Jan 19 Webinar: Oral PrEP Implementation and Implications for Next Generation PrEP

[UPDATE]: Visit here for the recording and to read a summary.

On Wednesday, January 19, AVAC and partners shared critical insights and lessons from oral PrEP programs in Kenya, South Africa, and Zimbabwe. Learning from these efforts, and other key lessons from oral PrEP introduction to date, is essential to faster, smarter and more affordable rollout of future HIV prevention products, including the Dapivirine Vaginal Ring and injectable cabotegravir. These lessons are built on more than six years of analysis and collaboration with partners and reflect urgent priorities for the field. The world cannot afford to make the same mistakes twice as a growing number of tools for prevention gain regulatory approval.

Click here to watch Oral PrEP Implementation and Implications for Next Generation PrEP. You’ll hear Saiqa Mullick of WitsRHI, Joseph Murungu of Pangaea Zimbabwe AIDS Trust (PZAT), and Daniel Were of Jhpiego discuss what has worked and what must change to transform options into choices, to finally reach the targets that will end the epidemic of HIV.

These insights offer a unique opportunity to fulfill the potential of HIV biomedical prevention, demonstrate the impact of informed choice, and realize the full benefits of increasing the use of HIV prevention among those who need it most. As additional PrEP options come to market, they could transform the landscape of HIV prevention—offering more personalized options, increasing the number of PrEP users, and ultimately contributing to lower HIV incidence. These products must be accessible, acceptable and used effectively by those who need them.

This webinar follows the important discussion AVAC convened yesterday, where leading voices in the field of HIV prevention identified their priorities in 2022. Check out the recording of Ups & Downs in the Field: Setting an agenda together for 2022, and watch the January 19th discussion to focus on next steps for these priorities on getting rollout right in 2022.

Jan 13 Webinar – Ups & Downs in the Field: Setting an agenda together for 2022

[UPDATE]: Visit here for the recording, to download slides, and read a summary.

On Thursday, January 13, AVAC held Ups & Downs in the Field: Setting an Agenda Together for HIV Prevention in 2022, a webinar looking at the latest advances, disappointments and opportunities in HIV prevention.

Watch the lively conversation with Rachel Baggaley from the World Health Organization; Linda-Gail Bekker from South Africa’s Desmond Tutu Health Foundation; Grace Kumwenda of Pakachere Institute of Health and Development Communication; and Kenneth Mwehonge, the new executive director of Coalition for Health Promotion and Social Development (HEPS-Uganda).

2022 begins in the midst of possibility and uncertainty. Some HIV prevention interventions are advancing at record speed while others face unexpected challenges. With lessons learned from oral PrEP, new targets from UNAIDS putting social drivers of epidemics in focus, and pioneering innovation ignited in the response to COVID-19, the ability is at hand to fundamentally impact the epidemic through primary prevention. It means offering a full spectrum of much needed prevention choices to the people who need them most. And it depends on the core priorities AVAC has long championed: follow the science, center communities in the response and lead with equity.

This webinar provided an opportunity to address key questions including: where we are with the introduction of injectable CAB-LA and the Dapivirine Vaginal Ring; the development status of islatravir as a monthly pill and injectable lenacapavir as promising new PrEP agents whose trials were put on hold late in 2021; and how to ensure HIV prevention, and equitable access to innovation, do not fall further behind; and much more.

Jan 10 Webinar: How to boost vaccine uptake with John Nkengasong

[UPDATE]: Visit here to view the recording and read a summary.

On January 10th, the COVID Advocates Advisory Board (CAAB), the Coalition to Accelerate and Support Prevention Research (CASPR) and AVAC held a webinar that looked closely at how global health leaders are tackling public resistance to COVID-19 vaccines, and lessons for the HIV field.

View the recording here for Understanding—and Improving—COVID-19 Vaccine Uptake, the first in a series of webinars on vaccine confidence. WACI Health’s Rosemary Mburu will moderate a discussion with:

The causes of vaccine hesitancy are complex, but its impact on prolonging pandemics is clear. Low uptake, particularly in countries with widespread access to vaccines, is hobbling the global COVID-19 response. Learning from efforts to build confidence in effective vaccines, and in the health systems that develop, manufacture, approve and distribute them, is essential. These lessons are integral to ending the current pandemic and preparing the field for future vaccines to address HIV, malaria, tuberculosis and whatever pandemic might be next.

This webinar is part of a series hosted by the CAAB and CASPR exploring key topics in pandemic preparedness and response. The series is focused on capturing insights from the response to COVID-19 that will inform public health policy and practice moving forward. For more, visit covidadvocates.org.

The Weekly NewsDigest will return January 7

There will be no issue next week. The NewsDigest will return on January 7, 2022. Our best wishes for happy holidays and a peaceful new year, and our thanks for reading!

Ups & Downs in the Field: Setting an Agenda Together for HIV Prevention in 2022

Join AVAC on Thursday, January 13 at 9:00 am EST for Ups & Downs in the Field: Setting an Agenda Together for HIV Prevention in 2022, a webinar to discuss the latest ups and downs in HIV prevention, and set an advocacy agenda together for the future. Click here to register.

A World In Transition: Charting the Future of HIV Prevention and Global Health Advocacy and Action

We close the year with the exciting news that injectable cabotegravir has gained FDA approval as PrEP. It’s an important achievement, adding another much needed HIV prevention option to the mix. But as we reflect on the many lessons of the year, we recognize this milestone sits within a larger, more complicated context. This regulatory approval is only one, albeit essential, step (for a single product among a much-needed pipeline of many) in a greater effort to transform options into real choices that have impact on epidemics and in people’s lives.

The story of 2021 is one of advances, disappointments, uncertainty, perseverance and solidarity. Through it all, we recognize themes that have been similar throughout AVAC’s 26-year history: follow the science, center community in the response, and lead with equity, always.

2021 brought no end to challenges in global health, and we hope that everyone finds time to reflect, and, hopefully, rejuvenate for the year ahead and the work that we hope to do collaboratively.

To start the new year right, please mark your calendars for Thursday, January 13 at 9:00 am EST for a webinar to discuss the latest ups and downs in HIV prevention, and set an advocacy agenda together for the future: Ups & Downs in the Field: Setting an Agenda Together for HIV Prevention in 2022; click here to register.

In the meantime, if you’re looking to catch-up on the year that was, planning for the year ahead, or just want to have some good holiday reading and listening, here are a few important reminders of 2021:

  1. On the heels of this week’s FDA approval of injectable PrEP, and with decisions from other regulatory bodies anticipated in early 2022, check out An Advocates’ Primer on Injectable Cabotegravir for PrEP and explore our Biomedical Prevention Implementation Collaborative (BioPIC) that is working to close the gap between research, regulatory approval and rollout for injectable cabotegravir and future products.
  2. In January, WHO officially recommended the Dapivirine Vaginal Ring (DVR) be included as a prevention choice for women at risk of HIV. The regulatory approval process has taken longer than we all wanted with various twists and turns, but happily WHO just this month restated their commitment to support countries as they consider whether to include the DVR as an additional prevention option for women.
  3. With the introduction of the new ring and injectable PrEP on the horizon in 2022, it has never been more important to reflect on the lessons we recently documented from the past decade of oral PrEP and their implications for these next generation PrEP products.
  4. Even as the new PrEP options rollout, the need to develop additional PrEP options continues. We have a full menu of resources related to the research agenda. New ethics guidelines support ongoing and future trials in an era of existing PrEP, which we reviewed earlier this year; our Px Pulse podcast series Research Fundamentals looks at the fundamental role of endpoints in trial design; our continued focus on next generation trial design includes this quick reference to critical updates on ethical guidance in HIV prevention trials; and a new fact sheet on Evolving Designs for HIV Prevention Trials that includes descriptions of new trials of the six-monthly injectable lenacapavir and once-monthly oral islatravir. Unfortunately, news in the past two weeks about holds on both the lenacapavir and islatravir trials (for very different reasons) are important reminders of the uncertainties of product development AND the enduring need for research literacy, ongoing stakeholder engagement and Good Participatory Practices to help navigate it all.
  5. Beyond ARV-based PrEP, what’s the future of antibody mediated prevention, following important results that were presented in January? Read our Understanding Results of the AMP Trials, and listen to our Px Pulse podcast with a Dive into the AMP Trials.
  6. Nothing about HIV vaccine research has ever been easy, and results of the Imbokodo study reminded us all both how difficult this research is and how essential it continues to be. Listen to our webinar from September to understand the results and their implications, and be sure to check out this special supplement on HIV vaccine R&D in the Journal of the International AIDS Society, including a number of critical articles from AVAC staff and partners. And if you want to learn even more about how HIV vaccine research paved the way for COVID mRNA vaccines—and how HIV might get paid back—be sure to watch this CNBC video with a number of leading researchers and advocates, including our Executive Director.
  7. Speaking of COVID-19, AVAC and many partners have spent the past two years developing the COVID Advocates Advisory Board (the CAAB), which is playing a critical role in engaging and convening essential conversations in responding to yet another pandemic. Check out the CAAB’s new website, and listen to a webinar on the global readiness for vaccine manufacturing with New York Times reporter Stephanie Nolen and another remarkable conversation on the Omicron variant with CAPRISA’s Slim Abdool Karim.
  8. In HIV or COVID or any area of public health, representation matters. It’s core to effective advocacy, and one of the reasons we are so excited about No Data, No More: Manifesto to Align HIV Prevention Research with Trans and Gender Diverse Realities. Developed in collaboration with trans and gender diverse activists from Cape Town to Berlin, this report takes critical steps toward a comprehensive research agenda for HIV prevention that serves trans and gender diverse people.
  9. Leadership also matters, which is why we are grateful to Acting US Global AIDS Coordinator Angeli Achrekar for her continued efforts to advance PEPFAR and excited about the nomination of John Nkengasong to lead PEPFAR going forward. Read more about our views here and here.
  10. Last but not least, 2021 got us at AVAC thinking not only about the larger field but our place in it. We undertook the most encompassing reflections on our work since AVAC was founded 26 years ago. As part of this process we reviewed our work from top to bottom and undertook a months-long process to forge a strategy for the years ahead that will advance HIV prevention in the broadest context necessary to advocate for global health equity. We are proud to share with you our strategic plan through 2026 and our commitment to equity, diversity and inclusion. We also issued a preview of our 2021 AVAC Report: Developing Options, Delivering Choices, which describes the concerted actions needed to transform prevention “options”, developed through research, into prevention “choices” that reach the people who need them most.

What a year—and what a “to do” list for our ongoing collaborations with all of you! We look forward to working with you to understand how the field is evolving, where it’s stuck, and what we will do together to advance HIV prevention and drive global health equity forward—so please do register to join us on Thursday, January 13 at 9:00 am EST to discuss the latest ups and downs and set an advocacy agenda together for the future.

AVAC Applauds FDA Approval of Injectable PrEP

Yesterday, December 20th, the US Food and Drug Administration (FDA) issued welcome news. It has approved injectable cabotegravir (CAB-LA, and brand name “Apretude”), the first injectable form of HIV PrEP. As another form of HIV PrEP that does not require taking a daily pill, CAB-LA is a much-needed addition to a proven HIV prevention toolbox that now also includes male and female condoms, daily oral PrEP, voluntary medical male circumcision (VMMC) and the Dapivirine Vaginal Ring.

“The approval of CAB-LA is a welcome and much-needed boost for HIV prevention,” said Mitchell Warren, executive director of AVAC. “With as few as six shots per year, this highly effective form of injectable PrEP can help bend the curve of the HIV epidemic – but only if its approval is accompanied by strategic, effective and equitable rollout that transforms the growing list of HIV prevention options into real and accessible choices for the people who need prevention most.”

CAB-LA is an injectable antiretroviral given to adults and adolescents who are confirmed to be HIV-negative at two-month intervals to reduce the risk of HIV. While today’s FDA action approves CAB-LA for use in the United States only, AVAC and its partners will be working in the months ahead to support the review of CAB-LA by regulatory authorities in other parts of the world where new HIV prevention options are sorely needed. AVAC is heartened that ViiV Healthcare, the developer of CAB-LA, has submitted applications to multiple regulatory authorities, including Brazil and several in sub-Saharan Africa that hosted the pivotal clinical trials led by the NIH-funded HIV Prevention Trials Network (HPTN).

“The experiences of oral PrEP for HIV prevention and from COVID vaccines are stark reminders that the US FDA approval is just one small, albeit important, step in translating exciting science into public health impact,” said Warren. “Without global regulatory approvals, clear guidance from WHO, a commitment to equitable access and fair pricing, and resources to deliver innovation, the best science does not prevent or end pandemics.”

The US approval of CAB-LA is an important and welcome milestone in HIV prevention, however, it is just the first in a series of steps needed to ensure that injectable PrEP can help reduce the 1.5 million new HIV infections that occurred in 2020. Supporting access to injectable PrEP, oral PrEP and the full range of proven prevention options requires programs that are strategically designed, user-centered, appropriately resourced, and promoted and designed to reach those who need prevention most, as outlined in the work of the Biomedical Prevention Implementation Collaborative (BioPIC). Lessons learned from nearly ten years of experience in supporting access to oral PrEP will be particularly important in shaping broad and effective access to injectable PrEP, alongside oral PrEP and the Dapivirine Vaginal Ring, and are detailed at prepwatch.org.

Effective global use of CAB-LA for HIV prevention will also require a significant and long-overdue upgrading of global HIV testing capacity, as injectable PrEP can only be used safely if the recipient is HIV-negative and is tested before every dose. It will also require advocacy around self-testing and lower age of consent to testing policies, which have been significantly correlated with oral PrEP initiations.

“Transparency and fairness in pricing, advocacy to accelerate global regulatory review, feasible testing policies, and upgrades to health systems are crucial to effective access to injectable cabotegravir and must all be part of the global HIV prevention agenda moving forward,” noted Warren. “Today’s approval announcement is warmly welcomed, but is also just the start of efforts to make long-acting injectable PrEP an accessible choice for all in need.”

PrEP’s Time has Come

Early planning for PrEP investment in PEPFAR countries is the next critical step for this intervention to fulfill its promise and bend the prevention curve of the epidemic in PEPFAR supported countries.

The President’s Emergency Plan for AIDS Relief (PEPFAR) has played a fundamental and unique role in bringing down the number of global deaths from AIDS and advancing global health, since it launched in 2003. But when it comes to preventing HIV, not just treating it, the world remains in crisis. Despite important declines in HIV rates in Eastern and Southern Africa, in others HIV is on the rise. A global health target to bring down new cases of HIV to 500,000 in 2020 was missed–by a lot, throwing off the global effort to end the epidemic by 2030 unless drastic action is taken now.

PEPFAR has an unparalleled ability to marshal data and support the development of effective programs, as it has done for treatment in countries hard hit by HIV. Today, PEPFAR must apply this capacity to HIV prevention in new and expanded ways. Some of the most crucial decisions about PEPFAR’s role in delivering prevention are too often overshadowed by the critical center-stage effort to achieve the 2025 treatment targets and reduce unacceptably high AIDS deaths in many countries. But some less known, behind-the-scenes decisions are also truly vital. One such issue involves PEPFAR budget codes that few may appreciate and love but have an outsized impact on whether the right commitments are made, and prevention reaches those who need it most. Currently, PEPFAR utilizes 19 budget codes for specific areas of HIV programming including testing, treatment, and prevention, including voluntary male medical circumcision.

PEPFAR’s budgeting approach to oral PrEP is a prime example of how HIV prevention must evolve and how PEPFAR’s long standing commitment to transparency can help lead the way. Oral PrEP is a daily pill that can be taken to prevent HIV. Despite its outstanding efficacy, not one of the budget codes PEPFAR uses for HIV programming tracks spending on PrEP. PrEP expenditures are only identified after they are allocated during the annual Country Operating Plan (COP) process used to develop individual country plans. Country programs designing prevention programming, and most importantly civil society advocating for PrEP as part of the COP process, don’t have a clear budget line as COP plans develop to measure and advocate against. As a result, PrEP programming, although a priority for PEPFAR, can sometimes get lost in the shuffle of COP planning. A budget code provides a benchmark to plan against and cements a program as a priority for PEPFAR.

The story of voluntary medical male circumcision (VMMC) rollout highlights the difference a dedicated budget can make. After the WHO and UNAIDS recommended VMMC for HIV prevention 2007, PEPFAR dedicated funds for countries to scale it up, and tracked the effort with an individual budget code. VMMC has since become a core component of prevention programs in PEPFAR supported countries. Investments in VMMC, totaling more than $1.5 billion according to 2017 information, are used for equipment, supplies, monitoring, evaluation, training and reporting. Since 2007, VMMC underwent a scale-up of historic proportions, reaching 15 million people, and contributing to lowering incidence in those countries. The budget code entailed more than funding and services, it incorporated planning, tracking, accountability, and impact. As the figure below suggests, the experience of PrEP roll-out now almost a decade after FDA approval without a designated budget code has been much slower.

PEPFAR’s track record in implementing HIV programs is historic. The program is credited with preventing infection in nearly 3 million babies, providing treatment to more than 17 million people who live with HIV, providing testing to 50 million people, and training 300,000 thousand new health workers. To finally end the epidemic, this same capacity can and must be brought to bear in prevention. PEPFAR’s strong call for programs to include oral PrEP and setting an overall goal of serving 1 million people with PrEP in 2021, become more difficult targets to aim at with vital planning tools missing. PEPFAR’s experience with VMMC taught us that establishing a designated budget code signals that a given program or product is a priority. PEPFAR supported countries are readying now to plan for COP22, to begin October 1, 2022. Getting a budget code for PrEP approved for COP22 would be an important step in planning for PrEP programs so that targets are met, and funding can succeed.

Ten years of effort to roll out PrEP has brought powerful lessons. The field has learned about complex barriers that inhibit HIV prevention. Stigma and economic hurdles put HIV prevention, such as PrEP, beyond reach for the millions who need it. Overcoming these forces will depend on critical investments that must be monitored for effectiveness. These include peer-led adherence support, marketing strategies to understand who must be reached and how to reach them, public campaigns to generate demand, reliable supply chains, specialized training for providers, and integrating HIV prevention with sexual and reproductive health services. Funding this full spectrum of support depends on clear dedicated budgets. The tools planners, advocates, policy makers and programmers need to be in place to double down on what works in HIV prevention, and, finally, end the epidemic.

New Podcast! Research Fundamentals: What is an endpoint?

We are delighted to share the next installment in our Px Pulse podcast series Research Fundamentals, explaining key concepts in HIV prevention research.

In this episode, Px Pulse host Jeanne Baron, and Matthew Rose, veteran HIV advocate and Director at Global Health Strategies, unpack what you need to know to understand endpoints in research.

Our series, Research Fundamentals is an addition to the regular schedule of programs on Px Pulse covering advances and challenges in HIV prevention research. Research Fundamentals offers short, concise and accessible conversations explaining scientific concepts in research that are key to understanding how HIV prevention science is advancing.

Endpoints are a crucial component in every clinical trial, but they are not always well understood. In addition, advocates can and should play a role, reviewing endpoints and interrogating how well the trial will serve communities that need HIV prevention.

Joining us to explore all this are:

  • Dave Glidden, Professor of Epidemiology & Bio-statistics at UC San Francisco
  • Erica Lessem, Senior Strategist for the New York City Department of Health and Mental Hygiene, former Deputy Executive Director, Treatment Action Group
  • Meagan O’Brien, Senior Medical Director of Early Clinical Development & Clinical Experimental Sciences at Regeneron

Listen to the full podcast (9 minutes) to learn how endpoints are used in clinical research, why they change over time, and what matters most about endpoints for advocates and researchers alike. And here’s a transcript of the recording.

Endpoints are one element in evolving trial design for HIV prevention. Go to our dedicated page on trial design for more information and resources to engage with this fast-changing area.

Webinar on Omicron and HIV with Salim Abdool Karim

On December 15, the COVID Advocates Advisory Board (CAAB) and AVAC held a webinar about the Omicron variant featuring Salim Abdool Karim, director of the Centre for the AIDS Program of Research in South Africa (CAPRISA). Karim shared the latest updates and what questions are being pursued about Omicron, vaccines and any potential connections to HIV.

For background, read a commentary Karim co-authored with Quarraisha Abdool Karim in The Lancet, Omicron SARS-CoV-2 variant: a new chapter in the COVID-19 pandemic.

Watch the recording.