| アブストラクト | BACKGROUND AND OBJECTIVE: As human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) use expands, real-world post-marketing safety evidence remains limited, particularly regarding potential formulation-specific adverse-event patterns across oral and long-acting agents. We aimed to characterise the post-marketing safety profiles of FDA-approved PrEP drugs using the FDA Adverse Event Reporting System (FAERS). METHODS: We conducted a disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) data from 2012 to 2024. Individual Case Safety Reports (ICSRs) listing emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), emtricitabine/tenofovir alafenamide (FTC/TAF) or cabotegravir (CAB) as suspected PrEP drugs were included. Two comparator groups were used: all non-PrEP ICSRs and ICSRs involving non-PrEP HIV drugs. Disproportionality was evaluated at the MedDRA high-level term (HLT) level using reporting odds ratios and 95% confidence intervals (CIs), identifying signals of disproportionate reporting (SDRs) with a lower bound of the 95%CIs > 1. Sensitivity analyses explored sex, reporter type, and indication. RESULTS: We identified 3201 PrEP-related ICSRs (FTC/TDF: 2688; FTC/TAF: 463; CAB: 50), predominantly involving young adult males. FTC/TDF exhibited a broad pattern of SDRs-including renal/metabolic abnormalities, muscular signals, mucosal disorders and some previously under-characterised signals-many of which attenuated when using HIV-treated comparators. FTC/TAF showed a narrower, highly consistent pattern dominated by hepatobiliary and metabolic monitoring procedures, renal function evaluations and neurosensory disturbances. CAB showed specific, reproducible signals for injection-site, dermatologic and procedure-related events. CONCLUSIONS: PrEP agents display distinct, formulation-specific and reproducible safety patterns in FAERS. Comparator choice substantially influences the detection and interpretation of SDRs and can help distinguish reproducible formulation-related reporting patterns from findings that may be driven by the clinical and reporting context. These insights highlight priority areas for future research. |
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| ジャーナル名 | Clinical drug investigation |
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| Pubmed追加日 | 2026/10/11 |
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| 投稿者 | Rozza, Davide; Poluzzi, Elisabetta; Antonazzo, Ippazio Cosimo; Boccia, Angela; Paccini, Marco; Gallucci, Fortuna; Ponticelli, Domenico; Geraci, Giulio; Aguero, Fernando; Mazzaglia, Giampiero; Mantovani, Lorenzo Giovanni; Raschi, Emanuel; Ferrara, Pietro |
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| 組織名 | Center for Public Health Research, University of Milan-Bicocca, Monza, Italy.;Department of Medical and Surgical Sciences, University of Bologna, Bologna,;Italy.;Department of Environmental and Prevention Sciences, University of Ferrara,;Ferrara, Italy. ippazio.antonazzo@unife.it.;Clinica Montevergine SpA, Mercogliano, AV, Italy.;Department of Medicine and Surgery, "Kore" University of Enna, Enna, Italy.;Internal Medicine Unit, Hospital Umberto I, ASP Enna, Enna, Italy.;Preventive Medicine Unit, Hospital Universitari General de Catalunya,;Quironsalud, Sant Cugat del Valles, Barcelona, Spain.;Laboratory of Public Health, IRCCS Istituto Auxologico Italiano, Milan, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42859365/ |
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