Study Results

HPTN 084 Study Demonstrates Superiority of Injectable Cabotegravir to Oral FTC/TDF for the Prevention of HIV in Cisgender Women in Sub-Saharan Africa

On November 5, 2020, a Data and Safety Monitoring Board (DSMB) reviewed HPTN 084 study data and recommended that the blinded phase of the study be stopped early for successfully meeting its specified objectives. The HPTN 084 study found that a regimen containing CAB LA injected once every eight weeks was superior to daily oral FTC/TDF at preventing HIV acquisition in cisgender women. Among the 38 women in the trial who acquired HIV, four were receiving CAB LA and 34 were receiving daily oral FTC/TDF. This translated to an HIV incidence rate of 0.21% (95% confidence interval [CI] 0.06%-0.54%) in the cabotegravir group and 1.79% (95% CI 1.24%-2.51%) in the FTC/TDF group: in other words, approximately 9 times the number of incident HIV infections were in the FTC/TDF arm than in the CAB LA arm. The study sponsor, the U.S. National Institute of Allergy and Infectious Diseases (NIAID), approved the decision to stop the blinded part of the study. The study investigators will report more detailed information about the HPTN 084 results in a peer-reviewed publication.