Pharmacovigilance study of INSTIs associated with weight gain and glucose/lipid metabolism adverse events based on the FDA adverse event reporting system - PubMed
12 hours ago
- #HIV
- #Metabolic Disorders
- #Pharmacovigilance
- Pharmacovigilance study on INSTIs (Integrase strand transfer inhibitors) and their association with weight gain and glucose/lipid metabolism adverse events.
- Analysis based on FDA Adverse Event Reporting System (FAERS) data from 2004 to 2025.
- INSTIs studied include bictegravir (BIC), dolutegravir (DTG), elvitegravir (EVG), and raltegravir (RAL).
- BIC showed the highest reporting odds ratio (ROR) for weight gain (ROR: 7.70).
- DTG had the highest ROR for glucose/lipid metabolism disorders (ROR: 1.81).
- Younger age and female sex linked to BIC-related weight gain.
- Older age identified as a risk factor for glucose/lipid AEs with DTG, EVG, and RAL.
- DTG-associated adverse events occurred earlier compared to other INSTIs.
- Study highlights the need for regular monitoring and individualized management during INSTI-based ART.