| アブストラクト | BACKGROUND AND OBJECTIVES: Integrase strand transfer inhibitors (INSTIs) and NNRTIs are widely used in the treatment of HIV, but the real-world adverse events (AEs) profiles of these drugs remain inadequately characterized. We prioritized AEs reported with INSTIs and NNRTIs using data from the FDA Adverse Event Reporting System (FAERS). METHODS: Using FAERS data (from FDA approval to June 2024) for 10 drugs (cabotegravir, dolutegravir, raltegravir, elvitegravir, bictegravir, nevirapine, efavirenz, rilpivirine, doravirine and etravirine), we assessed AE clinical priority using a multi-criteria score. The score evaluated four criteria: clinical relevance, reporting proportion, case fatality rate and signal stability. We calculated reporting odds ratios (RORs) with 95% CIs; signals required the lower limit of 95% CIs of the ROR, ROR025 > 1 after Bonferroni correction across [N] tested AEs per drug. Events related to medication errors or HIV-related conditions were excluded. A case-by-case assessment was conducted to evaluate the confounding factors from co-medications and indications. RESULTS: We found 4487/6362 (70.5%) were low priority (0-2 points) and 1849/6362 (29.1%) were moderate (3-5 points), 2, 8, 6 and 15 marginally high-priority (>/=4.5 points) adverse pregnancy outcomes were identified with dolutegravir, raltegravir, nevirapine, efavirenz, respectively; 26 AEs were high clinical priorities (>5 points). After case-by-case assessment, five noteworthy AEs remained. These included efavirenz-related haemolytic anaemia, etravirine-related hepatic failure, dolutegravir-related foetal death, raltegravir-related drug reaction with eosinophilia and systemic symptoms, and raltegravir-related hepatic failure. CONCLUSIONS: This study provides a systematic framework for evaluating post-marketing AEs of INSTIs and NNRTIs using a semi-quantitative scoring system. Our findings identified five high-priority AEs that require clinical validation and further investigation. |
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| ジャーナル名 | The Journal of antimicrobial chemotherapy |
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| Pubmed追加日 | 2026/3/11 |
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| 投稿者 | Wang, Gao-Yang; Xia, Shuang; Sarangdhar, Mayur; Noguchi, Yoshihiro; Zhou, Ji-Fang |
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| 組織名 | School of International Business, China Pharmaceutical University, Nanjing,;Jiangsu 211198, China.;Sorbonne Universite, INSERM, CIC-1901 Paris-Est, Assistance Publique - Hopitaux;de Paris, Pitie-Salpetriere Hospital, Department of Pharmacology, Paris, France.;Division of Biomedical Informatics, Cincinnati Children's Hospital Medical;Center, 3333 Burnet Avenue, Cincinnati, OH 45229-3026, USA.;Division of Oncology, Cincinnati Children's Hospital Medical Center, 3333 Burnet;Avenue, Cincinnati, OH 45229-3026, USA.;Department of Pediatrics, University of Cincinnati College of Medicine, 3333;Burnet Avenue, Cincinnati, OH 45229-3026, USA.;Laboratory of Clinical Pharmacy, Gifu Pharmaceutical University, 1-25-4;Daigakunishi, Gifu-shi, Gifu 501-1196, Japan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41808663/ |
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