Trends in utilization of deceased donor kidneys based on hepatitis C virus status and impact of public health service labeling on discard

BackgroundKidneys from deceased donors infected with hepatitis C virus (HCV) are underutilized. Most HCV virus‐infected donors are designated as Public Health Service increased donors (PHS‐IR). Impact of PHS and HCV designations on discard is not well studied.MethodsWe queried the UNOS data set for all deceased donor kidneys between January 2015 and December 2018. The final study cohort donors (n = 38 702) were stratified into three groups based on HCV antibody (Ab) and NAT status: (a) Ab−/NAT− (n = 35 861); (b) Ab+/NAT− (n = 973); and (c) Ab±/NAT+ (n = 1868). We analyzed utilization/discard rates of these organs, the impact of PHS‐IR and HCV designations on discard using multivariable two‐level hierarchical logistic regression models, forecasted number of HCV viremic donors/kidneys by 2023.ResultsDuring the study period, (a) the number of viremic donor kidneys increased 2 folds; (b) the multilevel mixed‐effects logistic regression models showed that, overall, the PHS labeling (OR 1.20, CI 95% CI 1.15‐1.29) and HCV designation (OR 2.29; 95% CI 2.15‐2.43) were independently associated with increased risk of discard; (c) contrary to the general perception, PHS‐IR kidneys across all HCV groups, compared to PHS‐IR kidneys were more likely to be discarded; (d) we forecasted that the number of kidneys from HCV viremic donor kidneys might increase from 1376 in 2019 to 2092 in 2023.ConclusionHepatitis C virus viremic kidneys might represent 10%‐15% of deceased donor organ pool soon with the current rate of the opioid epidemic. PHS labeling effect on discard requires further discussion of the utility of this classification.Peer Reviewedhttps://deepblue.lib.umich.edu/bitstream/2027.42/154409/1/tid13204_am.pdfhttps://deepblue.lib.umich.edu/bitstream/2027.42/154409/2/tid13204.pd

Lack of effectiveness of Bebtelovimab monoclonal antibody among high-risk patients with SARS-Cov-2 Omicron during BA.2, BA.2.12.1 and BA.5 subvariants dominated era.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron subvariants are expected to be resistant to Bebtelovimab (BEB) monoclonal antibody (MAb) and the real-world experience regarding its effectiveness is scarce. This retrospective cohort study reports a data analysis in Banner Healthcare System (a large not-for-profit organization) between 4/5/2022 and 8/1/2022 and included 19,778 Coronavirus disease-19 (COVID-19) positive (by PCR or direct antigen testing) patients who were selected from Cerner-Electronic Health Record after the exclusions criteria were met. The study index date for cohort was determined as the date of BEB MAb administration or the date of the first positive COVID-19 testing. The cohort consist of COVID-19 infected patients who received BEB MAb (N = 1,091) compared to propensity score (PS) matched control (N = 1,091). The primary composite outcome was the incidence of 30-day all-cause hospitalization and/or mortality. All statistical analyses were conducted on the paired (matched) dataset. For the primary composite outcome, the event counts and percentages were reported. Ninety-five percent Clopper-Pearson confidence intervals for percentages were computed. The study cohorts were 1:1 propensity matched without replacement across 26 covariates using an optimal matching algorithm that minimizes the sum of absolute pairwise distance across the matched sample after fitting and using logistic regression as the distance function. The pairs were matched exactly on patient vaccination status, BMI group, age group and diabetes status. Compared to the PS matched control group (2.6%; 95% confidence interval [CI]: 1.7%, 3.7%), BEB MAb use (2.2%; 95% CI: 1.4%, 3.3%) did not significantly reduce the incidence of the primary outcome (p = 0.67). In the subgroup analysis, we observed similar no-difference trends regarding the primary outcomes for the propensity rematched BEB MAb treated and untreated groups, stratified by patient vaccination status, age (<65 years or ≥65), and immunocompromised status (patients with HIV/AIDS or solid organ transplants or malignancy including lymphoproliferative disorder). The number needed to treat (1/0.026-0.022) with BEB MAb was 250 to avoid one hospitalization and/or death over 30 days. The BEB MAb use lacked efficacy in patients with SARS-CoV-2 Omicron subvariants (mainly BA.2, BA.2.12.1, and BA.5) in the Banner Healthcare System in the Southwestern United States

Multivariable Cox proportional hazard model^b'*' for the composite outcome among the post-propensity matched COVID-19 infected patients in the Banner Healthcare System between April 5, 2022, and August 1, 2022.

Multivariable Cox proportional hazard modelb'*' for the composite outcome among the post-propensity matched COVID-19 infected patients in the Banner Healthcare System between April 5, 2022, and August 1, 2022.</p

Subgroup analysis for the primary composite outcome stratified by patient vaccination status (fully vaccinated vs. not fully vaccinated), age category (age <65 vs. age ≥65), and immunocompromised status (comorbidities including HIV/AIDS or solid organ transplants or malignancy) between the propensity matched Bebtelovimab (BEB) and untreated control groups.

Subgroup analysis for the primary composite outcome stratified by patient vaccination status (fully vaccinated vs. not fully vaccinated), age category (age <65 vs. age ≥65), and immunocompromised status (comorbidities including HIV/AIDS or solid organ transplants or malignancy) between the propensity matched Bebtelovimab (BEB) and untreated control groups.</p

The primary composite outcome between the propensity matched Bebtelovimab (BEB) monoclonal antibody (MAb) and untreated control groups.

The primary composite outcome between the propensity matched Bebtelovimab (BEB) monoclonal antibody (MAb) and untreated control groups.</p

Patient characteristics and covariate balance before and after propensity matching.

Patient characteristics and covariate balance before and after propensity matching.</p

Kaplan Meier curves for the composite outcome in patients who received Bebtelovimab monoclonal antibody treated group vs. not-treated control group between April 5, 2022, and August 1, 2022.

Kaplan Meier curves for the composite outcome in patients who received Bebtelovimab monoclonal antibody treated group vs. not-treated control group between April 5, 2022, and August 1, 2022.</p

Study cohort selection.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron subvariants are expected to be resistant to Bebtelovimab (BEB) monoclonal antibody (MAb) and the real-world experience regarding its effectiveness is scarce. This retrospective cohort study reports a data analysis in Banner Healthcare System (a large not-for-profit organization) between 4/5/2022 and 8/1/2022 and included 19,778 Coronavirus disease-19 (COVID-19) positive (by PCR or direct antigen testing) patients who were selected from Cerner-Electronic Health Record after the exclusions criteria were met. The study index date for cohort was determined as the date of BEB MAb administration or the date of the first positive COVID-19 testing. The cohort consist of COVID-19 infected patients who received BEB MAb (N = 1,091) compared to propensity score (PS) matched control (N = 1,091). The primary composite outcome was the incidence of 30-day all-cause hospitalization and/or mortality. All statistical analyses were conducted on the paired (matched) dataset. For the primary composite outcome, the event counts and percentages were reported. Ninety-five percent Clopper-Pearson confidence intervals for percentages were computed. The study cohorts were 1:1 propensity matched without replacement across 26 covariates using an optimal matching algorithm that minimizes the sum of absolute pairwise distance across the matched sample after fitting and using logistic regression as the distance function. The pairs were matched exactly on patient vaccination status, BMI group, age group and diabetes status. Compared to the PS matched control group (2.6%; 95% confidence interval [CI]: 1.7%, 3.7%), BEB MAb use (2.2%; 95% CI: 1.4%, 3.3%) did not significantly reduce the incidence of the primary outcome (p = 0.67). In the subgroup analysis, we observed similar no-difference trends regarding the primary outcomes for the propensity rematched BEB MAb treated and untreated groups, stratified by patient vaccination status, age (</div