ViiV resubmits cabotegravir plus rilpivirine long-acting injections (Cabenuva, Vocabria) to FDA for approval

28 August 2020. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 29 July 2020, a press statement from GSK included information that the long-acting formulation of cabotegravir plus rilpivirine injections (CAB/RPV-LA) have been resubmitted to the US FDA. A decision on approval is expected in early 2021. [1]

The application for the first injectable HIV combination was expected to be decided last December, but outstanding questions relating to manufacturing delayed this decision. [2, 3]

The application includes safety and efficacy data from the phase 3 ATLAS and FLAIR studies that have already reported. This is for monthly injections, rather than two-monthly injections used in the ATLAS-2M study and reported at CROI 2020. [4]

Cabotegravir is an integrase inhibitor developed by ViiV Healthcare and rilpivirine is an NNRTI developed by Janssen Sciences. Development of CAB/RPV long-acting combination is led by ViiV Healthcare with the trade name Cabenuva in the US and Vocabria in the EU.

comment

It is good that a regulatory decision is closer given the high expectation among HIV positive people for an alternative to daily tablets. Access though in many countries will be dependent on price.

Although CAB/RPV-LA was approved in Canada in March 2020, it is not expected to be available through the public health system until September, when a price will also hopefully be announced. [5]

Several studies at AIDS 2020 also reported on the challenges for health systems in different settings to adapt to this new way of delivering ART and on results from a small expanded access programme. [6, 7, 8, 9]

The same press release also reported that development of the entry inhibitor combinectin in early stage development (GSK ‘934) has been ended due to “portfolio prioritisation”. [1]

This report was first posted on 6 August 2020.

References

1. GSK press release. Second quarter 2020 report. (29 July 2020).
   https://www.gsk.com/media/6064/q2-2020-results-announcement.pdf (PDF)
2. FDA decision on long-acting cabotegravir/rilpivirine (Cabenuva) injections delayed due to scale-up manufacturing problems. HTB (29 January 2020).
   https://i-base.info/htb/37064
3. ViiV Healthcare press statement. ViiV Healthcare receives complete response letter from US FDA for use of investigational cabotegravir and rilpivirine long-acting regimen in the treatment of HIV. (21 December 2019).
   https://viivhealthcare.com/en-gb/media/press-releases/2019/december/complete-response-letter-from-us-fda
4. Long-acting cabotegravir and rilpivirine injections support two-monthly dosing. HTB (12 March 2020).
   https://i-base.info/htb/37301
5. ViiV Healthcare press statement. ViiV Healthcare announces first global regulatory approval of CABENUVA; the first complete, long-acting, regimen for the treatment of HIV. (20 March 2020).
   https://viivhealthcare.com/en-gb/media/press-releases/2020/march/viiv-healthcare-announces-first-global-regulatory-approval-of-ca
6. Czarnogorski M et al. Perceived implementation barriers decrease during initial stages of the first implementation science hybrid III study (CUSTOMIZE) of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in US healthcare settings: Healthcare team perspective. AIDS 2020 virtual, Late-breaker poster LEPEE42.
   https://cattendee.abstractsonline.com/meeting/9289/Presentation/3781
7. Delany-Moretlwe S et al. Long acting cabotegravir (CAB LA): Planning for success across global at-risk populations. AIDS 2020 virtual, Late-breaker poster PEB0263.
   https://cattendee.abstractsonline.com/meeting/9289/Presentation/1006708
8. D’Amico R et al. Compassionate use of long acting (LA) cabotegravir (CAB) and rilpivirine (RPV) for patients in need of parenteral antiretroviral therapy. AIDS 2020 virtual, Poster abstract PEB0263.
   https://cattendee.abstractsonline.com/meeting/9289/Presentation/1319
9. Odongpiny EL et al. Willingness to use injectable antiretroviral therapy (ART) among women who disengage from prevention of mother-to-child transmission programmes in Uganda. AIDS 2020 virtual, Poster abstract PEB0262.
   https://cattendee.abstractsonline.com/meeting/9289/Presentation/1399
10. Kerrigan D et al. Feasibility of implementing long-acting injectable anti-retroviral therapy to treat HIV: A survey of health providers from the 13 countries participating in the ATLAS-2M trial. AIDS 2020 virtual, Poster abstract PEB0260.
    https://cattendee.abstractsonline.com/meeting/9289/Presentation/1375

This article was originally posted on 6 August 2020 and edited in October 2020 to include the EU trade name Vocabria.