A Leap Forward For the Dapivirine Vaginal Ring, the Next Steps Are Critical

After decades of research and advocacy, the Dapivirine Vaginal Ring is now one step closer to becoming available as a discreet, woman-initiated HIV prevention option. In July, the European Medicines Agency (EMA) issued a positive opinion for the ring, allowing the next steps in the regulatory process to go forward. Download this podcast to hear five different perspectives on the ring, how it expands HIV prevention options for women, and the most important next steps to bring the ring to women who need it.

New Resources on AVAC.org! The ring, long-acting PrEP and more

In the midst of harrowing trends in COVID-19 and growing concerns about its impact on HIV, HIV research has brought welcome good news. From a positive opinion on the Dapivirine Vaginal Ring, efficacy data on long-acting injectable cabotegravir (although limited to MSM and transgender women), and advocacy opportunities to demand the integration of HIV services with sexual and reproductive health, HIV prevention is making important strides in 2020. This round-up of new resources on AVAC.org and PrEPWatch.org features tools and information to advance prevention advocacy right now.

A Giant Step for the Dapivirine Vaginal Ring, What’s Next?

Understanding the EMA Opinion and Next Steps for the Dapivirine Vaginal, AVAC’s primer on the status of the ring after the EMA’s positive opinion, background on the relevant research and advocacy for what must happen next.

A webinar on Wednesday, July 29 brought together leading advocates and representatives from the ring’s developer (IPM) and WHO to talk about next steps on the regulatory process and implications for rollout.

On AVAC.org’s dedicated page for the dapivirine vaginal ring find links to key resources for advocacy.

AVAC’s debut episode of Research Fundamentals, on our podcast Px Pulse, explores the concept of partial protection. What is Partial Protection, an 11-minute episode on how and why an intervention can offer imperfect but still useful protection.

CAB-LA Shows Efficacy in One Trial, Results Coming Soon in Another

On AVAC.org’s page on long-acting injectable cabotegravir find a background on the research to date, including two trials testing this long-acting PrEP option, HPTN 083 & 084. Put the research in context with a host of additional resources found there.

An Advocates’ Primer on Long-Acting Injectable Cabotegravir for PrEP, AVAC’s primer for understanding the results of HPTN 083 and the status of HPTN 084, explores unanswered questions and next steps for advocacy.

A Conversation About Long-Acting PrEP for Cisgender Women, this discussion between Sinead Delany-Moretlwe, HPTN 084 Study Chair and Awelani Neluonde, CAB Member, was part of AVAC’s Research Literacy Networking Zone at AIDS 2020.

A Conversation About Long-Acting PrEP for MSM & Transgender Women, this discussion between Raphael Landovitz, HPTN 083 Study Chair and AVAC’s Jessica Salzwedel was part of AVAC’s Research Literacy Networking Zone at AIDS 2020.

Priorities for Advancing HIV/SRH Integration

Visit www.srhintegration.org, a joint initiative between AVAC and FP2020, which features a video series One Expert, One Question, One Minute, with key stakeholders framing the priorities for integration. There’s also a recording of a July 30th webinar, One Year After ECHO: Innovation in the time of COVID. And find links to a host of resources to inform your advocacy.

Thinking About Better PrEP Rollout?

Easier and Equitable Access to PrEP: How DSD Can Help Get Us There, by AVAC’s Jessica Rodrigues, Director of Product Introduction and Access, and published on the IAS blog devoted to differentiated service delivery (DSD), makes the case for expanding PrEP access with this user-centered approach, and using DSD for PrEP as a model for future prevention products.

See data on PrEP uptake in a whole new way with AVAC’s Global PrEP Tracker, showing dynamic trends over time. Download the Excel version of the Tracker for additional information on targets, programs, drug registration status, all sortable by country. Updated quarterly.

A Look at the Pipeline

The Years Ahead in Biomedical HIV Prevention Research provides an updated snapshot of the status of key biomedical HIV prevention strategies in research and development.

At this moment in the epidemic of COVID-19, many people who need HIV prevention products and services are struggling, and the stakes are high—will the world lose hard-won gains against HIV? But stakeholders in research are persevering with success and advocates are leveraging the day-to-day challenges to continue to demand the products people need today and in the future. We hope you’ll use these resources to tell the story, protect the global gains against HIV and push for more at this critical time.

Research Fundamentals: What is partial protection?

AVAC is launching a new series on our podcast Px Pulse—Research Fundamentals. In addition to our regular schedule of programs covering advances and challenges in HIV prevention research, Research Fundamentals we’ll explore scientific concepts in research, one at a time.

In our debut episode we explore the concept of partial protection, with:

  • David Evans, science and advocacy consultant for AVAC, formerly of Project Inform
  • Penny Moore from South Africa’s University of the Witwatersrand and National Institute for Communicable Diseases
  • And Sandhya Vasan of the US Military HIV Research Program

Together we explore the meaning of partial protection. Whether it’s condoms, a flu shot, oral PrEP or the dapivirine vaginal ring, proven products fall short of 100 percent protection against disease, and there’s a lot to know about how and why an intervention may offer imperfect but still useful protection.

Listen

Advocates’ Primer on Injectable Cabotegravir for PrEP: Trials, Approvals, Rollout and More

Results from two large-scale efficacy trials found that injectable cabotegravir (CAB-LA), given every two months, was effective as a form of pre-exposure prophylaxis (PrEP) in preventing HIV in gay men and other men who have sex with men, transgender women who have sex with men, and cisgender women. CAB-LA was developed by ViiV Healthcare and is currently used in HIV treatment. It was approved by the US Food and Drug Administration (FDA) as the first form of injectable PrEP in December 2021. This document focuses on CAB-LA for prevention, outlining what’s known and what’s next for this emerging biomedical HIV prevention strategy.

New Advocates’ Primer on HPTN 083 and Webinar

At a time when access, health justice and equity are uppermost for us all, AVAC is pleased to offer a new advocates’ guide to long-acting injectable PrEP, a new prevention strategy that’s shown benefit in some populations and generated a lot of buzz recently.

Want to know what’s known and unknown, who should do what, and what you can do? Click here to read Understanding the Results of HPTN 083.

We’ve also created a webpage of resources for advocates seeking to learn more—click thru to listen to conversations with HPTN 083 and 084 researchers at the AIDS 2020 Research Literacy Networking Zone, learn more about the history of these trials of long-acting cabotegravir (CAB-LA), and more.

Also, save the date for a webinar, this Thursday, July 16, hosted by the HPTN where you can hear the primary results of HPTN 083 and ask all your burning questions! The call is at 10:30am EDT (visit www.worldtimebuddy.com for your local time zone) and dial-in information is here.

In the coming months, we will be convening with prevention research advocates to talk about critical next steps—for CAB-LA and for prevention generally. At AVAC, we will be working to ensure that development and introduction of new PrEP strategies expands equitable access to existing daily oral PrEP, with multi-month prescriptions and self-testing where feasible, to support continued use in COVID-19 contexts. We need your help to advance primary prevention and research agendas that leave no one behind. Join us!

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Press Release

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

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

Contact

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

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

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

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

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

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

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

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

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

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

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

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

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

###

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.

Injectable PrEP Effective in MSM and Transgender Women

We are writing with breaking PrEP news—data now show that bi-monthly injections of long-acting cabotegravir (CAB-LA) appears to be safe and effective in preventing HIV in cisgender men and transgender women who have sex with men.

The data come from a large-scale efficacy trial, HPTN 083, which is ongoing in 4,500 participants at sites in the Americas, Asia and South Africa. These data were announced after a regularly scheduled review by its data and safety monitoring board (DSMB) found that CAB-LA provided significant protection against HIV. As reported, 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 one of the two active products.

Importantly, these data only apply to the population in HPTN 083—and there is an ongoing “sister” study, HPTN 084, which is evaluating CAB-LA for prevention in cisgender women. This trial began after HPTN 083 and is still enrolling participants. The DSMB recommended that HPTN 084 continue per protocol with both the active and placebo products.

The data announced today by the HPTN and partners show the promise of CAB-LA as a prevention option for some people. This is an exciting development and welcome news for HIV prevention but questions remain, including whether it’s safe and effective in cisgender women, how a bi-monthly injection might be delivered if licensed, how these findings will affect ongoing HIV prevention trials and more.

The HIV Prevention Trials Network (HPTN) held a community webinar on May 22 to discuss the preliminary results of HPTN 083 and the importance of its sister study, HPTN 084, as HIV prevention for cisgender women. Click here to watch the recording.

Press Release

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

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

Contact

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

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

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

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

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

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

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

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

###

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.

New Resources on AVAC.org and PrEPWatch.org

On the heels of our spotlight last week looking at the intersection of COVID-19 and HIV, this edition of the Advocates Network features new resources for HIV prevention research and advocacy, work that’s as important today as ever before. Both HIV and COVID-19 are urgent matters of public health, demanding a sustained commitment. Use these tools to stay informed and connected, and scroll down for COVID-19 materials.

PrEP Use Today

  • Our infographic, PrEP Initiations By Country World Wide, updates the global number of people initiating PrEP to date. We are monitoring this data particularly closely to see the impact of COVID-19 on PrEP use, so stay tuned for next quarter’s update and all things PrEP at PrEPWatch.org.

Three Weeks of Activism in Action: PEPFAR COPs 2020

Every year, country teams from more than 50 countries work with the US Government’s President’s Emergency Plan for AIDS Relief (PEPFAR) to make plans and set targets for the year ahead. Over three weeks, civil society and advocates are in meeting rooms fighting for better policies and winning important gains. Check out this year’s wins:

Px Pulse: Understanding HVTN 702

The latest installment of AVAC’s podcast, Px Pulse, talks about what’s next for HVTN 702 (also known as Uhambo). Data show the vaccine tested is safe, but offers no protection against HIV.

COVID-19 & HIV

AVAC.org’s dedicated page to COVID-19 and HIV provides essential resources to support an advocacy agenda on the combined impact of COVID-19 and HIV.