ArticleFrontiers in pharmacology2026
Comparative safety profile of biktarvy: insights from a clinical cohort and the FAERS database.
Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
- Erratum issued
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: 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. Methods: 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. Results: 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. Conclusion: 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.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.