ArticleHIV medicine2026
Pharmacovigilance study of INSTIs associated with weight gain and glucose/lipid metabolism adverse events based on the FDA adverse event reporting system.
Article in HIV medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.
What it found
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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
1 citing paper in PubMed.
Corrections and comments
- Erratum issued
Authors and funding
9 authors.
Funding
Abstract
objectiveIntegrase strand transfer inhibitors (INSTIs) are widely used in antiretroviral therapy (ART) for people with HIV due to their efficacy and tolerability. However, concerns about weight gain and metabolic disturbances have emerged. This study aimed to evaluate the association between INSTIs and metabolic adverse events (AEs), including weight gain and glucose/lipid disorders.
designThe US Food and Drug Administration Adverse Event Reporting System (FAERS) reports from the first quarter (Q1) of 2004 through Q1 2025 were analysed for AEs associated with bictegravir (BIC), dolutegravir (DTG), elvitegravir (EVG) and raltegravir (RAL), focusing on weight gain and glucose/lipid metabolism disorders. Kaplan-Meier curves and Weibull shape parameter tests were used to analyse the cumulative incidence and time to onset of AEs.
resultsAll four INSTIs were associated with safety signals for weight gain and glucose/lipid metabolism disorders. BIC had the highest reporting odds ratio (ROR) for weight gain (ROR: 7.70, 95% CI: 7.00-8.47), while DTG had the highest for glucose/lipid disorders (1.81, 95% CI: 1.66-1.97). Younger age and female sex were linked to BIC-related weight gain; older age was a risk factor for DTG-, EVG- and RAL-related glucose/lipid AEs. DTG-associated events occurred earlier than those with other agents.
conclusionThis study identified metabolic AEs associated with INSTIs, with agent-specific differences in risk and timing, highlighting the need for regular monitoring and individualized management during INSTI-based ART.
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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.