AVAC Applauds FDA Approval of Injectable PrEP

December 21, 2021

Yesterday, December 20th, the US Food and Drug Administration (FDA) issued welcome news. It has approved injectable cabotegravir (CAB-LA, and brand name “Apretude”), the first injectable form of HIV PrEP. As another form of HIV PrEP that does not require taking a daily pill, CAB-LA is a much-needed addition to a proven HIV prevention toolbox that now also includes male and female condoms, daily oral PrEP, voluntary medical male circumcision (VMMC) and the Dapivirine Vaginal Ring.

“The approval of CAB-LA is a welcome and much-needed boost for HIV prevention,” said Mitchell Warren, executive director of AVAC. “With as few as six shots per year, this highly effective form of injectable PrEP can help bend the curve of the HIV epidemic – but only if its approval is accompanied by strategic, effective and equitable rollout that transforms the growing list of HIV prevention options into real and accessible choices for the people who need prevention most.”

CAB-LA is an injectable antiretroviral given to adults and adolescents who are confirmed to be HIV-negative at two-month intervals to reduce the risk of HIV. While today’s FDA action approves CAB-LA for use in the United States only, AVAC and its partners will be working in the months ahead to support the review of CAB-LA by regulatory authorities in other parts of the world where new HIV prevention options are sorely needed. AVAC is heartened that ViiV Healthcare, the developer of CAB-LA, has submitted applications to multiple regulatory authorities, including Brazil and several in sub-Saharan Africa that hosted the pivotal clinical trials led by the NIH-funded HIV Prevention Trials Network (HPTN).

“The experiences of oral PrEP for HIV prevention and from COVID vaccines are stark reminders that the US FDA approval is just one small, albeit important, step in translating exciting science into public health impact,” said Warren. “Without global regulatory approvals, clear guidance from WHO, a commitment to equitable access and fair pricing, and resources to deliver innovation, the best science does not prevent or end pandemics.”

The US approval of CAB-LA is an important and welcome milestone in HIV prevention, however, it is just the first in a series of steps needed to ensure that injectable PrEP can help reduce the 1.5 million new HIV infections that occurred in 2020. Supporting access to injectable PrEP, oral PrEP and the full range of proven prevention options requires programs that are strategically designed, user-centered, appropriately resourced, and promoted and designed to reach those who need prevention most, as outlined in the work of the Biomedical Prevention Implementation Collaborative (BioPIC). Lessons learned from nearly ten years of experience in supporting access to oral PrEP will be particularly important in shaping broad and effective access to injectable PrEP, alongside oral PrEP and the Dapivirine Vaginal Ring, and are detailed at prepwatch.org.

Effective global use of CAB-LA for HIV prevention will also require a significant and long-overdue upgrading of global HIV testing capacity, as injectable PrEP can only be used safely if the recipient is HIV-negative and is tested before every dose. It will also require advocacy around self-testing and lower age of consent to testing policies, which have been significantly correlated with oral PrEP initiations.

“Transparency and fairness in pricing, advocacy to accelerate global regulatory review, feasible testing policies, and upgrades to health systems are crucial to effective access to injectable cabotegravir and must all be part of the global HIV prevention agenda moving forward,” noted Warren. “Today’s approval announcement is warmly welcomed, but is also just the start of efforts to make long-acting injectable PrEP an accessible choice for all in need.”