PrEP Tracker data, preparing for new products, the HIV prevention pipeline and our prevention “playlist.” All that and more in the latest issue of PxWire.

In mid-October, AVAC attended the World Health Summit in Berlin. Historically hosted by the German government, this year marked the first time the Summit was jointly led with the WHO (World Health Organization).

While there was lots to talk about in the three days of the summit, four areas for the coming year are clear priorities.

COVID, COVID, and more COVID

Structures that worked

The global response to COVID-19, particularly the collective failures in preventing spread and severe disease and death, dominated WHS 2022. Bright spots in the global response were noted throughout the meeting—systems known as infection prevention and control (IPC), set up in response to Ebola and HIV/AIDS, were successfully deployed in many places against COVID-19. But glaring gaps stood out. Questions around equity in the distribution of vaccines and treatments, manufacturing capacity, and cooperation across governments were pushed off to next year’s summit. Still, the laser focus on strengthening structures to respond to future pandemics was long overdue. For years, few have prioritized resources for pandemics, even as HIV/AIDS, cholera, hepatitis, and Ebola posed chronic challenges.

Other COVID highlights

In one session devoted to HIV/AIDS (featuring inaugural Virchow Prize winner PEPFAR Ambassador John Nkengasong), some panelists called for increased domestic resource mobilization. This issue is complex and deserves attention. Overall, national government funding makes up 60 percent of global HIV/AIDS resources, and countries are facing compounding challenges in raising funds for public health due to increasing need to divert domestic resources to debt repayment. Just this past week, advocates wrapped up the inaugural Africa Health R&D Week where community leaders discussed the importance of and challenges involved in increasing domestic financing of research and development in African countries. Advocates at the World Health Summit noted that many of the major failures in the COVID-19 response occurred in high-income countries, for example in the US. Some of the most successful responses were mounted in Senegal, Ghana, Vietnam, and many Pacific Island nations, and we saw successful vaccine rollouts in Chile, Uruguay, Nepal, and Cambodia. One shortcoming from the program as a whole was that the summit featured far too few speakers and advocates from countries that had success in stopping the spread in spite of funding constraints.

Community Engagement

WHO Initiatives

Meaningful inclusion of civil society & communities, or the lack thereof, was a major theme of the summit. A town hall with WHO Director General Tedros Adhanom Ghebreyesus highlighted new (and almost new) initiatives to broaden the range of voices included in decision-shaping at the WHO (though all decisions are still finalized by Member States only): a recently launched WHO Youth Council and the Civil Society Commission. The Civil Society Commission will be accepting applications in the coming months.

Beyond WHO

Mechanisms for civil society and community engagement were proposed or interrogated during Q&A portions of nearly every session, showing the real appetite among advocates for more meaningful inclusion in decision-making, particularly in forthcoming decisions on the global architecture of pandemic preparedness and response (PPR).

The formation of the WHO’s Intergovernmental Negotiating Body (INB) to draw up a global PPR agreement and the possibly linked Pandemic Fund (officially launched this week at the G20 Summit), developed by a coalition of donor countries, both present great opportunities for civil society participation. But there’s equal risk civil society could end up excluded from key points in the process, resulting in catastrophic failure to allocate resources to those that need them most.

Where is the money?

All roads lead to primary health care – that was the conclusion reached at every session. The answer to reaching the ‘last mile,’ to expanding access to the most vulnerable groups and key populations, to health system resiliency in the face of concurrent pandemics, to routine immunization challenges, and to quality surveillance of emerging threats is a strong, robustly staffed primary health system in every country. Advocates, institutional leaders, and multilateral champions are all aligned on this, but the funding hasn’t yet followed. As siloed, disease-specific emergency funding continues to drive the world’s efforts (even at WHS with large new commitments to polio from the German government and the Gates Foundation), where is the funding for health systems? Historically, global health security initiatives have not sufficiently considered the role of primary health systems in pandemic prevention and response. High-income countries and donors have typically been much more interested in surveillance, epidemiology, and monitoring than broad health systems strengthening. With no other global funding mechanism devoted to building such a foundation, Pandemic Fund presents a real opportunity to jumpstart global commitment to strong, inclusive, resilient health systems that are ready to weather future challenges. These health systems are prerequisites for hitting targets against global health threats, and finally overcoming decades-long challenges.

What does all of this mean for HIV?

The global attention to PPR structures presents a critical opportunity to drive progress toward the 2030 goals. The systems and structures created by the HIV/AIDS response provide a model for what to do and what not to do. Infrastructure and stakeholder engagement, with civil society recognized as equal partners, have brought innovation and measurable success. But progress has been uneven and unequal, with key populations continuing to be left behind, and far too many decisions controlled by Global North decision-makers. The institutions and groups working on PPR now have much to learn. Integration of global health priorities is essential to meeting 2030 goals. Those ‘in the room where it happens’ must prioritize comprehensive inclusion of community and civil society and growing the pot of resources to address health inequities, and retaining commitment to ending current pandemics and epidemic threats as much as future ones.

The International Conference on Family Planning (ICFP) convenes next week November 14- 17, in Pattaya City, Thailand. ICFP is the world’s largest gathering of family planning (FP) and sexual and reproductive health and rights (SRHR) professionals in the world and is a platform for advocates, researchers, and stakeholders to help achieve access to family planning for all.

At AVAC we know that making options real choices is key to effective prevention. We’ll be at ICFP advocating for multilayered prevention, an approach that can—and should—integrate both SRH and HIV information, services and products, including multipurpose prevention technologies (MPTs), such as condoms or the Dual Prevention Pill; and embed these services and products in “multisectoral strategies”, such as policy reform, community norms-changing and economic empowerment. Learn more about how SRH integration should be at the center of products, policies, and programs in a video called “What Does Successful HIV/SRH Integration Require?”.

Follow AVAC and FP2030 for more on-the-ground updates at ICFP, and be on the lookout for a special Twitter takeover from AVAC’s own Kate Segal who will share a day-of perspective on November 15 live from our Twitter feed!

If you are participating in ICFP, make sure to check out AVAC’s sessions below.

Tuesday, November 15 – Wednesday, November 16

The DPP (Dual Prevention Pill) would be a revolutionary tool to prevent HIV and unintended pregnancy. It is one of the many multipurpose prevention technologies (MPTs) products poised to address multiple health prevention needs. Although a lot of the groundwork of the DPP is in place, including a coalition of organizations committed to the acceleration of the product named The DPP Project, there is still much work to be done to advocate meaningful investment in communities and ensuring universal access when rollout happens.

Tuesday, November 15

3:15

An all-Inclusive Look: Tailored FP Services to Meet the Needs of LGBTI groups, with FP2030, where AVAC will have the opportunity to present our commitment to take specific actions to expand access to voluntary, rights-based contraception.

Wednesday, November 16

10:15 – 11:30

Nothing About Us Without Us: Putting Advocates at the Forefront from Product Development to Delivery, where Advocacy for Prevention of HIV & AIDS (APHA), Pangaea Zimbabwe Aids Trust (PZAT), and AVAC will discuss the critical role advocates have played in advancing HIV prevention products through the pipeline and the need to ensure research, development and delivery of additional multipurpose prevention products (MPTs) and new contraceptives leverage these experiences and networks.

AVAC, IAVI, the Coalition to Accelerate & Support Prevention Research (CASPR) and stakeholders invite you to the inaugural Africa Health R&D Week, November 8 – 11, a week-long virtual event intended to build on international, continental, and regional advocacy efforts towards increasing domestic financing of research and development as a critical component of health in Africa. Register here.

The event will feature a range of speakers, including: Agnes Binagwaho, Vice Chancellor of the University of Global Health Equity, Vuyiseka Dubula, Director of the Africa Centre for HIV/AIDS Management, Stellenbosch University, Ogwell Ouma, Acting Director of Africa CDC, as well as a panel of African researchers and advocates.

Africa Health R&D Week will be an annual forum to catalyze a continental movement that builds bridges between researchers, policymakers, regulators, civil society and community members committed to Africa’s health transformation through health.

We encourage you to register for this event, which will comprise a series of informative, networking, and motivational events for advocates, media, policymakers, program implementors, researchers, and funders. The week will help bring clarity to key issues and trends of domestic resource mobilization for health R&D on the continent.

Learn more:
Agenda / Concept Note / Flyers

IAS – the International AIDS Society – will host HIVR4P 2023, the 5th HIV Research for Prevention Conference, in Lima, Peru, and virtually from 22 to 26 October 2023. Learn more.

There is lots happening in the world of PrEP, and this update provides news on the first African country to approve injectable CAB for PrEP; a new resource, Cost of Goods Sold Analyses, to understand a key consideration for the introduction of new products; and an upcoming webinar to introduce the new and improved PrEPWatch.

First African country to approve injectable CAB for PrEP

Earlier today we learned that the Medicines Control Authority of Zimbabwe approved injectable cabotegravir for PrEP(CAB for PrEP) – a historic milestone as Zimbabwe is the first country in sub-Saharan Africa to approve the product. Zimbabwe is showing bold leadership in approving the product for all populations, supporting access to everyone who can benefit from it.

AVAC applauds Zimbabwe’s leadership as a model of far-sighted vision to advance HIV prevention. We also call on other regulators reviewing the application for CAB for PrEP in their countries to move more quickly – and on ViiV Healthcare, the product’s developer, to accelerate additional regulatory filings and its application for WHO pre-qualification. As we said in June with the launch of our plan to accelerate access to injectable CAB for PrEP, actions like this must be matched with global and country planning, coordination and funding to bring effective prevention to everyone who needs it.

Understanding Cost of Goods Sold Analyses

AVAC and the Clinton Health Access InitiativeClinton Health Access Initiative (CHAI) are delighted to release our new briefing document on Cost of Goods Sold (COGS) Analyses. COGS is defined as the direct costs and expenses required to manufacture a product assuming a given volume of production. COGS analyses can help inform introduction planning for new products.

Last year, CHAI estimated the production costs of manufacturing generic injectable CAB for PrEP, and there have been many questions about how COGS analyses can be used, and what this particular analysis means for understanding opportunities for ensuring affordability of injectable CAB for PrEP. To be clear, CHAI’s COGS analyses are often used to understand whether generic production could increase affordability of a product, but these analyses do not attempt to estimate production costs for the originator company, nor do they estimate the price at which a product will or could be available. This new frequently asked questions about COGS analyses covers the basics of COGS, answers key questions around differences between originator and generic drugs, and how this can inform product introduction planning.

New and Improved PrEPWatch Clearinghouse

Please join us November 10 at 9:00am ET as we introduce AVAC’s updated PrEPWatch.org, a one-stop clearinghouse for the latest PrEP implementation data, information and resources on PrEP policies, programs and products (approved and in development)! Register here.

During this webinar, we’ll share:

• New data on PrEP rollout worldwide and by country.
• New ways to access global and country-specific PrEP resources for PrEP planning and advocacy.
• Stories of innovation from the field.
• Toolkits for each phase of planning, from policies & budgets to monitoring & evaluation and everything in between.

Hope to see you there.

P.S. ICYMI: Award-winning, New York Times journalist Stephanie Nolen recently published an in-depth story on the promises and perils of injectable CAB for PrEP: A New Shot Guards Against HIV, but Access for Africans Is Uncertain.