直接观察治疗丙型肝炎病毒与 glecaprevir/pibrentasvir 联合使用阿片类药物替代疗法在注射毒品者中的应用 - 来自奥地利的首个真实世界数据。
Directly observed therapy for HCV with glecaprevir/pibrentasvir alongside opioid substitution in people who inject drugs-First real world data from Austria.
机构信息
Department of Internal Medicine IV, Wilhelminenspital, Vienna, Austria.
Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
出版信息
PLoS One. 2020 Mar 10;15(3):e0229239. doi: 10.1371/journal.pone.0229239. eCollection 2020.
BACKGROUND
Directly acting antivirals (DAA) against hepatitis C virus (HCV) infection have facilitated sustained virologic response (SVR) rates >90% in clinical studies. Yet, real life data regarding DAA treatment in people who inject drugs (PWIDs) are scarce. We evaluated the effectiveness of glecaprevir/pibrentasvir (G/P) in difficult-to-treat PWIDs with presumed high risk of non-adherence to DAA therapy using the concept of directly observed therapy involving their opioid substitution therapy (OST) facility.
METHODS
N = 145 patients (m/f: 91/54; median age: 41.1 (IQR 19.5) years; HCV-genotype (GT) 1/2/3/4: 82/1/56/5, GT3: 38.6%; cirrhosis: n = 6; 4.1%) treated with G/P were included. PWIDs at high risk for non-adherence to DAA therapy received HCV treatment together with their OST under the supervision of medical staff ("directly observed therapy", DOT). The effectiveness of G/P given as DOT in PWIDs with presumed high risk of non-adherence to DAA therapy was compared to patients with suspected "excellent compliance" in the "standard setting" (SS) of G/P prescription at a tertiary care center and self-managed G/P intake at home. Treatment duration was 8-16 weeks according to the G/P drug label.
RESULTS
DOT-patients (n = 74/145; 51.0%) were younger than SS-patients (median 38.7, IQR 12.5 vs. median 50.6, IQR 20.3 years), all had psychiatric co-morbidities and most had a poor socioeconomic status. 50/74 (67.6%) reported ongoing intravenous drug use (IDU). SVR was achieved in n = 70/74 (94.6%) patients with n = 3 being lost to follow-up (FU) and n = 1 showing nonresponse to therapy. SS-patients achieved SVR in 97.2% (69/71) with n = 1 patient being lost to FU and n = 1 patient with GT3 showing HCV relapse.
CONCLUSION
G/P given as DOT along with OST in PWIDs with high risk of non-adherence to DAA therapy resulted in similarly high SVR rates (94.6%) as in patients with presumed "excellent compliance" under standard drug intake.
背景
直接作用抗病毒药物（DAA）治疗丙型肝炎病毒（HCV）感染，在临床试验中实现了超过 90%的持续病毒学应答（SVR）率。然而，关于在吸毒者（PWIDs）中使用 DAA 治疗的真实数据却很少。我们使用涉及阿片类药物替代疗法（OST）设施的直接观察治疗的概念，评估了难治疗的 PWIDs 使用 glecaprevir/pibrentasvir（G/P）治疗的效果，这些 PWIDs 可能存在不遵守 DAA 治疗的高风险。
方法
纳入了 145 名接受 G/P 治疗的患者（男/女：91/54；中位年龄：41.1（IQR 19.5）岁；HCV 基因型（GT）1/2/3/4：82/1/56/5，GT3：38.6%；肝硬化：n=6；4.1%）。高风险不遵守 DAA 治疗的 PWIDs 在医疗人员的监督下（直接观察治疗，DOT）同时接受 HCV 治疗和 OST。将 G/P 作为 DOT 在高风险不遵守 DAA 治疗的 PWIDs 中的有效性，与在三级护理中心的 G/P 处方标准设置（SS）中疑似“良好依从性”的患者（n=71）和在家中自我管理 G/P 摄入的患者（n=54）进行比较。根据 G/P 药物标签，治疗持续时间为 8-16 周。
结果
DOT 患者（n=74/145；51.0%）比 SS 患者（中位数 38.7，IQR 12.5 与中位数 50.6，IQR 20.3 岁）年轻，均患有精神共病，大多数社会经济地位较差。50/74（67.6%）报告正在进行静脉内药物使用（IDU）。74 名患者中的 70 名（94.6%）达到 SVR，3 名患者失访（FU），1 名患者对治疗无反应。71 名 SS 患者中有 69 名（97.2%）达到 SVR，1 名患者失访，1 名 GT3 患者 HCV 复发。
结论
在高风险不遵守 DAA 治疗的 PWIDs 中，与 OST 一起使用 G/P 进行 DOT 治疗，其 SVR 率（94.6%）与标准药物摄入下疑似“良好依从性”的患者相似。
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