Africa: WHO Applauds Agreement to Scale-Up Generic Manufacturing for Access to Long-Acting Injectable Antiretrovirals


WHO welcomes the announcement of a new voluntary licensing agreement for patents relating to long acting-cabotegravir (CAB-LA) between ViiV Healthcare and the Medicine Patent Pool. This agreement, will give selected generic manufacturers the opportunity to develop, manufacture and supply generic versions of CAB-LA, in 90 low- and middle-income countries, subject to required regulatory approvals. This is a critical step to support long-term access in the least developed, low-income, lower middle-income and countries in sub-Saharan African.

On the back of WHO’s new guidelines on CAB-LA, which recommend CAB-LA administered by injection once every two months, as a safe and effective alternative to oral PrEP, WHO applauds VIiV and MPP for providing a pathway to supporting this important new prevention option to people for substantial risk of HIV infection.

WHO guidelines also suggest that the use of expensive molecular testing, as stipulated by ViiV, which will further limit feasibility and access in low- and middle-income countries, is not a prerequisite. It proposes countries should be able to consider testing approaches which support effective use in their contexts.

The majority of people who could benefit from HIV prevention option live in low- and middle-income countries and 70% of new HIV infection are in people from key populations where access to effective prevention is often limited. WHO is aware that generic manufacturing will likely take time to set up and so it is important for ViiV to quickly announce a price that ensures CAB-LA is available outside high-income countries and so that countries and health systems can prepare for implementation. Furthermore, it will be important to outline how upper middle-income countries not included in the ViiV and MPP agreement will be able to access the medicines at an affordable price.

WHO also welcomes the announcement of a new coalition of partners led by WHO, Unitaid, UNAIDS, Global Fund and AVAC, which is collectively bringing together communities and funders to unlock access and believes there is an immediate need and opportunity to support the delivery of the effective new PrEP option. CAB-LA implementation is urgently needed to understand how people will choose between PrEP choices, where and how CAB-LA should be delivered for greatest acceptability and impact and to resolve some of the outstanding delivery issues.

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Author : WHO

Publish date : 2022-08-05 07:36:22

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