HCV NAT Research Articles

Determinants of Long Waiting Time to Kidney Transplantation

BackgroundDisparity in waiting time to kidney transplantation led to new policy (KAS250). Our aims were to identify variables associated with long wait time (LWT); assess the impact of KAS250 on WT; and analyze modifiable transplant center behaviors correlated with WT. MethodsSRTR data for adult deceased donor kidney transplants were analyzed. Time-periods from 8/1/2018-7/31/2019 and 5/1/2021-4/30/2022 were chosen for pre- and post-KAS250 analyses. Transplant centers were categorized as LWT or SWT centers depending on whether pre-KAS250 median center waiting times were greater or less than the national pre-KAS250 median waiting time of 57.8 months. ResultsIn multivariate analysis, transplantation with HCV NAT negative kidneys was associated with an additional 21.3 months of WT (CI: 18.5-24.2, P < .0001), and transplantation with KDPI <85% kidneys was associated with an additional 10.8 months (CI: 8.2-13.3, P < .0001). Post-KAS250 national kidney transplant waiting time decreased from 61-58 months (P < .0001) and waiting time at LWT centers decreased from 74-69 months (P < .0001). Cold ischemic times (CIT) increased (20.2 hours vs 18.3 hours, P < .0001) and DGF rates also increased (32.7% vs 31.0%, P < .0001). Centers generally displayed more aggressive transplantation practices post-KAS250 however significant differences in DCD utilization, organ offer acceptance ratios and tolerance for long CIT persist between SWT and LWT centers. ConclusionKAS250 has reduced waiting time disparities between SWT and LWT centers at the cost of increased CIT and DGF and reduced allocation efficiency. Significant differences in transplant practice persist between SWT and LWT centers.

P8.1: Kidney acceptance from HCV NAT positive donors - Improving Organ utilization in NSW, Australia.

P8.1: Kidney acceptance from HCV NAT positive donors - Improving Organ utilization in NSW, Australia.

Evaluation of Hepatitis C Virus Nucleic Acid Testing and HIV Nucleic Acid Testing for Blood Donors

ABSTRACT Objective: This study aimed to evaluate the HCV NAT test and HIV NAT test in the recognition of the presence of RNA of HCV and HIV in blood samples from blood donors. Materials and Methods: We collected 2124 specimens of blood from male volunteer blood donors with their age group of 18–60 years who were visiting the blood bank of King Khalid Hospital, Al-Majmaah, Saudi Arabia, from January 2021 to May 2022. The samples from each donor were screened for anti-HCV and HIV Ab-Ag by commercial immunoassays and for qualitative assessments of RNA of HIV-1, HIV-2, and HCV in plasma specimens from each donor of blood by NAT testing. Results: Of the 2124 blood donors studied, 10 (0.47%) were positive for anti-HCV. HCV-NAT testing was non-reactive in all Anti-HCV -positive subjects 100% (10/10), and 1/2114 (0,05%) for Anti-HCV- negative donors was reactive and 2113 (99.95%) were non-reactive. HIV-NAT testing was nonreactive in 100% (2124/2124) of HIV Ab-Ag-negative subjects. Conclusions: The effectiveness of introducing the NAT test was attempted to be evaluated as the implementation of NAT technology has to be thoroughly evaluated for the actual yield in blood safety achieved must be assessed.

OS-125 - Outcomes of early vs late treatment initiation in solid organ transplantation from HCV NAT+ donors to HCV-uninfected recipients: results from the HCV-TARGET study

OS-125 - Outcomes of early vs late treatment initiation in solid organ transplantation from HCV NAT+ donors to HCV-uninfected recipients: results from the HCV-TARGET study

(59) Mid-Term Outcomes of Heart Transplants from HCV NAT+ Donors

(59) Mid-Term Outcomes of Heart Transplants from HCV NAT+ Donors

(95) Lung Transplantation from HCV NAT+ Donors: Reassuring Mid-Term Outcomes

(95) Lung Transplantation from HCV NAT+ Donors: Reassuring Mid-Term Outcomes

Kidney Transplantation in an Elderly Veteran Population With Hepatitis C Virus Nucleic Acid Test–Positive Donors Results in Improved Outcomes After Prophylactic Glecaprevir/Pibrentasvir Therapy

BackgroundThe average age of waitlisted veterans is 64. Recent data has shown the safety and benefits of using kidneys from hepatitis C virus nucleic acid test (HCV NAT)-positive donors. However, these studies were limited to younger patients with initiation of therapy after transplant. The aim of this study was to determine the safety and efficacy of a preemptive treatment protocol in an elderly veteran population. MethodsThis was a prospective, open-label trial with 21 deceased donor kidney transplantations (DDKTs) with HCV NAT-positive kidneys and 32 DDKTs with HCV NAT-negative transplanted between November 2020 and March 2022. The HCV NAT-positive recipients were treated with once-daily glecaprevir/pibrentasvir started preoperatively and continued for 8 weeks. Sustained virologic response (SVR)12 was determined by negative NAT Student's t test. Other endpoints included patient and graft survival as well as graft function. ResultsThere was no major difference between the cohorts other than the increased number of donation after circulatory death kidneys in the non-HCV recipients. Post-transplant graft and patient outcomes were equivalent between the groups. Eight of the 21 HCV NAT-positive recipients had detectable HCV viral loads 1 day after transplant, but all were undetectable by day 7 with 100% SVR12. Calculated estimated glomerular filtration rate was improved in the HCV NAT-positive cohort at week 8 (58.26 vs 47.16 mL/min; P < .05) and continued to be improved over non-HCV recipients 1 year after transplant (71.38 vs 42.15 mL/min; P < .05). Immunologic risk stratification was similar in both cohorts. ConclusionThe HCV NAT-positive transplants with a preemptive treatment protocol results in improved graft function with minimal to no complications in an elderly veteran population.

Kidney transplant from HCV viremic donors to HCV-negative recipients and risk for de novo donor specific antibodies and acute rejection.

Kidney transplantation from HCV-viremic donors into uninfected recipients is associated with excellent short-term outcomes. However, concerns regarding an increased risk for the development of de novo donor specific antibodies (DSA) and acute rejection have been raised in single center reports. A retrospective study of HCV-negative kidney-only transplant recipients between 2018 and 2020. Patients were grouped based on the donor HCV status into group 1; HCV-viremic donors, and group 2; HCV-negative donors. Inverse probability of treatment weighting (IPTW), with weights derived from the propensity score, were used to estimate the effect of donors' HCV-viremia on the recipients. The primary objective was to compare the 1-year incidence of de novo DSA. Secondary outcomes included group comparison of the incidence of biopsy proven acute rejection (BPAR), 1-year patient and allograft survival, and 1-year renal allograft function. A total of 71 patients were included in the HCV NAT+ group, and 440 in the HCV- negative group. One-year incidence of de novo DSA was higher in the HCV NAT+ group in the IPTW weighted analysis (19%vs. 9%, p=.02). In the unweighted analysis, BPAR occurred in 7% of recipients in the HCV NAT+ group, compared to 3% in the control group (p=.06). However, due to the low event rate in the in the IPTW weighted groups, a statistical significance test could not be performed. Average estimated GFR was higher in the HCV-viremic group at 3 months (61vs. 53ml/min/1.73m2 p=.002), but comparable at 6 (59vs. 56ml/min/1.73m2 , p=.31) and 12 months (60vs. 55ml/min/1.73m2 , p=.07). Patient and allograft survival were comparable between the two groups. Kidney transplant from HCV-viremic donors was associated with an increased risk for the development of post-transplant de novo DSA in the first year after transplantation, but no difference in patient and graft survival.

Treatment of Pulmonary Sarcoidosis Using Allogenic Bone Marrow-Derived Mesenchymal Stem Cell Therapy is Safe: A Case Report

Mesenchymal stem cells have a proven potent immunomodulatory effect both in vitro and in vivo. We report a case of a 67-year-old male patient, first diagnosed with sarcoidosis in 2005, that responded well clinically and biologically to ImmunoARTTM (developed by Educell Ltd.) allogenic, HLA-incompatible, and non-related bone marrow-derived MSCs in a dose of 106/kg. The patient presented to St. Catherine Specialty Hospital in 2021 with an exacerbation of respiratory symptoms. After a clinical and radiological examination with laboratory workup, radiological findings were consistent with pulmonary sarcoidosis, while laboratory work revealed increased leucocytes at 14.2 g/L, CRP at 51.2 mg/L, and lymphocytes at 4.25 g/L. The patient was then administered intravenous application of MSCs on three occasions in the out-patient clinic. MSC doses were prepared from a young, healthy donor who agreed to donate bone marrow for allogeneic treatment and who was negative for viral markers (HBs Ag, HBc Ab, HCV Ab, HIV 1-2 Ab, TPHA, HBV NAT, HCV NAT, HIV NAT) according to EU legislation. Cells were prepared in a controlled and verified laboratory for “Hospital exemption” cell preparation in the cleanroom facility in safety cabinet class A and expressed CD105, CD 73, and CD 90 but lacked the expression of CD45 and CD34. Before the treatment, standard print and detailed verbal information were provided to patients undergoing treatment. Immediately after the informed consent form (ICF) was signed by the patient. Throughout MSC therapy, the patient showed an improvement clinically and biologically with a decrease in inflammatory parameters. Laboratory values were assessed on days 2, 5, and 7. On day 7, leucocytes were 11.2 g/L, CRP 5.1 mg/L, and lymphocytes 4.0 g/L. In the follow-up period, the patient felt subjectively better, without any side effects of the MSC therapy. Unfortunately, the patient dropped out from follow-up, therefore, the prolonged effects of this therapy were not able to be assessed. Therefore, systemic MSC therapy presents an opportunity to treat sarcoidosis that needs to be further researched.

Impact of Donor Hepatitis C Viremia on Acute Rejection in Heart Transplant Recipients

<h3>Purpose</h3> With the advent of direct acting antivirals, hepatitis C viremic donors are being increasingly used for heart transplantation. Single institutions have reported increased incidence of acute rejection when utilizing these hearts. The goal of this study was to evaluate one-year acute rejection following heart transplant from HCV viremic donors. <h3>Methods</h3> We conducted retrospective review of UNOS of all primary adult heart transplants conducted between March 31, 2015 and June 30, 2020, excluding recipients with prior transplants, multiorgan transplants, or those waitlisted for other organs. Donors were dichotomized as being HCV NAT+ or HCV NAT-. One-year acute rejection requiring treatment was compared and evaluated by univariable and multivariable logistic regression. <h3>Results</h3> Of 11,058 heart transplant recipients in our cohort during the study period, 432 (3.9%) came from HCV NAT+ donors. HCV NAT+ donors were significantly older (34±8 vs 32±11 years, p<0.01), more likely to be white (82% vs 64%, p<0.01), blood group O (61% vs 49%, p<0.01), CDC high risk (88% vs 30%, p<0.01), and have drug use as cause of death (61% vs 17%, p<0.01). Recipients in the HCV NAT+ group were older [58(49-64) vs 56 (46-63) years, p<0.01), had higher ischemic times (3.5±1.0 vs 3.1±1.1 hours, p<0.01) and were more likely to be blood group O (49% vs 39%, p<0.01) and HCV antibody positive (5% vs 2%, p<0.01). They were less likely to be on inotropes (31% vs 37%, p<0.01) or any life support (81% vs 86%, p<0.01) at the time of transplant. Incidence of acute rejection requiring treatment within one year was not significantly different between the two groups (21% HCV NAT+ vs 19% HCV NAT-, p = 0.31). Donor HCV NAT+ was not associated with one-year acute rejection on either univariable (OR 1.13, 95% CI 0.89-1.43) or multivariable (aOR 1.08, 95% CI 0.84-1.41) logistic regression. <h3>Conclusion</h3> Despite single center studies reporting potential increases in acute rejection when utilizing HCV-viremic donor hearts for transplantation, our UNOS registry analysis did not demonstrate increased treatment for acute rejection after one year. We should continue to utilize these donor hearts with careful surveillance and monitoring of long-term outcomes.

Heart Transplant Outcomes by Donor HCV NAT Status: Intermediate Analysis

<h3>Purpose</h3> Donor hearts are a limited resource and inclusion of non-traditional donors such as those with hepatitis C (HCV) may help to increase transplantation rates. We sought to compare post-heart transplant outcomes of patients who received hearts from either HCV NAT positive or negative donors. <h3>Methods</h3> Recipients were identified from the UNOS Registry and stratified by donor HCV NAT status. Comparisons between cohorts were assessed using standard statistical methods, survival analysis was censored at 36 months using the Kaplan-Meier method, and multivariate Cox proportional hazard regression analysis (adjusted for age, sex, diabetes, race, ischemic time, dialysis, life support, waiting time and HLA mismatch. <h3>Results</h3> 18,828 recipients were identified of which 849 and 17,979 received HCV NAT positive (HCV+) and HCV NAT negative (HCV-) donors, respectively. HCV+ recipients were older (55.2 vs 53.5, p<0.001), male (77.4% vs 73.3%, p=0.008), and Caucasian (66.1% vs 62.1%, p=0.023). HCV+ recipients also had higher incidence of pre-transplant cardiac surgery (83.3% vs 77.9%, p<0.001), life support use (20.8% vs 16.5%, p<0.001), older donors (34.2 vs 32.1y, p<0.001), longer ischemic time (p<0.001), and with worse renal function (Cr 1.5 vs 1.4, p = 0.001). Notably, there was no difference in waitlist time. Recipients of HCV- donors were more likely to have diabetes (71.1% vs 66.4%, p = 0.004) and higher waitlist status (p<0.001). There was no difference in overall mortality between the two groups with cardiovascular (27.1% vs 26.4%) or non-cardiovascular (72.9% vs 73.6%, p=0.90) death. Unadjusted analysis demonstrated HR 0.98 (CI 0.78-1.22) and following adjustment HR 0.99 (0.78-1.24). <h3>Conclusion</h3> Utilization of HCV NAT positive donor hearts presents as a safe and effective way to expand the donor pool with no survival difference in this intermediate analysis. Further study is needed to understand the long-term outcomes of this population, particularly in the setting of widely available curative therapies.

Long Term Hematologic and Graft Outcomes After Cardiac Transplant in Al Amyloidosis

<h3>Purpose</h3> Advances in the systemic treatment of AL amyloidosis have allowed some patients with end-stage cardiac disease to undergo heart transplantation (HT). There is limited data on long-term hematologic and graft outcomes of patients with AL amyloidosis who underwent HT. <h3>Methods</h3> Outcomes of patients with cardiac AL amyloidosis who underwent HT at our center between 2008 and 2020 were analyzed. Descriptive data on treatments and International Myeloma Working Group hematologic response after HT were included. Incidence and interval between HT and development of coronary allograft vasculopathy (CAV, ISHLT classification), incidence of graft rejection and survival were reported. <h3>Results</h3> Eight patients with cardiac AL amyloidosis were included in the study. Three (38%) patients had concurrent multiple myeloma. Median recipient age was 53 years (range 37 - 74 years) and median follow-up was 25.2 months (range 9.6 - 150 months) from HT. Median donor age was 32 years (range 19 - 61 years). Three donors were HCV NAT+. At the time of HT, 4 patients were in complete remission (CR), 1 had stable disease (SD), and 2 had partial response (PR). Three (38%) patients underwent autologous stem cell transplant (SCT) after HT; and seven (87%) received systemic therapy after HT. Five (63%) pts developed CAV (four ISHLT CAV-1 and one ISHLT CAV-3) at a median of 13.2 months after HT. At 3 years post HT, 7 (87%) patients maintained in CR or stringent CR and only 1 (12%) patient had progressive disease (PD). Three patients died during follow-up: two from CAV and one from complications of GI amyloidosis (Figure 1). <h3>Conclusion</h3> In this single center study, most patients with cardiac AL amyloidosis experienced durable CR after HT. However, a significant proportion developed CAV and almost 40% died within three years of transplant. Further studies with larger numbers of patients are required to determine the incidence of CAV in this population. The long term outcome of heart transplantation in patients with cardiac AL amyloidosis remains to be elucidated.

Outcomes of over 1,000 Heart Transplants Using Hepatitis C Positive Donors in the Modern Era

<h3>Purpose</h3> Advances in the treatment of hepatitis C (HCV) and an ongoing opioid epidemic have made HCV-positive (HCV+) donor organs increasingly available for transplantation. Recent reports of outcomes after heart transplantation (HT) using HCV+ donors have limited cohort size and follow up. This analysis reports mid-term outcomes of over 1,000 HCV+ HT performed in the United States in the modern era. <h3>Methods</h3> The United Network of Organ Sharing registry was used to identify patients undergoing HT between 2015-2021. Recipients were stratified by donor HCV serostatus and nucleic acid amplification test positivity (NAT+). The primary outcome was one-year mortality. A subanalysis comparing recipients of HCV NAT+ to NAT- organs was performed. Risk-adjustment for mortality was performed using Cox proportional hazards modeling. Kaplan-Meier analysis was used to compare post-HT survival. <h3>Results</h3> There was a significant annual increase in the frequency of HCV+ HT from 1.2% of HT in 2015 to 12.9% in 2021 (<i>p</i> < 0.001). Of 16,648 patients undergoing HT within the study period, 1,170 (7.0%) received an HCV+ organ. Recipients of HCV+ organs were more likely to be HCV seropositive, older, and white. HCV+ donors were more likely to be older, female, and white, and their organs had significantly longer cold ischemic times. In multivariable analysis, the adjusted risk for one-year mortality for an HCV+ donor was 0.87 (95% CI [0.69-1.10], <i>p</i> = 0.242). Of 1,170 HCV+ HT, 772 (61.7%) were NAT+. The adjusted risk for one-year mortality in a NAT+ HT was 0.73 (95% CI [0.47-1.13] <i>p</i> = 0.159) compared to NAT- HT. Unadjusted 3-year survival was 84.9%, 81.5%, and 85.5% in HCV-, HCV+NAT-, and HCV+ NAT+, respectively (<i>p</i> = 0.374) (Figure). <h3>Conclusion</h3> The annual proportion of HT using HCV+ donors has increased over ten-fold in the last six years. This analysis of the United States experience demonstrates that recipients of HCV+ hearts, including those that are NAT+, have acceptable outcomes with similar mid-term survival as HCV- cases.

Background rate of low-level HCV RNA in anti-HCV confirmed-positive and minipool nucleic acid test-nonreactive blood donations.

In 2019, the Food and Drug Administration revised the requirement for further testing of anti-HCV-reactive donations testing nucleic acid (NAT)-nonreactive via routine mini-pool (MP)-NAT. Individual donation (ID)-HCV NAT was required as a supplemental test prior to a second FDA-licensed anti-HCV assay; if ID-HCV-NAT is reactive, no further testing is required. This study investigated the rate of low-level RNA in anti-HCV-reactive donation samples prior to and following the implementation of supplemental ID-HCV NAT. A retrospective analysis was conducted on frozen plasma unit samples from 1161 anti-HCV confirmed-positive/HCV-NAT-nonreactive donations collected from December 2014 to January 2020. Samples were tested by multiple replicates on the Grifols Procleix Ultrio Elite (UE) assay and corresponding discriminatory HCV (dHCV) assay on the Procleix Panther System. Prospectively, the prevalence of low-level RNA in 2912 anti-HCV-reactive donations detected through routine screening from April 2020 through March 2021 was determined. In retrospective analyses, 10 (0.86%) of 1161 plasma samples were UE reactive, of which four (0.34%) were dHCV reactive (in all replicates of UE and dHCV). Of 2912 anti-HCV-reactive donation samples testing NAT-nonreactive via routine MP-NAT, three (0.1%; 95% CI: 0.04-0.30) were dHCV reactive; 37% of the remaining samples were reactive by a second anti-HCV assay and thus serologically confirmed. Retrospective and prospective analysis in comparison to earlier studies revealed that low-level HCV-RNA reactivity is decreasing over time. The very low HCV-RNA rates may be due to the widespread use of highly effective, direct-acting anti-viral treatments for those diagnosed with HCV infection.

Clinician and patient attitudes toward use of organs from hepatitis C viremic donors and their impact on acceptance: A contemporary review

The use of Hepatitis C (HCV) NAT positive allografts remains unusual and is clustered at few centers. We conducted a contemporary literature review to assess whether patient and clinician attitudes toward viremic organs impact acceptance. Databases including PubMed, MEDLINE, and SCOPUS databases were reviewed to identify studies focused on evaluating patient and provider perceptions of HCV NAT positive organ use within the DAA era (January 2015-April 2021). Search included MeSH terms related to Hepatitis C, transplantation, and patient and clinician attitudes. Two investigators extracted study characteristics including information on willingness to accept viremic organs, HCV-specific outcomes knowledge, HCV-specific concerns, and factors that contributed to acceptance or non-acceptance. Eight studies met all inclusion criteria. These included three pretransplant patient-directed studies, two post-transplant patient-directed studies, one pre- and post-transplant patient-directed study, and two clinician-directed studies. Common themes identified were concerns regarding HCV cure rates, viremic organ quality, DAA cost, stigma, and the possibility of HCV transmission to household members. The perception of decreased waitlist time was associated with viremic organ acceptance. Physician trust played a mixed role in acceptance patterns. Knowledge of high cure rates, shorter waitlist times, and higher organ quality appear to have the highest impact on organ acceptance.

Best practice recommendations for the use of hepatitis C viremic donor organs for hepatitis C virus naïve recipients.

The combination of the transplant organ deficit, the increase in HCV nucleic acid positive donors (HCV NAT+), and the development of direct-acting antiviral agents (DAAs) has resulted in a rapid increase in HCV NAT+ organ transplants into HCV naïve recipients. Early clinical experience with HCV NAT+ donor organs has shown promising outcomes; however, best practices are lacking to guide transplant programs during all phases of patient care. Transplant programs developing protocols for the utilization of HCV NAT+ organs will need a multidisciplinary team to address all aspects of pre-transplant and post-transplant patient care. Reports of fibrosing cholestatic hepatitis in HCV NAT+ organ transplant recipients receiving delayed DAA initiation highlight the need for the transplant community to develop safe and effective protocols. A failure to do so will inevitably lead to the erosion of public trust from cases of missed or inadequately treated donor-derived HCV infections. Herein, we provide best practice guidelines for the utilization of HCV NAT+ organs into HCV-negative recipients based on literature review and expert opinion from the faculty of the ASTS Standards and Quality Committee.

Should Lungs from Hepatitis C NAT+ Donors Continue to Be Transplanted? A UNOS Registry Analysis

<h3>Purpose</h3> With the advent of a cure for HCV, HCV NAT+ donor lungs are being increasingly utilized for transplantation, but their outcomes are understudied. Our goal was to examine one-year survival of lung transplant recipients from HCV NAT+ donors. <h3>Methods</h3> We conducted retrospective review of all primary adult lung transplant recipients in the UNOS registry between January 1, 2015 and June 12, 2020. Donors were identified as being HCV NAT+ or HCV NAT-. One-year survival was examined with the Kaplan Meier method and a multivariable Cox-proportional hazards model. <h3>Results</h3> Of 11809 lung transplants performed during the study period, 222 (2%) came from HCV NAT+ donors. HCV NAT+ donors tended to be younger (33±8 vs 35±14 yrs, p=0.01) and were more likely to be white (82% vs 61%, p<0.01), blood group O (61% vs 50%, p<0.01), CDC high risk (84% vs 24%, p<0.01), and have drug intoxication as cause of death (61% vs 12%, p<0.01). Recipients of HCV NAT+ donor lungs were less likely to have diabetes (10% vs 20%, p<0.01), cystic fibrosis (5% vs 9%, p<0.01), IPF (28% vs 36%, p<0.01), have chronic steroid use (32% vs 44%) or be treated with IV antibiotics 2 weeks prior transplant (5% vs 12%, p=0.02). They had lower LAS scores (42±15 vs 48 ± 18, p<0.01), oxygen requirements at rest (4.5 vs 5.5 L, p<0.01), and were more likely to receive double lungs (83% vs 74%, p<0.01). One-year survival was not significantly different among recipients of HCV NAT+ and NAT- donor lungs on univariate (HR 1.00, 95% CI 0.62-1.62, p=0.98) or multivariate analysis (aHR 0.94, 95% CI 0.53-1.67, p=0.84). Incidence of treatment for acute rejection at one year was also not significantly different (23% vs 23%, p=0.86). <h3>Conclusion</h3> Despite coming from high-risk donors, HCV NAT+ lungs have similar one-year survival and acute rejection as those coming from HCV NAT- donors. While longer-term studies are necessary, this report supports the use of NAT+ donor lungs among lung transplant candidates.

Impact of Transplanting Hepatitis C Nucleic Acid Testing Positive (NAT+) Donors to Hepatitis C Virus NAT- Cardiothoracic Recipients

<h3>Purpose</h3> The purpose of this study is to assess the clinical impact of utilizing HCV NAT+ donors in aviremic heart (HT) and lung (LT) transplant recipients. <h3>Methods</h3> A single-center, retrospective chart review was conducted on patients who received a HT or LT between 4/1/19-5/27/20. HCV antibody - and NAT- recipients of a HCV NAT+ graft were included in the analysis. <h3>Results</h3> Nineteen HCV NAT- patients underwent cardiothoracic transplantation (CT) with a HCV NAT+ organ (10 HT and 9 LT) and were included for evaluation; 47.4% male, average age 58 ± 7.9 years, 73.7% white. HCV transmission occurred in 100% of recipients. Average time to direct acting antiviral (DAA) initiation was 46 ± 20.7 days after transplant. SVR12 was achieved in 93.3% (14/15; 4 patients have not completed 12-week follow up post DAA completion). Treatment failure occurred in 1 LT patient with P32del mutation on glecaprevir/pibrentasvir, requiring alternative therapy (sofosbuvir/velpatasvir/voxilaprevir and ribavirin). 84.2% of patients developed post-transplant liver dysfunction. No patients developed fibrosing cholestatic hepatitis. Two patients died, 1 due to anastomotic complication (LT) and 1 due to pulmonary embolism (HT). De novo donor specific antibodies were present in 1 HT and 2 LT recipients, developing 4 days and a median of 137.5 (56-219) days post-transplant, respectively. Clinically significant rejection was identified and treated in 1 HT patient (ACR2). No episodes of rejection were identified in LT recipients. Five patients (26.3%) had documented DAA related adverse effects, including gastrointestinal, fatigue, orthostatic hypotension, and nail discoloration. <h3>Conclusion</h3> A high SVR12 rate was achieved in HCV NAT donor +/recipient - CT, who were initiated on DAA therapy after insurance approval. These results are reflective of real-word experience for patients not included in clinical trials. Few reported clinically significant episodes of rejection or DAA adverse effects occurred.

From Heresy to Standard of Care: A Virologic Journey.

In this month's journal, Bohorquez and colleagues review their experience with transplanting HCV + donor livers into HCV - recipients. In a retrospective analysis, the authors report from June 2018 to December 2019, following verification of DAA access, absence of critical drug-drug interactions and informed consent, allocated HCV NAT + organs were routinely offered to all patients on the waiting list for liver transplant irrespective of recipient HCV status.

Invalid results of quantitative HIV and HCV NAT from living, heart beating and after circulatory death donors.

Invalid results of quantitative HIV and HCV NAT from living, heart beating and after circulatory death donors.