| アブストラクト | BACKGROUND: The introduction of Direct-Acting Antivirals (DAA) brought about a breakthrough in the treatment of HCV. This study aims to analyze the hepatic safety profile of Harvoni(R) (sofosbuvir/ledipasvir), Epclusa(R) (sofosbuvir/velpatasvir), and Vosevi(R) (sofosbuvir/velpatasvir/voxilaprevir) through a review of the Individual Case Safety Reports (ICSRs) reported in EudraVigilance (EV). RESEARCH DESIGN AND METHODS: ICSRs with adverse events (AE) belonging to the system organ class (SOC) hepatobiliary disorders were retrieved from the EV database. A descriptive analysis was performed. Reporting odds ratios (ROR) were calculated to assess the reporting frequency of hepatobiliary disorders among the DAA combinations. RESULTS: Out of 5,552 ICSRs reported between January 2018 and December 2023, 1,942 were for Harvoni(R), 3,180 for Epclusa(R) and 430 for Vosevi(R). Three hundred and thirty-nine ICSRs reported 1,616 PT within the SOC hepatobiliary disorders. Harvoni(R) showed a statistically significant lower frequency of reporting for the hepatobiliary disorders SOC when compared to Epclusa(R) and Vosevi(R) (ROR, 0.33; 95% CI [0.26-0.41] and ROR 0.31; 95% CI [0.19-0.48], respectively). CONCLUSION: Harvoni(R) showed a lower reporting frequency of hepatobiliary disorders and fewer drug ineffectiveness reports, suggesting it may be preferred over Epclusa(R) and Vosevi(R) in patients with preexisting liver or biliary conditions. |
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| ジャーナル名 | Expert opinion on drug safety |
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| Pubmed追加日 | 2025/4/17 |
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| 投稿者 | Scicluna, John; Di Napoli, Raffaella; Pirozzi, Daniele; Fraenza, Federica; Cardillo, Mirko; Scavone, Cristina; Capuano, Annalisa |
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| 組織名 | Eu2P Programme, University of Bordeaux, Bordeaux, France.;Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples,;Italy.;Department of Experimental Medicine - Section of Pharmacology "L. Donatelli",;University of Campania "Luigi Vanvitelli", Naples, Italy.;Department of Life Sciences, Health, and Health Professions, Link Campus;University, Rome, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40243008/ |
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