Author Response: Reducing Infection Transmission in Solid Organ Transplantation Through Donor Nucleic Acid Testing: A Cost-Effectiveness Analysis
Year: 2014
Type: peer-review
Abstract: To the Editor: We appreciate Dr. Kiberd’s interest in our manuscript (1Kiberd B Cost-effectiveness of routine nucleic acid testing in organ donors.Am J Transplant. 2014; 14: 979-980Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar,2Lai JC Kahn JG Tavakol M Peters MG Roberts JP Reducing infection transmission in solid organ transplantation through donor nucleic acid testing: A cost-effectiveness analysis.Am J Transplant. 2013; 13: 2611-2618Abstract Full Text Full Text PDF PubMed Scopus (13) Google Scholar), in particular in hepatitis C virus (HCV) screening. To clarify our model, we started with the HCV prevalence observed in donor populations. We assumed a 10-year (520-week) mean duration between infection and removal from the donor pool due to HCV death or diagnosis leading to positive historical screen. The HCV antibody test becomes positive at 10 weeks of infection. Thus, 98.1% (510/520 weeks) of HCV-infected donors are identified by antibody testing, and 1.9% are not. So, assuming an HCV prevalence of 1.5%, this means that there will be one potentially nucleic acid-amplification testing (NAT)-identifiable infection per approximately 3500 donors (1/[0.015 × 0.019]). This rate scales with donor HCV prevalence, and we have provided estimates of the incremental cost-effectiveness ratios (ICER) associated with higher prevalence rates (3.5%, 5.6%, 12.9% and 18.2%). Citing the study by Zou et al (3Zou S Dodd RY Stramer SL Strong DM Tissue Safety Study GroupProbability of viremia with HBV, HCV, HIV, and HTLV among tissue donors in the United States.N Engl J Med. 2004; 351: 751-759Crossref PubMed Scopus (163) Google Scholar), Dr. Kiberd’s (1Kiberd B Cost-effectiveness of routine nucleic acid testing in organ donors.Am J Transplant. 2014; 14: 979-980Abstract Full Text Full Text PDF PubMed Scopus (1) Google Scholar) argument is that we have grossly overestimated the rate of HCV infection in a potential organ donor within the 10-week window period for HCV serology testing. In this study, Zou et al (3Zou S Dodd RY Stramer SL Strong DM Tissue Safety Study GroupProbability of viremia with HBV, HCV, HIV, and HTLV among tissue donors in the United States.N Engl J Med. 2004; 351: 751-759Crossref PubMed Scopus (163) Google Scholar) reported that the incident rate of HCV infection among tissue donors was 12.380 per 100,000 person-years (0.012% per year). This is equivalent to about one-tenth of the lowest HCV incidence implicit in our model. While there is undoubtedly overlap between tissue and solid organ donors, they are not identical populations, and there is reason to believe that there would be a higher proportion of individuals within the solid organ donor pool who engage in riskier behaviors that increase their likelihood of incident HCV infection within the 10-week HCV antibody window period. The estimates provided by Ellingson et al (4Ellingson K Seem D Nowicki M Strong DM Kuehnert MJ for the Organ Procurement Organization Nucleic Acid Testing Yield Project TeamEstimated risk of human immunodeficiency virus and hepatitis C virus infection among potential organ donors from 17 organ procurement organizations in the United States.Am J Transplant. 2011; 11: 1201-1208Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar), who reported the incidence of undetected infection during the serologic screening window period among solid organ donors, supports this statement: the incident rate of HCV infection was 0.17% per year among all donors (ranging from 0.10% for donors classified as “normal risk” and 0.55% for donors classified as “high risk”). This is similar to the lowest HCV incidence in our model. These estimates are considerably higher than those estimated among tissue donors (3Zou S Dodd RY Stramer SL Strong DM Tissue Safety Study GroupProbability of viremia with HBV, HCV, HIV, and HTLV among tissue donors in the United States.N Engl J Med. 2004; 351: 751-759Crossref PubMed Scopus (163) Google Scholar). Given that the population studied in the Ellingson et al (4Ellingson K Seem D Nowicki M Strong DM Kuehnert MJ for the Organ Procurement Organization Nucleic Acid Testing Yield Project TeamEstimated risk of human immunodeficiency virus and hepatitis C virus infection among potential organ donors from 17 organ procurement organizations in the United States.Am J Transplant. 2011; 11: 1201-1208Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar) article mimicked our population of interest, we used their data to inform our own model. However, we agree with Dr. Kiberd that, if the true incidence rate of HCV infection is much lower than the estimates reported by Ellingson et al (4Ellingson K Seem D Nowicki M Strong DM Kuehnert MJ for the Organ Procurement Organization Nucleic Acid Testing Yield Project TeamEstimated risk of human immunodeficiency virus and hepatitis C virus infection among potential organ donors from 17 organ procurement organizations in the United States.Am J Transplant. 2011; 11: 1201-1208Abstract Full Text Full Text PDF PubMed Scopus (75) Google Scholar), universal HCV NAT screening will become much less favorable. For example, if the incidence rate of HCV infection is 0.012% per year (as reported in tissue donors (3Zou S Dodd RY Stramer SL Strong DM Tissue Safety Study GroupProbability of viremia with HBV, HCV, HIV, and HTLV among tissue donors in the United States.N Engl J Med. 2004; 351: 751-759Crossref PubMed Scopus (163) Google Scholar)), then universal HCV NAT testing will yield ICERs >$2 million, a much less favorable strategy. The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.
DOI: 10.1111/ajt.12644
Authors: J.C. Lai, J.G. Kahn, J.P. Roberts
Language: English
Topic: Hepatitis C virus research
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,300
OpenAlex ID: W1527229628