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.
- PRESS RELEASE (21 December 2021): HPTN Studies Inform FDA’s Approval of ViiV Healthcare’s Long-Acting Cabotegravir Injections for HIV Prevention
- PRESS RELEASE (9 November 2020): HPTN 084 Study Demonstrates Superiority of CAB LA to Oral TDF/FTC for the Prevention of HIV
- HPTN 084 FAQ (Updated November 2020)
- Long acting injectable cabotegravir is safe and effective in preventing HIV infection in cisgender women: results from HPTN 084 (HIV R4P 2021)