Zimbabwe Approves CAB for PrEP; a New PrEPWatch.org; and Other PrEP Updates

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.

The Way Forward for HIV Vaccine Development

HIV vaccine science is at a crossroads. New science, new findings from recent phase III trials that ended without efficacy, innovations learned from COVID-19 vaccines, and new approaches to trial design are all contributing to a period of innovation and transition in HIV vaccine development. AVAC’s latest blog, An HIV Vaccine: The challenges ahead, frames these issues and draws highlights from a webinar series AVAC convened earlier this year.

In July, the Treatment Action Group (TAG) released its 2022 annual overview of research and development in HIV, Hepatitis and TB; it included a specific report on HIV vaccines and passive immunization, or bNAbs. This pipeline report provides added context to our blog.

And for more on HIV vaccines, read the May JIAS Viewpoint, HIV vaccines in 2022: where to from here?; AVAC’s backgrounder on experimental medicine vaccine trials (EMVTs), and AVAC’s fact sheet of early phase trials testing mRNA-based HIV vaccines—a one-stop sheet including a expanded snapshot of up-to-date mRNA trials and additional resources to explore and learn more.

A few highlights from these resources include:

  • Research using mRNA technology for an HIV vaccine is in very early stages. This innovation could speed the research process, but cannot alone answer some of the most crucial questions bedeviling the advance of HIV vaccine research.
  • The development of quick, iterative trial designs has become crucial, as the field continues to try and answer a fundamental question: what immune response needs to be triggered for effective protection against HIV. The use of innovative trial designs, including experimental medicine vaccine trials (EMVTs) hold promise and potential, and should be prioritized.
  • Re-invigorated collaboration, recognizing the quest for an HIV vaccine as one of the greatest scientific challenges of the modern era, is essential to analyse closely what the field has learned to date, develop clarity on the critical scientific challenges and agree on a coordinated strategy to pursue answers.

Stay tuned for more updates on HIV vaccine R&D after next month’s bi-annual HIV Vaccine Trials Network meeting.

Now Accepting Applications for Global Online Course

Join the hundreds of global learners – from more than 20 countries since 2014 – who have benefitted from the Good Participatory Practices (GPP) Course, a unique online learning opportunity about the criticality of stakeholder engagement as part of the research process.

The 10-week online course—running from October 17 – December 16—provides research implementers and advocates with a foundational knowledge of the Good Participatory Practice (GPP) Guidelines. The course draws from lessons learned from various infectious disease areas, the rollout of new interventions, and COVID-19 research to date. Insights from these efforts will be used to foster participants’ capacity to develop quick and responsive stakeholder engagement in research and beyond. Participants who complete the course will finish with a customized stakeholder engagement plan that reflects the landscape of their local environment.

Apply Here to participate in the course today!

Participants will benefit from a combination of interactive online modules, video webinars, written assignments, discussion forums, and a suite of specially curated resources. Learners will customize the course topics and resources that meet their needs. Global GPP experts will discuss high-impact models of engagement and help synthesize theory into easy-to-understand actionable steps. Participants will spend 2-4 hours per week on the course, culminating in a GPP action plan that aligns with their specific work and role in the field.

Applications are due by October 12, 2022.

As always, please reach out out with any questions.

About the GPP Online Course:

More than 10 years ago, UNAIDS and AVAC published the Good Participatory Practice Guidelines for Biomedical HIV Prevention Trials (GPP). Created to provide a consistent global standard for stakeholder engagement across the research life-cycle, GPP has emerged as a point of reference for how to engage stakeholders. It has also given rise to a robust community of practice.