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抗 HCV 阴性肝移植受者接受 HCV 病毒血症供者器官时直接作用抗病毒药物的应用。

Access to direct-acting antivirals for hepatitis C-negative transplant recipients receiving organs from hepatitis C-viremic donors.

机构信息

Department of Pharmacy, University of Maryland Medical Center, Baltimore, MD, USA.

Division of Transplantation, The Johns Hopkins Hospital, Baltimore, MD, USA.

出版信息

Am J Health Syst Pharm. 2022 Jan 24;79(3):173-178. doi: 10.1093/ajhp/zxab207.

DOI:10.1093/ajhp/zxab207
PMID:33987658
Abstract

PURPOSE

A barrier to using organs from hepatitis C virus (HCV)-viremic donors is the high cost of direct-acting antivirals (DAAs) and concerns about access for recipients after transplantation. The purpose of this study was to evaluate access, cost, and timing for HCV DAAs following transplantation.

METHODS

This was a single-center, retrospective study of HCV-negative adult transplant recipients from June 2017 to December 2019 who received grafts from HCV-viremic and/or HCV-seropositive individuals and became HCV viremic after transplantation.

RESULTS

Between June 2017 and December 2019, there were 60 HCV-negative transplant recipients who became viremic after receiving grafts from HCV-viremic or HCV-seropositive donors. Thirty-eight patients met the inclusion criteria (n = 25 with liver transplants, n = 6 with lung transplants, n = 4 with simultaneous liver and kidney transplants, and n = 3 with kidney transplants). Of these patients, 23 had commercial insurance, 13 had Medicare, and 2 had Medicaid. All patients ultimately received insurance coverage for treatment; however, 36 (95%) required prior authorization and 9 (24%) required appeals to obtain insurance coverage. The median time from DAA prescription to insurance approval was 6 days. The median time from transplantation to start of treatment was 29 days (range, 0-84 days). Patients with Medicaid insurance had a significantly longer time to insurance approval (31.5 vs 6 days, P = 0.007). The average out-of-pocket cost to patients was less than $10 a month after patient assistance. All patients who completed treatment and 12-week follow-up after treatment achieved a sustained virologic response (n = 36).

CONCLUSION

In this study, all HCV-negative recipients who developed HCV following transplantation had access to DAA therapy, with the majority starting treatment in the first month after transplantation.

摘要

目的

使用丙型肝炎病毒(HCV)病毒血症供体器官的障碍是直接作用抗病毒药物(DAA)的高成本,以及对移植后受者获得药物的担忧。本研究的目的是评估移植后 HCV DAA 的可及性、成本和时间。

方法

这是一项单中心、回顾性研究,纳入 2017 年 6 月至 2019 年 12 月期间接受 HCV 病毒血症和/或 HCV 血清阳性个体供体器官移植后发生 HCV 病毒血症的 HCV 阴性成年移植受者。

结果

2017 年 6 月至 2019 年 12 月期间,共有 60 例 HCV 阴性移植受者在接受 HCV 病毒血症或 HCV 血清阳性供者的移植物后发生病毒血症。38 例患者符合纳入标准(n = 25 例肝移植,n = 6 例肺移植,n = 4 例肝肾联合移植,n = 3 例肾移植)。这些患者中,23 例有商业保险,13 例有医疗保险,2 例有医疗补助。所有患者最终都获得了治疗的保险覆盖;然而,36 例(95%)需要事先授权,9 例(24%)需要上诉才能获得保险覆盖。从 DAA 处方到保险批准的中位时间为 6 天。从移植到开始治疗的中位时间为 29 天(范围,0-84 天)。有医疗补助保险的患者获得保险批准的时间明显更长(31.5 天 vs 6 天,P = 0.007)。患者援助后,患者每月自付费用低于 10 美元。所有完成治疗并在治疗后 12 周随访的患者均获得持续病毒学应答(n = 36)。

结论

在这项研究中,所有移植后发生 HCV 的 HCV 阴性受者均获得 DAA 治疗,大多数患者在移植后第一个月内开始治疗。

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