Details
Bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is currently approved for the treatment of human immunodeficiency virus type 1 (HIV-1). The FDA initiated a study in Sentinel using a self-controlled risk interval analysis and tree-based scan statistics to monitor for new safety concerns among new users of BIC/FTC/TAF. Pre/post and temporal cluster analyses were conducted.
The goal of the study was to monitor non-pregnancy and non-cancer outcomes among new users of BIC/FTC/TAF. After evaluating the statistical alerts generated by this study in the context of other information, the FDA did not identify any new safety concerns and determined that no further evaluation is warranted at this time. Statistical alerts are triaged in consideration of the study design, existing drug knowledge, therapeutic context, treated population, and potential public health impact. Alerts determined to be newly identified safety signals (NISS) follow the FDA’s Center for Drug Evaluation and Research manual of policies and procedures for NISS (MAPP 4121.3). Overall, the study did not identify any new safety concerns for BIC/FTC/TAF in this sample of real-world adult patients.