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

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.


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.


  1. GSK press release. Second quarter 2020 report. (29 July 2020). (PDF)
  2. FDA decision on long-acting cabotegravir/rilpivirine (Cabenuva) injections delayed due to scale-up manufacturing problems. HTB (29 January 2020).
  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).
  4. Long-acting cabotegravir and rilpivirine injections support two-monthly dosing. HTB (12 March 2020).
  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).
  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.
  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.
  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.
  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.
  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.

This article was originally posted on 6 August 2020.

Links to other websites are current at date of posting but not maintained.