Skip to main content

Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) & Signal Identification

Basic Details
Status
Complete
Last Updated
Thursday, September 11, 2025
Original Posting Date
Health Outcome(s)
signal identification
Purpose
Signal Identification
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

The U.S Food and Drug Administration (FDA) initiated this study in the Sentinel System to augment the postmarket safety monitoring of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) to identify any previously unknown safety concerns. BIC/FTC/TAF is currently indicated for the treatment of human immunodeficiency virus type 1 (HIV-1). Sentinel investigators monitored non-pregnancy and non-cancer outcomes among new users of BIC/FTC/TAF using TreeScan™ and a self-control study design.

Results found a statistical alert for syndrome of inappropriate secretion of antidiuretic hormone (SIADH), which was triaged as potentially drug-related. As a result of these findings, FDA opened a newly identified safety signal (NISS). Further pre-evaluation activities suggested that the NISS did not currently meet the criteria to move to the evaluation phase and that it would be closed in pre-evaluation with monitoring.

Analytic Code Link(s) (1)
Outcome Monitoring Following Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Use: A Self-Controlled Risk Interval Signal Identification Analysis
Result(s) (3)
Utilization of Biktarvy, Odefsey, Symtuza, and Genvoya: A Descriptive Analysis Outcome Monitoring Following Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Use: A Self-Controlled Risk Interval Signal Identification Analysis Proportion of Incident Syndrome of Inappropriate Antidiuretic Hormone Secretion Cases with Evidence of Pulmonary Opportunistic Infections Among New Users of BIC/TC/TAF: A Descriptive Analysis