多药治疗和衰老对接受泛型直接作用抗病毒药物(pDAA)治疗的HCV患者多重药物-药物相互作用(ddi)风险影响的意大利真实世界分析

IF 4.6 Q2 MATERIALS SCIENCE, BIOMATERIALS ACS Applied Bio Materials Pub Date : 2023-01-01 DOI:10.2147/TCRM.S394467
Stefano Fagiuoli, Pierluigi Toniutto, Nicola Coppola, Domenica Daniela Ancona, Margherita Andretta, Fausto Bartolini, Fulvio Ferrante, Alessandro Lupi, Stefano Palcic, Francesca Vittoria Rizzi, Davide Re, Gema Alvarez Nieto, Candido Hernandez, Francesca Frigerio, Valentina Perrone, Luca Degli Esposti, Alessandra Mangia
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引用次数: 1

摘要

目的:本研究旨在探讨多种药物和年龄对使用索非布韦/维帕他韦(SOF/VEL)或glecaprevir/pibrentasvir (GLE/PIB)治疗的HCV患者多重药物相互作用(ddi)发生率的影响。患者和方法:这是一项基于约690万人的行政数据的回顾性分析。纳入2017年11月至2020年3月期间接受SOF/VEL或GLE/PIB治疗的患者。与此期间的SOF/VEL或GLE/PIB首开处方对应的索引日期;随访患者治疗时间。然后将分析重点放在具有多重ddi风险的≥2种药物的患者。使用利物浦大学的工具确定多重DDI的严重程度和影响。结果:共入选SOF/VEL患者2057例,GLE/PIB患者2128例。SOF/VEL患者的平均年龄为58.5岁,高于GLE/PIB患者的平均年龄(52.5岁)(p < 0.001),并且>50岁的患者在SOF/VEL和GLE/PIB队列中更多:72%比58%,(p < 0.001)。大多数联合用药是心血管、消化和神经系统药物。使用≥2种药物的患者比例在SOF/VEL组高于GLE/PIB组(56.5% vs 32.3%, p < 0.001)。≥2种药物治疗的SOF/VEL患者中有11.6% (N = 135)存在多重ddi高危,GLE/PIB患者中有19.6% (N = 135)存在多重ddi高危(p < 0.001)。其中,DDI的潜在影响是降低血清DAA水平(占SOF/VEL和GLE/PIB患者的11%),增加血清药物浓度(占SOF/VEL的14%和GLE/PIB的42%)。结论:这一真实世界的分析提供了一个全面的特征,即在接受SOF/VEL或GLE/PIB治疗的HCV患者中,多重药物治疗方案的负担使这些患者的ddi风险增加。在我们的样本人群中,SOF/VEL方案在老年患者和使用≥2种药物有多重ddi风险的患者中更常见,即在合并症和多种药物发生率较高的患者中。
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Italian Real-World Analysis of the Impact of Polypharmacy and Aging on the Risk of Multiple Drug-Drug Interactions (DDIs) in HCV Patients Treated with Pangenotypic Direct-Acting Antivirals (pDAA).

Purpose: The study aims at investigating the impact of polymedication and aging in the prevalence of multiple drug-drug interactions (DDIs) on HCV patients treated with sofosbuvir/velpatasvir (SOF/VEL) or glecaprevir/pibrentasvir (GLE/PIB).

Patients and methods: This is a retrospective analysis based on administrative data covering around 6.9 million individuals. Patients treated with SOF/VEL or GLE/PIB over November 2017-March 2020 were included. Index date corresponded to SOF/VEL or GLE/PIB first prescription during such period; patients were followed up for treatment duration. Analyses were then focused on patients with ≥2 comedications at risk of multiple DDIs. The severity and the effect of multiple DDI were identified using the Liverpool University tool.

Results: A total of 2057 patients with SOF/VEL and 2128 with GLE/PIB were selected. Mean age of SOF/VEL patients was 58.5 years, higher than GLE/PIB ones (52.5 years) (p < 0.001), and patients >50 years were more present in SOF/VEL vs GLE/PIB cohorts: 72% vs 58%, (p < 0.001). Most prescribed co-medications were cardiovascular, alimentary and nervous system drugs. Proportion of patients with ≥2 comedications was higher in SOF/VEL compared to GLE/PIB cohort (56.5% vs 32.3%, p < 0.001). Those at high-risk of multiple DDIs accounted for 11.6% (N = 135) of SOF/VEL and 19.6% (N = 135) of GLE/PIB (p < 0.001) patients with ≥2 comedications. Among them, the potential effect of DDI was a decrease of DAA serum levels (11% of SOF/VEL and GLE/PIB patients) and an increased concentration of comedication serum levels (14% of SOF/VEL and 42% of GLE/PIB patients).

Conclusion: This real-world analysis provided a thorough characterization on the burden of polymedication regimens in HCV patients treated with SOF/VEL or GLE/PIB that expose such patients to an increased risk of DDIs. In our sample population, SOF/VEL regimen was more frequently detected on elderly patients and on those with ≥2 comedications at risk of multi-DDI, ie, among patients characterized by higher rates of comorbidities and polypharmacy.

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ACS Applied Bio Materials
ACS Applied Bio Materials Chemistry-Chemistry (all)
CiteScore
9.40
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2.10%
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464
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