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在真实世界环境中,丙型肝炎病毒阳性供者至丙型肝炎病毒阴性受者实体器官移植中丙型肝炎直接作用抗病毒治疗的应用。

Access to hepatitis C direct-acting antiviral therapy in hepatitis C-positive donor to hepatitis C-negative recipient solid-organ transplantation in a real-world setting.

机构信息

Vanderbilt Specialty Pharmacy, Vanderbilt University Medical Center, Nashville, TN, USA.

Department of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.

出版信息

Am J Surg. 2022 May;223(5):975-982. doi: 10.1016/j.amjsurg.2021.09.005. Epub 2021 Sep 14.

Abstract

BACKGROUND

Emerging data supports expanding the solid organ donor pool with transplantation from hepatitis C virus (HCV)-positive donors into HCV-negative recipients. However, concerns exist regarding the ability to access direct-acting antivirals (DAAs) post-transplant in a real-world setting.

METHODS

This single-center, retrospective study evaluated DAA access rates, time to first dose, and patient cost in donor-derived HCV solid-organ transplant recipients utilizing an integrated specialty pharmacy process.

RESULTS

Among 91 patients, all accessed DAAs through prescription insurance (97%) or patient assistance programs (3%). Of those who received DAAs through insurance, only 65% received approval on initial insurance submission. Median time from transplant to first dose was 45d [IQR 34-66]. The on-site specialty pharmacy was used by 69% of patients. Copay assistance programs reduced the median monthly patient cost from $1914 [range $7-7536] to $0 [range $0-5].

CONCLUSION

Our findings indicate that access to DAAs in donor-derived HCV post-transplant is achievable and affordable; however, significant added administrative efforts may be required for insurance approval as well as obtaining copay assistance, which is a limited resource.

摘要

背景

新出现的数据支持将丙型肝炎病毒(HCV)阳性供体移植到 HCV 阴性受者中,以扩大实体器官捐献者群体。然而,在实际环境中,人们对移植后获得直接作用抗病毒药物(DAA)的能力存在担忧。

方法

本单中心回顾性研究通过综合专科药房流程,评估了供体来源 HCV 实体器官移植受者获得 DAA 的比率、首次用药时间和患者费用。

结果

在 91 例患者中,所有患者均通过处方保险(97%)或患者援助计划(3%)获得 DAA。在通过保险获得 DAA 的患者中,只有 65%在初次保险提交时获得批准。从移植到首次用药的中位时间为 45d [IQR 34-66]。现场专科药房被 69%的患者使用。共付援助计划将中位每月患者费用从 1914 美元(范围 7-7536 美元)降低至 0 美元(范围 0-5 美元)。

结论

我们的研究结果表明,在 HCV 供体移植后获得 DAA 是可行且负担得起的;然而,获得保险批准以及获得共付援助可能需要大量额外的行政工作,而共付援助是一种有限的资源。

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