1,997 results on '"Reddy, K. Rajender"'
Search Results
2. Hepatitis B care cascade among people with HIV/HBV coinfection in the North American AIDS Cohort Collaboration on Research and Design, 2012–2016
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Kim, Jessica, Newcomb, Craig W, Carbonari, Dena M, Torgersen, Jessie, Althoff, Keri N, Kitahata, Mari M, Klein, Marina B, Moore, Richard D, Reddy, K Rajender, Silverberg, Michael J, Mayor, Angel M, Horberg, Michael A, Cachay, Edward R, Lim, Joseph K, Gill, M John, Chew, Kara, Sterling, Timothy R, Hull, Mark, Seaberg, Eric C, Kirk, Gregory D, Coburn, Sally B, Lang, Raynell, McGinnis, Kathleen A, Gebo, Kelly A, Napravnik, Sonia, Kim, H Nina, Re, Vincent Lo, and Research and Design of IeDEA, for the North American AIDS Cohort Collaboration on
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Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Sciences ,Hepatitis ,Infectious Diseases ,Digestive Diseases ,Hepatitis - B ,HIV/AIDS ,Sexually Transmitted Infections ,Liver Disease ,Infection ,Good Health and Well Being ,Female ,Humans ,Middle Aged ,Male ,Hepatitis B virus ,HIV Infections ,Acquired Immunodeficiency Syndrome ,Coinfection ,Cross-Sectional Studies ,DNA ,Viral ,Canada ,Hepatitis B ,Tenofovir ,North American AIDS Cohort Collaboration on Research and Design of IeDEA ,General Science & Technology - Abstract
A care cascade is a critical tool for evaluating delivery of care for chronic infections across sequential stages, starting with diagnosis and ending with viral suppression. However, there have been few data describing the hepatitis B virus (HBV) care cascade among people living with HIV infection who have HBV coinfection. We conducted a cross-sectional study among people living with HIV and HBV coinfection receiving care between January 1, 2012 and December 31, 2016 within 13 United States and Canadian clinical cohorts contributing data to the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD). We evaluated each of the steps in this cascade, including: 1) laboratory-confirmed HBV infection, 2) tenofovir-based or entecavir-based HBV therapy prescribed, 3) HBV DNA measured during treatment, and 4) viral suppression achieved via undetectable HBV DNA. Among 3,953 persons with laboratory-confirmed HBV (median age, 50 years; 6.5% female; 43.8% were Black; 7.1% were Hispanic), 3,592 (90.9%; 95% confidence interval, 90.0-91.8%) were prescribed tenofovir-based antiretroviral therapy or entecavir along with their antiretroviral therapy regimen, 2,281 (57.7%; 95% confidence interval, 56.2-59.2%) had HBV DNA measured while on therapy, and 1,624 (41.1%; 95% confidence interval, 39.5-42.6) achieved an undetectable HBV DNA during HBV treatment. Our study identified significant gaps in measurement of HBV DNA and suppression of HBV viremia among people living with HIV and HBV coinfection in the United States and Canada. Periodic evaluation of the HBV care cascade among persons with HIV/HBV will be critical to monitoring success in completion of each step.
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- 2023
3. Healthcare utilization and outcomes of living donor liver transplantation for patients with APASL-defined acute-on-chronic liver failure
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Kulkarni, Anand V., Reddy, Raghuram, Sharma, Mithun, Iyengar, Sowmya, Rambhatla, Anuhya, GV, Premkumar, Menon, Balachandran, Rao, Padaki Nagaraja, Reddy, Nageshwar, and Reddy, K. Rajender
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- 2023
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4. Significant Reduction in Posttransplant Hepatocellular Carcinoma Recurrence in the Post 6-Mo Waiting Policy Era
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Mahmud, Nadim, Yagan, Lina, Hoteit, Maarouf A., Reddy, K. Rajender, Abt, Peter L., and Abu-Gazala, Samir
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- 2024
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5. A multiancestry genome-wide association study of unexplained chronic ALT elevation as a proxy for nonalcoholic fatty liver disease with histological and radiological validation
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Vujkovic, Marijana, Ramdas, Shweta, Lorenz, Kim M, Guo, Xiuqing, Darlay, Rebecca, Cordell, Heather J, He, Jing, Gindin, Yevgeniy, Chung, Chuhan, Myers, Robert P, Schneider, Carolin V, Park, Joseph, Lee, Kyung Min, Serper, Marina, Carr, Rotonya M, Kaplan, David E, Haas, Mary E, MacLean, Matthew T, Witschey, Walter R, Zhu, Xiang, Tcheandjieu, Catherine, Kember, Rachel L, Kranzler, Henry R, Verma, Anurag, Giri, Ayush, Klarin, Derek M, Sun, Yan V, Huang, Jie, Huffman, Jennifer E, Creasy, Kate Townsend, Hand, Nicholas J, Liu, Ching-Ti, Long, Michelle T, Yao, Jie, Budoff, Matthew, Tan, Jingyi, Li, Xiaohui, Lin, Henry J, Chen, Yii-Der Ida, Taylor, Kent D, Chang, Ruey-Kang, Krauss, Ronald M, Vilarinho, Silvia, Brancale, Joseph, Nielsen, Jonas B, Locke, Adam E, Jones, Marcus B, Verweij, Niek, Baras, Aris, Reddy, K Rajender, Neuschwander-Tetri, Brent A, Schwimmer, Jeffrey B, Sanyal, Arun J, Chalasani, Naga, Ryan, Kathleen A, Mitchell, Braxton D, Gill, Dipender, Wells, Andrew D, Manduchi, Elisabetta, Saiman, Yedidya, Mahmud, Nadim, Miller, Donald R, Reaven, Peter D, Phillips, Lawrence S, Muralidhar, Sumitra, DuVall, Scott L, Lee, Jennifer S, Assimes, Themistocles L, Pyarajan, Saiju, Cho, Kelly, Edwards, Todd L, Damrauer, Scott M, Wilson, Peter W, Gaziano, J Michael, O’Donnell, Christopher J, Khera, Amit V, Grant, Struan FA, Brown, Christopher D, Tsao, Philip S, Saleheen, Danish, Lotta, Luca A, Bastarache, Lisa, Anstee, Quentin M, Daly, Ann K, Meigs, James B, Rotter, Jerome I, Lynch, Julie A, Rader, Daniel J, Voight, Benjamin F, and Chang, Kyong-Mi
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Genetics ,Liver Disease ,Human Genome ,Digestive Diseases ,Chronic Liver Disease and Cirrhosis ,Aetiology ,2.1 Biological and endogenous factors ,Alanine Transaminase ,Alpha-Ketoglutarate-Dependent Dioxygenase FTO ,Genome-Wide Association Study ,Humans ,Intracellular Signaling Peptides and Proteins ,Lipase ,Membrane Proteins ,Non-alcoholic Fatty Liver Disease ,Polymorphism ,Single Nucleotide ,Protein Serine-Threonine Kinases ,Regeneron Genetics Center ,Geisinger-Regeneron DiscovEHR Collaboration ,EPoS Consortium ,VA Million Veteran Program ,Biological Sciences ,Medical and Health Sciences ,Developmental Biology - Abstract
Nonalcoholic fatty liver disease (NAFLD) is a growing cause of chronic liver disease. Using a proxy NAFLD definition of chronic elevation of alanine aminotransferase (cALT) levels without other liver diseases, we performed a multiancestry genome-wide association study (GWAS) in the Million Veteran Program (MVP) including 90,408 cALT cases and 128,187 controls. Seventy-seven loci exceeded genome-wide significance, including 25 without prior NAFLD or alanine aminotransferase associations, with one additional locus identified in European American-only and two in African American-only analyses (P
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- 2022
6. Prevalence and Factors Associated With Statin Use Among Patients With Nonalcoholic Fatty Liver Disease in the TARGET-NASH Study
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Thomson, Mary J, Serper, Marina, Khungar, Vandana, Weiss, L Michael, Trinh, Huy, Firpi-Morell, Roberto, Roden, Michael, Loomba, Rohit, Barritt, A Sidney, Gazis, Derek, Mospan, Andrea R, Fried, Michael W, Reddy, K Rajender, and Lok, Anna S
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Cardiovascular ,Chronic Liver Disease and Cirrhosis ,Liver Disease ,Prevention ,Clinical Research ,Rare Diseases ,Hepatitis ,Digestive Diseases ,Oral and gastrointestinal ,Good Health and Well Being ,Humans ,Hydroxymethylglutaryl-CoA Reductase Inhibitors ,Liver Cirrhosis ,Liver Neoplasms ,Non-alcoholic Fatty Liver Disease ,Prevalence ,Clinical Sciences ,Gastroenterology & Hepatology - Abstract
Patients with nonalcoholic fatty liver disease (NAFLD) are at an increased risk of cardiovascular disease. Hydoxy-3-methyglutaryl-coenzyme reductase inhibitors, statins, reduce the risk of cardiovascular events.1 Studies have shown that statins are safe among patients with liver disease, including those with compensated cirrhosis,2 and their use is associated with lower mortality, hepatic decompensation, and possibly hepatocellular carcinoma.3,4 Despite these data, statins are under prescribed among patients with liver disease due to concerns about hepatotoxicity.5 This study aimed to assess prevalence and patient factors associated with indicated statin use in patients with NAFLD in a real-world cohort.
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- 2022
7. Impact of Donor and Recipient Clinical Characteristics and Hepatic Histology on Steatosis/Fibrosis Following Liver Transplantation
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Shaked, Oren, Demetris, Jack, Levitsky, Josh, Feng, Sandy, Loza, Bao-Li, Punch, Jeff, Reyes, Jorge, Klintmalm, Goran, Jackson, Whitney, DesMarais, Michele, Sayre, Peter, Shaked, Abraham, and Reddy, K Rajender
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Biomedical and Clinical Sciences ,Clinical Sciences ,Digestive Diseases ,Infectious Diseases ,Hepatitis - C ,Hepatitis ,Chronic Liver Disease and Cirrhosis ,Organ Transplantation ,Emerging Infectious Diseases ,Clinical Research ,Liver Disease ,Transplantation ,Good Health and Well Being ,Fatty Liver ,Humans ,Liver Cirrhosis ,Liver Transplantation ,Living Donors ,Treatment Outcome ,Medical and Health Sciences ,Surgery ,Clinical sciences ,Immunology - Abstract
BackgroundDeceased donor and recipient predictors of posttransplant steatosis/steatohepatitis and fibrosis are not well known. Our aim was to evaluate the prevalence and assess donor and recipient predictors of steatosis, steatohepatitis, and fibrosis in liver transplantation recipients.MethodsUsing the immune tolerance network A-WISH multicenter study (NCT00135694), donor and recipient demographic and clinical features were collected. Liver biopsies were taken from the donor liver at transplant, and from recipients per protocol and for-cause (ie, abnormal transaminases and to rule out rejection) and were interpreted by a central pathologist.ResultsOne hundred eighty-three paired donor/recipients liver biopsies at the time of transplant and posttransplant follow-up (median time 582 d; average time to last biopsies was 704 d [SD ± 402 d]) were analyzed. Donor steatosis did not influence recipient steatosis or fibrosis. Ten of 183 recipients had steatohepatitis on the last biopsy. Recipient body mass index at the time of liver biopsy was the most influential factor associated with posttransplant steatosis. Both donor and recipient metabolic syndrome features were not associated with graft steatosis. Untreated hepatitis C viral (HCV) infection was the most influential factor associated with the development of allograft fibrosis.ConclusionsIn a large experience evaluating paired donor and recipient characteristics, recipient body mass index at the time of liver biopsy was most significantly associated with posttransplant steatosis. Untreated HCV etiology influenced graft fibrosis. Thus relative to untreated HCV, hepatic fibrosis in those with steatosis/steatohepatitis is less common though long-term follow-up is needed to determine the course of posttransplant fibrosis. Emphasis on recipient weight control is essential.
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- 2022
8. Clinical Predictors of Intensive Care Unit Transfer in Admitted Patients with Cirrhosis
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Dukewich, Matthew, Liu, Chung-Heng, Weinberg, Ethan M, Mahmud, Nadim, and Reddy, K. Rajender
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- 2023
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9. Type of Infection Is Associated with Prognosis in Acute-on-Chronic Liver Failure: A National Veterans Health Administration Study
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Mahmud, Nadim, Reddy, K. Rajender, Taddei, Tamar H., and Kaplan, David E.
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- 2023
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10. Liver transplantation for acute liver failure and acute-on-chronic liver failure
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Kulkarni, Anand V., Gustot, Thierry, and Reddy, K. Rajender
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- 2024
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11. Inpatient Frailty Assessment Is Feasible and Predicts Nonhome Discharge and Mortality in Decompensated Cirrhosis
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Serper, Marina, Tao, Sunny Y, Kent, Dorothea S, Garren, Patrik, Burdzy, Alexander E, Lai, Jennifer C, Gougol, Amir, Bloomer, Pamela M, Reddy, K Rajender, Dunn, Michael A, and Duarte‐Rojo, Andres
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Biomedical and Clinical Sciences ,Clinical Sciences ,Digestive Diseases ,Clinical Research ,Liver Disease ,Good Health and Well Being ,Female ,Frailty ,Humans ,Inpatients ,Liver Cirrhosis ,Liver Transplantation ,Patient Discharge ,Prospective Studies ,Risk Factors ,Surgery ,Clinical sciences - Abstract
Objective inpatient frailty assessments in decompensated cirrhosis are understudied. We examined the feasibility of inpatient frailty measurements and associations with nonhome discharge, readmission, and all-cause mortality among patients admitted for cirrhosis complications. We conducted a prospective study at 3 liver transplantation (LT) centers. Frailty was assessed using the liver frailty index (LFI). Multivariable logistic and competing risk models evaluated associations between frailty and clinical outcomes. We included 211 patients with median MELD-Na score 21 (interquartile range [IQR],15-27); 96 (45%) were women, and 102 (48%) were on the LT waiting list. At a median follow-up of 8.3 months, 29 patients (14%) were nonhome discharged, 144 (68%) were readmitted, 70 (33%) underwent LT, and 44 (21%) died. A total of 124 patients (59%) were frail, with a median LFI of 4.71 (IQR, 4.07-5.54). Frail patients were older (mean, 59 versus 54 years) and more likely to have chronic kidney disease (40% versus 20%; P = 0.002) and coronary artery disease (17% versus 7%; P = 0.03). Frailty was associated with hospital-acquired infections (8% versus 1%; P = 0.02). In multivariable models, LFI was associated with nonhome discharge (odds ratio, 1.81 per 1-point increase; 95% confidence interval [CI], 1.14-2.86). Frailty (LFI≥4.5) was associated with all-cause mortality in models accounting for LT as competing risk (subhazard ratio [sHR], 2.4; 95% CI, 1.13-5.11); results were similar with LFI as a continuous variable (sHR, 1.62 per 1-point increase; 95% CI, 1.15-2.28). A brief, objective inpatient frailty assessment was feasible and predicted nonhome discharge and mortality in decompensated cirrhosis. Inpatient point-of-care frailty assessment prior to hospital discharge can be useful for risk stratification and targeted interventions to improve physical fitness and reduce adverse outcomes.
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- 2021
12. Admission Urinary and Serum Metabolites Predict Renal Outcomes in Hospitalized Patients With Cirrhosis
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Bajaj, Jasmohan S, Garcia‐Tsao, Guadalupe, Reddy, K Rajender, O’Leary, Jacqueline G, Vargas, Hugo E, Lai, Jennifer C, Kamath, Patrick S, Tandon, Puneeta, Subramanian, Ram M, Thuluvath, Paul, Fagan, Andrew, Sehrawat, Tejasav, de la Rosa Rodriguez, Randolph, Thacker, Leroy R, and Wong, Florence
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Digestive Diseases ,Clinical Research ,Chronic Liver Disease and Cirrhosis ,Liver Disease ,Kidney Disease ,Renal and urogenital ,Acute Kidney Injury ,Aged ,Biomarkers ,End Stage Liver Disease ,Female ,Humans ,Liver Cirrhosis ,Male ,Metabolomics ,Middle Aged ,Patient Admission ,Prognosis ,Prospective Studies ,Renal Dialysis ,Risk Assessment ,Medical Biochemistry and Metabolomics ,Clinical Sciences ,Immunology ,Gastroenterology & Hepatology - Abstract
Background and aimsAcute kidney injury (AKI) has a poor prognosis in cirrhosis. Given the variability of creatinine, the prediction of AKI and dialysis by other markers is needed. The aim of this study is to determine the role of serum and urine metabolomics in the prediction of AKI and dialysis in an inpatient cirrhosis cohort.Approach and resultsInpatients with cirrhosis from 11 North American Consortium of End-stage Liver Disease centers who provided admission serum/urine when they were AKI and dialysis-free were included. Analysis of covariance adjusted for demographics, infection, and cirrhosis severity was performed to identify metabolites that differed among patients (1) who developed AKI or not; (2) required dialysis or not; and/pr (3) within AKI subgroups who needed dialysis or not. We performed random forest and AUC analyses to identify specific metabolite(s) associated with outcomes. Logistic regression with clinical variables with/without metabolites was performed. A total of 602 patients gave serum (218 developed AKI, 80 needed dialysis) and 435 gave urine (164 developed AKI, 61 needed dialysis). For AKI prediction, clinical factor-adjusted AUC was 0.91 for serum and 0.88 for urine. Major metabolites such as uremic toxins (2,3-dihydroxy-5-methylthio-4-pentenoic acid [DMTPA], N2N2dimethylguanosine, uridine/pseudouridine) and tryptophan/tyrosine metabolites (kynunerate, 8-methoxykyunerate, quinolinate) were higher in patients who developed AKI. For dialysis prediction, clinical factor-adjusted AUC was 0.93 for serum and 0.91 for urine. Similar metabolites as AKI were altered here. For dialysis prediction in those with AKI, the AUC was 0.81 and 0.79 for serum/urine. Lower branched-chain amino-acid (BCAA) metabolites but higher cysteine, tryptophan, glutamate, and DMTPA were seen in patients with AKI needing dialysis. Serum/urine metabolites were additive to clinical variables for all outcomes.ConclusionsSpecific admission urinary and serum metabolites were significantly additive to clinical variables to predict AKI development and dialysis initiation in inpatients with cirrhosis. These observations can potentially facilitate earlier initiation of renoprotective measures.
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- 2021
13. Living Donor Liver Transplantation for Adults With High Model for End-stage Liver Disease Score: The US Experience
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Rosenthal, Benjamin E., Abt, Peter L., Schaubel, Douglas E., Reddy, K. Rajender, and Bittermann, Therese
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- 2024
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14. Use and Outcomes of Hepatitis B Virus-positive Grafts for Kidney or Heart Transplantation in the United States From 1999 to 2021
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Singal, Ashwani K., Reddy, K. Rajender, Nguyen, Mindie H., Younossi, Zobair, Kwo, Paul, and Kuo, Yong-Fang
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- 2024
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15. Patient Determinants for Histologic Diagnosis of NAFLD in the Real World: A TARGET‐NASH Study
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Barritt, A Sidney, Watkins, Stephanie, Gitlin, Norman, Klein, Samuel, Lok, Anna S, Loomba, Rohit, Schoen, Cheryl, Reddy, K Rajender, Trinh, Huy Ngoc, Mospan, Andrea R, Vos, Miriam B, Weiss, L Michael, Cusi, Kenneth, Neuschwander‐Tetri, Brent A, and Sanyal, Arun J
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Biomedical and Clinical Sciences ,Clinical Sciences ,Liver Disease ,Digestive Diseases ,Chronic Liver Disease and Cirrhosis ,Hepatitis ,Clinical Research ,Good Health and Well Being ,Clinical sciences - Abstract
Much of the current data on nonalcoholic fatty liver disease (NAFLD) are derived from biopsy-based studies that may introduce ascertainment and selection bias. Selection of patients for liver biopsy has implications for clinical practice and the reported epidemiology of NAFLD. The aim of this study was to determine patient factors predictive of histologic versus empiric clinical diagnosis of NAFLD in real-world practice. Adults from TARGET-NASH were included in this study. Descriptive statistics are provided for the cohort and compare the characteristics of histologic NAFLD versus patients with clinically diagnosed NAFLD, followed by logistic regression and machine-learning models to describe predictors of liver biopsy. The records of 3,474 subjects were analyzed; median age was 59 years, 59% were female, 75% were White, and median body mass index was 32 kg/m2. Using histologic and/or clinical criteria, a diagnosis of nonalcoholic steatohepatitis was made in 37%, and cirrhosis in 33%. Comorbid conditions included cardiovascular disease (19%), mental health diagnoses (49%), and osteoarthritis (10%). Predictors of a biopsy diagnosis included White race, female sex, diabetes, and elevated alanine aminotransferase (ALT). ALT increased the odds of liver biopsy by 14% per 10-point rise. Machine-learning analyses showed non-White patients with ALT
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- 2021
16. INFUSE: Rationale and design of a multi-center, open label, collaborative study to treat HRS-AKI with continuous terlipressin infusion
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Weinberg, Ethan, Rahematpura, Suditi, Gonzalez, Stevan A., Izzy, Manhal J., Simonetto, Douglas A., Frederick, R. Todd, Rubin, Raymond A., Ikahihifo-Bender, Jade, Harte, Maggie, Kim-Lee, Grace, Witkiewicz, Sherry, Tobin, William, Jamil, Khurram, Fricker, Zachary, and Reddy, K. Rajender
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- 2023
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17. Validation of a Clinical Risk-based Classification System in a Large Nonalcoholic Fatty Liver Disease Real-world Cohort
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Abdelmalek, Manal, Aguilar, Humberto, Ahmed, Aijaz, Allen, Alina, Barlow, Sarah, Barritt, Sid, Bernstein, David, Bhamidimarri, Kaylan, Billings, Liana, Brown, Kyle, Brown, Robert, Corbin, Karen, Cusi, Kenneth, deLemos, Andrew, Emerick, Karan, Firpi-Morell, Roberto, Ghali, Maged Adel, Henry, Zachary, Jackson, Whitney, Janardhan, Sujit, Kabbany, Mohammad, Kemmer, Nyingi, Koch, David, Kupec, Justin, Landis, Charles, Lawrence, Mary Katherine, Levy, Cynthia, Lidofsky, Steven, Lok, Anna, Luketic, Velimir, Martinez, Enrique, McClain, Craig, McKiernan, Patrick, Mitchell, Ellen, Noureddin, Mazen, Palle, Sirish, Pham, Yen, Pound, David, Reddy, Rajender, Regenstein, Fredric, Rinella, Mary, Rochling, Fedja, Rudolph, Bryan, Rustgi, Vinod, Said, Adnan, Samala, Niharika, Sarkar, Souvik, Sherman, Kenneth, Shiffman, Mitchell, Smith, Coleman, Taunk, Jawahar, Tetri, Brent, Thuluvath, Paul, Trinh, Huy, Verna, Elizabeth, Vos, Miriam, Weiss, L. Michael, Wong, Mark, Wyne, Kathleen, Xanthakos, Stavra, Sanyal, Arun J., Munoz, Breda, Barritt, A. Sidney, IV, Muthiah, Mark, Mospan, Andrea R., Reddy, K. Rajender, Thuluvath, Paul J., Bhamidimarri, Kalyan Ram, and Fried, Michael W.
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- 2023
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18. Incidence and Risk Factors for Hepatocellular Carcinoma in Cirrhosis: The Multicenter Hepatocellular Carcinoma Early Detection Strategy (HEDS) Study
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Reddy, K. Rajender, McLerran, Dale, Marsh, Tracey, Parikh, Neehar, Roberts, Lewis R., Schwartz, Myron, Nguyen, Mindie H., Befeler, Alex, Page-Lester, Stephanie, Tang, Runlong, Srivastava, Sudhir, Rinaudo, Jo Ann, Feng, Ziding, and Marrero, Jorge A.
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- 2023
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19. A Real‐World Observational Cohort of Patients with Hepatocellular Carcinoma: Design and Rationale for TARGET‐HCC
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Cabrera, Roniel, Singal, Amit G, Colombo, Massimo, Kelley, R Kate, Lee, Hannah, Mospan, Andrea R, Meyer, Tim, Newell, Pippa, Parikh, Neehar D, Sangro, Bruno, Reddy, K Rajender, Watkins, Stephanie, Zink, Richard C, and Di Bisceglie, Adrian M
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Cancer ,Hepatitis ,Liver Disease ,Liver Cancer ,Chronic Liver Disease and Cirrhosis ,Clinical Research ,Clinical Trials and Supportive Activities ,Digestive Diseases ,Rare Diseases ,Good Health and Well Being ,Adult ,Aged ,Carcinoma ,Hepatocellular ,Europe ,Female ,Health Services Research ,Humans ,Liver Neoplasms ,Longitudinal Studies ,Male ,Middle Aged ,Outcome Assessment ,Health Care ,Prospective Studies ,Research Design ,United States - Abstract
This study describes the design of the TARGET-hepatocellular carcinoma (HCC) cohort and descriptive characteristics of the patient population at diagnosis among those who were enrolled in the cohort across academic and community clinical centers. TARGET-HCC is a 5-year, longitudinal, observational cohort of patients with HCC receiving care in usual clinical practice. Redacted clinical information, obtained from medical records, captures the natural history and management of the disease, including the safety and efficacy of treatment interventions used in usual clinical practice. Patients can complete patient-reported outcome measures and provide biological specimens for future translational studies. The TARGET-HCC study includes adults with histologic, cytologic, or radiologic diagnosis of HCC from academic and community centers in both the United States and Europe. A total of 1,841 participants were enrolled between January 9, 2017, and July 23, 2019, at 67 sites in the United States and Europe. To date, the most common liver disease etiology in the cohort continues to be hepatitis C, although nearly half had a nonviral etiology, including alcohol-related liver disease or nonalcoholic steatohepatitis. Most included patients were diagnosed at an early stage (Barcelona Clinic Liver Cancer Stage [BCLC] 0/A), but only approximately one third underwent curative treatment. Systemic therapy has been used in 7.3% of enrolled patients, including 45.7% of those with BCLC stage C tumors. Conclusion: Overall, the TARGET-HCC cohort allows for the assessment of patient characteristics and investigation of new treatment paradigms and sequencing with existing agents as well as novel regimens for HCC.
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- 2021
20. Liver Transplantation in Acute-on-Chronic Liver Failure
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Kulkarni, Anand V. and Reddy, K. Rajender
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- 2023
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21. Global disparities in mortality and liver transplantation in hospitalised patients with cirrhosis: a prospective cohort study for the CLEARED Consortium
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Sarin, Shiv K, Kumar, Shiva, Marciano, Sebastián, Gadano, Adrián, Tudehope, Fiona, Gibson, Robert, Prudence, Alexander, Doyle, Adam, Si, Hooi Ling, Riordan, Stephen, Farias, Alberto, Zitelli, Patricia, Bera, Chinmay, Faisal, Nabiha, Tandon, Puneeta, Dahiya, Monica, Lohoues, Marie Jeanne, Lah, Ponan Claude Regis, Benítez, Carlos, Arrese, Marco, Xian, Yongchao, Guan, Jin, Zhu, Chuanwu, Wang, Yingling, Su, Minghua, Su, Man, Gao, Yanhang, Wang, Xinrui, Jiang, Yongfang, Peng, Feng, Zhao, Caiyan, Wang, Wei, Wang, Lei, Yin, Dedong, Lu, Mingqin, Cai, Yijing, Zhang, Ningping, Zhang, Wanqin, Li, Hai, Dong, Fuchen, Zheng, Xin, Liu, Jing, Tang, Hong, Yan, Libo, Xu, Bin, Wei, Linlin, Gao, Zhiliang, Xu, Zhen, Lin, Minghua, Gao, Haibin, Chen, Jinjun, Li, Beiling, Liu, Chenghai, Zhang, Yanyun, Hu, Peng, Deng, Huan, Belimi, Hibat Allah, Debzi, Nabil, Fisseha, Henok, Aravinthan, Aloysious D, Venkatachalapathy, Suresh Vasan, Rajoriya, Neil, Faulkes, Rosemary, Leith, Damien, Forrest, Ewan, Adebayo, Danielle, Kennedy, James, Yung, Diana, Seto, Wai-Kay, Fung, James, Katchman, Helena, Rabinowich, Liane, Nagral, Aabha, Jhaveri, Ajay, Kulkarni, Anand, Sharma, Mithun, Eapen, C E, Goel, Ashish, Gandotra, Akash, Duseja, Ajay, Saraya, Anoop, Yegurla, Jatin, Rela, Mohamed, Jothimani, Dinesh, Arora, Anil, Kumar, Ashish, Dhiman, Radha Krishan, Roy, Akash, Anand, Anil C, Praharaj, Dibyalochan, Hueso, Sarai Gonzalez, Cabrera, Araceli Bravo, Pérez Hérnandez, José Luis, Gutierrez, Oscar Morales, Miranda Zazueta, Godolfino, Ramos-Pineda, Abraham, Castillo Barradas, Mauricio, Velazquez, Rene Male, Made, Lilian Torres, Velarde-Ruiz Velasco, José Antonio, Félix-Tellez, Francisco, Cordova-Gallardo, Jacqueline, Rajaram, Ruveena, Nik Muhamad Afendi, Nik Arsyad, Okeke, Edith N, Nyam, David P, Allam, Dalia, Kumar Patwa, Yashwi Haresh, Tan, Hiang Keat, Liou, Wei Lun, Treeprasertsuk, Sombat, Wejnaruemarn, Salisa, Haktaniyan, Busra, Gunduz, Feyza, Aslan, Rahmi, Yildirim, Abdullah Emre, Barutcu, Sezgin, Karasu, Zeki, Uysal, Alper, Ucbilek, Enver, Kosay, Tolga, Adanir, Haydar, Dinçer, Dinç, Albhaisi, Somaya, Asrani, Sumeet, Fallahadeh, Mohammad Amin, Reddy, K Rajender, Rahematpura, Suditi, Shaw, Jawaid, Vargas, Hugo E., Bayne, David, Biggins, Scott W, Filipek, Natalia, Thuluvath, Paul, Sheshadri, Somya, Keaveny, Andrew, Duarte Rojo, Andres, Cabello Negrillo, Ricardo, Bajaj, Jasmohan S, Choudhury, Ashok K, Xie, Qing, Kamath, Patrick S, Topazian, Mark, Hayes, Peter C, Torre, Aldo, Desalegn, Hailemichael, Idilman, Ramazan, Cao, Zhujun, Alvares-da-Silva, Mario R, George, Jacob, Bush, Brian J, Thacker, Leroy R, and Wong, Florence
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- 2023
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22. Early living donor liver transplantation for alcohol-associated hepatitis
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Kulkarni, Anand V., Reddy, Raghuram, Arab, Juan Pablo, Sharma, Mithun, Shaik, Sameer, Iyengar, Sowmya, Kumar, Naveen, Sabreena, Gupta, Rajesh, Premkumar, Giri Vishwanathan, Menon, Balachandran Palat, Reddy, Duvvur Nageshwar, Rao, Padaki Nagaraja, and Reddy, K. Rajender
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- 2023
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23. Role of Oral Health, Frailty, and Minimal Hepatic Encephalopathy in the Risk of Hospitalization: A Prospective Multi-Center Cohort of Outpatients With Cirrhosis
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Bajaj, Jasmohan S., Lai, Jennifer C., Tandon, Puneeta, O’Leary, Jacqueline G., Wong, Florence, Garcia-Tsao, Guadalupe, Vargas, Hugo E., Kamath, Patrick S., Biggins, Scott W., Limon-Miro, Ana, Shaw, Jawaid, Mbachi, Chimezie, Chew, Michael, Golob Deeb, Janina, Thacker, Leroy R., and Reddy, K. Rajender
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- 2023
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24. Hospitalized Women With Cirrhosis Have More Nonhepatic Comorbidities and Associated Complications Than Men
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Rubin, Jessica B, Srisengfa, Yanin T, Albhaisi, Somaya, Acharya, Chathur, Nangia, Gayatri, Shaikh, Tahira, Thacker, Leroy R, Reddy, K Rajender, Tandon, Puneeta, Bajaj, Jasmohan S, and Lai, Jennifer C
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Biomedical and Clinical Sciences ,Clinical Sciences ,Organ Transplantation ,Transplantation ,Digestive Diseases ,Chronic Liver Disease and Cirrhosis ,Liver Disease ,Good Health and Well Being ,Comorbidity ,Creatinine ,Female ,Humans ,Liver Cirrhosis ,Liver Transplantation ,Male ,Waiting Lists ,Gastroenterology & Hepatology ,Clinical sciences - Abstract
Gender differences in the natural history of chronic liver disease have been well-described. Women have lower rates of chronic liver disease and slower fibrosis progression, yet higher rates of waitlist mortality.1,2 Although previous studies have identified several clinical factors including height and creatinine that explain some of this transplant disparity, most have used data from administrative records, which are limited in their ability to identify clinically relevant differences and opportunities for intervention to reduce disparities.3-5 Additionally, most studies have focused on the period between waitlist and transplant, failing to capture gender differences in access to transplant.3,6 In the present study, we took advantage of a multicenter inpatient cohort with granular clinical data to characterize how women and men with cirrhosis differ, to stimulate future research aimed at reducing the well-established gender disparity in liver transplantation.
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- 2020
25. Clinical Research in Hepatology in the COVID‐19 Pandemic and Post‐Pandemic Era: Challenges and the Need for Innovation
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Verna, Elizabeth C, Serper, Marina, Chu, Jaime, Corey, Kathleen, Fix, Oren K, Hoyt, Karen, Page, Kimberly A, Loomba, Rohit, Li, Ming, Everson, Gregory T, Fried, Michael W, Garcia‐Tsao, Guadalupe, Terrault, Norah, Lok, Anna S, Chung, Raymond T, and Reddy, K Rajender
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Biomedical and Clinical Sciences ,Clinical Sciences ,Liver Disease ,Clinical Research ,Digestive Diseases ,Good Health and Well Being ,Biomedical Research ,COVID-19 ,Coronavirus Infections ,Delivery of Health Care ,Female ,Forecasting ,Gastroenterology ,Humans ,Male ,Needs Assessment ,Pandemics ,Pneumonia ,Viral ,Program Development ,Program Evaluation ,Research Design ,Telemedicine ,United States ,Medical Biochemistry and Metabolomics ,Immunology ,Gastroenterology & Hepatology ,Clinical sciences - Abstract
The severe acute respiratory syndrome coronavirus 2 pandemic has drastically altered all facets of clinical care and research. Clinical research in hepatology has had a rich tradition in several domains, including the discovery and therapeutic development for diseases such as hepatitis B and C and studying the natural history of many forms of chronic liver disease. National Institutes of Health, foundation, and industry funding have provided important opportunities to advance the academic careers of young investigators while they strived to make contributions to the field. Instantaneously, however, all nonessential research activities were halted when the pandemic started, forcing those involved in clinical research to rethink their research strategy, including a shift to coronavirus disease 2019 research while endeavoring to maintain their preexisting agenda. Strategies to maintain the integrity of ongoing studies, including patient follow-up, safety assessments, and continuation of investigational products, have included a shift to telemedicine, remote safety laboratory monitoring, and shipping of investigational products to study subjects. As a revamp of research is being planned, unique issues that face the research community include maintenance of infrastructure, funding, completion of studies in the predetermined time frame, and the need to reprogram career path timelines. Real-world databases, biomarker and long-term follow up studies, and research involving special groups (children, the homeless, and other marginalized populations) are likely to face unique challenges. The implementation of telemedicine has been dramatically accelerated and will serve as a backbone for the future of clinical research. As we move forward, innovation in clinical trial design will be essential for conducting optimized clinical research.
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- 2020
26. Serum Levels of Metabolites Produced by Intestinal Microbes and Lipid Moieties Independently Associated With Acute-on-Chronic Liver Failure and Death in Patients With Cirrhosis
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Bajaj, Jasmohan S, Reddy, K Rajender, O'Leary, Jacqueline G, Vargas, Hugo E, Lai, Jennifer C, Kamath, Patrick S, Tandon, Puneeta, Wong, Florence, Subramanian, Ram M, Thuluvath, Paul, Fagan, Andrew, White, Melanie B, Gavis, Edith A, Sehrawat, Tejasav, de la Rosa Rodriguez, Randolph, Thacker, Leroy R, Sikaroodi, Masoumeh, Garcia-Tsao, Guadalupe, and Gillevet, Patrick M
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Medical Biochemistry and Metabolomics ,Biomedical and Clinical Sciences ,Clinical Sciences ,Liver Disease ,Clinical Research ,Digestive Diseases ,Chronic Liver Disease and Cirrhosis ,Oral and gastrointestinal ,Good Health and Well Being ,Acute-On-Chronic Liver Failure ,Adult ,Aged ,Bacteria ,Biomarkers ,Databases ,Factual ,Feces ,Female ,Gastrointestinal Microbiome ,Hospital Mortality ,Humans ,Lipidomics ,Lipids ,Liver Cirrhosis ,Male ,Metabolomics ,Middle Aged ,North America ,Patient Admission ,Predictive Value of Tests ,Prognosis ,Prospective Studies ,Risk Assessment ,Risk Factors ,Time Factors ,Tryptophan ,Estrone ,Sepsis ,Neurosciences ,Paediatrics and Reproductive Medicine ,Gastroenterology & Hepatology ,Clinical sciences ,Nutrition and dietetics - Abstract
Background & aimsInpatients with cirrhosis have high rates of acute-on-chronic failure (ACLF) development and high mortality within 30 days of admission to the hospital. Better biomarkers are needed to predict these outcomes. We performed metabolomic analyses of serum samples from patients with cirrhosis at multiple centers to determine whether metabolite profiles might identify patients at high risk for ACLF and death.MethodsWe performed metabolomic analyses, using liquid chromatography, of serum samples collected at time of admission to 12 North American tertiary hepatology centers from 602 patients in the North American Consortium for the Study of End-Stage Liver Disease sites from 2015 through 2017 (mean age, 56 years; 61% men; mean model for end-stage liver disease score, 19.5). We performed analysis of covariance, adjusted for model for end-stage liver disease at time of hospital admission, serum levels of albumin and sodium, and white blood cell count, to identify metabolites that differed between patients who did vs did not develop ACLF and patients who did vs did not die during hospitalization and within 30 days. We performed random forest analysis to identify specific metabolite(s) that were associated with outcomes and area under the curve (AUC) analyses to analyze them in context of clinical parameters. We analyzed microbiomes of stool samples collected from 133 patients collected at the same time and examined associations with serum metabolites.ResultsOf the 602 patients analyzed, 88 developed ACLF (15%), 43 died in the hospital (7%), and 72 died within 30 days (12%). Increased levels of compounds of microbial origin (aromatic compounds, secondary or sulfated bile acids, and benzoate) and estrogen metabolites, as well as decreased levels of phospholipids, were associated with development of ACLF, inpatient, and 30-day mortality and were also associated with fecal microbiomes. Random forest analysis and logistic regression showed that levels of specific microbially produced metabolites identified patients who developed ACLF with an AUC of 0.84 (95% confidence interval [CI] 0.78-0.88; P = .001), patients who died while in the hospital with an AUC of 0.81 (95% CI 0.74-0.85; P = .002), and patients who died within 30 days with an AUC of 0.77 (95% CI 0.73-0.81; P = .02). The metabolites were significantly additive to clinical parameters for predicting these outcomes. Metabolites associated with outcomes were also correlated with microbiomes of stool samples.ConclusionsIn an analysis of serum metabolites and fecal microbiomes of patients hospitalized with cirrhosis at multiple centers, we associated metabolites of microbial origin and lipid moieties with development of ACLF and death as an inpatient or within 30 days, after controlling for clinical features.
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- 2020
27. Liver Transplantation for the Nonhepatologist
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So, Bethany Nahri and Reddy, K. Rajender
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- 2023
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28. Admission Serum Metabolites and Thyroxine Predict Advanced Hepatic Encephalopathy in a Multicenter Inpatient Cirrhosis Cohort
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Bajaj, Jasmohan S., Tandon, Puneeta, O’Leary, Jacqueline G., Reddy, K. Rajender, Garcia-Tsao, Guadalupe, Thuluvath, Paul, Lai, Jennifer C., Subramanian, Ram M., Vargas, Hugo E., Wong, Florence, Fagan, Andrew, McGeorge, Sara, Thacker, Leroy R., and Kamath, Patrick S.
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- 2023
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29. Clinical Best Practice Advice for Hepatology and Liver Transplant Providers During the COVID‐19 Pandemic: AASLD Expert Panel Consensus Statement
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Fix, Oren K, Hameed, Bilal, Fontana, Robert J, Kwok, Ryan M, McGuire, Brendan M, Mulligan, David C, Pratt, Daniel S, Russo, Mark W, Schilsky, Michael L, Verna, Elizabeth C, Loomba, Rohit, Cohen, David E, Bezerra, Jorge A, Reddy, K Rajender, and Chung, Raymond T
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Clinical Research ,Transplantation ,Organ Transplantation ,Emerging Infectious Diseases ,Liver Disease ,Digestive Diseases ,Oral and gastrointestinal ,Good Health and Well Being ,Betacoronavirus ,COVID-19 ,Comorbidity ,Consensus ,Coronavirus Infections ,Drug Interactions ,Gastroenterology ,Humans ,Immunosuppression Therapy ,Internship and Residency ,Liver Diseases ,Liver Transplantation ,Occupational Health ,Pandemics ,Patient Safety ,Pneumonia ,Viral ,Practice Guidelines as Topic ,SARS-CoV-2 ,Tissue Donors ,COVID-19 Drug Treatment ,Medical Biochemistry and Metabolomics ,Clinical Sciences ,Immunology ,Gastroenterology & Hepatology - Abstract
Background and aimsCoronavirus disease 2019 (COVID-19), the illness caused by the SARS-CoV-2 virus, is rapidly spreading throughout the world. Hospitals and healthcare providers are preparing for the anticipated surge in critically ill patients, but few are wholly equipped to manage this new disease. The goals of this document are to provide data on what is currently known about COVID-19, and how it may impact hepatologists and liver transplant providers and their patients. Our aim is to provide a template for the development of clinical recommendations and policies to mitigate the impact of the COVID-19 pandemic on liver patients and healthcare providers.Approach and resultsThis article discusses what is known about COVID-19 with a focus on its impact on hepatologists, liver transplant providers, patients with liver disease, and liver transplant recipients. We provide clinicians with guidance for how to minimize the impact of the COVID-19 pandemic on their patients' care.ConclusionsThe situation is evolving rapidly, and these recommendations will need to evolve as well. As we learn more about how the COVID-19 pandemic impacts the care of patients with liver disease, we will update the online document available at https://www.aasld.org/about-aasld/covid-19-and-liver.
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- 2020
30. Liver and Biliary Tract Disease in Patients with Coronavirus disease-2019 Infection
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Ekpanyapong, Sirina and Reddy, K. Rajender
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- 2023
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31. Long-term Follow-up of Hepatitis C Patients Who Achieved Sustained Virologic Response in the Pragmatic PRIORITIZE Study
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Morelli, Giuseppe, Peter, Joy, Nelson, David R., Pearlman, Brian, Michael, Larry, Fried, Michael W., Segal, Jodi B., Sulkowski, Mark S., Lok, Anna S., Moon, Juhi, Sherman, Kenneth E., Khalili, Mandana, Fishbein, Dawn, and Reddy, K. Rajender
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- 2023
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32. The SHELTER Trial of Transplanting Hepatitis C Virus–Infected Lungs Into Uninfected Recipients
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Reese, Peter P., Diamond, Joshua M., Goldberg, David S., Potluri, Vishnu, Prenner, Stacey, Blumberg, Emily A., Van Deerlin, Vivianna M., Reddy, K. Rajender, Mentch, Heather, Hasz, Richard, Woodards, Ashley, Gentile, Caren, Smith, Jennifer, Bermudez, Christian, and Crespo, Maria M.
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- 2023
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33. THU-060 Lower inpatient mortality and second infections in inpatients with cirrhosis managed between 2021–22 than between 2011–13 in prospective North American cohorts
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Bajaj, Jasmohan, primary, Tandon, Puneeta, additional, Thuluvath, Paul J., additional, Wong, Florence, additional, Kamath, Patrick S., additional, Vargas, Hugo, additional, Asrani, Sumeet, additional, O'Leary, Jacqueline, additional, Thacker, Leroy, additional, and Reddy, K. Rajender, additional
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- 2024
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34. Safety and efficacy of continuous terlipressin infusion in HRS-AKI in a transplant population
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Reddy, K. Rajender, primary, Weinberg, Ethan M., additional, Gonzalez, Stevan A., additional, Izzy, Manhal J., additional, Simonetto, Douglas A., additional, Frederick, R. Todd, additional, Rubin, Raymond A., additional, Fricker, Zachary, additional, Ikahihifo-Bender, Jade, additional, Harte, Maggie, additional, Garcia, Sandra, additional, Campbell, Kathryn, additional, Olofson, Amy, additional, Razavi, Ryan F., additional, James, Janelle M., additional, Patel, Het, additional, Kim-Lee, Grace, additional, Witkiewicz, Sherry, additional, Tobin, William, additional, and Jamil, Khurram, additional
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- 2024
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35. Donor and recipient genetics: implications for the development of post-transplant diabetes mellitus
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Shaked, Oren, primary, Loza, Bao-Li, additional, Olthoff, Kim M., additional, Reddy, K. Rajender, additional, Keating, Brendan J., additional, Testa, Giuliano, additional, Asrani, Sumeet K., additional, and Shaked, Abraham, additional
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- 2024
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36. Hepatitis B virus reactivation associated with new classes of immunosuppressants and immunomodulators: A systematic review, meta-analysis, and expert opinion
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Papatheodoridis, George V., Lekakis, Vasileios, Voulgaris, Thodoris, Lampertico, Pietro, Berg, Thomas, Chan, Henry L.Y., Kao, Jia-Horng, Terrault, Norah, Lok, Anna S., and Reddy, K. Rajender
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- 2022
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37. Weight Loss and Weight Regain in Usual Clinical Practice: Results From the TARGET-NASH Observational Cohort
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Malespin, Miguel H., Barritt, Alfred Sidney, IV, Watkins, Stephanie E., Schoen, Cheryl, Tincopa, Monica A., Corbin, Karen D., Mospan, Andrea R., Munoz, Breda, Trinh, Huy N., Weiss, L. Michael, Reddy, K. Rajender, Loomba, Rohit, Kemmer, Nyingi, and Lok, Anna S.
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- 2022
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38. Patient-reported symptoms during and after direct-acting antiviral therapies for chronic hepatitis C: The PROP UP study
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Evon, Donna M, Sarkar, Souvik, Amador, Jipcy, Lok, Anna S, Sterling, Richard K, Stewart, Paul W, Reeve, Bryce B, Serper, Marina, Reau, Nancy, Reddy, K Rajender, Di Bisceglie, Adrian M, Nelson, David R, Golin, Carol E, Lim, Joseph K, and Fried, Michael W
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Behavioral and Social Science ,Infectious Diseases ,Emerging Infectious Diseases ,Clinical Research ,Brain Disorders ,Hepatitis - C ,Hepatitis ,Chronic Liver Disease and Cirrhosis ,Liver Disease ,Digestive Diseases ,Mental Health ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Good Health and Well Being ,2-Naphthylamine ,Adult ,Aged ,Aged ,80 and over ,Amides ,Anilides ,Antiviral Agents ,Benzimidazoles ,Benzofurans ,Carbamates ,Cyclopropanes ,Drug Therapy ,Combination ,Female ,Fluorenes ,Hepacivirus ,Hepatitis C ,Chronic ,Heterocyclic Compounds ,4 or More Rings ,Humans ,Imidazoles ,Lactams ,Macrocyclic ,Macrocyclic Compounds ,Male ,Middle Aged ,Patient Reported Outcome Measures ,Proline ,Prospective Studies ,Quinoxalines ,Ritonavir ,Sofosbuvir ,Sulfonamides ,Sustained Virologic Response ,Uracil ,Valine ,Young Adult ,HCV ,Liver ,PRO ,Patient-reported outcome ,Quality of life ,Treatment ,Sleep ,Pain ,Functioning ,Symptom ,Clinical Sciences ,Public Health and Health Services ,Gastroenterology & Hepatology - Abstract
Background & aimsA comprehensive analysis of changes in symptoms and functioning during and after direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection has not been conducted for patients treated in real-world clinical settings. Therefore, we evaluated patient-reported outcomes (PROs) in a diverse cohort of patients with HCV treated with commonly prescribed DAAs.MethodsPROP UP is a US multicenter observational study of 1,601 patients with HCV treated with DAAs in 2016-2017. PRO data were collected at baseline (T1), early on-treatment (T2), late on-treatment (T3) and 3-months post-treatment (T4). PRO mean change scores were calculated from baseline and a minimally important change (MIC) threshold was set at 5%. Regression analyses investigated patient and treatment characteristics independently associated with PRO changes on-treatment and post-treatment.ResultsOf 1,564 patients, 55% were male, 39% non-white, 47% had cirrhosis. Sofosbuvir/ledipasvir was prescribed to 63%, sofosbuvir/velpatasvir to 21%, grazoprevir/elbasvir to 11%, and paritaprevir/ombitasvir/ritonavir + dasabuvir to 5%. During DAA therapy, mean PRO scores improved slightly in the overall cohort, but did not reach the 5% MIC threshold. Between 21-53% of patients experienced >5% improved PROs while 23-36% experienced >5% worse symptoms. Of 1,410 patients with evaluable sustained virologic response (SVR) data, 95% achieved SVR. Among those with SVR, all mean PRO scores improved, with the 5% MIC threshold met for fatigue, sleep disturbance, and functioning well-being. Regression analyses identified subgroups, defined by age 35-55, baseline mental health issues and a higher number of health comorbidities as predictors of PRO improvements.ConclusionsIn real-world clinical practices, we observed heterogeneous patient experiences during and after DAA treatment. Symptom improvements were more pronounced in younger patients, those with baseline mental health issues and multiple comorbidities.Lay summaryPatients who received direct-acting antiviral medications for hepatitis C at several liver centers in the US did not generally experience significant changes in baseline symptoms during treatment. We observed a full range of patient experiences with some patients experiencing substantial symptom improvements, yet others experiencing less improvements and some even experiencing a worsening of symptoms. The 1,346 patients who were cured of hepatitis C experienced improvements in fatigue, sleep disturbance, and functional well-being, and trends for improved pain and depression; whereas the 64 who were not cured experienced minimal improvements. Clinicaltrial.gov: NCT02601820.
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- 2019
39. Determinants of Liver Complications Among HIV/Hepatitis B Virus-Coinfected Patients.
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Lo Re, Vincent, Newcomb, Craig W, Carbonari, Dena M, Roy, Jason A, Althoff, Keri N, Kitahata, Mari M, Reddy, K Rajender, Lim, Joseph K, Silverberg, Michael J, Mayor, Angel M, Horberg, Michael A, Cachay, Edward R, Kirk, Gregory D, Hull, Mark, Gill, John, Sterling, Timothy R, Kostman, Jay R, Peters, Marion G, Moore, Richard D, Klein, Marina B, and Kim, H Nina
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Public Health ,Biomedical and Clinical Sciences ,Clinical Sciences ,Health Sciences ,Hepatitis ,Clinical Research ,Digestive Diseases ,HIV/AIDS ,Infectious Diseases ,Alcoholism ,Alcohol Use and Health ,Chronic Liver Disease and Cirrhosis ,Substance Misuse ,Hepatitis - B ,Rare Diseases ,Sexually Transmitted Infections ,Liver Disease ,Liver Cancer ,Cancer ,Aetiology ,2.1 Biological and endogenous factors ,Infection ,Good Health and Well Being ,Adult ,CD4 Lymphocyte Count ,Canada ,Carcinoma ,Hepatocellular ,End Stage Liver Disease ,Esophageal and Gastric Varices ,Female ,Gastrointestinal Hemorrhage ,HIV Infections ,Hepatitis B ,Humans ,Liver ,Liver Cirrhosis ,Liver Neoplasms ,Male ,Middle Aged ,Retrospective Studies ,Risk Factors ,United States ,hepatitis B ,HIV ,end-stage liver disease ,hepatocellular carcinoma ,coinfection ,North American AIDS Cohort Collaboration on Research and Design of IeDEA ,Public Health and Health Services ,Virology ,Clinical sciences ,Epidemiology ,Public health - Abstract
BackgroundHepatitis B virus (HBV) infection is a leading cause of end-stage liver disease (ESLD) and hepatocellular carcinoma (HCC) in HIV. Factors contributing to the high rates of liver complications among HIV/HBV-coinfected individuals remain unknown.SettingNorth American AIDS Cohort Collaboration on Research and Design.MethodsWe performed a retrospective cohort study among HIV/HBV-coinfected patients in 10 US and Canadian cohorts of the North American AIDS Cohort Collaboration on Research and Design that validated ESLD (ascites, spontaneous bacterial peritonitis, variceal hemorrhage, and/or hepatic encephalopathy) and HCC diagnoses from 1996 to 2010. Multivariable Cox regression was used to examine adjusted hazard ratios [aHRs with 95% confidence interval (CIs)] of liver complications (first occurrence of ESLD or HCC) associated with hypothesized determinants and with increasing durations of HIV suppression (≤500 copies/mL).ResultsAmong 3573 HIV/HBV patients with 13,790 person-years of follow-up, 111 liver complications occurred (incidence rate = 8.0 [95% CI: 6.6 to 9.7] events/1000 person-years). Rates of liver complication were increased with non-black/non-Hispanic race [aHR = 1.76 (1.13-2.74)], diabetes mellitus [aHR = 2.07 (1.20-3.57)], lower time-updated CD4 cell count [3.25: aHR = 9.79 (5.73-16.74); 1.45-3.25: aHR = 3.20 (1.87-5.47) versus FIB-4
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- 2019
40. Nosocomial Infections Are Frequent and Negatively Impact Outcomes in Hospitalized Patients With Cirrhosis.
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Bajaj, Jasmohan S, OʼLeary, Jacqueline G, Tandon, Puneeta, Wong, Florence, Garcia-Tsao, Guadalupe, Kamath, Patrick S, Biggins, Scott W, Lai, Jennifer C, Vargas, Hugo E, Maliakkal, Benedict, Fallon, Michael B, Thuluvath, Paul J, Subramanian, Ram M, Thacker, Leroy R, and Reddy, K Rajender
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Medical Microbiology ,Biomedical and Clinical Sciences ,Clinical Sciences ,Liver Disease ,Chronic Liver Disease and Cirrhosis ,Infectious Diseases ,Digestive Diseases ,Infection ,Oral and gastrointestinal ,Good Health and Well Being ,Adult ,Age Distribution ,Aged ,Cause of Death ,Cohort Studies ,Cross Infection ,End Stage Liver Disease ,Female ,Hospital Mortality ,Hospitalization ,Humans ,Incidence ,Liver Function Tests ,Male ,Middle Aged ,Prognosis ,Prospective Studies ,Reference Values ,Risk Assessment ,Sex Distribution ,Treatment Outcome ,Gastroenterology & Hepatology ,Clinical sciences - Abstract
ObjectivesNosocomial infections (NIs) can be a major cause of morbidity and mortality in cirrhosis. This study aims to define the determinants of NI development and its impact on 30-day outcomes among hospitalized patients with cirrhosis.MethodsNorth American Consortium for the Study of End-Stage Liver Disease enrolled patients with cirrhosis who were admitted nonelectively. Admission variables and 30-day outcomes were compared between patients with and without NI. These were also compared based on whether there was an isolated admission infection, NI, or both. Models were created for NI development using admission variables and for 30-day mortality.ResultsThe study included 2,864 patients; of which, 15% (n = 436) developed NI. When comparing NI vs no NI, 1,866 patients were found to be infection free, whereas 562 had admission infections only, 228 had only NI, and 208 had both infections. At admission, patients with NI were more likely to be infected and have advanced cirrhosis. NIs were associated with higher rates of acute-on-chronic liver failure, death, and transplant regardless of admission infections. Patients with NI had higher respiratory infection, urinary tract infection, Clostridium difficile infection, fungal infections, and infection with vancomycin-resistant enterococci compared with patients without NI. Risk factors for NIs were admission infections, model for end-stage liver disease (MELD) > 20, systemic inflammatory response syndrome criteria, proton pump inhibitor, rifaximin, and lactulose use, but the regression model (sensitivity, 0.67; specificity, 0.63) was not robust. Age, alcohol etiology, admission MELD score, lactulose use, acute-on-chronic liver failure, acute kidney injury, intensive care unit, and NI increased the risk of death, whereas rifaximin decreased the risk of death.DiscussionNIs are prevalent in hospitalized patients with cirrhosis and are associated with poor outcomes. Although higher MELD scores and systemic inflammatory response syndrome are associated with NI, all hospitalized patients with cirrhosis require vigilance and preventive strategies.
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- 2019
41. Targets to improve quality of care for patients with hepatic encephalopathy: data from a multi‐centre cohort
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Bajaj, Jasmohan S, O’Leary, Jacqueline G, Tandon, Puneeta, Wong, Florence, Kamath, Patrick S, Biggins, Scott W, Garcia‐Tsao, Guadalupe, Lai, Jennifer, Fallon, Michael B, Thuluvath, Paul J, Vargas, Hugo E, Maliakkal, Benedict, Subramanian, Ram M, Thacker, Leroy R, and Reddy, K Rajender
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Digestive Diseases ,Liver Disease ,Clinical Research ,Aged ,Cohort Studies ,Drug Therapy ,Combination ,End Stage Liver Disease ,Female ,Gastrointestinal Agents ,Hepatic Encephalopathy ,Humans ,Lactulose ,Liver Cirrhosis ,Male ,Middle Aged ,Quality of Health Care ,Recurrence ,Rifaximin ,Clinical Sciences ,Pharmacology and Pharmaceutical Sciences ,Gastroenterology & Hepatology - Abstract
BackgroundHepatic encephalopathy (HE) can adversely affect outcomes in both in-patients and out-patients with cirrhosis.AimTo define targets for improving quality of care in HE management in the multi-centre North American Consortium for End-Stage Liver Disease (NACSELD) cohort.MethodNACSELD in-patient cohort was analysed for (a) medication-associated precipitants, (b) aspiration pneumonia development, (c) HE medication changes, and (d) 90-day HE recurrence/readmissions. Comparisons were made between patients on no-therapy, lactulose only, rifaximin only or both. Ninety-day HE-readmission analysis was adjusted for MELD score.ResultsTwo thousand eight hundred and ten patients (1102 no-therapy, 659 lactulose, 154 rifaximin, 859 both) were included. HE on admission, and HE rates during hospitalisation were highest in those on lactulose only or dual therapy compared to no-therapy or rifaximin only (P
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- 2019
42. Outcomes in Patients With Cirrhosis on Primary Compared to Secondary Prophylaxis for Spontaneous Bacterial Peritonitis.
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Bajaj, Jasmohan S, Tandon, Puneeta, OʼLeary, Jacqueline G, Wong, Florence, Biggins, Scott W, Garcia-Tsao, Guadalupe, Kamath, Patrick S, Maliakkal, Benedict, Fallon, Michael B, Lai, Jennifer C, Thuluvath, Paul J, Vargas, Hugo E, Subramanian, Ram M, Thacker, Leroy R, and Reddy, K Rajender
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Biomedical and Clinical Sciences ,Clinical Sciences ,Digestive Diseases ,Clinical Research ,Chronic Liver Disease and Cirrhosis ,Liver Disease ,Prevention ,Patient Safety ,Good Health and Well Being ,Antibiotic Prophylaxis ,Bacterial Infections ,Biomarkers ,Female ,Humans ,Liver Cirrhosis ,Male ,Middle Aged ,North America ,Peritonitis ,Primary Prevention ,Registries ,Retrospective Studies ,Secondary Prevention ,Gastroenterology & Hepatology ,Clinical sciences - Abstract
ObjectivesAntibiotic prophylaxis is recommended for prevention of the first episode of spontaneous bacterial peritonitis (SBP; primary prophylaxis 1°) and subsequent episodes (secondary prophylaxis 2°). We aimed to compare outcomes in cirrhotic inpatients on 1° vs 2° SBP prophylaxis.MethodsData from North American Consortium for the Study of End-Stage Liver Disease were evaluated for cirrhosis details, reasons for admission/medications, inpatient course recorded, and outcomes over 90 days. Outcomes (intensive care units, acute kidney injury, inpatient/90-day mortality) were compared between the 2 groups after propensity-matching on admission model for end-stage liver disease (MELD) score and serum albumin.ResultsAmong the 2,731 patients enrolled, 305 were on 1° and 187 on 2° SBP prophylaxis. After propensity-matching, 154 patients remained in each group. Patients on 1° prophylaxis were more likely to have admission systemic inflammatory response syndrome (P = 0.02), with higher intensive care unit admissions (31% vs 21%; P = 0.05) and inpatient mortality (19% vs 9%; P = 0.01) than the 2° prophylaxis group. Patients on 2° prophylaxis had higher total (22% vs 10%; P = 0004), readmission (16% vs 9%; P = 0.03), and nosocomial (6% vs 0.5%; P = 0.01) SBP rates with predominant Gram-negative organisms compared to 1° prophylaxis patients. At 90 days, 1° prophylaxis patients had a higher mortality (35% vs 22%; P = 0.02) and acute kidney injury incidence (48% vs 30%; P = 0.04) compared to 2° prophylaxis patients.DiscussionIn this inpatient cirrhosis study, despite prophylaxis, a high proportion of patients developed SBP, which was associated with mortality. Cirrhotic inpatients on 1° prophylaxis had worse outcomes than those on 2° prophylaxis when propensity-matched for the MELD score and serum albumin during the index admission and 90-day follow-up.
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- 2019
43. Hepatitis C Guidance 2018 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection
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Chung, Raymond T, Ghany, Marc G, Kim, Arthur Y, Marks, Kristen M, Naggie, Susanna, Vargas, Hugo E, Aronsohn, Andrew I, Bhattacharya, Debika, Broder, Tina, Falade-Nwulia, Oluwaseun O, Fontana, Robert J, Gordon, Stuart C, Heller, Theo, Holmberg, Scott D, Jhaveri, Ravi, Jonas, Maureen M, Kiser, Jennifer J, Linas, Benjamin P, Re, Vincent Lo, Morgan, Timothy R, Nahass, Ronald G, Peters, Marion G, Reddy, K Rajender, Reynolds, Andrew, Scott, John D, Searson, Gloria, Swan, Tracy, Terrault, Norah A, Trooskin, Stacey B, Wong, John B, and Workowski, Kimberly A
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Infectious Diseases ,Hepatitis ,Chronic Liver Disease and Cirrhosis ,Digestive Diseases ,Hepatitis - C ,Emerging Infectious Diseases ,Prevention ,Liver Disease ,Infection ,Good Health and Well Being ,Antiviral Agents ,Hepacivirus ,Hepatitis C ,Hepatitis C ,Chronic ,Humans ,Practice Guidelines as Topic ,Renal Insufficiency ,Chronic ,United States ,hepatitis C ,direct-acting antiviral treatment ,HCV guidance ,chronic HCV treatment ,AASLD-IDSA HCV Guidance Panel ,Biological Sciences ,Medical and Health Sciences ,Microbiology - Abstract
Recognizing the importance of timely guidance regarding the rapidly evolving field of hepatitis C management, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) developed a web-based process for the expeditious formulation and dissemination of evidence-based recommendations. Launched in 2014, the hepatitis C virus (HCV) guidance website undergoes periodic updates as necessitated by availability of new therapeutic agents and/or research data. A major update was released electronically in September 2017, prompted primarily by approval of new direct-acting antiviral agents and expansion of the guidance's scope. This update summarizes the latest release of the HCV guidance and focuses on new or amended recommendations since the previous September 2015 print publication. The recommendations herein were developed by volunteer hepatology and infectious disease experts representing AASLD and IDSA and have been peer reviewed and approved by each society's governing board.
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- 2018
44. The Course of LIRADS 3 and 4 Hepatic Abnormalities as Correlated With Explant Pathology: A Single Center Experience
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Mettikanont, Panita, Kalluri, Anita, Bittermann, Therese, Phillips, Neil, Loza, Bao-Li, Rosen, Mark, Siegelman, Evan, Furth, Emma, Abt, Peter, Olthoff, Kim, Shaked, Abraham, Hoteit, Maarouf, and Reddy, K. Rajender
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- 2022
- Full Text
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45. Validation of a Novel Multitarget Blood Test Shows High Sensitivity to Detect Early Stage Hepatocellular Carcinoma
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Chalasani, Naga P., Porter, Kyle, Bhattacharya, Abhik, Book, Adam J., Neis, Brenda M., Xiong, Kong M., Ramasubramanian, Tiruvidaimarudur S., Edwards, David K., V, Chen, Irene, Johnson, Scott, Roberts, Lewis R., Kisiel, John B., Reddy, K. Rajender, Singal, Amit G., Olson, Marilyn C., and Bruinsma, Janelle J.
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- 2022
- Full Text
- View/download PDF
46. Liver function and portal‐systemic shunting quantified by the oral cholate challenge test and risk for large oesophageal varices.
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Hassanein, Tarek, Keaveny, Andrew P., Mantry, Parvez, Smith, Alastair D., McRae, Michael P., Kittelson, John, Helmke, Steve, Everson, Gregory T., Bambha, Kiran, Fuchs, Michael, Gilroy, Richard K., Reddy, K. Rajender, Shiffman, Mitchell L., Rahimi, Robert S., Hellstern, Paul A., Hill, John M., Kayali, Zeid, Denham, Doug, Qureshi, Kamran, and Smith, Brian
- Subjects
ESOPHAGEAL varices ,ORAL drug administration ,LIVER diseases ,LIVER function tests ,GENERATING functions - Abstract
Summary: Background: The quantitative HepQuant SHUNT test of liver function and physiology generates a disease severity index (DSI) that correlates with risk for clinical complications, such as large oesophageal varices (LEVs). A derivative test, HepQuant DuO, generates an equivalent DSI and simplifies testing by requiring only oral administration of the test solution and two blood samples at 20 and 60 min. Aims: Since the DSIs measured from DuO and SHUNT are equivalent, we compared the diagnostic performance for large oesophageal varices (LEVs) between the DSIs measured from DuO and SHUNT tests. Methods: This study combined the data from two prospectively conducted US studies: HALT‐C and SHUNT‐V. A total of 455 subjects underwent both the SHUNT test and esophagogastroduodenoscopy (EGD). Results: DSI scores correlated with the probability of LEVs (p < 0.001) and demonstrated a stepwise increase from healthy lean controls without liver disease to subjects with chronic liver disease and no, small or large varices. Furthermore, a cutoff of DSI ≤ 18.3 from DuO had a sensitivity of 0.98 (missing only one case) and, if applied to the endoscopy (EGD) decision, would have prevented 188 EGDs (41.3%). The AUROC for DSI from DuO did not differ from that of the reference SHUNT test method (0.82 versus 0.81, p = 0.3500). Conclusions: DSI from HepQuant DuO links liver function and physiology to the risk of LEVs across a wide spectrum of patient characteristics, disease aetiologies and liver disease severity. DuO is minimally invasive, easy to administer, quantitative and may aid the decision to avoid or perform EGD for LEVs. [ABSTRACT FROM AUTHOR]
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- 2024
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47. A comprehensive assessment of patient reported symptom burden, medical comorbidities, and functional well being in patients initiating direct acting antiviral therapy for chronic hepatitis C: Results from a large US multi-center observational study
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Evon, Donna M, Stewart, Paul W, Amador, Jipcy, Serper, Marina, Lok, Anna S, Sterling, Richard K, Sarkar, Souvik, Golin, Carol E, Reeve, Bryce B, Nelson, David R, Reau, Nancy, Lim, Joseph K, Reddy, K Rajender, Di Bisceglie, Adrian M, and Fried, Michael W
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Biomedical and Clinical Sciences ,Clinical Sciences ,Health Sciences ,Digestive Diseases ,Pain Research ,Hepatitis ,Infectious Diseases ,Chronic Liver Disease and Cirrhosis ,Hepatitis - C ,Patient Safety ,Emerging Infectious Diseases ,Chronic Pain ,Clinical Research ,Clinical Trials and Supportive Activities ,Liver Disease ,Substance Misuse ,Good Health and Well Being ,Adult ,Aged ,Aged ,80 and over ,Antiviral Agents ,Cohort Studies ,Comorbidity ,Female ,Hepatitis C ,Chronic ,Humans ,Insurance ,Major Medical ,International Normalized Ratio ,Liver ,Liver Cirrhosis ,Male ,Mental Disorders ,Middle Aged ,Patient Reported Outcome Measures ,RNA ,Viral ,United States ,Young Adult ,General Science & Technology - Abstract
BackgroundSymptom burden, medical comorbidities, and functional well-being of patients with chronic hepatitis C virus (HCV) initiating direct acting antiviral (DAA) therapy in real-world clinical settings are not known. We characterized these patient-reported outcomes (PROs) among HCV-infected patients and explored associations with sociodemographic, liver disease, and psychiatric/substance abuse variables.Methods and findingsPROP UP is a large US multicenter observational study that enrolled 1,600 patients with chronic HCV in 2016-2017. Data collected prior to initiating DAA therapy assessed the following PROs: number of medical comorbidities; neuropsychiatric, somatic, gastrointestinal symptoms (PROMIS surveys); overall symptom burden (Memorial Symptom Assessment Scale); and functional well-being (HCV-PRO). Candidate predictors included liver disease markers and patient-reported sociodemographic, psychiatric, and alcohol/drug use features. Predictive models were explored using a random selection of 700 participants; models were then validated with data from the remaining 900 participants. The cohort was 55% male, 39% non-white, 48% had cirrhosis (12% with advanced cirrhosis); 52% were disabled or unemployed; 63% were on public health insurance or uninsured; and over 40% had markers of psychiatric illness. The median number of medical comorbidities was 4 (range: 0-15), with sleep disorders, chronic pain, diabetes, joint pain and muscle aches being present in 20-50%. Fatigue, sleep disturbance, pain and neuropsychiatric symptoms were present in over 60% and gastrointestinal symptoms in 40-50%. In multivariable validation models, the strongest and most frequent predictors of worse PROs were disability, unemployment, and use of psychiatric medications, while liver markers generally were not.ConclusionsThis large multi-center cohort study provides a comprehensive and contemporary assessment of the symptom burden and comorbid medical conditions in patients with HCV treated in real world settings. Pain, fatigue, and sleep disturbance were common and often severe. Sociodemographic and psychiatric markers were the most robust predictors of PROs. Future research that includes a rapidly changing population of HCV-infected individuals needs to evaluate how DAA therapy affects PROs and elucidate which symptoms resolve with viral eradication.Trial registration(Clinicaltrial.gov: NCT02601820).
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- 2018
48. A Novel Blood-Based Panel of Methylated DNA and Protein Markers for Detection of Early-Stage Hepatocellular Carcinoma
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Chalasani, Naga P., Ramasubramanian, Tiruvidaimarudur S., Bhattacharya, Abhik, Olson, Marilyn C., Edwards V, David K., Roberts, Lewis R., Kisiel, John B., Reddy, K. Rajender, Lidgard, Graham P., Johnson, Scott C., and Bruinsma, Janelle J.
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- 2021
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49. Impacts of glucagon‐like peptide‐1 receptor agonists on the risk of adverse liver outcomes in patients with metabolic dysfunction‐associated steatotic liver disease cirrhosis and type 2 diabetes
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Elsaid, Mohamed I., primary, Li, Na, additional, Firkins, Stephen A., additional, Rustgi, Vinod K., additional, Paskett, Electra D., additional, Acharya, Chathur, additional, Reddy, K. Rajender, additional, Chiang, Chien Wei, additional, and Mumtaz, Khalid, additional
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- 2024
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50. In the Era of Direct-Acting Antivirals, Liver Transplant Delisting Due to Clinical Improvement for Hepatitis C Remains Infrequent
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Bittermann, Therese and Reddy, K. Rajender
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- 2021
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