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

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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.

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).

Vaccine Efficacy Trials Pipeline

This infographic shows a timeline for each of the three major vaccine efficacy trials proposed or underway now.

Vaccines Research Pipeline

This graphic shows the many types of Vaccines undergoing research, categorized by the immune response they are designed to elicit—broadly neutralizing antibodies, non-neutralizing antibodies, T-cell responses or a combination of these.

AVAC’s “3D” View of the World: 2019 and beyond

This infographic lays out AVAC’s top-line recommendations from AVAC Report 2019: Now What? The recommendations fall into three categories: deliver — prevention programs whose impact is well-measured and -defined; demonstrate — next-generation engagement for next-generation trials; develop — new targets for the post-2020 world.

AVAC Report 2019: With 2020 targets sure to be missed, we ask Now What?

Report cover

Today, AVAC released Now What?, our 2019 annual report on the state of the HIV prevention field. Each year, the AVAC Report frames the most pressing advocacy issues facing the HIV response. At the threshold of 2020, it’s clear that global goals for HIV prevention will miss the mark by a long shot.

Though important progress has been made, the crisis UNAIDS called out in 2016 persists today with new infections around 1.7 million annually, a far cry from the 2020 target of fewer than 500,000.

So, we asked ourselves, Now What?, and answered with cross-cutting analysis and an advocacy agenda to match.

FIRST, we call for leadership that is bold, visible and activist, from the new head of UNAIDS, to houses of parliament to civil society coalitions: take uncompromising stances, demand accountability, speak out for intersectional issues of race, gender, class and climate. This work needs to be funded, full-throttle and fearless.

SECOND, we call for the use of today’s most recent evidence to guide new prevention targets that will pave the way for epidemic control. Clear milestones for the prevention research pipeline must be set. Investments over the past decades have provided us with the prevention options we have today, and much-needed new strategies are under now investigation. The field needs targets for prevention research that people can understand and influence.

THIRD, we call for multilayered prevention approaches that are centered around the person, not the virus. Since last World AIDS Day, we’ve learned again, perhaps most strikingly from the ECHO trial, about the dynamic needs of women for HIV and pregnancy prevention. The complexity of translating results into policy, bring renewed urgency to the need for comprehensive HIV prevention and reproductive health approaches. Multilayered prevention incorporates multipurpose strategies (i.e., products that prevent both pregnancy and HIV) within programs designed to address structural barriers (i.e., policy reform, transforming community norms, facilitating educational empowerment).

2020 will be a pivotal year—join us in calling on leaders, from the grassroots to global capitals, to make 2020 a turning point, when siloes come down, crises are transformed by innovation, and prevention is center stage in the fight against HIV.

Happy reading, and we’d love to hear how you answer Now What?

HVAD 2019: Vaccine science needs your support!

[UPDATE: Slides and recordings from both webinars are now available. Links are provided below.]

HIV Vaccine Awareness Day (HVAD) 2019, on May 18, comes with promising headlines about advances in potential vaccines for HIV and other diseases that imperil public health. But, 2019 has also seen outbreaks of a highly infectious, vaccine-preventable disease, the result of misinformation and fear being spread by anti-vaccine campaigners.

This HVAD, AVAC has an updated toolkit of resources for translating HIV vaccine research with a renewed sense of urgency, and two dedicated hashtags to rally the call on social media: #HIVvaccineAware and #HVAD2019. We hope you’ll join the conversation — with the updated HVAD 2019 toolkit and our upcoming webinars (below and online)!

Explore all of our updated HVAD resources:

broadly Neutralizing Antibody graphic

One of AVAC’s HVAD Toolkit infographics showing bNAb combination research.

We also hope you will join two upcoming webinars:

Resources like these are essential for public understanding and support for vaccine research. Vaccines are not simple products. They require sustained investment to develop, they can be challenging to manufacture, and just as challenging to explain to potential users.

This HVAD, join us in thanking the ongoing dedication and ingenuity – of scientists, trial participants and community advocates – to find a vaccine against HIV, and let us renew our commitment to advance public understanding and support for vaccine research, development and delivery.

HIV-Specific Neutralizing Antibodies – Targets and research status

Numerous studies, both early and late phase, are investigating the efficacy of neutralizing antibodies. This infographic shows the ongoing studies and the differing locations they target on the virus.