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Background: Patients with decompensated cirrhosis have a higher risk of hospitalization, ICU admission, and death from COVID-19. The impact of demographics on these outcomes remains uncertain., Methods: The SECURE-Liver and COVID-Hep databases were utilized to evaluate disparities in COVID-19 outcomes. Patients were stratified by North American and European cohorts. Bivariate and multivariable logistic regression was performed., Results: A total of 718 cirrhosis patients with COVID-19 were evaluated. In the North American cohort, Black patients had more comorbidities (CI: 1.86 vs. 1.83, p  < 0.01), higher rates of hospitalization (77% vs. 85%, p < 0.01), ICU admission (27% vs. 40%, p  = 0.05), and death (18% vs. 28%, p  = 0.07). Hispanic patients had the lowest adverse outcome rates. In the European cohort, White patients had more comorbidities (CI; 1.63 vs. 1.31, p  = 0.02), but non-White patients had higher hospitalization rates (82% vs. 67%, p  = 0.01), ICU admissions (15% vs. 18%, p  = 0.04), and lower mortality rates (28% vs. 34%, p = 0.01)., Conclusion: Black patients in North America had higher hospitalization, ICU admission, and death rates. In the European subgroup, White patients had higher death rates than non-White patients. These disparities became statistically insignificant after adjusting for confounders, suggesting that non-liver-related comorbidities might increase the risk of adverse outcomes., Competing Interests: A. Sidney Barritt IV and Andrew Moon are consultants for TARGET RWE., (© 2024 The Author(s). JGH Open published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.)

Introduction: Hyman Zimmerman observed that hepatocellular (HC) drug-induced liver injury (DILI) with jaundice had a mortality rate of ≥ 10% (Hy Law). Hy Law does not specify the timing of liver tests nor the definition of HC DILI versus cholestatic or mixed (C/M) DILI. We aimed to assess the validity of Hy Law in the prospective DILI Network (DILIN) cohort., Methods: Drugs with ≥10 confirmed DILI cases with jaundice were analyzed. Four permutations of Hy Law were applied: R ≥ 5 using initial (1) or peak (2) alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase levels, and the Food and Drug Administration associated criteria of alanine aminotransferase or aspartate aminotransferase ≥ 3x upper limit of normal with alkaline phosphatase ≤ 2x upper limit of normal using initial (3) or peak values (4). Mortality was death or liver transplant adjudicated to be due to DILI., Results: Using initial R values, mortality was 11.1% for HC vs 2.0% for C/M ( P < 0.001); using peak R values, mortality was 10.3% vs 1.6% ( P < 0.001). Using Food and Drug Administration-associated definition, mortality was 7.9% vs 3.9% ( P = 0.04) using initial values and 7.9% vs 3.0% ( P = 0.01) using peak values. Using initial R values, drugs that frequently caused HC injury generally had mortality rates ≥ 10%, while drugs that typically caused C/M injury all had rates < 10%. Occasional agents that caused HC injury with jaundice were associated with low mortality., Discussion: Initial R values were the most reliable means of identifying Hy Law cases. There were some drugs that caused HC injury with jaundice but with mortality rates < 10%. Refinement of Hy Law is warranted., (Copyright © 2024 by The American College of Gastroenterology.)

Background:  The attribution of drug-induced liver injury (DILI) to specific herbal and dietary supplements (HDS) is confounded by inaccurate labels and undisclosed ingredients. The US Drug-Induced Liver Injury Network (DILIN) determines the attribution of injury to an agent through its structured expert opinion causality assessment process, but without the use of chemical analysis data of HDS. We aimed to determine the impact of chemical analysis of HDS products on prior causality assessment scores., Methods: Obtained samples of HDS consumed by DILIN-enrolled patients were analyzed by high-performance liquid chromatography-mass spectrometry (HPLC-MS). Chemical analysis data were compared to label accuracy and detect whether the product contained botanical and non-botanical compounds. A comparison of the causality scores reassessed with chemical analysis was compared with the original scores., Results: A total of 54 previously adjudicated cases with chemical analysis available were reassessed for causality with chemical analysis data; reviewers were blinded to original causality scores. Using the chemical analysis data, 37% (n = 20) of the 54 cases were scored with a higher likelihood of DILI compared with the original causality scores; 14 of the 20 (70%) moved from probable to highly likely; 52% had no change in causality score; and 11% of cases were scored as a lower likelihood of DILI., Conclusions:  Our study demonstrates that there is value in using HDS chemical analysis data in the causality assessment process for DILI. In more than a third of cases, chemical analysis of products led to an increased confidence in DILI attribution to HDS. These findings suggest that chemical analysis is an important tool in causality assessment for HDS agents, specifically in challenging situations, and further studies are needed to confirm its applicability in clinical practice., (© 2024. The Author(s).)

Introduction: This study investigates the applicability of the new metabolic dysfunction-associated steatotic liver disease (MASLD) nomenclature to the real-world TARGET-NASH US adult cohort., Methods: The new MASLD/metabolic steatohepatitis nomenclature was applied to patients enrolled with pragmatic diagnoses of nonalcoholic fatty liver and nonalcoholic steatohepatitis (NASH), and NASH cirrhosis and concordance were determined between the definitions., Results: Approximately 99% of TARGET-NASH participants met the new MASLD diagnostic criteria. Approximately 1,484/1,541 (96.3%, kappa 0.974) nonalcoholic fatty liver patients (metabolic dysfunction-associated steatotic liver), 2,195/2,201 (99.7%, kappa 0.998) NASH patients (metabolic steatohepatitis), and 1,999/2,003 (99.8%, kappa 0.999) NASH cirrhosis patients met the new criteria., Discussion: The new MASLD nomenclature is highly concordant with the previous TARGET-NASH pragmatic definitions., (Copyright © 2024 by The American College of Gastroenterology.)