Clinical and Financial Implications of 2 Treatment Strategies for Donor-derived Hepatitis C Infections

Abstract

Infectious DiseaseBackground. Transplanting hepatitis C viremic donor organs into hepatitis C virus (HCV)-negative recipients is becoming increasingly common; however, practices for posttransplant direct-acting antiviral (DAA) treatment vary widely. Protracted insurance authorization processes for DAA therapy often lead to treatment delays. Methods. At our institution, 2 strategies for providing DAA therapy to HCVrecipients of HCV + transplants have been used. For thoracic organ recipients, an institution-subsidized course of initial therapy was provided to ensure an early treatment initiation date. For abdominal organ recipients, insurance approval for DAA coverage was sought once viremia developed, and treatment was initiated only once the insurance-authorized supply of drug was received. To evaluate the clinical impact of these 2 strategies, we retrospectively collected data pertaining to the timing of DAA initiation, duration of recipient viremia, and monetary costs incurred by patients and the institution for patients managed under these 2 DAA coverage strategies. Results. One hundred fifty-two transplants were performed using HCV viremic donor organs. Eighty-nine patients received DAA treatment without subsidy, and 62 received DAA treatment with subsidy. One patient who never developed viremia posttransplant received no treatment. Subsidizing the initial course enabled earlier treatment initiation (median, 4 d [interquartile range (IQR), 2-7] vs 10 [IQR, 8-13]; P < 0.001) and shorter duration of viremia (median, 16 d [IQR,(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29) vs 36 [IQR,[30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47]; P < 0.001). Institutional costs averaged $9173 per subsidized patient and $168 per nonsubsidized patient. Three needlestick exposures occurred in caregivers of viremic patients. Conclusions. Recipients and their caregivers stand to benefit from earlier DAA treatment initiation; however, institutional costs to subsidize DAA therapy before insurance authorization are substantial. Insurance authorization processes for DAAs should be revised to accommodate this unique patient group.

Caregiver exposure to hepatitis C virus following transplantation with hepatitis C viremic donor organs: A case series

“…Given the rapid reduction in recipient viral loads following initiation of DAA therapy, this case series underscores the importance of instituting DAA therapy as early as possible following HCV D+/R– transplantation 1,28–30 . When DAAs have been used prophylactically (initiated immediately prior to transplantation), recipients had much lower peak viral loads; in some cases, viremia was never detectable 1,17,28 . It is possible that the risk of at‐home transmission to a caregiver could be eliminated if recipient HCV viremia was cleared prior to hospital discharge.…”

“…Recently, attention has been called to factors that may delay initiation of DAA therapy, as this results in prolonged recipient viremia. 12,17,20,[22][23][24] It is likely that the longer the duration of recipient viremia, the greater the risks of HCVassociated adverse events. In general, the risk-to-benefit balance is deemed acceptable for HCV D+/R-transplants because the recipients themselves give informed consent accepting the risks, and they directly derive the benefits of increased survival or improved quality of life.…”

“…1,[28][29][30] When DAAs have been used prophylactically (initiated immediately prior to transplantation), recipients had much lower peak viral loads; in some cases, viremia was never detectable. 1,17,28 It is possible that the risk of athome transmission to a caregiver could be eliminated if recipient HCV viremia was cleared prior to hospital discharge.…”

“…Details of the counseling/consenting practices for recipients have been described previously. 17 In accordance with our institutional protocols, recipient surveillance for acute HCV viremia commences within the first week after transplant and is continued weekly until sustained virologic response at 12 weeks (SVR12) is achieved. The authorization process for DAA treatment is initiated as soon as HCV viremia is confirmed and choice of DAA agent used depends upon which is authorized by the patient insurer.…”

“…Herein, we report three cases of potential HCV exposures via needlesticks to caregivers of HCV D+/R– transplant recipients. In our center's experience to date with HCV D+/R– solid organ transplants, 17 three recipient family members reported needlestick injuries while assisting a HCV D+/R– recipient with either glycemic testing or insulin administration. In response to these events, our institution adopted a postexposure surveillance policy for caregivers of HCV D+/R‐ transplant recipients.…”