HPTN Studies Inform FDA’s Approval of CAB-LA Injections for HIV Prevention

Dec 21, 2021
CAB LA (Photo courtesy of ViiV Healthcare)

Data from HPTN studies HPTN 083 and HPTN 084 helped provide important information for the December 20, 2021 decision by the U.S. Food and Drug Administration (FDA) to approve ViiV Healthcare’s long-acting cabotegravir (CAB-LA) injections for the prevention of HIV. Sponsored and co-funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), these studies showed that CAB-LA injected once every eight weeks was superior to daily oral tenofovir/emtricitabine (TDF/FTC) for HIV prevention among cisgender men and transgender women who have sex with men (HPTN 083) and cisgender women (HPTN 084). Both studies also demonstrated that CAB-LA was well-tolerated, offering a new and important pre-exposure prophylaxis (PrEP) option for individuals at risk for HIV infection.  ViiV Healthcare will market CAB-LA for PrEP under the brand name Apretude.