New Resources on AVAC.org and PrEPWatch

In this round-up of new AVAC resources you’ll find a wide range of new resources:

Understanding the Latest in HIV Prevention Research

HIV Vaccine Awareness Day is just around the corner—May 18th! In preparation, AVAC hosted a webinar, HIV Vaccines in the Midst of COVID, on Thursday, May 13.

An Advocates’ Primer on Long-Acting Injectable Cabotegravir for PrEP: In 2020, two large-scale efficacy trials, HPTN 083 & 084, found that a long-acting injectable form of cabotegravir as PrEP provided high levels of protection among people at risk of HIV. That’s truly exciting. There’s also a lot to learn and understand about next steps. What do the trial results explain, what still needs to be explored, and what do advocates think needs to happen next? Check out our primer for what’s known and what’s next for this emerging biomedical HIV prevention strategy.

A webinar: Long-Acting Injectable Cabotegravir for PrEP – Understanding the results and key areas for advocacy: AVAC’s May 3rd webinar on CAB-LA featured the researchers who led the studies on long-acting injectable PrEP, and advocates who are defining key issues for the introduction of CAB-LA.

Dive into the AMP Trials: In this episode of Px Pulse, AVACers Jeanne Baron and Daisy Ouya talk to leading bNAb researcher, IAVI’s Devin Sok; veteran HIV research advocate Mark Hubbard who served on AMP’s protocol team; and a senior member of the HVTN’s community engagement team, a chief explainer of the AMP trails, Gail Broder. Together they explore why these findings point to the need for combination antibodies, the need for a better understanding of the types of HIV that are circulating in a community, the complicated implications of a key lab test, the TZM-bl assay, and more.

Developments in the HIV Prevention Pipeline: PrEP, vaccines and more: Created by AVAC, EATG, PrEP in Europe, and PrEPster, this slide deck and recorded webinar offers community educators and advocates a concise summary of existing and future PrEP products, and a community-level perspective on strategic advocacy for PrEP access and uptake.

Watchdogging PEPFAR

PEPFAR Watch is a new online resource from a collaboration working to hold PEPFAR accountable to communities. The website features reports, news, and resources to support community-led monitoring, a core initiative for accountability in PEPFAR programs. You can also sign up to become members and gain access to webinars, PEPFAR quarterly data and more. The collaboration includes Health GAP, AVAC, TAG, the O’Neill Institute, MPact, the PLUS Coalition, amfAR, and CHANGE. It should be a one stop shop for all the information you need to monitor and influence PEPFAR Country Operational Plans. Find other supportive resources on AVAC’s page: Advocate for Access to High-Impact Prevention.

A Spotlight on Equity and Ethics

Make Your Voice Heard: Towards advancing racial equity & diversity in biomedical research: In response to a call from the NIH for proposals to advance racial equity, diversity, and inclusion within all facets of the biomedical research workforce, and expand research to eliminate or lessen health disparities and inequities, AVAC’s John Meade authored a blog on the major recommendations offered to the NIH from a coalition of 25 HIV research advocate organization.

How can research ethics committees help to strengthen stakeholder engagement in health research in South Africa? An evaluation of REC documents: This article, co-authored by our CASPR partners at South Africa’s HIV AIDS Vaccines Ethics Group (HAVEG) and AVAC’s Jess Salzwedel, and published in the South African Journal of Bioethics and Law, recommends research ethics committees (RECs) step up the focus on stakeholder engagement. Researchers working with REC’s should plan for robust stakeholder engagement and REC documentation should be harmonized to reflect this priority.

Advocacy for Vaccine Access

Breaking the Bottlenecks to COVID-19 Vaccine Access: Ensuring global access to COVID vaccines—and any health commodity—requires a multi-pronged effort to get the right policies in place. This new infographic identifies the multiple factors that contribute to bottlenecks in the global supply of #COVID19 vaccines and how to address them.

We hope these resources, which cut across issues facing the field, will empower your advocacy where change is both crucial and possible.

Dive into the AMP Trials

Results from the AMP Trials, studying a broadly neutralizing antibody (bNAb) known as VRC01, were complex, with still unfolding implications for the field.

The AMP Trials, two Phase IIb studies, tested the safety and efficacy of an infusion of VRC01 received every eight weeks. HVTN 703/HPTN 081 enrolled 1,900 women in sub-Saharan Africa, and HVTN 704/HPTN 085 enrolled 2,700 men who have sex with men and transgender people in North and South America and in Europe.

The overall efficacy demonstrated in the trials was not protective. But when VRC01 was fighting strains of HIV that were highly sensitive to it, the antibody did provide partial protection. So what does that mean for the field, and what other questions have been raised by these pioneering trials?

In this episode of Px Pulse, AVACers Jeanne Baron and Daisy Ouya talk to leading bNAb researcher, IAVI’s Devin Sok; a veteran HIV research advocate Mark Hubbard who served on AMP’s protocol team; and a senior member of the HVTN’s community engagement team, a chief explainer of the AMP trails, Gail Broder. Together we explore why these findings point to the need for combination antibodies, the need for a better understanding of the types of HIV that are circulating in a community, the complicated implications of a key lab test, the TZM-bl assay and more.

Hosted and produced by Jeanne Baron.

Highlights

Resources

New Episode of Px Pulse! Dive into the AMP Trials

Findings from two trials on antibody-mediated prevention, the AMP Trials, have been generating discussion since the beginning of the year. The results are complex, and the implications for HIV prevention research are unfolding. The overall efficacy finding from these two Phase IIb studies was not protective. But when the broadly neutralizing antibody (bNAb) known as VRC01 was fighting strains of HIV that were highly sensitive to it, the antibody did provide partial protection. So what does that mean for the field, and what other questions have been raised by these pioneering trials?

In this episode of Px Pulse, AVACers Jeanne Baron and Daisy Ouya talk to leading bNAb researcher, IAVI’s Devin Sok; a veteran HIV research advocate Mark Hubbard who served on AMP’s protocol team; and a senior member of the HVTN’s community engagement team, a chief explainer of the AMP trials, Gail Broder. Together, we explore why these findings point to the need for combination antibodies, the need for a better understanding of the types of HIV that are circulating in a community, the complicated implications of a key lab test and more.

For more resources on these trials and antibody research for HIV prevention generally, AVAC has you covered. See AVAC’s dedicated page on the AMP trials, stay tuned for our forthcoming publication on “understanding the AMP results”, and for a broader context go to our page on antibody related research with access to our updated graphics on individual bNAbs and combinations.

Also, be sure to check out IAVI’s special report out today, The Future of antibody-based HIV Prevention, which analyzes the results and deepens the discussion with insights from experts across the field.

For the full podcast episode, highlights and more resources, visit avac.org/px-pulse. And subscribe on Apple Podcasts, Spotify or wherever you get your podcasts!

New Resources on AVAC.org!

Read on for a roundup of new resources on AVAC.org and PrEPWatch.org!

It’s one year into the COVID-19 pandemic, and the pace of advocacy for many people has only accelerated. In this time, when vast quantities of information—good and bad—must be sorted and priorities set, AVAC has been generating resources to help you keep up-to-date and to inform your advocacy.

HIVR4P in 3D

Okay, maybe it’s not really three dimensions; it’s more! Catch up on many angles of R4P starting with AVAC’s coverage:

Recordings from the Advocates’ Corner went deep into the content and include insightful, lively exchanges:

Funding for HIV Prevention R&D

The 16th annual analysis of funding trends in HIV Prevention R&D is out with 2019 data, and it can all be found on a newly launched website: www.hivresourcetracking.org. The annual report is a collaboration among AVAC, IAVI and UNAIDS, and the website includes 20 years of funding trends.

1 Million PrEP Initiations…almost

These two resources will help you understand the trends in PrEP uptake, and keep you up-to-date on PrEP initiations around the world, which is fast approaching 1 million but still well below global targets.

Ending TB

AVAC, Partners in Health, Friends of the Global Fight, Results, Treatment Action Group (TAG) and the Zero TB Initiative collaborated on a report and a new website that includes case studies from around the world. Find out what successful programs in Cambodia, Ethiopia, Pakistan, Russia, South Africa and the United States have in common and learn more about the critical components needed to achieve the eradication of TB.

Protecting Global Gains

Two new vignettes on Protecting Global Gains explore how communities are adapting to maintain critical healthcare as COVID-19 threatens hard-won gains in global health. This project is a collaboration including AVAC, Partners in Health, Friends of the Global Fight, Results, Treatment Action Group (TAG) and the Zero TB Initiative.

HIV Research for Prevention Conference Presents Important Research Insights Across a Range of New Options

Today at a press conference hosted by the HIV Research for Prevention (HIV R4P) conference, research teams presented a range of data from ongoing studies of antibody-mediated prevention, long-acting injectable PrEP, a monthly PrEP pill, and trends in daily oral PrEP use. Together, they point to a future of biomedical HIV prevention research and programs with a greater understanding of mechanisms of prevention, enhanced trial designs and a wider range of prevention options.

HIV R4P Virtual 2021 begins officially on January 27th. Today’s press conference offered top-line findings from the full scientific presentations that will be made later this week. These data have not yet been published in peer-reviewed journals but warrant close attention for their implications for the field.

At the press conference, researchers from the NIH-funded HIV Vaccine Trials Network (HVTN) and HIV Prevention Trials Network (HPTN) presented initial data from the Antibody-Mediated Prevention (AMP) trials of an HIV-specific broadly neutralizing antibody (bNAb) called VRC01, delivered intravenously once every eight weeks. The trials enrolled cisgender women in sub-Saharan Africa and gay men and transgender persons who have sex with men in Brazil, Peru, Switzerland and the United States. According to Larry Corey, AMP Studies protocol chair and principal investigator of the HVTN, VRC01 did not significantly reduce the overall risk of HIV acquisition in participants who received the antibody compared to those who received the placebo. However, VRC01 did safely and effectively reduce the risk of acquiring HIV strains classified as “highly-sensitive” to neutralization by VRC01.

“These were complex and well-designed trials of a novel HIV prevention concept, and the results move the field forward in important ways,” said Mitchell Warren, AVAC Executive Director. “The AMP trials show that a broadly neutralizing antibody can reduce the risk of acquiring viruses that are very sensitive to that antibody. This is welcome news; it is the first evidence in humans that intravenous infusions of a broadly neutralizing HIV antibody can reduce a person’s risk of acquiring HIV via sex.”

The AMP results also demonstrate the extent of the challenge that lies ahead for antibody-mediated prevention. There are multiple strains of HIV circulating through communities. The trial team used lab tests to predict how many HIV strains in trial communities would be sensitive to, and blocked by, VRC01. The trial data didn’t match these predictions. Fewer viruses were highly-sensitive to VRC01 than the AMP team had hoped. The trials showed that a bNAb like VRC01 does not offer sufficient protection on its own and that a combination of bNAbs is likely needed if broad protection is to be achieved.

“AVAC is grateful to the research teams, trial participants, clinic staff and community advocates who made these trials possible. The next step for the prevention field is to determine how these results can be used to guide the selection of combination bNAb products to advance to efficacy trials. Advocates should monitor — and be engaged in — these deliberations,” said Stacey Hannah, AVAC’s Director of Research Engagement.

“With new prevention options like the Dapivirine Vaginal Ring and injectable cabotegravir for PrEP advancing towards licensure, people at risk of HIV will have more choices. This is a great thing. As choice expands, efficacy trials of future products will need to be designed in new ways, and advocates’ support for investigation of bNAbs as part of this prevention pipeline is crucial,” said Hannah, who also led the development of AVAC’s Advocates’ Trial Design Academy that is engaging with developers and trial designers in considering the future.

Participants in the AMP trials received one of two different doses of VRC01 or a placebo administered every eight weeks via intravenous infusion. Some participants — in both the placebo and VRC01 arms — acquired HIV in spite of counseling, condom provision and PrEP referrals and counseling at all study sites. Viruses from these participants were isolated from their blood samples, sequenced and analyzed in the laboratory to determine the concentration of VRC01 that blocked viral activity. Viruses neutralized with a

Press Release

Data from Antibody-Mediated Prevention Studies Advance the Field and Show the Challenges that Lie Ahead

HIV Research for Prevention Conference Presents Important Research Insights Across a Range of New Options

Contact

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

New York City, January 26, 2021 — Today at a press conference hosted by the HIV Research for Prevention (HIV R4P) conference, research teams presented a range of data from ongoing studies of antibody-mediated prevention, long-acting injectable PrEP, a monthly PrEP pill, and trends in daily oral PrEP use. Together, they point to a future of biomedical HIV prevention research and programs with a greater understanding of mechanisms of prevention, enhanced trial designs and a wider range of prevention options.

HIV R4P Virtual 2021 begins officially on January 27th. Today’s press conference offered top-line findings from the full scientific presentations that will be made later this week. These data have not yet been published in peer-reviewed journals but warrant close attention for their implications for the field.

At the press conference, researchers from the NIH-funded HIV Vaccine Trials Network (HVTN) and HIV Prevention Trials Network (HPTN) presented initial data from the Antibody-Mediated Prevention (AMP) trials of an HIV-specific broadly neutralizing antibody (bNAb) called VRC01, delivered intravenously once every eight weeks. The trials enrolled cisgender women in sub-Saharan Africa and gay men and transgender persons who have sex with men in Brazil, Peru, Switzerland and the United States. According to Larry Corey, AMP Studies protocol chair and principal investigator of the HVTN, VRC01 did not significantly reduce the overall risk of HIV acquisition in participants who received the antibody compared to those who received the placebo. However, VRC01 did safely and effectively reduce the risk of acquiring HIV strains classified as “highly-sensitive” to neutralization by VRC01.

“These were complex and well-designed trials of a novel HIV prevention concept, and the results move the field forward in important ways,” said Mitchell Warren, AVAC Executive Director. “The AMP trials show that a broadly neutralizing antibody can reduce the risk of acquiring viruses that are very sensitive to that antibody. This is welcome news; it is the first evidence in humans that intravenous infusions of a broadly neutralizing HIV antibody can reduce a person’s risk of acquiring HIV via sex.”

The AMP results also demonstrate the extent of the challenge that lies ahead for antibody-mediated prevention. There are multiple strains of HIV circulating through communities. The trial team used lab tests to predict how many HIV strains in trial communities would be sensitive to, and blocked by, VRC01. The trial data didn’t match these predictions. Fewer viruses were highly-sensitive to VRC01 than the AMP team had hoped. The trials showed that a bNAb like VRC01 does not offer sufficient protection on its own and that a combination of bNAbs is likely needed if broad protection is to be achieved.

“AVAC is grateful to the research teams, trial participants, clinic staff and community advocates who made these trials possible. The next step for the prevention field is to determine how these results can be used to guide the selection of combination bNAb products to advance to efficacy trials. Advocates should monitor — and be engaged in — these deliberations,” said Stacey Hannah, AVAC’s Director of Research Engagement.

“With new prevention options like the Dapivirine Vaginal Ring and injectable cabotegravir for PrEP advancing towards licensure, people at risk of HIV will have more choices. This is a great thing. As choice expands, efficacy trials of future products will need to be designed in new ways, and advocates’ support for investigation of bNAbs as part of this prevention pipeline is crucial,” said Hannah, who also led the development of AVAC’s Advocates’ Trial Design Academy that is engaging with developers and trial designers in considering the future.

Participants in the AMP trials received one of two different doses of VRC01 or a placebo administered every eight weeks via intravenous infusion. Some participants — in both the placebo and VRC01 arms — acquired HIV in spite of counseling, condom provision and PrEP referrals and counseling at all study sites. Viruses from these participants were isolated from their blood samples, sequenced and analyzed in the laboratory to determine the concentration of VRC01 that blocked viral activity. Viruses neutralized with a <1 microgram/mL, a measure of the virus’s susceptibility to neutralization by VRC01, were classified as highly-sensitive. Participants who received VRC01 were significantly less likely to acquire a virus highly-sensitive to VRC01 compared to those who received the placebo. For viruses with a sensitivity greater than 1, no statistically significant protection was observed.

Importantly, the study’s findings have shown that a specific test, or assay, used in the study may predict whether future antibodies are likely to provide protection against a broader range of HIV sensitivities when used alone or in combination. The identification of such an assay that can be used to evaluate whether the future bNABs, alone or in combination, are likely to protect is an important step forward for the field and may help predict the combination and amount of antibodies needed for protection.

In the press conference update, AMP investigators reported that no difference in trial findings across gender and in the context of regions where clade B and clade C predominate (HVTN 704 and 703 trials, respectively.) This is the first time that a trial in humans has shown that an intravenously-administered bNAb reaches the mucosal surfaces where sexual exposure occurs, and that it can protect at these surfaces.

The AMP results were presented alongside other important HIV prevention advances, including interim results of the HPTN 084 efficacy study showing safety and efficacy of injectable cabotegravir amongst cisgender women presented by Sinead Delany-Moretlwe, protocol chair, director of research at Wits Reproductive Health and HIV Institute. The data also provided more information on how injectable CAB-LA compared to daily oral PrEP in terms of reducing risk of HIV. The investigators reported that, while rates of HIV in cisgender women were low in both trial groups, CAB-LA was more effective than daily oral PrEP. The efficacy a product shows in a clinical trial is just one factor affecting its effectiveness. As the contraceptive field has long known, the most effective product is the one that fits into a person’s life and is used. HPTN 084 provides more information to help cisgender women make informed choices.

At the press conference, Sharon Hillier of the Magee-Women’s Research Institute at the University of Pittsburgh reported on an interim analysis of the Phase 2a trial of the once-monthly pill form of the antiretroviral Islatravir, which found it to be safe and well-tolerated, with presence in the blood over time that researchers believe will correlate with protection. Islatravir is moving into efficacy trials in 2021.

An analysis of oral PrEP uptake data from AVAC’s Global PrEP Tracker, showed increased initiation of daily oral PrEP, even in the midst of the COVID-19 pandemic, but also noted that the rate of increase is slowing down — a sign that work must be done to ensure expanded uptake of existing options even as new ones become available Kate Segal, Program Manager for Product Introduction and Access at AVAC said, “Many of the countries with the highest PrEP initiations exhibit shared traits that have contributed to their success with scaling up PrEP: early adoption of PrEP, national commitment to scale-up, and programs tailored to populations at high risk offering community-led, accessible, non-discriminatory services and linkages to social support.”

“Taken together, this suite of studies being presented at HIV R4P offer a set of clear imperatives for HIV prevention: national governments, funders and advocates must work to continue to increase access to daily oral PrEP; and work to ensure that today’s PrEP programs provide a platform for tomorrow’s products, including injectable cabotegravir and the Dapivirine Vaginal Ring. At the same time, research must continue, including efficacy trials of Islatravir and other next-generation PrEP options and research that builds on the AMP results to inform both antibody and vaccine development,” Hannah said.

AVAC looks forward to working with researchers, funders, policy makers, advocates and activists to ensure that the results of these trials are translated into impact.

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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. Follow AVAC on Twitter @HIVpxresearch.

The Curtain Raises on R4P: Findings on the AMP Trials and more…

Today at a press conference hosted by the HIV Research for Prevention (HIV R4P) conference, research teams presented a range of data from studies of antibody-mediated prevention (AMP), long-acting injectable PrEP, a monthly PrEP pill and trends in daily oral PrEP use. Together, they point to a future of HIV prevention, in research and programs, with a greater understanding of the biology that informs effective prevention, enhanced trial designs and a wider range of prevention options.

HIV R4P Virtual 2021 officially kicks off tomorrow, January 27th. Today’s press conference offered top-line findings from the scientific presentations that will be made later this week. These data have not yet been published in peer-reviewed journals but warrant close attention for their implications for the field.

Taken together, this suite of studies offer a set of clear imperatives for HIV prevention: national governments, funders and advocates must work to continue to increase access to daily oral PrEP; and work to ensure that today’s PrEP programs provide a platform for tomorrow’s products, including injectable cabotegravir and the Dapivirine Vaginal Ring. At the same time, research must continue, including efficacy trials of Islatravir and other next-generation PrEP options and research that builds on the AMP results to inform both antibody and vaccine development. Click here to read AVAC’s press statement on these new data.

And just after the press conference, the World Health Organization officially recommended the Dapivirine Vaginal Ring (DVR) be included as a prevention choice for women at risk of HIV. This recommendation, along with a similar, strong statement for choice in the recent PEPFAR Country Operating Plan guidance, represents a critical step in making the DVR available to women who want it, and paving the way for additional prevention options.

As a reminder, here are sessions and a schedule for the Advocates Corner, to tune in as you’re able, where AVAC and partners will be shining light on the prevention agenda.

AMP Study FAQ

From the two trial networks conducting the AMP Study, this document provides answers to commonly asked questions about the VRC01 antibody, details on the study design and more.

New Resources to Help Navigate the News on HIV and COVID-19

The latest news on R&D breakthroughs for prevention of COVID-19 and HIV brings to our lips this call: it’s time to be ready for action with dogged determination to demand transparency, accountability, evidence and equity. In case you missed it, AVAC has new resources to help prepare.

Long-Acting PrEP and the HIV Prevention Pipeline

HPTN 084 Primary Study Results Webinar – Download the HPTN webinar with trial leaders from HPTN 084 who discuss the primary results of HPTN 084.

Landmark Trial in East and Southern Africa Finds Injectable PrEP Safe and Effective for Cisgender Women – Read AVAC’s statement on HPTN 084’s efficacy findings and what must come next.

The Future of ARV-Based Prevention and Biomedical HIV Prevention Trials: Results, milestones and more – Check out the updates to our infographics on the HIV prevention pipeline.

HIV-Specific Neutralizing Antibodies by Target and Broadly Neutralizing Antibody Combinations – We’ve also updated these infographics on broadly neutralizing antibodies in HIV prevention research.

AMP-ticipation: Context and concepts for understanding the AMP Trials – Read this blog to prepare for the forthcoming results from the Antibody Mediated Prevention Study.

Protecting Global Gains

Protectingglobalgains.org – At this recently launched site, Amref Health Africa, AVAC and Friends of the Global Fight have come together to document the impact COVID-19 is having on global health programs and the innovative solutions that are being developed and implemented all over the world.

Global PrEP Tracker – This update of Q3 data shows overall global uptake continued to climb even in the midst of COVID-19. The number of people who have started on PrEP has reached 773,474, an increase of more than 23 percent since the year began.

The Promise and Challenge of PrEP for Adolescent Girls and Young Women – Listen to this podcast from our colleagues at CSIS, which includes perspectives from AVAC and Wits RHI.

Efficacy & Equity: Twin Powers to End Epidemics

Why exciting results from vaccine research are just the beginning of efforts to end COVID-19 – AVAC’s Mitchell Warren penned this Devex op-ed, pointing to important lessons from the field HIV on the steep but scalable challenges of turning highly effective prevention tools into real and accessible options for people in need.

Advocate’s Guide to COVID-19 Vaccine Access – A plain-language guide covering the necessary components for equitable COVID-19 vaccine access to help inform and support advocates.

Treatment Action Group and AVAC Statement on Pfizer/BioNTech COVID-19 Vaccine Efficacy Announcement – Read our statement with the Treatment Action Group (TAG) to learn more about what must come next to move forward with COVID-19 vaccines.

Efficacy News from Second COVID-19 Vaccine Trial Underscores Need for Transparency and Cooperation between Outgoing and Incoming US Administrations – Read this statement joint statement from AVAC and TAG to learn how and why US leaders must put people ahead of politics.

At AVAC, we’re watching for more COVID-19 vaccines that may soon join the two now showing efficacy, while our eyes remain firmly on HIV prevention options still in the pipeline. At the same time, no less focus is needed on programs and policies for equitable access. Use these resources to work with health leaders of all stripes to build the systems the world needs for prevention to become a reality everywhere it’s needed.

Biomedical HIV Prevention Trials: Results, milestones and more

This graphic shows the updated status of large-scale prevention trials through 2022 and the impact of COVID-19 on each trial.

Another version of this graphic is available here (same content, different visual Treatment U=U).