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1. Investigation of the Role of Chemical Analysis in Causality Assessment of Herbal and Dietary Supplement-Induced Liver Injury: Role of Chemical Analysis in Causality Assessment

Author

Halegoua-DeMarzio, Dina, Navarro, Victor J., Davis, Ashley, Ahmad, Jawad, Avula, Bharathi, Barnhart, Huiman, Barritt, IV, A. Sidney, Bonkovsky, Herbert L., Chen, Vincent L., Choi, Gina, Fontana, Robert J., Ghabril, Marwan S., Khan, Ikhlas, Koh, Christopher, Odin, Joseph, Rockey, Don C., Rostami, Hoss, Serrano, Jose, Sherker, Averell H., Stolz, Andrew, Tillmann, Hans L., and Vuppalanchi, Raj

Published
2025
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5. Patient-reported outcomes in HCC: A scoping review by the Practice Metrics Committee of the American Association for the Study of Liver Diseases.

Author

Serper, Marina, Parikh, Neehar, Thiele, Grace, Ovchinsky, Nadia, Mehta, Shivang, Kuo, Alexander, Ho, Chanda, Kanwal, Fasiha, Volk, Michael, Asrani, Sumeet, Ghabril, Marwan, Lake, John, Merriman, Raphael, Tapper, Elliot, and Morgan, Timothy

Subjects
Benchmarking, Carcinoma, Hepatocellular, Humans, Liver Neoplasms, Patient Reported Outcome Measures, Quality of Life, United States
Abstract

BACKGROUND AND AIMS: HCC is a leading cause of mortality in patients with advanced liver disease and is associated with significant morbidity. Despite multiple available curative and palliative treatments, there is a lack of systematic evaluation of patient-reported outcomes (PROs) in HCC. APPROACH AND RESULTS: The American Association for the Study of Liver Diseases Practice Metrics Committee conducted a scoping review of PROs in HCC from 1990 to 2021 to (1) synthesize the evidence on PROs in HCC and (2) provide recommendations on incorporating PROs into clinical practice and quality improvement efforts. A total of 63 studies met inclusion criteria investigating factors associated with PROs, the relationship between PROs and survival, and associations between HCC therapy and PROs. Studies recruited heterogeneous populations, and most were cross-sectional. Poor PROs were associated with worse prognosis after adjusting for clinical factors and with more advanced disease stage, although some studies showed better PROs in patients with HCC compared to those with cirrhosis. Locoregional and systemic therapies were generally associated with a high symptom burden; however, some studies showed lower symptom burden for transarterial radiotherapy and radiation therapy. Qualitative studies identified additional symptoms not routinely assessed with structured questionnaires. Gaps in the literature include lack of integration of PROs into clinical care to guide HCC treatment decisions, unknown impact of HCC on caregivers, and the effect of palliative or supportive care quality of life and health outcomes. CONCLUSION: Evidence supports assessment of PROs in HCC; however, clinical implementation and the impact of PRO measurement on quality of care and longitudinal outcomes need future investigation.

Published
2022

21. Fecal Microbiota Transplantation Is Safe and Effective in Patients With Clostridioides difficile Infection and Cirrhosis

Author

Cheng, Yao-Wen, Alhaffar, Dana, Saha, Srishti, Khanna, Sahil, Bohm, Matthew, Phelps, Emmalee, Ghabril, Marwan, Orman, Eric, Sashidhar, Sagi, Rogers, Nicholas, Xu, Huiping, Khoruts, Alexander, Vaughn, Byron, Kao, Dina, Wong, Karen, Cammarota, Giovanni, Ianiro, Gianluca, Dhere, Tanvi, Kraft, Colleen S., Mehta, Nirja, Woodworth, Michael H., Allegretti, Jessica R., Nativ, Lotem, Marcus, Jenna, El-Nachef, Najwa, and Fischer, Monika

Published
2021
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25. Emricasan to prevent new decompensation in patients with NASH-related decompensated cirrhosis

Author

Corey, Kathleen, Bernstein, David, Noureddin, Mazen, Kemmer, Nyingi, DeLemos, Andrew, Pyrsopoulos, Nikolaos, Lee, William, Ghabril, Marwan, Scanga, Andrew, McKenzie, Mark, Lawitz, Eric, Figueroa-Diaz, Viviana, Simonetto, Douglas, Frederick, Richard, Brown, Kimberly, Therapondos, George, Sheikh, Aasim, Brandman, Danielle, Stein, Lance, Ankoma-Sey, Victor, Bhamidimarri, Kalyan, Landis, Charles, Fortune, Brett, Vargas, Hugo, Abdelmalek, Manal, Freilich, Bradley, Rockey, Don, Vierling, John, Tatum, Harvey, Curry, Michael, Shiffman, Mitchell, Bambha, Kiran, Ghalib, Reem, Stratton, Amy, Anwar, Nadeem, Caldwell, Stephen, Koteish, Ayman, Siddiqui, Mohammad, Saab, Sammy, Shah, Nikunj, Kohli, Anita, Rinella, Mary, Sarkar, Souvik, Torres, Dawn, Verna, Elizabeth, Ravendhran, Ravi, Reynolds, Justin, Thomason, Ray, Kim, Ray, Membreno, Fernando, Jakab, Sofia, Gonzalez, Stevan, Keaveny, Andrew, Pan, Jen-Jung, Gill, Satinder, Huang, Jonathan, Strobel, James, Wieland, Amanda, Morelli, Giuseppe, Amankonah, Thomas, Roytman, Marina, Schmidt, Warren, Abrams, Gary, Patel, Bhaktasharan, Frenette, Catherine, Kayali, Zeid, Mena, Edward, Mantry, Parvez S., Lucas, Kathryn J., Neff, Guy, Rodriguez, Miguel, Thuluvath, Paul J., Weinberg, Ethan, Bhandari, Bal R., Robinson, James, Wedick, Nicole, Chan, Jean L., Hagerty, David T., and Kowdley, Kris V.

Published
2021
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27. Clinical characteristics and HLA associations of azithromycin‐induced liver injury.

Author

Conlon, Caroline, Li, Yi‐Ju, Ahmad, Jawad, Barnhart, Huiman, Fontana, Robert J., Ghabril, Marwan, Hayashi, Paul H., Kleiner, David E., Lee, William M., Navarro, Victor, Odin, Joseph A., Phillips, Elizabeth J., Stolz, Andrew, Vuppalanchi, Raj, and Halegoua‐DeMarzio, Dina

Subjects
CHILD patients, LIVER injuries, LIVER failure, LIVER transplantation, GENE frequency
Abstract

Summary: Background: Azithromycin (AZ) is a widely used antibiotic. The aim of this study was to characterise the clinical features, outcomes, and HLA association in patients with drug‐induced liver injury (DILI) due to AZ. Methods: The clinical characteristics of individuals with definite, highly likely, or probable AZ‐DILI enrolled in the US Drug‐Induced Liver Injury Network (DILIN) were reviewed. HLA typing was performed using an Illumina MiSeq platform. The allele frequency (AF) of AZ‐DILI cases was compared to population controls, other DILI cases, and other antibiotic‐associated DILI cases. Results: Thirty cases (4 definite, 14 highly likely, 12 probable) of AZ‐DILI were enrolled between 2004 and 2022 with a median age of 46 years, 83% white, and 60% female. Median duration of AZ treatment was 5 days. Latency was 18.5 days. 73% were jaundiced at presentation. The injury pattern was hepatocellular in 60%, cholestatic in 27%, and mixed in 3%. Ten cases (33%) were severe or fatal; 90% of these were hepatocellular. Two patients required liver transplantation. One patient with chronic liver disease died of hepatic failure. Chronic liver injury developed in 17%, of which 80% had hepatocellular injury at onset. HLA‐DQA1*03:01 was significantly more common in AZ‐DILI versus population controls and amoxicillin‐clavulanate DILI cases (AF: 0.29 vs. 0.11, p = 0.001 and 0.002, respectively). Conclusion: Azithromycin therapy can lead to rapid onset of severe hepatic morbidity and mortality in adult and paediatric populations. Hepatocellular injury and younger age were associated with worse outcomes. HLA‐DQA1*03:01 was significantly more common in AZ cases compared to controls. [ABSTRACT FROM AUTHOR]

Published
2024
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29. Quality measures in pre-liver transplant care by the Practice Metrics Committee of the American Association for the Study of Liver Diseases.

Author

Brahmania, Mayur, Kuo, Alexander, Tapper, Elliot B., Volk, Michael L., Vittorio, Jennifer M., Ghabril, Marwan, Morgan, Timothy R., Kanwal, Fasiha, Parikh, Neehar D., Martin, Paul, Mehta, Shivang, Winder, Gerald Scott, Im, Gene Y., Goldberg, David, Lai, Jennifer C., Duarte-Rojo, Andres, Paredes, Angelo H., Patel, Arpan A., Sahota, Amandeep, and McElroy, Lisa M.

Published
2024
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32. Randomized placebo-controlled trial of emricasan for non-alcoholic steatohepatitis-related cirrhosis with severe portal hypertension

Author

Abdelmalek, M., Bhamidimarri, K., Borg, B., Caldwell, S., Fenkel, J., Freilich, B., Fuchs, M., Ghabril, M., Ghalib, R., Gonzalez, S., Gordon, S., Hameed, B., Harrison, S., Kayali, Z., Kemmer, N., Korenblat, K., Lai, M., Landis, C., Lawitz, E., Lee, W., Lidofsky, S., Mena, E., Noureddin, M., Paredes, A., Pyrsopoulos, N., Reddy, R., Rinella, M., Rockey, D., Rodriguez, M., Ryan, M., Sarkar, S., Satapathy, S., Scanga, A., Shiffman, M., Siddiqui, M., Simonetto, D., Syn, W., Thuluvath, P., Vemulapalli, R., Vierling, J., Younes, Z., Albillos, A., Ruiz-Tapiador, J. Arenas, Augustin, S., Calleja, J., Garcia, J. Crespo, Buey, L. Garcia, Garcia-Pagan, J.C., Villanueva, C., Bureau, C., Carbonell, N., Leroy, V., Rautou, P.-E., Heinzow, H., Schiefke, I., Zipprich, A., Berzigotti, A., Muellhaupt, B., Garcia-Tsao, Guadalupe, Bosch, Jaime, Kayali, Zeid, Harrison, Stephen A., Abdelmalek, Manal F., Lawitz, Eric, Satapathy, Sanjaya K., Ghabril, Marwan, Shiffman, Mitchell L., Younes, Ziad H., Thuluvath, Paul J., Berzigotti, Annalisa, Albillos, Agustin, Robinson, James M., Hagerty, David T., Chan, Jean L., and Sanyal, Arun J.

Published
2020
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33. Patient Sex, Reproductive Status, and Synthetic Hormone Use Associate With Histologic Severity of Nonalcoholic Steatohepatitis

Author

Yang, Ju Dong, Abdelmalek, Manal F, Guy, Cynthia D, Gill, Ryan M, Lavine, Joel E, Yates, Katherine, Klair, Jagpal, Terrault, Norah A, Clark, Jeanne M, Unalp-Arida, Aynur, Diehl, Anna Mae, Suzuki, Ayako, Dasarathy, Srinivasan, Dasarathy, Jaividhya, Hawkins, Carol, McCullough, Arthur J, Pagadala, Mangesh, Pai, Rish, Sargent, Ruth, Bashir, Mustafa, Buie, Stephanie, Guy, Cynthia, Kigongo, Christopher, Pan, Yi-Ping, Piercy, Dawn, Chalasani, Naga, Cummings, Oscar W, Gawrieh, Samer, Ghabril, Marwan, Marri, Smitha, Ragozzino, Linda, Sandrasegaran, Kumar, Vuppalanchi, Raj, King, Debra, Osmack, Pat, Siegner, Joan, Stewart, Susan, Neuschwander-Tetri, Brent A, Torretta, Susan, Ang, Brandon, Behling, Cynthia, Bhatt, Archana, Loomba, Rohit, Middleton, Michael, Patton, Heather, Sirlin, Claude, Aouizerat, Bradley, Bass, Nathan M, Brandman, Danielle, Ferrell, Linda D, Gill, Ryan, Hameed, Bilal, Ramos, Claudia, Terrault, Norah, Ungermann, Ashley, Atla, Pradeep, Croft, Brandon, Garcia, Rebekah, Garcia, Sonia, Sheikh, Muhammad, Singh, Mandeep, Boyett, Sherry, Carucci, Laura, Contos, Melissa J, Kraft, Kenneth, Luketic, Velimir AC, Puri, Puneet, Sanyal, Arun J, Schlosser, Jolene, Siddiqui, Mohhamad S, Wolford, Ben, Ackermann, Sarah, Cooney, Shannon, Coy, David, Gelinas, Katie, Kowdley, Kris V, Lee, Maximillian, Pierce, Tracey, Mooney, Jody, Nelson, James E, Shaw, Cheryl, Siddique, Asma, Wang, Chia, Brunt, Elizabeth M, Fowler, Kathryn, Kleiner, David E, Grave, Gilman D, Doo, Edward C, Hoofnagle, Jay H, Robuck, Patricia R, Sherker, Averell, Belt, Patricia, Donithan, Michele, Hallinan, Erin, and Isaacson, Milana

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Sciences, Liver Disease, Digestive Diseases, Hepatitis, Estrogen, Chronic Liver Disease and Cirrhosis, Contraception/Reproduction, Aging, 4.1 Discovery and preclinical testing of markers and technologies, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Adult, Aged, Cross-Sectional Studies, Female, Histocytochemistry, Hormones, Humans, Male, Menopause, Middle Aged, Non-alcoholic Fatty Liver Disease, Reproduction, Risk Factors, Sex Factors, United States, Young Adult, Gender Differences, Fibrosis, Risk Factor Analysis., Nonalcoholic Steatohepatitis Clinical Research Network, Risk Factor Analysis, Gastroenterology & Hepatology, Clinical sciences
Abstract

Background & aimsSex and sex hormones can affect responses of patients with nonalcoholic fatty liver disease (NAFLD) to metabolic stress and development of hepatocyte injury and inflammation.MethodsWe collected data from 3 large U.S. studies of patients with NAFLD (between October 2004 and June 2013) to assess the association between histologic severity and sex, menopause status, synthetic hormone use, and menstrual abnormalities in 1112 patients with a histologic diagnosis of NAFLD. We performed logistic or ordinal logistic regression models, adjusting for covariates relevant to an increase of hepatic metabolic stress.ResultsPremenopausal women were at an increased risk of lobular inflammation, hepatocyte ballooning, and Mallory-Denk bodies than men and also at an increased risk of lobular inflammation and Mallory-Denk bodies than postmenopausal women (P < .01). Use of oral contraceptives was associated with an increased risk of lobular inflammation and Mallory-Denk bodies in premenopausal women, whereas hormone replacement therapy was associated with an increased risk of lobular inflammation in postmenopausal women (P < .05).ConclusionsBeing a premenopausal woman or a female user of synthetic hormones is associated with increased histologic severity of hepatocyte injury and inflammation among patients with NAFLD at given levels of hepatic metabolic stress.

Published
2017

34. Management of coagulopathy among patients with cirrhosis undergoing upper endoscopy and paracentesis: Persistent gaps and areas of consensus in a multispecialty Delphi

Author

Tapper, Elliot B., primary, Warner, Matthew A., additional, Shah, Rajesh P., additional, Emamaullee, Juliet, additional, Dunbar, Nancy M., additional, Sholzberg, Michelle, additional, Poston, Jacqueline N., additional, Soto, Robin J., additional, Sarwar, Ammar, additional, Pillai, Anjana, additional, Reyner, Karina, additional, Mehta, Shivang, additional, Ghabril, Marwan, additional, Morgan, Timothy R., additional, and Caldwell, Stephen, additional

Published
2024
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41. Drug‐induced liver injury (DILI) ascribed to non‐steroidal anti‐inflammatory drugs (NSAIDs) in the USA—Update with genetic correlations.

Author

Bonkovsky, Herbert L., Ghabril, Marwan, Nicoletti, Paola, Dellinger, Andrew, Fontana, Robert J., Barnhart, Huiman, Gu, Jiezhun, Daly, Ann K., Aithal, Guruprasad P., Phillips, Elizabeth J., and Kleiner, David E.

Subjects
*ANTI-inflammatory agents, *DRUG side effects, *LIVER injuries, *ACETIC acid derivatives, *NONSTEROIDAL anti-inflammatory agents
Abstract

Objective: To describe patients with NSAID‐DILI, including genetic factors associated with idiosyncratic DILI. Methods: In DILIN, subjects with presumed DILI are enrolled and followed for at least 6 months. Causality is adjudicated by a Delphic approach. HLA sequencing of multiethnic NSAID‐DILI patients and HLA allele imputation of matching population controls were performed following overall, class and drug‐based association analysis. Significant results were tested in a non‐Hispanic White (NHW) case–control replication cohort. Results: Between September 2004 and March 2022, causality was adjudicated in 2498, and 55 (41 [75%] women) were assessed as likely due to NSAIDs. Median age at onset was 55 y (range 22–83 y). Diclofenac was the causative drug in 29, celecoxib in 7, ibuprofen in 5, etodolac and meloxicam each in 4. Except for meloxicam and oxaprozin (n = 2), the liver injury was hepatocellular with median R 15–25. HLA‐DRB1*04:03 and HLA‐B*35:03 were significantly more frequent in NSAID‐DILI patients than in non‐NSAID DILI controls. Interestingly, 85% of the HLA‐DRB1*04:03 carriers developed DILI due to the use of acetic acid derivative NSAIDs, supporting the hypothesis that HLA‐DRB1*04:03 could be a drug and/or class risk factor. HLA‐B*35:03 but not HLA‐DRB1*04:03 association was confirmed in the independent NHW replication cohort, which was largely driven by diclofenac. Conclusions: Despite prevalent use, NSAID‐DILI is infrequent in the United States. Diclofenac is the most commonly implicated, and adherence to warnings of risk and close observation are recommended. The increased frequency of HLA‐B*35:03 and DRB1*04:03, driven by diclofenac, suggests the importance of immune‐mediated responses. [ABSTRACT FROM AUTHOR]

Published
2024
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42. Comparison of endoscopic ultrasound‐guided primary and secondary prophylaxis for gastric variceal bleeding.

Author

Sarkis, Yara, Masuoka, Howard, Ghabril, Marwan, Gutta, Aditya, Al‐Haddad, Mohammad A., Stainko, Sarah, Cohen, Lainna, Perkins, Anthony, and DeWitt, John M.

Subjects
ENDOSCOPIC ultrasonography, GASTRIC varices, HEMORRHAGE, PREVENTIVE medicine, SURGICAL decompression, LIVER transplantation
Abstract

Objectives: Endoscopic ultrasound (EUS)‐guided injection of cyanoacrylate (CYA) for primary prophylaxis (PP) of gastric varices (GV) is controversial. This study evaluates the safety and efficacy of this intervention. Methods: Patients treated for PP of GV bleeding by EUS injection of CYA with or without coils were identified. Endoscopic techniques, outcomes, and adverse events (AEs) were reviewed and compared with a group treated for secondary prophylaxis (SP). Patients were followed until: (i) loss to follow‐up; (ii) GV bleeding; (iii) interventional radiology or surgery decompression; (iv) liver transplant; or (v) death or comfort care. Results: One hundred and nineteen patients (61 men; mean 59 ± 12 years) underwent EUS for PP (n = 24) or SP (n = 95). The PP group was treated with CYA alone (n = 18) or with coils (n = 4). Eight (33%) mild (n = 6) or moderate (n = 2) AEs and no index GV bleeding occurred during a mean of 6.1 ± 5.9 months follow‐up. Repeat EUS in 22 (92%) PP patients showed 7 (32%) residual GVs, which were retreated with CYA alone (n = 6) or with coils (n = 1). Two (29%) mild (n = 1) or moderate (n = 1) AEs occurred after repeat EUS and 1/22 (5%) index GV bleed occurred during a mean 23 ± 25 months follow‐up. Compared to the SP group, the PP group had lower Model for End‐stage Liver Disease (MELD) score (P = 0.03), fewer GV stigmata (P < 0.001), required less CYA (P = 0.019) during index EUS, and had a longer time between index and surveillance EUS (P = 0.014). The incidence of AEs and GV bleeding between the two groups were similar. Conclusion: Posttreatment GV bleeding and AEs are similar following EUS‐guided primary and secondary GV prophylaxis. [ABSTRACT FROM AUTHOR]

Published
2024
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44. Incidence, clinical characteristics, and risk factors associated with recurrent alcohol-associated hepatitis

Author

Patidar, Kavish R., primary, Guarnizo Ortiz, Maria, additional, Slaven, James E., additional, Nephew, Lauren D., additional, Vilar Gomez, Eduardo, additional, Kettler, Carla D., additional, Ghabril, Marwan S., additional, Desai, Archita P., additional, Orman, Eric S., additional, Chalasani, Naga, additional, and Gawrieh, Samer, additional

Published
2023
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50. Clinical characteristics and prognosis of hospitalized patients with moderate alcohol‐associated hepatitis

Author

Gaurnizo‐Ortiz, Maria, primary, Nephew, Lauren D., additional, Vilar‐Gomez, Eduardo, additional, Kettler, Carla D., additional, Slaven, James E., additional, Ghabril, Marwan S., additional, Desai, Archita P., additional, Orman, Eric S., additional, Chalasani, Naga, additional, Gawrieh, Samer, additional, and Patidar, Kavish R., additional

Published
2023
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