Details
This analysis performed signal identification for Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide, BIC/FTC/TAF) by monitoring non‐pregnancy and non‐cancer outcomes among new users of BIC/FTC/TAF in the Sentinel Distributed Database (SDD). We conducted this signal identification assessment using a self-controlled risk interval (SCRI) design to identify incident outcomes and temporal clusters of incident outcomes following initiation of treatment with BIC/FTC/TAF in Tree-Only Scan and Tree-Temporal Scan analyses. A follow up analysis uses a SCRI analysis to estimate the proportion of incident syndrome of inappropriate antidiuretic hormone secretion (SIADH) cases with evidence of pulmonary opportunistic infections among new users of BIC/FTC/TAF.
We distributed this request to 13 Sentinel Data Partners on October 23, 2024. The study period includes data from February 8, 2018 to May 31, 2024.
Statistical alerts generated by this analysis do not on their own represent safety signals. 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).
The analytic package associated with this analysis can be found externally in Sentinel's Git Repository located here. The Git Repository serves as Sentinel's version control tracking system for analytic packages and technical documentation.