| アブストラクト | BACKGROUND AND AIMS: Due to the increasing number of hepatitis C virus (HCV)-infected patients being treated with direct antiviral agents (DAAs) in Romania, we aimed to conduct a pharmacovigilance study in order to comprehensively evaluate the safety profile for the ombitasvir/paritaprevir/ritonavir and dasabuvir (Om/Pa/Ri+Da) regimen. METHODS: A retrospective analysis was conducted on the individual case safety reports (ICSRs), extracted from VigiBase(R) on 1 st February 2018, which included the Om/Pa/Ri+Da regimen as suspected for causing adverse drug reactions (ADRs). Potential drug-drug interactions (DDIs) were checked for all concomitant medication using the IBM Micromedex(R) tool. RESULTS: Among the 1,102 ICSRs retrieved, 260 were serious (23.5%). Ribavirin was significantly associated with more ADRs reported per case (on average 5.1 vs. 3.2 ADRs/case, p<0.001). Most commonly reported ADRs were pruritus (6.8%), fatigue (5.4%), dizziness (4.3%) and headache (3.8%). For the serious ICSRs, a significant relationship was found between age and renal and urinary disorders, and between gender and neoplasms, injury, poisonings and procedural complications. Hepatotoxicity was identified in six ICSRs, four of them being serious. Potential contraindicated DDIs were identified in 1.9% of all ICSRs and major DDIs in 20.4%. CONCLUSIONS: About a third of the ICSRs related to Om/Pa/Ri+Da regimen were serious. Pruritus, fatigue, dizziness and headache were the most commonly reported ADRs. The frequent use of multiple co- medications in HCV-infected patients requires the consideration of potential DDIs when using the Om/ Pa/Ri+Da regimen. |
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| ジャーナル名 | Journal of gastrointestinal and liver diseases : JGLD |
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| Pubmed追加日 | 2020/10/30 |
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| 投稿者 | Cazacu, Irina; Stroe, Roxana; Dondera, Roxana; Apan, Bogdan; Farcas, Andreea; Cristina, Anamaria; Bucsa, Camelia; Mogosan, Cristina |
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| 組織名 | Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy,;Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.;cazacuirina16@gmail.com.;Pharmacovigilance and Risk Management Service. National Agency for Medicines and;Medical Devices of Romania, Bucharest, Romania. roxana.stroe@anm.ro.;Medical Devices of Romania, Bucharest, Romania. roxana.dondera@anm.ro.;Department of Pharmacology, Toxicology and Clinical pharmacology, Functional;Sciences, Faculty of Medicine, Iuliu Hatieganu University of Medicine and;Pharmacy, Cluj-Napoca, Romania. apan_bogdan@yahoo.com.;Drug Information Research Centre, Iuliu Hatieganu University of Medicine and;Pharmacy, Cluj-Napoca, Romania. afarcas@umfcluj.ro.;cristina.anam@yahoo.com.;Pharmacy, Cluj-Napoca, Romania. cfarah@umfcluj.ro.;Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca; Drug;Information Research Centre, Iuliu Hatieganu University of Medicine and Pharmacy,;Cluj-Napoca, Romania. cmogosan@umfcluj.ro. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/33118546/ |
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