META-INSTI: metabolic adverse events following integrase strand transfer inhibitor administration in spontaneous adverse event reports

BACKGROUND: Metabolic effects of integrase strand transfer inhibitors (INSTIs) have been reported. The FDA Adverse Event Reporting System (FAERS) is a publicly available database that captures spontaneously reported adverse events. The objective of this study was to evaluate the relationship between INSTIs and metabolic adverse events using the FAERS database. METHODS: FAERS data were queried from quarter 4 of 2007 through quarter 4 of 2019 and limited to adults. The Standardized MedDRA Query for ‘hyperglycaemia/new-onset diabetes mellitus’ (H/DM) was used to identify metabolic adverse events of interest. Weight gain was analysed as a separate event. Reporting odds ratios (RORs) and 95% CIs were calculated for the INSTI class and individual agents. RESULTS: Over 10.1 million FAERS reports were identified. Any INSTI was mentioned as a primary and/or secondary suspect agent in 18,400 (0.18%) reports (bictegravir: 1414 [0.01%]; dolutegravir: 7840 [0.08%]; elvitegravir: 4034 [0.04%]; raltegravir: 5551 [0.05%]). RORs (95% CI) for H/DM and weight gain for any INSTI were 1.20 (1.15–1.27) and 2.16 (1.96–2.38). For individual agents, RORs (95% CI) for H/DM and weight gain were as follows: bictegravir, 1.23 (1.10–1.37) and 6.82 (5.50–8.41); dolutegravir, 1.28 (1.19–1.39) and 1.86 (1.58–2.18); elvitegravir, 0.76 (0.56–1.02) and 1.63 (1.37–1.92); and raltegravir, 1.00 (0.90–1.11) and 3.29 (2.77–3.91). H/DM was noted in 159 bictegravir and 712 dolutegravir reports. CONCLUSION: Overall, H/DM was associated with bictegravir and dolutegravir and weight gain with all INSTIs. Clinicians should know the potential relationship between INSTIs and metabolic effects and institute appropriate monitoring. THIS PAPER WAS PREVIOUSLY PRESENTED: META-INSTI: Metabolic Adverse Events Following Integrase Strand Transfer Inhibitor Administration in Spontaneous Adverse Event Reports. Platform Presentation. ID Week. Virtual 2020.