Contact: Jeremiah Johnson, Jeremiah.Johnson@treatmentactiongroup.org

NEW YORK CITY, November 12, 2020 – Treatment Action Group (TAG) welcomes the announcement that the phase 3 HPTN 084 trial proved that intramuscular injections of ViiV’s long acting cabotegravir (CAB-LA) every eight weeks were superior to daily oral TDF/FTC pre-exposure prophylaxis (PrEP) in preventing new HIV infections in cisgender women in sub-Saharan Africa.[i]

The randomized, controlled study was originally scheduled to end in 2022, but has been unblinded earlier than expected after a scheduled early review by the Data and Safety Monitoring Board (DSMB) revealed the superiority of CAB-LA. This is the second trial of CAB-LA PrEP to be unblinded early this year; in May a scheduled DSMB review for HPTN 083 also unexpectedly demonstrated superiority of CAB-LA to oral TDF/FTC in cisgender men and transgender women who have sex with men.[ii] Both trials build on ViiV’s existing work to bring long acting antiretroviral formulations to market; the company has previously demonstrated that co-administered injections of CAB-LA and rilpivirine (RPV-LA) are noninferior to oral regimens in the treatment of HIV.[iii]

Major hurdles remain for full implementation of CAB-LA for PrEP in both the U.S. and global contexts, and community-led discussions on plans for regulatory approval and scale-up are urgently needed. The challenges faced by long acting agents were put on full display in January when the FDA denied approval of CAB-LA and RPV-LA for treatment citing production concerns.[iv] Previous findings from a phase 2a study of CAB-LA PrEP showing that the drug can persist for up to three years in cisgender men or four years in cisgender women also need to be fully addressed, as infections acquired at a time when CAB is present at subtherapeutic levels could lead to a rise in resistance mutations associated with integrase inhibitors.[v] And there are, of course, always the concerns of whether CAB-LA will be set at a price point that makes it accessible to those who need it worldwide.

The results of HPTN 084 and 083 provide compelling evidence that overcoming these hurdles must be an urgent priority, with community advocates at the helm. In cisgender women, CAB-LA successfully reduced incidence down to 0.21% in a population that regularly sees significantly higher new infection rates. HPTN 084 also underscored the importance of continuing to scale up oral TDF/FTC PrEP availability as the active control arm of the trial experienced a significant reduction in incidence to just 1.79%. ViiV and other key stakeholders in the scale up of CAB-LA PrEP must prioritize conversations with leading HIV prevention community advocates to address lingering concerns for implementation, particularly at a time when breakthrough technologies may help regain ground in ending HIV as an epidemic after a year of COVID-19 related interruptions. Community advocates must also quickly grapple with the increasing complexity of offering comprehensive HIV prevention options as we simultaneously seek to scale up daily and on demand oral PrEP options, the dapivirine ring, CAB-LA, U=U messaging, and additional prevention options under development.

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About TAG: Treatment Action Group (TAG) is an independent, activist and community-based research and policy think tank fighting for better treatment, prevention, a vaccine, and a cure for HIV, tuberculosis, and hepatitis C virus. TAG works to ensure that all people with HIV, TB, and HCV receive lifesaving treatment, care, and information. We are science-based treatment activists working to expand and accelerate vital research and effective community engagement with research and policy institutions.

[i] ViiV. ViiV Healthcare announces investigational injectable cabotegravir is superior to oral standard of care for HIV prevention in women. November 9, 2020. https://viivhealthcare.com/en-gb/media/press-releases/2020/november/viiv-Healthcare-announces-investigational-injectable-cabotegravir-is-superior-to-oral-standard-of-care-for-HIV-prevention-in-women/

[ii] Treatment Action Group. Long-Acting Injectable Cabotegravir for HIV Pre-Exposure Prophylaxis (PrEP): Promising Results from HPTN 083. May 19, 2020. https://www.treatmentactiongroup.org/statement/long-acting-injectable-cabotegravir-for-hiv-pre-exposure-prophylaxis-prep-promising-results-from-hptn-083/

[iii] Currier JS. Monthly Injectable Antiretroviral Therapy – Version 1.0 of a New Treatment Approach. N Engl J Med. 2020 Mar 19;382(12):1164-1165. doi: 10.1056/NEJMe2002199. Epub 2020 Mar 4. PMID: 32130808.

[iv] Collins S. FDA decision on long-acting cabotegravir/rilpivirine (Cabenuva) injections delayed due to scale-up manufacturing problems. HIV i-Base. January 29, 2020. http://i-base.info/htb/37064

[v] Scarsi KK. Chasing the cabotegravir tail: implications for prevention. Lancet HIV. 2020 Jul;7(7):e451-e453. doi: 10.1016/S2352-3018(20)30165-X. Epub 2020 Jun 1. PMID: 32497490.