ViiV licenses long-acting cabotegravir (CAB-LA) for generic access

Simon Collins, HIV i-Base

On 26 May 2022, ViiV Healthcare announced that it will now add long-acting cabotegravir injections (CAB-LA) to the Medicines Patent Pool (MPP) for use as PrEP. [1]

This will enable other manufacturers to make generic versions of this innovative and important new option to protect against HIV.

This is similar to the company’s licensing of oral dolutegravir for generic use in HIV treatment (ART).

ViiV say they will be “working at pace with MPP to execute the licence, building on the experience of our valued and long-standing partnership. We are excited about this important step forward which reflects ViiV’s commitment to voluntary licensing as an integral part of our access to medicines strategies.”

The announcement follows recent high-profile demands from community activists for early and widespread access to long-acting PrEP in lower- and middle-income countries (LMICs). [2]

These demands were based on impressive results from clinical studies reporting higher rates of adherence and protection in international studies. They were also driven by concerns that access to CAB-LA in LMICs looked extremely limited unless it was available at a comparable price to oral PrEP.

It is also based on research from the Clinton Health Access Initiative (CHAI) showing that generic formulations of CAB-LA injections could be produced at around $15-23 for a year’s course of six injections. [3]

This would be more cost effective (and more effective) than voluntary medical male circumcision which has been widely available for many years.

comment

The announcement is welcomed and matches earlier commitments by ViiV Healthcare to license dolutegravir to MPP for global access to integrase inhibitor based ART.

This agreement also works well for ViiV Healthcare, who initially were unable to identify generic manufactures, although later said they were more open to this approach. [5]

It also ensures ViiV meets the commitment to make sure that medicines need to be available in countries where approval studies were run.

References

1. ViiV Healthcare. ViiV Healthcare commits to grant voluntary licence for patents relating to cabotegravir long-acting for PrEP to medicines patent pool. (27 May 2022).
   https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/may/viiv-healthcare-commits-to-grant-voluntary-licence-for-patents
2. AfroCAB. Communities demand ViiV/GSK accelerate access to CAB-LA in LMICs. (1 March 2022).
   http://www.afrocab.info/2022/03/communities-demand-viiv-gsk-accelerate-access-to-cab-la-in-lmics (link page)
   http://www.afrocab.info/wp-content/uploads/2022/03/CAB-LA-Community-Statement-Final_v2.pdf (PDF statement)
3. Ripin D. Approach for delivery of long-acting ARVs for treatment and prevention in LMICs: cabotegravir as a precedent-setting case study. LEAP conference, March 2022.
   https://longactinghiv.org/files/inline-files/DavidRipin-LEAP2022.mp4 (MP3 recording)
4. ViiV Healthcare. ViiV Healthcare open to voluntary licensing as part of approach to enable greater access to cabotegravir la for prep in low- and middle-income countries. (March 2022)
   https://viivhealthcare.com/hiv-news-and-media/news/company-statements/viiv-healthcare-statement-on-voluntary-license/

This report was first published on 27 May 2022.