Abstract and Introduction
Abstract
For solid organ transplant (SOT) donors, nucleic acid-amplification testing (NAT) may reduce human immunodeficiency virus (HIV) and hepatitis C virus (HCV) transmission over antibody (Ab) testing given its shorter detection window period. We compared SOT donor NAT + Ab versus Ab alone using decision models to estimate incremental cost-effectiveness ratios (ICERs; cost per quality-adjusted life year [QALY] gained) from the societal perspective across a range of HIV/HCV prevalence values and NAT costs. The cost per QALY gained was calculated for two scenarios: (1) favorable: low cost ($150/donor)/high prevalence (HIV: 1.5%; HCV: 18.2%) and (2) unfavorable: high cost ($500/donor)/low prevalence (HIV: 0.1%; HCV: 1.5%). In the favorable scenario, adding NAT screening cost $161 013 per QALY gained for HIV was less costly) for HCV, and cost $86 653 per QALY gained for HIV/HCV combined. For the unfavorable scenario, the costs were $15 568 484, $221 006 and $10 077 599 per QALY gained, respectively. Universal HCV NAT + Ab for donors appears cost-effective to reduce infection transmission from SOT donors, while HIV NAT + Ab is not, except where HIV NAT is ≤$150/donor and prevalence is ≥1.5%. Our analyses provide important data to facilitate the decision to implement HIV and HCV NAT for deceased SOT donors and shape national policy regarding how to reduce infection transmission in SOT.
Introduction
Donor-derived infection transmission in solid organ transplantation (SOT) remains a critical patient safety and public health concern. Between 2005 and 2007, the Organ Procurement Transplantation Network (OPTN) Patient Safety System received nine reports of donor-derived hepatitis C virus (HCV) infections from five donors and seven reports of donor-derived human immunodeficiency virus (HIV) infections from three donors. Eight of these donor-derived infections resulted in confirmed infections in the SOT recipients; two resulted in death.
Guidelines for infection screening of organ donors—established in 1994—recommend serologic testing for HIV and HCV. But an alternative method of HIV and HCV screening exists—nucleic-acid amplification testing (NAT)—which significantly shortens the window period during which infection cannot be detected through serologies alone. Given this advantage, NAT has already been incorporated routinely into screening of blood donors. Recently, the Centers for Disease Control and Prevention (CDC) issued guidelines proposing the incorporation of HIV and HCV NAT into screening algorithms for deceased SOT donors; specifically, the guidelines recommended HCV NAT for all deceased donors and HIV NAT for those at increased risk for HIV infection transmission. However, HIV and HCV NAT take longer to run and are more expensive than serologic testing, particularly when performed on the urgent, single-sample basis necessary for expeditious organ placement. Furthermore, the prevalence of HIV and HCV in the United States varies widely by organ procurement organization (OPO), potentially reducing the benefit of SOT donor NAT in low-prevalence areas.
Therefore, to facilitate the decision to implement SOT donor NAT by individual OPOs, we aimed in this study to determine specific thresholds of HIV and HCV prevalence and NAT costs using cost-effectiveness analysis.