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

October 18, 2022

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.