s largest HIV vaccine efficacy trial and conducted in Thailand. In Thailand, the concept of community participation in HIV research was rarely mentioned before the RV144 vaccine trial. In the pre-RV144 era, almost all HIV studies in Thailand were treatment, and participants were AIDS patients of the hospitals that also contain research centers. Hence there was no need to engage others besides the patients and their families. Recruitment strategies of that time were word of mouth, banners posted around the hospitals, and pamphlets. For HIV prevention trials such as HIV vaccine, recruitment might involve one or two meetings with villagers of the target area and the local health officers.

Due to its sheer size and the resources that came with it, RV144 inadvertently changed all of these. A few Thai AIDS activists heard about the trial for the first time at an international AIDS conference and were upset for being left out. They thus demanded that the researchers discuss the plan of the trial with the communities living in the target area to prepare them. Attempting to pacify the NGOs, the researchers held several meetings to discuss the ways to move forward with them. Even though both sides agreed that community participation was necessary, they couldn’t agree on the approach or the definition of community. At the same time, the model of the community advisory board (CAB) had been used in the USA for quite some time. The Thai NGOs involved in the meetings seized on the idea of CAB because it allows laypersons to become involved in HIV research, and it was romantically linked to AIDS activism. From then on, CAB became popular among Thai NGOs. Later on, some institutes conducting HIV research in the country also adopted the CAB model to appease Thai AIDS activists (or agitators depending on viewpoint) and to fulfill requirement of the trials’ sponsors. As a result, several CABs were desultorily formed; a couple of CABs were formed even before the responsible research institutes had a study to consult them with.

Unfortunately only the name (of CAB) is adopted. Most CABs in Thailand are not clear about their roles and responsibilities. In the beginning, a couple of CABs existed in name only. There was no meeting, no activity. The selection (of CAB members) process was, and still is, not clearly defined. Criterion for CAB members is ambiguous; some CABs include researchers and members of research teams as bona fide members. In many cases, CAB members were selected based on their deferential attitude toward researchers and staff rather than their qualifications, experiences, or representativeness. The only CAB activity is bimonthly meetings that dedicated mainly to routine update of the trials with very little (or no time) for other discussion. CAB members are not consulted about the meeting agenda ahead of the meeting. The consultations sought from CAB members in the meeting are limited to informed consent forms and, occasionally, educational/communication materials. Most CABs, except one, have never seen protocols of the studies about which they are to give advice. A few CAB members think that the purpose of informed consent is to absolve the researchers from legal responsibility. Many CAB members think that CAB is an additional arm of the research team to recruit people for the trials.

In general CAB members receive no formal or structured training on relevant topics including clinical research and research ethics. Other activities that could improve CAB capability are also lacking such as orientation for new members, mentoring and coaching for new and old members who may benefit from such activities, or reading materials to improve their research knowledge. Regarding capacity building for CAB, the only exception is the youngest CAB formed about 3 years ago by a bio-ethicist working with a few AIDS activists who have CAB experience. This particular CAB has regular CAB training sessions built into their bimonthly CAB meetings as well as annual training workshop and orientation for new members.

The idea of the national CAB was born during the implementation of RV144. A few AIDS activists involved in community engagement of the trial wanted to create an autonomous coordinating CAB to promote cross-learning between existing CABs. After informal discussions with other NGO workers who were CAB members of various research institutes and a meeting to discuss the idea, the national CAB was formed in May 2014. The goal of the National CAB is to promote ethical HIV clinical research through meaningful community participation. The national CAB wants to focus on capacity building in HIV research and research ethics for existing CABs and relevant community members. Members of the national CAB are selected from six HIV CABs in the country. Notwithstanding the name, the national CAB receives no funding from government agency or research institutes.

Almost from the beginning all associated research institutes, except one, are supportive of the national CAB. Only one research institute reckons that the national CAB has to be linked to specific institute/s and formalized by a government body.The national CAB meets every 2 months to discuss various topics that are not specific to trials or institutes but related to wider issues such as the national guidelines on HIV prevention and treatment, ethics of HIV research on vulnerable populations, and the drafts of the national law on human subjects research. The national CAB also conducts activities including GPP training for CABs and community groups, annual NCAB workshop, and training on research ethics for CABs and community groups.

It is too early to gauge the impact of the national CAB. For Thailand, this kind of CAB, an independent and NGO-initiated CAB, is unprecedented. Presently key HIV research institutes and a few HIV-related national bodies are aware of the national CAB and have no object regarding its existence or function. A chairperson of a national sub-committee related to HIV wants the national CAB to serve as additional IRB in parallel with other IRBs in reviewing biomedical HIV prevention trials conducted in Thailand. This is an important challenge for the national CAB considering its tender age and the members’ combined experience. To fulfill the expectation, members of the national CAB have to significantly improve their knowledge on HIV science and research ethics. They also have to expand their involvement horizontally and vertically. It is naïve to expect that this will be easy or encounter no opposition or resistance from other stakeholders. In the end it is left to members of the national CAB to prove that they are relevant and capable of the responsibility.

AVAC Report 2014/15: HIV Prevention on the Line

In AVAC Report 2014/15: HIV Prevention on the Line, we take on the current state of global targets for the AIDS response, looking beyond pithy slogans to explore what’s in place and what’s not in terms of targets, resources and action to begin to end the AIDS epidemic. We also provide concise updates and calls to action on key prevention interventions including AIDS vaccines, voluntary medical male circumcision, microbicides, PrEP, and hormonal contraception use and HIV risk.

Intervention Update: What’s Next for AIDS Vaccines and the P5 Partnership?

Excerpted from AVAC Report: HIV Prevention on the Line, this update details attempts to test vaccine strategy which showed promise in the RV144 trial.

What’s Next for the Pox-Protein Public-Private Partnership (P5)?

This timeline, appearing in AVAC Report 2014/2015: HIV Prevention on the Line, shows the progress and future of the P5.

An Advocate’s Guide to Tracking the P5 Development Tracks

This graphic, shown in the AVAC Report 2014/15, shows the P5 development and research track trials.

AVAC Report: HIV Prevention on the Line

AVAC’s annual report of the field, the upcoming CROI meeting and why the coming year is the best and worst of times for HIV prevention

Next week, scientists, advocates and clinicians will gather in Seattle for the Conference on Retroviruses and Opportunistic Infections (CROI), a venerable HIV meeting that often triggers media coverage of the AIDS epidemic and the potential for curbing it and preserving health in people living with HIV.

A range of data is expected from CROI including “late-breaker” abstracts that will showcase data from IPERGAY and PROUD, two trials of oral PrEP using TDF/FTC in gay men and other men who have sex with men in Europe and Canada, and another trial of the microbicide 1% vaginal tenofovir gel in South African women. There will also be data from a PrEP “demonstration project” that provided the strategy in a real-life context for Kenyan and Ugandan couples with one HIV-positive and one HIV-negative partner.
We don’t know what the specific headlines will be, but we can say with confidence that one take-away must be this: The future of HIV prevention is on the line.

In our latest report, AVAC Report 2014/15: Prevention on the Line, we provide a clear agenda for what needs to happen, what’s missing, and why it matters now more than ever before.

Specifically, we argue that:

  • Ambitious prevention goals matter. They can galvanize new action, in part by expanding our sense of what’s possible.
  • But these goals will only work if they’re feasible, well-defined, measurable, and backed by adequate resources and political support. The prevention goals issued so far are inspiring but they don’t yet meet those requirements.
  • As the UNAIDS “Fast Track” for 2020 set aspirational goals, clear short-term targets are also urgently needed. We can’t wait for five years to see if the world is on track to end the AIDS epidemic.
  • The global AIDS response is running at a major financial deficit. New targets will not be met—and may even be irrelevant—if we fail to close a growing global funding gap.

Recent breakthroughs in HIV research have transformed the ability to curb new infections, making it possible to contemplate the end of the global AIDS epidemic. But prevention could be left behind if global leadership fails to make it a priority.

Recently, UNAIDS issued broad goals for HIV testing, ART provision and virologic suppression over the next five years. According to the agency, achieving these “90-90-90” goals would put the world on track to effectively end the AIDS epidemic by 2030.

On the prevention front, UNAIDS seeks to reduce new infections worldwide from 2.1 million in 2013 to 500,000 in 2020, and to eliminate stigma and discrimination. These are ambitious goals and worth aspiring to. But something important is missing from the picture—intervention-specific targets with the specificity, strategy and resources to match. The goal is great. What’s missing is how to get there.

In twenty years, we will have ample hindsight as to whether today’s targets mattered in the quest to end AIDS.

But right now, foresight and focus are urgently required. We’re concerned about whether the targets that have been set are the right ones, how much targets matter—particularly in the context of a global response running at a disastrous funding deficit—and where prevention targets other than those focused on the antiretrovirals in HIV-positive individuals—fit in. We’re also cognizant that targets can turn from audacious to absurd in the blink of an eye if financing, political will and community buy-in are missing.

AVAC works in coalitions in many of the countries hardest hit by the epidemic. Targets that are developed Geneva, Washington DC and other corridors of power can bear little resemblance to the realities of AIDS endemic countries and communities. Where there’s no reality, there’s no relevance. It’s essential that countries have the technical and financial resources to make global targets relevant to national context. Otherwise, the loftiest goals will be ignored.

As we argue in this Report, targets have played a critical role in changing the course of the epidemic. Likewise, a poorly-thought out target can have no impact at all. Right now, it’s critical that targets and tactics are matched to the lofty but achievable goal of bringing an end to AIDS. This is why we’ve devoted the first section of the Report to a look at why targets matter, what targets are missing, and how advocates for a comprehensive response need to work together to ensure smart, strategic targets across the spectrum of prevention options.

We also focus on issues that underpin (and, sometimes, undermine) the ability to meet these targets. We identify three specific areas for action:

  • Align high impact strategies with human rights and realities. Biomedical advances of the past eight years have made it scientifically plausible to talk about ending the epidemic. But plausible doesn’t mean possible. Today some scientists and public health professionals are focused on what can be achieved biomedically—without enough attention to the structural and social contexts in which treatment prevention are delivered. At the same time, some rights-focused partners speak of HIV as being exclusively pill-oriented, suggesting that there isn’t any dynamism or action on the rights-based fronts. It need not be a permanent rift—indeed it cannot be. If science does not get synched up with human rights then then there is little hope of bringing the epidemic to a conclusive end.
  • Invest in an oral PrEP-driven paradigm shift. The world is failing to deliver the most effective interventions with smart strategy and at scale. Daily oral PrEP for HIV prevention is just one example. Global targets for PrEP may be released in the coming months, but there aren’t any plans in place to meet them. Demonstration projects are small and disconnected, funding is limited and policy makers aren’t heeding the growing demand from men and women, including young women in Africa. Now is the time to spend and act to fill these gaps.
  • Demand short-term results on the path to long-term goals. It will be years before the world has an AIDS vaccine, cure strategies, long-acting injectable ARVs or multipurpose prevention technologies that reduce the risk of HIV acquisition and provide contraception. But there’s plenty of activity in clinical trials and basic science for these long-term goals. This activity needs to be aligned with short-term goals that can be used to measure progress and manage expectations.

As AVAC Report goes to press this week and as we prepare for CROI next week, the United States is grappling with profound questions about the ways that the lives of Black men and women are valued under the law. The world is trying to understand how the West African Ebola epidemics got out of control—and how to bring them to an end. And there is continued concern and vigilance over anti-homosexuality laws in Nigeria and the Gambia, and in hate-mongering environments and legislation that endanger LGBT individuals and many other marginalized groups around the world.

These events are not separate from the work that we do to fight AIDS. They embody the issues of racism, inequity, poverty and security that drive the epidemic that must be addressed to end it. In addition to the HIV-specific work laid out in these pages, it is essential to work towards fundamental, lasting and positive change in each of these areas. That will be history-making, indeed.

In Childhood Vaccine Controversy, an Indirect Lesson for HIV/AIDS Advocates

This blog post first appeared on The Body

From all the recent attention to parents’ rejection (and some politicians’ naiveté) of vaccines and a possible resurgence of measles in the United States, one welcome theme has emerged: Such a controversy could never occur if vaccines weren’t so powerfully effective in the first place.

Former Secretary of State Hillary Clinton put it best on Twitter, writing, “The science is clear: The earth is round, the sky is blue, and #vaccineswork.”

Melinda Gates spoke for many when, in a widely circulated interview, she said, “We’re incredibly lucky to have that technology and we ought to take full advantage of it.” She prefaced that by saying that people in poorer countries can truly understand the power of vaccines because they’ve experienced the devastation that preventable diseases can bring to their families.

The anti-vaccine movement has gained ground in the U.S. in part because vaccines work so well that many parents have never seen the devastating effect of the diseases that vaccines protect us from.

From the beginning of the HIV/AIDS epidemic we’ve hoped for a vaccine that could help control and eliminate HIV in the same way polio and to a lesser degree measles have been controlled. That hope for and need for a vaccine has stayed with many of us through the rise and spread of HIV treatment, new prevention options and through many setbacks and a few breakthroughs in vaccine research.

It is the power of vaccines — the seeming magic that can keep disease at bay – that keeps us hoping and working toward an HIV vaccine.

But for many in the global community of advocates, researchers, funders and policymakers seeking to end the HIV/AIDS epidemic, an HIV vaccine has slipped off the list of “must haves” to respond to the epidemic, and even sometimes is left out of the equation when they talk about how to end AIDS.

To be fair, recent advances have altered how a vaccine would fit into the HIV/AIDS response. Within just a few years, we’ve learned definitively that antiretroviral treatment not only saves the lives of people living with HIV, but drastically reduces their chances of transmitting the virus. We’ve seen that daily pre-exposure prophylaxis (PrEP) with Truvada (tenofovir/emtricitabine) is highly effective at helping HIV-negative men and women avoid infection. In sub-Saharan Africa, voluntary medical male circumcision is being rolled out widely after studies showed it can greatly reduce heterosexual men’s risk of infection. Other new options for women and men are in clinical trials.

But amidst the drive to scale up these options — enthusiastically supported by this author — are troubling assertions that current tools might be sufficient to end AIDS.

Most advocates know this isn’t true. They realize that today’s treatment and prevention options can get us well on our way toward ending the epidemic, but that our work will never be finished until we have an effective vaccine.

The problem is that knowing it isn’t enough. We need to continually raise our voices in support of the full range of prevention strategies, including those that still remain to be developed. Beyond the clear need, three critical reasons should drive us all to be advocates for HIV/AIDS vaccine research:

  1. An effective vaccine is now more possible than ever. In 2009, a trial showed for the first time that an experimental vaccine modestly reduced the risk of HIV transmission. Now, researchers are testing potentially improved versions of the same approach, known as a pox-protein prime-boost vaccine, while preparing a range of other strategies for clinical trials.
  2. Basic science continues to open whole new areas of vaccine discovery. Over the past six years, a remarkable number of basic science discoveries of new antibodies have presented vaccine researchers with entirely new avenues for research and development.
  3. With advances occurring in other areas of prevention, the impact of an effective vaccine could be even more transformative. As of 2013, some 2.1 million people were becoming infected with HIV annually. But the number has been declining, and the continued scale-up of treatment, PrEP and other options could greatly reduce that figure in the next decade. By the time a vaccine is available, its role could very well be to drive the number of infections close to zero.

My organization AIDS Vaccine Advocacy Coalition (AVAC) was founded 20 years ago with the mission of advocating for AIDS vaccine research. Since then, we’ve expanded our advocacy to include many other critical prevention technologies, but our commitment to the vaccine search remains paramount. We urge you to join us.

In the case of measles, antipathy toward vaccines is an unfortunate but not-too-surprising consequence of their stunning success. With HIV, antipathy is simply not an option.

Press Release

With future of HIV prevention “on the line,” AVAC calls for sharper, bolder strategy to end the epidemic

Contacts

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

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

New York — In a report issued today, AVAC warned that global HIV prevention efforts are in jeopardy due to an absence of strategic targets, resources and specific implementation plans to translate science, slogans and goals into action. The report calls for a robust set of global HIV prevention targets tailored to specific interventions and demands action in several key areas of the global AIDS response, including expanded rollout of daily oral pre-exposure prophylaxis, or PrEP, and alignment of science and human rights-based agendas.

“We’re at a make-or-break moment and the future of HIV prevention is on the line,” said Mitchell Warren, AVAC’s executive director. “Advances in HIV treatment and prevention research have made it possible to contemplate ending the AIDS epidemic in our lifetimes, but that will only happen with smarter planning, increased resources and greater accountability.”

The report was released ahead of the Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle (Feb. 23-26), where researchers are expected to present data from several major HIV prevention trials, including studies that could help drive global implementation of PrEP, as well as a key study of a tenofovir-based vaginal gel for women.

Report calls for smart, realistic goals and targets for HIV prevention

Today’s report, entitled Prevention on the Line, takes a close look at global goals for HIV prevention and what it will take to make them a reality. UNAIDS recently adopted the broad goals of reducing new HIV infections worldwide from 2.1 million in 2013 to 500,000 and eliminating stigma and discrimination, both by the year 2020.

Drawing upon lessons from WHO’s “3 x 5” HIV treatment initiative and other case studies, the AVAC Report concludes that ambitious prevention goals are critical – but that they will only work if they’re feasible, well-defined, measurable and supported with adequate resources and political commitment. In the case of the new UNAIDS prevention goals, the report points to a critical need for more specific, interim targets that can be tracked between now and 2020; for better data and monitoring approaches; and for resource allocations that are directly tied to achieving those targets.

“The UNAIDS prevention goals for 2020 are ambitious and inspiring,” said Warren. “But something important is missing from this picture: how to get there. We need a clear path forward, including short-term targets, so we don’t wait five years to see if the world is on track. And new targets won’t be met – and may even be irrelevant – if we fail to close the growing global funding gap for HIV prevention.”

Bold action needed to advance AVAC’s agenda to end AIDS

The report also recommends key actions to advance AVAC’s three-part agenda to end AIDS. First issued in 2011, the agenda calls for sustained efforts to deliver proven prevention tools, demonstrate and roll out new options such as PrEP and develop long-term solutions such as long-acting ARV-based prevention, vaccines and cure strategies.

Key recommendations for 2015 include:

1. Align high-impact HIV prevention with human rights and realities. Research has demonstrated the potential of high-impact prevention strategies, including biomedical approaches like HIV treatment for people living with HIV and voluntary medical male circumcision (VMMC). But these strategies won’t succeed in the real world if we give short shrift to human rights concerns, or if we fail to involve affected communities in designing and implementing prevention programs. Recent experience with treatment and VMMC, in particular, has shown that community buy-in is an essential ingredient of successful rollout and scale-up.

2. Invest now to scale up access to PrEP. Landmark trials have shown that daily oral PrEP is a powerful HIV prevention tool, and studies at next week’s CROI meeting could provide additional support. But the pace of rollout remains far too slow. Demonstration projects are small and disconnected, funding is limited and policy makers are not yet heeding growing demands for access. Funders should invest now in large-scale targeted implementation of PrEP, linked to national programs. National regulatory authorities and health ministries should prioritize licensure and rollout.

3. Accelerate research into long-term solutions. We must sustain and accelerate research on solutions such as an effective AIDS vaccine, long-acting antiretroviral prevention and treatment and a cure. Just like the rest of the AIDS response, this research needs its own short-term targets, aligned to long-term goals.

The new report and related resources, including downloadable graphics, are available now at www.avac.org/report2014-15.

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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.