Details
This analysis performed a self-controlled risk interval analysis for Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide, BIC/FTC/TAF) 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 in the Sentinel Distributed Database (SDD). We conducted this self-controlled risk interval (SCRI) design to identify SIADH cases with pulmonary opportunistic infections following initiation of treatment with BIC/FTC/TAF in Tree-Temporal Scan analyses. We identified all valid episodes of new BIC/FTC/TAF use among those of all ages at the time of treatment initiation and screened for the occurrence of health outcomes of interest (HOIs) during pertinent risk and control windows, intending to capture incident SIADH specifically. This is a follow up to an analysis that performed signal identification for 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 distributed this request to six Sentinel Data Partners on January 17, 2025. The study period includes data from February 8, 2018 to July 31, 2024.