Comparative safety profile of biktarvy: insights from a clinical cohort and the FAERS database

Biktarvy, a second-generation integrase strand-transfer inhibitor, is approved for treating human immunodeficiency virus (HIV) in patients with no known resistance to its components. This study compared adverse events (AEs) associated with biktarvy based on data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database and real-world evidence from a hospital setting to inform clinical practice.

AE reports were extracted from the FAERS database and our hospital's internal records. The Reporting Odds Ratio (ROR) and the Bayesian Confidence Propagation Neural Network (BCPNN) were used to assess the reporting of AEs associated with biktarvy. A positive signal was defined as meeting all of the following criteria: case number ≥ 3, ROR 95% confidence interval lower limit > 1.0, (IC-2SD) > 0.

A total of 10,424 AE reports were retrieved (6,850 from FAERS and 3,574 from hospital data). Males and patients aged 18-64.9 years accounted for a larger proportion of AE reports in terms of raw counts. Overall, 343 unique AEs met the positive signal threshold (263 from FAERS and 80 from the hospital). Hospital data identified signals including elevated urine vitamin C, triglycerides, and uric acid. FAERS data revealed signals for cerebrovascular accident, myocardial infarction, and cardiomegaly.

Hospital data indicated a risk of eye disorders and certain abnormal investigation findings not mentioned in the package insert, while the FAERS data pointed to a potential risk domain of vascular diseases such as cerebrovascular accident and myocardial infarction. Our study provides evidence for the use of biktarvy in the treatment of HIV.