Innovations in GPP

This webinar on September 11 featured speakers from around the world with experience implementing GPP at research sites, within networks, and at the sponsorship level.

They illustrated how GPP can expand beyond the more familiar (but always reliable) CABs and town hall meetings to newer ideas like partnership-based approaches, the creation of a community scorecard, and more.

Moderator and Presenter:

  • Ntando Yola, Desmond Tutu Health Foundation

Presenters:

  • Sarah Read, National Institute of Allergy and Infectious Diseases
  • Clever Chilende, Treatment Advocacy & Literacy Campaign (TALC)

Recording / Clever Chilende Slides / Sarah Read Slides / Ntando Yola Slides

Avac Event

Breaking New Ground: Expanding Access to Lenacapavir—Lessons from Dolutegravir and the Future of HIV Prevention

This UAN Call, titled Breaking New Ground: Expanding Access to Lenacapavir—Lessons from Dolutegravir and the Future of HIV Prevention, brought together global health experts, community advocates, and civil society organizations to discuss the challenges and opportunities in ensuring equitable access to Lenacapavir.

This webinar was hosted by Unitaid.

Explore STIWatch.org and get the latest resources to navigate the IUSTI & STI Prevention meetings!

Dear Advocate, 

AVAC is delighted to share its all-new STIWatch.org website just as advocates, clinicians, researchers and partners convene in Atlanta, GA for the Centers for Disease Control and Prevention STI Prevention Conference, and in Sydney, Australia for the 25th International Union Against Sexually Transmitted Infections (IUSTI) World Congress.  

Rates of sexually transmitted infections (STIs) continue to rise globally with too little public health intervention and investment. While many STIs are curable, they often go undiagnosed and untreated because they tend to cause few or no initial symptoms. Available diagnostics are often too costly to use for routine screening and testing in many low to middle-income countries (LMICs), and few vaccines exist to address the most common STIs. 

Discover STIWatch.org!

STIWatch.org is an updated platform designed to enhance understanding and advocacy for STI vaccine and diagnostics research, development, and rollout. It offers comprehensive information on common STIs, a clinical trials dashboard, advocacy priorities, and a range of resources and tools to support STI prevention and treatment efforts. 

Scroll down for more STI prevention resources advocates need to navigate these two conferences.

Resources

Follow the STI Prevention Conference events in real time in Atlanta on Twitter at #STIConf24 and on AVAC’s feed at @HIVpxresearch

STI Clinical Trial Dashboard: shares the latest STI research on diagnostics and vaccines

STIs: A Review of the 2022 Vaccine and Diagnostic R&D Pipeline and Investments: provides an annual analysis of global funding trends for STI prevention research

Advocates’ Guide to Doxycycline to Prevent Bacterial STIs (DoxyPEP): explores and addresses the explore and address the critical questions around who will benefit most from DoxyPEP and how to implement this strategy broadly to ensure equitable access. 

STIWatch.org is an initiative of AVAC with funding and support from the World Health Organization, the Bill & Melinda Gates Foundation and the National Institutes of Allergy and Infectious Diseases.  

Contact sti@avac.org for more information. To receive email updates from AVAC, signup here. 

Lenacapavir: The case for investing in delivering HIV prevention

The promise of long-acting PrEP has been super-charged this year by studies showing the powerful efficacy of an antiretroviral known as lenacapavir (LEN).

This episode of PxPulse goes deep on LEN for PrEP. Recorded just days before Gilead’s announcement that PURPOSE 2 also found very high efficacy, Dr. Flavia Kiweewa, a principal investigator of PURPOSE 1, the first trial to announce efficacy, lays out the research findings and what they mean. And Chilufya Kasanda Hampongo of Zambia’s Treatment Advocacy and Literacy Campaign and Mitchell Warren of AVAC talk about how to change a long history of squandered opportunities to get rollout right.

The PURPOSE1 trials announced findings in June that a twice-yearly injection of LEN was 100% effective among cisgender women, with zero new cases of HIV. And the PURPOSE 2 trial among cisgender men, and trans and non-binary people, was shown to reduce the risk of HIV by 96%.

LEN now enters a select category, one of five ARV-based options for PrEP that all protect against HIV if you take them. But many of the people applauding the results from PURPOSE 1 and 2 will tell you that breakthrough science like this is, as hard as it is, is still the easy part. To break the back of the HIV epidemic demands overcoming an altogether different challenge—coordinating and accelerating every step in rolling out new products so that everyone who needs HIV prevention can get it.

Listen to this podcast to learn what must be done to finally deliver on the promise of highly effective HIV prevention, from pills to rings to injectable PrEP and beyond.

Listen

Resources

Press Release

Second Pivotal Trial of Twice-Yearly HIV Prevention Injection Safe and Highly Effective: PURPOSE 2 Trial Among Gay Men, Trans and Nonbinary People  

AVAC Calls for Accelerated Regulatory Review and Ambitious, Equitable Access Plans

New York City, September 12, 2024 – AVAC welcomes the groundbreaking results of the PURPOSE 2 HIV prevention study of twice-yearly injectable lenacapavir for PrEP among 3,200 cisgender men, transgender men, transgender women, and nonbinary individuals who have sex with partners assigned male at birth. Among more than 2,000 people in the trial who received lenacapavir, there were only two HIV infections.

Preliminary safety and efficacy results were reported today by Gilead Sciences, the drug’s developer. An independent data and safety monitoring board (DSMB), at a scheduled review of the trial data, found the regimen to be safe and highly effective, with a 96% lower HIV rate compared with the expected background incidence of HIV infection and 89% lower compared with oral TDF/FTC. These results follow the results of PURPOSE 1, released earlier this year, that showed 100% efficacy of lenavcapavir among cisgender women in South Africa and Uganda.

“This is the second impressive result for this new HIV prevention option, opening up more possibilities for choice for even more people to find an option that is right for them,” said Mitchell Warren, AVAC’s executive director. “Beyond expanded choice, a twice-yearly injection has the potential to transform the way we deliver HIV prevention to people who need and want it most – from an easier to follow regimen for individuals to a decreased burden on healthcare systems that are stretched to the limit. But these data only matter if the field moves with speed, scale and equity.”

“Having results from a trial population that includes trans men and women, nonbinary people and gay men is an important milestone for community inclusion in HIV prevention studies,” said Kenyon Farrow, AVAC communications director and PrEP user since 2015. “I am excited that people who want to use PrEP or who fear stigma or discrimination, may soon have the possibility of another option that could be much easier to use and provide more discretion. It is imperative that we accelerate planning for rollout of lenacapavir. We know that even with the most ambitious timeline, it will take time for lenacapavir to be rolled out to all who need and want to use it.”

The study evaluated the safety and efficacy of twice-yearly injectable lenacapavir for PrEP compared to once-daily oral emtricitabine/tenofovir and background HIV incidence. All trial participants will now be offered lenacapavir. Additional studies in critical populations, including PURPOSE 3 among cisgender women in the US and PURPOSE 4 among people who inject drugs, are also underway. It will be imperative to understand how today’s results influence these trials. A schematic of the suite of studies is here.

“We applaud Gilead’s commitment to Good Participatory Practice in this and the other PURPOSE studies, especially through the inclusion of multiple populations in the PURPOSE studies and a commitment to including community voices in trial design and in access plans” said Stacey Hannah, AVAC director of research engagement. “Access and implementation plans must be shaped and informed by continuous, robust participatory engagement. AVAC and our partners look forward to continuing engagement with Gilead and other key stakeholders in this process.”

Importance of Access and Equity 

Gilead said it is committed to making lenacapavir available for prevention in countries where it is needed most and to granting direct voluntary licenses for longer-term availability. Today’s results make it clear that Gilead, along with regulatory and normative agencies, funders and civil society, must work on an accelerated timeline to ensure broad and timely access to individuals and communities everywhere.

“In an updated access statement today, Gilead committed to beginning global regulatory filings by the end of 2024 and to facilitating faster access to target populations and countries,” Warren said. “This raises the stakes to accelerate speed, scale and equitable access. Gilead needs to urgently grant these licenses even before regulatory approval and name its prices, so that funders can prepare to accelerate product introduction. And WHO must urgently initiate its guideline review process so that lenacapavir, if approved by regulatory agencies, can be immediately added into the PrEP method mix. There is no time to waste if we are to translate these exciting clinical trial results into actual public health impact.”

“We now know that lenacapivir for PrEP is safe and highly effective among a range of populations,” Farrow added. “Even as we await regulatory submission and review, there is urgent work to be done now by communities, policy makers, funders and program implementers to design and build HIV prevention programs and prepare health systems to deliver the growing array of biomedical PrEP options, including the addition of twice-yearly injectable lenacapavir. The full range of PrEP products—including oral PrEP—must be made feasible choices for all people who need and want HIV prevention options.”

Lessons learned from rollout of daily oral PrEP, and more recently the dapivirine vaginal ring and injectable cabotegravir, can help speed regulatory approval and guideline development in key countries, design of effective programs, and community understanding of and acceptance of lenacapavir for PrEP. 

“For many years, AVAC and a coalition of international partners have been planning for successful, accelerated introduction of PrEP at scale and with equity. There can be no excuses, no delays, and no repeats of the failures of oral PrEP rollout. We must move with speed, scale, and equity to ensure lenacapavir has the impact we need to prevent new HIV infections,” said Warren.

###

About AVAC

AVAC is an international non-profit organization that provides an independent voice and leverages global partnerships to accelerate ethical development and equitable delivery of effective HIV prevention options, as part of a comprehensive and integrated pathway to global health equity. Follow AVAC on Twitter @HIVpxresearch; find more at www.avac.org and www.prepwatch.org. 

Avac Event

Restrategizing Civil Society Engagement for Pandemic and Global Governance

As we are building back from the aftermath of the COVID-19 pandemic, current and future generations face multiple grand-scale challenges, including the climate crisis, related disasters, pollution, and biodiversity loss. These challenges also heighten the threat of future pandemics from emerging or re-emerging diseases. On the 14th of August 2024, the WHO has declared the Mpox outbreak as a public health emergency of international concern (PHEIC) under the International Health Regulations (2005) (IHR), which highlighted the growing concerns.

The recent amendments to the IHR (2005), agreed upon during the 77th World Health Assembly, are pivotal in enhancing global health regulations. These amendments aim to address the shortcomings revealed by the COVID-19 pandemic. Fundamental changes include a broadened definition of pandemic emergencies, principles of solidarity and equality, and reinforced WHO authority.

We aim to draw lessons from the successful experiences of diverse CSOs in enhancing inclusivity in multilateral discussions and implementation of agreements/treaties on topics such as one health, other health issues, climate, human rights, and more. For example, the processes leading to the Paris Agreement have set important precedents for integrating diverse voices and ensuring meaningful participation in global decision-making. Indigenous groups have also been involved in the inception to implementation processes of the Convention on Biological Diversity (CBD).

This side event aims to serve as a consolidation platform for civil society to share and find strategies that redefine civil society roles in global decision-making processes that address health threats such as future pandemics, climate crises, and others.

Objectives

The side event will reassess the strategies utilized to expand the role and involvement of civil society in global governance for health, climate, and other development sectors. The event’s objectives are further detailed in the following:

  • To explore and develop concrete strategies that enhance participatory, inclusive global governance for health, climate, human rights and other global challenges, starting from the Pandemic Agreement through meaningful civil society engagement, particularly in the face of shrinking civic spaces.
  • To foster collaborations among CSOs from multiple sectors to advance health and health-related development agendas.

Moderator:

  • Samantha Rick, Multilateral Engagement and Pandemic Preparedness Advocacy Specialist, AVAC

Speakers:

  • Eloise Todd, Co-Founder and Executive Director of Pandemic Action Network
  • Lawrence O. Gostin, Faculty Director O’Neill Institute for National and Global Health Law
  • Neil Vora, Executive Director of Preventing Pandemics at the Source
  • Olivia Herlinda, Chief Research and Policy at CISDI

Avac Event

Sustainability of the HIV/AIDS Response – Getting to 2030 & Beyond

The state of the HIV/AIDs endemic is reaching a critical point requiring evaluation of the current state of the global response, progress made thus far, and planning for post-2030 goals. The National Academy of Medicine is hosting a timely international meeting to facilitate discussion on these issues.

This one-day workshop is being held on September 18, 2024, from 9:00 AM – 5:00 PM US Eastern. Ambassador John N. Nkengasong, the Senior Bureau Official for Global Health Security and Diplomacy at the US State Department, will deliver the opening remarks. His address will set the stage for discussions across three subsequent panels.

Broadly, the goals of this workshop are to:

  • Explore how we can re-energize the global HIV response to reach the 2030 goals but also to look beyond.
  • Craft strategies to increase and sustain political commitment.
  • Highlight global accountability and domestic-donor financing.

AGENDA HIGHLIGHTS:

Introduction and Welcome

  • Victor Dzau, National Academy of Medicine
  • Carlos del Rio, Emory University and National Academy of Medicine

Opening Remarks

  • John N. Nkengasong, U.S. State Department

Post-2030 Strategy: Achieving 2025 Goals & Optimizing Future Response

  • A summary of response since the setting of the 2030 agenda – successes, shortfalls, areas to evolve – and discussion of how to build upon momentum to design impactful, sustained response post-2030.

Sustaining Political Commitment to Ending HIV as a Public Health Threat

  • Discussion of how to sustain and increase global political support for prioritizing the HIV response to end the epidemic and sustain support post 2030.

Global Accountability: Domestic and Donor Support

  • A conversation on strategies to garner joint accountability as well as domestic and donor support for current and future financing of the HIV response.

Avac Event

Vaccinology of HSV

Akiko Iwasaki, PhD, a professor of immunobiology at Yale School of Medicine and an investigator of the Howard Hughes Medical Institute, turned her focus to SARS-CoV-2 soon after reading the first reports coming out of China, before COVID-19 surfaced in the United States. Though she has long been recognized for her work within the scientific community, her work around COVID-19 has raised her media profile considerably. She is frequently quoted by newspapers and reporters, and has amassed a huge Twitter following of people seeking out her research updates. (Iwasaki believes that public education is a key ingredient for slowing the spread of the virus.)

This webinar is in partnership with Herpes Cure Advocacy.

Avac Event

Innovations in GPP

This webinar featured speakers from around the world with experience implementing GPP at research sites, within networks, and at the sponsorship level.

They illustrated how GPP can expand beyond the more familiar (but always reliable) CABs and town hall meetings to newer ideas like partnership-based approaches, the creation of a community scorecard, and more.

Moderator and Presenter:

  • Ntando Yola, Desmond Tutu Health Foundation

Presenters:

  • Sarah Read, National Institute of Allergy and Infectious Diseases
  • Clever Chilende, Treatment Advocacy & Literacy Campaign (TALC)

Recording / Clever Chilende Slides / Sarah Read Slides / Ntando Yola Slides

Generic Cabotegravir Timelines

As CAB for PrEP is a long-acting, extended-release injection, bioequivalence (BE) testing takes time to determine whether the generic drug functions in the body similarly to the original drug. As shown in this timeline graphic, the BE study (as determined by WHO guidance) is the longest part of the development process for generic CAB. But other steps, such as selecting and licensing generic manufacturers and technology transfer could be done faster.