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泛基因型直接抗病毒药物与西班牙慢性丙型肝炎病毒感染患者所使用的伴随药物之间潜在药物相互作用的患病率。

Prevalence of the potential drug-drug interactions between pangenotypic direct-acting antivirals and the concomitant medications associated with patients with chronic hepatitis C virus infection in Spain.

作者信息

Sicras Mainar Antoni, Navarro Artieda Ruth, Hernández Ignacio, Morillo Ramón

机构信息

Health Economics & Outcomes Research, Real Life Data, Madrid, España.

Documentación Médica. Hospital Germans Trias i Pujol, Badalona, Barcelona, España.

出版信息

Gastroenterol Hepatol. 2019 Oct;42(8):465-475. doi: 10.1016/j.gastrohep.2019.03.014. Epub 2019 Aug 23.

Abstract

OBJECTIVE

To determine the comorbidity and potential for drug-drug interactions (DDIs) among pangenotypic direct-acting-antivirals (pDAAs) and the concomitant medications associated with chronic hepatitis C (CHC) patients in routine clinical practice in Spain.

METHODS

Retrospective observational study. Included patients were ≥18 years, diagnosed with CHC, on antiviral treatment and required medical attention during 2017. Two groups were differentiated according to age ranges (<50 and ≥50 years). The variables collected were: age, gender, general/specific comorbidity, concomitant medication and potential DDIs (www.hep-druginteractions.org). The pDAAs analysed were: a) Sofosbuvir/Velpatasvir (SOF/VEL), b) Glecaprevir/Pibrentasvir (GLE/PIB) and c) Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX). Bivariate statistical analysis, P<.05.

RESULTS

3,430 patients with a mean age of 56.9 years and 60.3% males were enrolled. The average Charlson index was 0.8. Age range distribution: 18-49 years (28.9%) and ≥50 years (71.1%). The average number of medications per patient/year was 3.1 (SD 2.6). The total percentage of potential DDIs was: 8.6% minor DDIs, 40.5% clinically significant DDIs and 10.0% contraindicated medication. These DDIs were greater in patients ≥50 years (8.6%, 43.8% and 12.4%, respectively, P<.001). For all ages, SOF/VEL showed a lower percentage of: minor interactions (1.3% vs. 6.6% and 5.9%, P<.001); clinically significant interactions (53.4%, vs. 77.4% and 66.3%, P<.001) and contraindicated medication (1.7% vs. 8.3% and 10.7%, P<.001) compared to GLE/PIB and SOF/VEL/VOX, respectively.

CONCLUSIONS

Patients with CHC present high comorbidity and concomitant medication use, particularly elderly patients, thus implying a greater exposure to potential DDIs. Although the DDI rate was considerable with the three combinations analysed, SOF/VEL showed a lower number of clinically significant interactions.

摘要

目的

确定泛基因型直接抗病毒药物(pDAA)之间的合并症及药物相互作用(DDI)可能性,以及西班牙常规临床实践中慢性丙型肝炎(CHC)患者的伴随用药情况。

方法

回顾性观察研究。纳入患者年龄≥18岁,诊断为CHC,正在接受抗病毒治疗且在2017年需要医疗护理。根据年龄范围(<50岁和≥50岁)分为两组。收集的变量包括:年龄、性别、一般/特定合并症、伴随用药及潜在DDI(www.hep-druginteractions.org)。分析的pDAA包括:a)索磷布韦/维帕他韦(SOF/VEL),b)格卡瑞韦/哌仑他韦(GLE/PIB),c)索磷布韦/维帕他韦/伏西瑞韦(SOF/VEL/VOX)。双变量统计分析,P<0.05。

结果

共纳入3430例患者,平均年龄56.9岁,男性占60.3%。平均查尔森指数为0.8。年龄范围分布:18 - 49岁(28.9%),≥50岁(71.1%)。每位患者每年用药平均数量为3.1种(标准差2.6)。潜在DDI的总百分比为:轻微DDI占8.6%,具有临床意义的DDI占40.5%,禁忌用药占10.0%。这些DDI在≥50岁患者中更高(分别为8.6%、43.8%和12.4%,P<0.001)。对于所有年龄段,与GLE/PIB和SOF/VEL/VOX相比,SOF/VEL出现以下情况的百分比更低:轻微相互作用(1.3%对6.6%和5.9%,P<0.001);具有临床意义的相互作用(53.4%对77.4%和66.3%,P<0.001);禁忌用药(1.7%对8.3%和10.7%,P<0.001)。

结论

CHC患者合并症及伴随用药情况较多,尤其是老年患者,因此面临潜在DDI的风险更高。尽管所分析的三种联合用药的DDI发生率都相当可观,但SOF/VEL具有临床意义的相互作用数量较少。

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