Department of Pharmacy, University of Maryland Medical Center, Baltimore, MD, USA.
Division of Transplantation, The Johns Hopkins Hospital, Baltimore, MD, USA.
Am J Health Syst Pharm. 2022 Jan 24;79(3):173-178. doi: 10.1093/ajhp/zxab207.
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.
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.
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).
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.
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。
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。
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)。
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。