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2. FRI-074-YI Rifaximin reduces healthcare utilization but not overall costs in patients with cirrhosis and recurrent episodes of hepatic encephalopathy: a retrospective efficacy study

Author

van Doorn, Diederick, primary, van Eekhout, Kirsi, additional, de Wit, Koos, additional, Baak, L.C., additional, Klemt-Kropp, Michael, additional, Verwer, Bart, additional, Friederich, Philip W., additional, de Bruin, Gijs J., additional, Vos, Xander, additional, and Bart Takkenberg, R., additional

Published
2024
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3. Safety of two different doses of simvastatin plus rifaximin in decompensated cirrhosis (LIVERHOPE-SAFETY): a randomised, double-blind, placebo-controlled, phase 2 trial

Author

Pose, Elisa, Napoleone, Laura, Amin, Ahmed, Campion, Daniela, Jimenez, César, Piano, Salvatore, Roux, Olivier, Uschner, Frank Erhard, de Wit, Koos, Zaccherini, Giacomo, Alessandria, Carlo, Angeli, Paolo, Bernardi, Mauro, Beuers, Ulrich, Caraceni, Paolo, Durand, François, Mookerjee, Rajeshwar P, Trebicka, Jonel, Vargas, Victor, Andrade, Raúl J, Carol, Marta, Pich, Judit, Ferrero, Juan, Domenech, Gema, Llopis, Marta, Torres, Ferran, Kamath, Patrick S, Abraldes, Juan G, Solà, Elsa, and Ginès, Pere

Published
2020
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4. Simvastatin plus Rifaximin to prevent ACLF in patients with decompensated cirrhosis. A randomised, double-blind, placebo-controlled, phase-3 trial: the liverhope efficacy trial

Author

Pose, Elisa, primary, Jiménez, César, additional, Zaccherini, Giacomo, additional, Campion, Daniela, additional, Piano, Salvatore, additional, Uschner, Frank Erhard, additional, de Wit, Koos, additional, Roux, Olivier, additional, Gananandan, Kohilan, additional, Laleman, Wim, additional, Solé, Cristina, additional, Alonso, Sonia, additional, Cuyas, Berta, additional, Ariza, Xavier, additional, Juanola, Adria, additional, Ma, Ann T, additional, Napoleone, Laura, additional, Gratacos, Jordi, additional, Tonon, Marta, additional, Pompili, Enrico, additional, Sánchez-Delgado, Jordi, additional, Carol, Marta, additional, Perez, Martina, additional, Fabrellas, Núria, additional, Pich, Judit, additional, Martell, Claudia, additional, Casanovas, Georgina, additional, Domenech, Gemma, additional, Torres, Ferran, additional, Manuel, Víctor, additional, Blasco, Vargas, additional, Caraceni, Paolo, additional, Alessandria, Carlo, additional, Angeli, Paolo, additional, Trebicka, Jonel, additional, Beuers, Ulrich, additional, Francoz, Claire, additional, Mookerjee, Raj, additional, Bañares, Rafael, additional, Soriano, German, additional, Hernaez, Ruben, additional, Allegretti, Andrew S., additional, Morales-Ruiz, Manuel, additional, Serra, Miquel, additional, Watson, Hugh, additional, Abraldes, Juan G, additional, Kamath, Patrick S., additional, and Ginès, Pere, additional

Published
2023
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5. Novel prognostic biomarkers in decompensated cirrhosis: a systematic review and meta-analysis

Author

Juanola, Adrià, Ma, Ann Thu, de Wit, Koos, Gananandan, Kohilan, Roux, Olivier, Zaccherini, Giacomo, Jiménez, César, Tonon, Marta, Solé, Cristina, Villaseca, Clara, Uschner, Frank E, Graupera, Isabel, Pose, Elisa, Moreta, Maria José, Campion, Daniela, Beuers, Ulrich, Mookerjee, Rajeshawar P, Francoz, Claire, Durand, Francois, Vargas, Victor, Piano, Salvatore, Alonso, Sonia, Trebicka, Jonel, Laleman, Wim, Asrani, Sumeet K, Soriano, German, Alessandria, Carlo, Serra-Burriel, Miquel, Morales-Ruiz, Manuel, Torres, Ferran, Allegretti, Andrew S, Krag, Aleksander, Caraceni, Paolo, Watson, Hugh, Abraldes, Juan G, Solà, Elsa, Kamath, Patrick S, Hernaez, Ruben, and Ginès, Pere

Abstract

BackgroundPatients with decompensated cirrhosis experience high mortality rates. Current prognostic scores, including the model for end-stage liver disease (MELD), may underperform in settings other than in those they were initially developed. Novel biomarkers have been proposed to improve prognostication accuracy and even to predict development of complications.MethodsWe performed a systematic review and meta-analysis on novel urine and blood biomarkers and their ability to predict 90-day mortality in patients with decompensated cirrhosis. Secondary outcomes included 28-day and 1-year mortality, and development of acute-on-chronic liver failure, acute kidney injury and other complications. To overcome differences in units, temporal changes in assays and reporting heterogeneity, we used the ratio of means (RoM) as measure of association for assessing strength in predicting outcomes. An RoM>1 implies that the mean biomarker level is higher in those that develop the outcome than in those that do not.ResultsOf 6629 unique references, 103 were included, reporting on 29 different biomarkers, with a total of 31 362 biomarker patients. Most studies were prospective cohorts of hospitalised patients (median Child-Pugh-Turcotte score of 9 and MELD score of 18). The pooled 90-day mortality rate was 0.27 (95% CI 0.24 to 0.29). The RoM for predicting 90-day mortality was highest for interleukin 6 (IL-6) (2.56, 95% CI 2.39 to 2.74), followed by urinary neutrophil gelatinase-associated lipocalin (uNGAL) (2.42, 95% CI 2.20 to 2.66) and copeptin (2.33, 95% CI 2.17 to 2.50). These RoMs were all higher than for MELD (1.44, 95% CI 1.42 to 1.46).ConclusionNovel biomarkers, including IL-6, uNGAL and copeptin, can probably improve prognostication of patients with decompensated cirrhosis compared with MELD alone.

Published
2024
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7. Issue Cover

Author

de Wit, Koos, primary, Beuers, Ulrich, additional, Mukha, Anna, additional, Stigter, Edwin C. A., additional, Gulersonmez, M. Can, additional, Ramos Pittol, Jose M., additional, Middendorp, Sabine, additional, Takkenberg, R. Bart, additional, and van Mil, Saskia W. C., additional

Published
2023
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12. Treatment With Simvastatin and Rifaximin Restores the Plasma Metabolomic Profile in Patients With Decompensated Cirrhosis

Author

Pose, Elisa, primary, Solà, Elsa, additional, Lozano, Juan J., additional, Juanola, Adrià, additional, Sidorova, Julia, additional, Zaccherini, Giacomo, additional, de Wit, Koos, additional, Uschner, Frank, additional, Tonon, Marta, additional, Kazankov, Konstantin, additional, Jiménez, Cesar, additional, Campion, Daniela, additional, Napoleone, Laura, additional, Ma, Ann T., additional, Carol, Marta, additional, Morales-Ruiz, Manuel, additional, Alessandria, Carlo, additional, Beuers, Ulrich, additional, Caraceni, Paolo, additional, Francoz, Claire, additional, Durand, François, additional, Mookerjee, Rajeshwar P., additional, Trebicka, Jonel, additional, Vargas, Victor, additional, Piano, Salvatore, additional, Watson, Hugh, additional, Abraldes, Juan G., additional, Kamath, Patrick S., additional, Davis, Mark M., additional, Ginès, Pere, additional, Schulz, M., additional, Ferstl, P., additional, Giovo, I., additional, Roux, O., additional, Simon-Talero, M., additional, Pérez-Guasch, M., additional, Rubio, A. B., additional, Cervera, M., additional, Martínez, S., additional, Fabrellas, N., additional, Pich, J., additional, Vives, A., additional, Avitabile, E., additional, Graupera, I., additional, Solé, C., additional, Bassegoda, O., additional, Gratacós-Ginès, J., additional, Joyera, M., additional, Palacio, E., additional, Aban, M., additional, Lanzillotti, T., additional, Nicolao, G., additional, Chiappa, M. T., additional, Esnault, V., additional, Andrade, R., additional, Pavesi, M., additional, Korenjak, M., additional, Farrés, J., additional, Serra-Burriel, M., additional, and Angeli, P., additional

Published
2022
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13. Rifaximin stimulates nitrogen detoxification by PXR‐independent mechanisms in human small intestinal organoids.

Author

de Wit, Koos, Beuers, Ulrich, Mukha, Anna, Stigter, Edwin C. A., Gulersonmez, M. Can, Ramos Pittol, Jose M., Middendorp, Sabine, Takkenberg, R. Bart, and van Mil, Saskia W. C.

Subjects
*RIFAXIMIN, *PREGNANE X receptor, *AMINO acid metabolism, *HEPATIC encephalopathy, *ORGANOIDS
Abstract

Background and Aims: Recurrent hepatic encephalopathy (HE) is characterized by hyperammonaemia in combination with neuropsychiatric abnormalities and is treated with lactulose and rifaximin. Rifaximin is a pregnane X receptor (PXR) agonist with low systemic and high intestinal bioavailability. The mechanisms by which it alleviates HE are unclear. We used human small intestinal (hSI) organoids to study whether rifaximin, via PXR activation, affects the epithelial biotransformation machinery, and to gain understanding of its low systemic availability. Methods: We generated PXR knockdown hSI organoids via lentiviral delivery of short hairpin RNAs. Organoids were cultured for 24 h with rifaximin or rifampicin. RNA‐sequencing and metabolomics were performed to analyse gene expression and amino acid metabolism. Luminal rifaximin was quantified by photospectrometry. Results: Treatment of wild‐type hSI organoids with rifaximin resulted in >twofold differential expression of 131 genes compared to DMSO. These effects were largely PXR independent and related to amino acid metabolism. Rifaximin decreased expression of glutaminase‐2 and increased expression of asparagine synthetase and solute carrier 7A11, thereby increasing intracellular glutamine and asparagine concentrations, indicating active ammonia detoxification. Rifaximin was apically excreted into the lumen in an ATP binding cassette B1 (ABCB1)‐dependent manner. Conclusions: Rifaximin—after uptake into enterocytes—stimulates intracellular nitrogen detoxification by PXR‐independent mechanisms. Active apical excretion of rifaximin by ABCB1 into the intestinal lumen explains its low systemic bioavailability. Our study implies that rifaximin, next to modulation of the microbiome, has direct effects on ammonia scavenging in the human small intestinal epithelium. [ABSTRACT FROM AUTHOR]

Published
2023
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14. Endpoints and design of clinical trials in patients with decompensated cirrhosis: Position paper of the LiverHope Consortium

Author

Solà, Elsa, primary, Pose, Elisa, additional, Campion, Daniela, additional, Piano, Salvatore, additional, Roux, Olivier, additional, Simon-Talero, Macarena, additional, Uschner, Frank, additional, de Wit, Koos, additional, Zaccherini, Giacomo, additional, Alessandria, Carlo, additional, Beuers, Ulrich, additional, Caraceni, Paolo, additional, Francoz, Claire, additional, Mookerjee, Rajeshwar P., additional, Trebicka, Jonel, additional, Vargas, Victor, additional, Serra, Miquel, additional, Torres, Ferran, additional, Montagnese, Sara, additional, Krag, Aleksander, additional, Hernaez, Ruben, additional, Korenjak, Marko, additional, Watson, Hugh, additional, Abraldes, Juan G., additional, Kamath, Patrick S., additional, Ginès, Pere, additional, Durand, F., additional, Bernardi, M., additional, Solé, C., additional, Pich, J., additional, Graupera, I., additional, Napoleone, L., additional, Jiménez, C., additional, Juanola, A., additional, Avitabile, E., additional, Ma, A., additional, Fabrellas, N., additional, Carol, M., additional, Palacio, E., additional, Aban, M., additional, Lanzillotti, T., additional, Nicolao, G., additional, Chiappa, M.T., additional, Esnault, V., additional, Forner, A., additional, Graf-Dirmeier, S., additional, Helder, J., additional, Lopez, M., additional, Cervera, M., additional, and Pérez-Guasch, M., additional

Published
2021
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15. LBO-01 - Simvastatin plus Rifaximin to prevent ACLF in patients with decompensated cirrhosis. A randomised, double-blind, placebo-controlled, phase-3 trial: the liverhope efficacy trial

Author

Pose, Elisa, Jiménez, César, Zaccherini, Giacomo, Campion, Daniela, Piano, Salvatore, Uschner, Frank Erhard, de Wit, Koos, Roux, Olivier, Gananandan, Kohilan, Laleman, Wim, Solé, Cristina, Alonso, Sonia, Cuyas, Berta, Ariza, Xavier, Juanola, Adria, Ma, Ann T, Napoleone, Laura, Gratacos, Jordi, Tonon, Marta, Pompili, Enrico, Sánchez-Delgado, Jordi, Carol, Marta, Perez, Martina, Fabrellas, Núria, Pich, Judit, Martell, Claudia, Casanovas, Georgina, Domenech, Gemma, Torres, Ferran, Manuel, Víctor, Blasco, Vargas, Caraceni, Paolo, Alessandria, Carlo, Angeli, Paolo, Trebicka, Jonel, Beuers, Ulrich, Francoz, Claire, Mookerjee, Raj, Bañares, Rafael, Soriano, German, Hernaez, Ruben, Allegretti, Andrew S., Morales-Ruiz, Manuel, Serra, Miquel, Watson, Hugh, Abraldes, Juan G, Kamath, Patrick S., and Ginès, Pere

Published
2023
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18. The Use of Rifaximin in Patients With Cirrhosis.

Author

Caraceni, Paolo, Vargas, Victor, Solà, Elsa, Alessandria, Carlo, de Wit, Koos, Trebicka, Jonel, Angeli, Paolo, Mookerjee, Rajeshwar P., Durand, François, Pose, Elisa, Krag, Aleksander, Bajaj, Jasmohan S., Beuers, Ulrich, Ginès, Pere, Juanola, Adrià, Napoleone, Laura, Carol, Marta, Avitabile, Emma, Thu, Ann Ma, and Cervera, Marta

Published
2021
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22. Novel prognostic biomarkers in decompensated cirrhosis: a systematic review and meta-analysis.

Author

Juanola A, Ma AT, de Wit K, Gananandan K, Roux O, Zaccherini G, Jiménez C, Tonon M, Solé C, Villaseca C, Uschner FE, Graupera I, Pose E, Moreta MJ, Campion D, Beuers U, Mookerjee RP, Francoz C, Durand F, Vargas V, Piano S, Alonso S, Trebicka J, Laleman W, Asrani SK, Soriano G, Alessandria C, Serra-Burriel M, Morales-Ruiz M, Torres F, Allegretti AS, Krag A, Caraceni P, Watson H, Abraldes JG, Solà E, Kamath PS, Hernaez R, and Ginès P

Subjects
Humans, Prognosis, Prospective Studies, Interleukin-6, Severity of Illness Index, Biomarkers, Liver Cirrhosis complications, End Stage Liver Disease
Abstract

Background: Patients with decompensated cirrhosis experience high mortality rates. Current prognostic scores, including the model for end-stage liver disease (MELD), may underperform in settings other than in those they were initially developed. Novel biomarkers have been proposed to improve prognostication accuracy and even to predict development of complications., Methods: We performed a systematic review and meta-analysis on novel urine and blood biomarkers and their ability to predict 90-day mortality in patients with decompensated cirrhosis. Secondary outcomes included 28-day and 1-year mortality, and development of acute-on-chronic liver failure, acute kidney injury and other complications. To overcome differences in units, temporal changes in assays and reporting heterogeneity, we used the ratio of means (RoM) as measure of association for assessing strength in predicting outcomes. An RoM>1 implies that the mean biomarker level is higher in those that develop the outcome than in those that do not., Results: Of 6629 unique references, 103 were included, reporting on 29 different biomarkers, with a total of 31 362 biomarker patients. Most studies were prospective cohorts of hospitalised patients (median Child-Pugh-Turcotte score of 9 and MELD score of 18). The pooled 90-day mortality rate was 0.27 (95% CI 0.24 to 0.29). The RoM for predicting 90-day mortality was highest for interleukin 6 (IL-6) (2.56, 95% CI 2.39 to 2.74), followed by urinary neutrophil gelatinase-associated lipocalin (uNGAL) (2.42, 95% CI 2.20 to 2.66) and copeptin (2.33, 95% CI 2.17 to 2.50). These RoMs were all higher than for MELD (1.44, 95% CI 1.42 to 1.46)., Conclusion: Novel biomarkers, including IL-6, uNGAL and copeptin, can probably improve prognostication of patients with decompensated cirrhosis compared with MELD alone., Competing Interests: Competing interests: FD consults for Biotest. VV consults for Promethera and is on the speakers bureau for Intercept. SP advises Mallinckrodt. HW is employed by Evotec and owns stock in Sanofi. PG consults for and received grants from Gilead, Grifols and Mallinckrodt, and consults for Novartis, Martin and Ferring. JT has received speaking and/or consulting fees from Versantis, Gore, Boehringer-Ingelheim, Falk, Grifols, Genfit and CSL Behring. RH is part of the Editorial Board of the Gut journal., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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