| アブストラクト | OBJECTIVE: to investigate whether drug resistance is differentially reported for integrase strand-transfer inhibitors (INSTIs) in a global pharmacovigilance database. METHODS: A disproportionality analysis was conducted to assess resistance to the five available INSTIs using VigiBase, the WHO global database of individual case safety reports (ICSRs). ICSRs were identified through Medical Dictionary for Regulatory Activities - MedDRA preferred terms (PTs) drug resistance, drug resistance mutation, genotype drug resistance test/test positive, multiple-drug resistance and pathogen resistance between October 2007 and September 2024. Descriptive analyses were employed to characterize individual cases according to sociodemographic and reporting-related variables. Disproportionality signals for at least one resistance-related MedDRA PTs compared with all other drugs in the database were expressed as reporting odds ratios (ROR) and information component (IC), with 95% confidence intervals (CI). RESULTS: 35,406,826 deduplicated ICSRs were identified; 22,825 comprised reports of drug resistance and 1,084 involved exposure to INSTIs. Cases of HIV resistance were predominantly males. Most reports were regarded as serious and originated from Europe and the Americas. Disproportionality signals for drug resistance were observed for all first-generation (ROR= 52.5; CI 95% = 47.6-57.9; IC = 5.56; 95% CI = 5.4-5.7 - raltegravir) and second-generation INSTIs (ROR = 55.9; CI 95% = 50.8-61.5; IC = 5.65; 95% CI = 5.5-5.8 - dolutegravir). CONCLUSIONS: HIV drug resistance to all INSTIs as well significant disproportionate safety signals were identified. These findings should be interpreted with caution given the inherent limitations of spontaneous reporting. Resistance monitoring in clinical settings is relevant. |
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| ジャーナル名 | Current medical research and opinion |
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| Pubmed追加日 | 2026/6/11 |
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| 投稿者 | Basilio, Helena Sclauser; Reis, Adriano Max Moreira; Braga, Leticia Penna; Fonseca, Laura Beatriz; Drummond, Paula Lana Miranda; Malta, Jessica Soares; Menezes de Padua, Cristiane Aparecida |
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| 組織名 | Department of Social Pharmacy, Universidade Federal de Minas Gerais, Belo;Horizonte, Brazil.;Department of Pharmaceutical Products, Universidade Federal de Minas Gerais, Belo;Department of Epidemiological Analysis and Surveillance of Noncommunicable;Diseases, Ministry of Health, Distrito Federal, Brazil.;Pharmacovigilance and Clinical studies Service, Ezequiel Dias Foundation, Belo;Department of Population Health Sciences, University of Wisconsin-Madison,;Madison, WI, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42275135/ |
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