Fagiuoli Stefano, Toniutto Pierluigi, Coppola Nicola, Ancona Domenica Daniela, Andretta Margherita, Bartolini Fausto, Ferrante Fulvio, Lupi Alessandro, Palcic Stefano, Rizzi Francesca Vittoria, Re Davide, Alvarez Nieto Gema, Hernandez Candido, Frigerio Francesca, Perrone Valentina, Degli Esposti Luca, Mangia Alessandra
Department of Medicine and Surgery, University of Milan Bicocca & Gastroenterology Hepatology and Transplantation Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.
Hepatology and Liver Transplantation Unit, Azienda Ospedaliero Universitaria, Udine, Italy.
Ther Clin Risk Manag. 2023 Jan 18;19:57-65. doi: 10.2147/TCRM.S394467. eCollection 2023.
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).
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.
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).
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.
本研究旨在调查联合用药及衰老对接受索磷布韦/维帕他韦（SOF/VEL）或格卡瑞韦/哌仑他韦（GLE/PIB）治疗的丙型肝炎病毒（HCV）患者中多种药物相互作用（DDIs）发生率的影响。
这是一项基于约690万个体管理数据的回顾性分析。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。索引日期对应于该期间SOF/VEL或GLE/PIB的首次处方；对患者进行治疗期随访。然后分析聚焦于有≥2种合并用药且存在多种DDIs风险的患者。使用利物浦大学工具确定多种DDIs的严重程度和影响。
共选择了2057例接受SOF/VEL治疗的患者和2128例接受GLE/PIB治疗的患者。接受SOF/VEL治疗患者的平均年龄为58.5岁，高于接受GLE/PIB治疗的患者（52.5岁）（p<0.001），且SOF/VEL队列中年龄>50岁的患者比GLE/PIB队列更多：72%对58%，（p<0.001）。最常开具的合并用药为心血管、消化道和神经系统药物。与GLE/PIB队列相比，SOF/VEL队列中合并用药≥2种的患者比例更高（56.5%对32.3%，p<0.001）。在合并用药≥2种的患者中，存在多种DDIs高风险的患者在接受SOF/VEL治疗的患者中占11.6%（N = 135），在接受GLE/PIB治疗的患者中占19.6%（N = 135）（p<0.001）。其中，DDIs的潜在影响是直接抗病毒药物（DAA）血清水平降低（SOF/VEL和GLE/PIB患者各占11%）以及合并用药血清水平升高（SOF/VEL患者占14%，GLE/PIB患者占42%）。
这项真实世界分析全面描述了接受SOF/VEL或GLE/PIB治疗的HCV患者联合用药方案的负担，使这些患者面临更高的DDIs风险。在我们的样本人群中，SOF/VEL方案在老年患者以及有≥2种合并用药且存在多种DDIs风险的患者中更常被检测到，即在合并症和联合用药率较高的患者中。
