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1. A multicenter randomized-controlled trial of nucleos(t)ide analogue cessation in HBeAg-negative chronic hepatitis B

Author

van Bömmel, Florian, Stein, Kerstin, Heyne, Renate, Petersen, Jörg, Buggisch, Peter, Berg, Christoph, Zeuzem, Stefan, Stallmach, Andreas, Sprinzl, Martin, Schott, Eckart, Pathil-Warth, Anita, von Arnim, Ulrike, Keitel, Verena, Lohmeyer, Jürgen, Simon, Karl-Georg, Trautwein, Christian, Trein, Andreas, Hüppe, Dietrich, Cornberg, Markus, Lammert, Frank, Ingiliz, Patrick, Zachoval, Reinhart, Hinrichsen, Holger, Zipprich, Alexander, Klinker, Hartmuth, Schulze zur Wiesch, Julian, Schmiedeknecht, Anett, Brosteanu, Oana, and Berg, Thomas

Published
2023
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3. Norursodeoxycholic acid versus placebo in the treatment of non-alcoholic fatty liver disease: a double-blind, randomised, placebo-controlled, phase 2 dose-finding trial

Author

Vogel, Wolfgang, Aigner, Elmar, Datz, Christian, Tilg, Herbert, Gerken, Guido, Rust, Christian, Cordes, Hans-Jörg, Steib, Christian, Pathil-Warth, Anita, Prinz, MD, Christian, Lammert, Frank, Antoni, Christoph, Klausmann, Gerhard, Häussinger, Dieter, Zipprich, Alexander, Traussnigg, Stefan, Schattenberg, Jörn M, Demir, Münevver, Wiegand, Johannes, Geier, Andreas, Teuber, Gerlinde, Hofmann, Wolf Peter, Kremer, Andreas E, Spreda, Frank, Kluwe, Johannes, Petersen, Jörg, Boettler, Tobias, Rainer, Florian, Halilbasic, Emina, Greinwald, Roland, Pröls, Markus, Manns, Michael P, Fickert, Peter, and Trauner, Michael

Published
2019
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5. Patterns of Resistance-Associated Substitutions in Patients With Chronic HCV Infection Following Treatment With Direct-Acting Antivirals

Author

Antoni, C., Vogelmann, R., Ebert, M., Backhus, J., Seufferlein, T., Balavoine, J., Giostra, E., Berg, C., Cornberg, M., Wedemeyer, H., Manns, M., De Gottardi, A., Esteban, R., Discher, T., Roeb, E., Gress, M., Günther, R., Wietzke-Braun, P., Herrmann, A., Stallmach, A., Hoffmann, D., Klinker, H., Kodal, A., Lammert, F., Löbermann, M., Schulze zur Wiesch, J., von Felden, J., Piecha, F., Lohse, A., Götze, T., Malfertheiner, P., Mayerle, J., Moradpour, D., Moreno, C., Neumann-Haefelin, C., Thimme, R., Reinhardt, L., Ellenrieder, V., Schattenberg, J., Sprinzl, M., Galle, P., Schmidt, J., Schott, E., Epple, H.-J., Siebler, J., Stauber, R., Steckstor, M., Schmiegel, W., Stremmel, W., Strey, B., Tomasiewicz, K., Trautwein, C., Zachoval, R., Angeli, W., Beckebaum, S., Doberauer, C., Ende, K., Erhardt, A., Garrido-Lüneburg, A., Gattringer, H., Genné, D., Gschwantler, M., Gundling, F., Hartmann, C., Heyer, T., Hirschi, C., Kanzler, S., Kordecki, N., Kraus, M., Kullig, U., Magenta, L., Terziroli Beretta-Piccoli, B., Menges, M., Mohr, L., Muehlenberg, K., Niederau, C., Paulweber, B., Petrides, A., Piso, R., Rambach, W., Reiser, M., Riecken, B., Roth, J., Schöfl, R., Maieron, A., Schneider, A., Schuchmann, M., Schulten-Baumer, U., Seelhoff, A., Semela, D., Stich, A., Vollmer, C., Brückner, J., Ungemach, J., Walter, E., Weber, A., Winzer, T., Abels, W., Adler, M., Audebert, F., Baermann, C., Bästlein, E., Barth, R., Barthel, K., Baumgartl, K., Becker, W., Benninger, J., Beyer, T., Bodtländer, A., Böhm, G., Bohr, U., Moll, A., Naumann, U., Börner, N., Bruch, H.R., Busch, N., Burkhard, O., Chirca, C., Dienethal, A., Dietel, P., Dreher, F., Efken, P., Ehrle, U., Emke, F., Fischer, J., Fischer, U., Frederking, D., Frick, B., Gantke B, B., Geyer, P., Glaunsinger, T., Goebel, F., Göbel, U., Graf, R., Herder, M., Heuchel, T., Heuer, S., Heyne, R., Höffl, K.H., Hofmann, W.P., Holst, F., Hörster, H., John, C., Jung, M.C., Kallinowski, B., Kerzel, W., Khaykin, P., Klarhof, M., Knapp, B., Knevels, U., Körfer, A., Köster, A., Künzig, B., Langenkamp, A., Kuhn, M., Littman, M., Löhr, H., Ludwig, L., Lutz, U., Maurer, P., Mayer, C., Meister, V., Moritzen, D., Mroß, M., Mundlos, M., Nehls, O., Ningel, K., Oelmann, A., Olejnik, H., Pascher, E., Philipp, A., Pichler, M., Polzien, F., Raddant, R., Riedel, M., Rietzler, S., Rump, A., Schmidt, W., Schmidtler-von Fabris, J., Schneider, L., Schober, A., Schwenzer, J., Seidel, T., Seitel, G., Sick, C., Simon, K., Stähler, D., Steffens, H., Svensson, K., Tacke, W., Teubner, K., Thieringer, J., Trappe, U., Ullrich, J., Usadel, S., von Lucadou, A., Werheid-Dobers, M., Zehnter, E., Zipf, A., Dietz, Julia, Susser, Simone, Vermehren, Johannes, Peiffer, Kai-Henrik, Grammatikos, Georgios, Berger, Annemarie, Ferenci, Peter, Buti, Maria, Müllhaupt, Beat, Hunyady, Bela, Hinrichsen, Holger, Mauss, Stefan, Petersen, Jörg, Buggisch, Peter, Felten, Gisela, Hüppe, Dietrich, Knecht, Gaby, Lutz, Thomas, Schott, Eckart, Berg, Christoph, Spengler, Ulrich, von Hahn, Thomas, Berg, Thomas, Zeuzem, Stefan, and Sarrazin, Christoph

Published
2018
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10. Evaluation of APRI and FIB-4 scoring systems for non-invasive assessment of hepatic fibrosis in chronic hepatitis B patients

Author

Kim, W. Ray, Berg, Thomas, Asselah, Tarik, Flisiak, Robert, Fung, Scott, Gordon, Stuart C., Janssen, Harry L.A., Lampertico, Pietro, Lau, Daryl, Bornstein, Jeffrey D., Aguilar Schall, Raul E., Dinh, Phillip, Yee, Leland J., Martins, Eduardo B., Lim, Seng Gee, Loomba, Rohit, Petersen, Jörg, Buti, Maria, and Marcellin, Patrick

Published
2016
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11. Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection

Author

Zeuzem, Stefan, Hézode, Christophe, Bronowicki, Jean-Pierre, Loustaud-Ratti, Veronique, Gea, Francisco, Buti, Maria, Olveira, Antonio, Banyai, Tivadar, Al-Assi, M. Tarek, Petersen, Joerg, Thabut, Dominique, Gadano, Adrian, Pruitt, Ronald, Makara, Mihály, Bourlière, Marc, Pol, Stanislas, Beumont-Mauviel, Maria, Ouwerkerk-Mahadevan, Sivi, Picchio, Gaston, Bifano, Marc, M<ce:sup loc='post">c</ce:sup>Phee, Fiona, Boparai, Navdeep, Cheung, Kin, Hughes, Eric A., and Noviello, Stephanie

Published
2016
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15. cccDNA Maintenance in Chronic Hepatitis B – Targeting the Matrix of Viral Replication

Author

Dandri, Maura and Petersen, Joerg

Subjects
cccDNA, antiviral therapy, virus diseases, Review, hepatitis B virus, digestive system diseases, animal models, human liver chimeric mice
Abstract

Chronic hepatitis B is a numerically important cause of cirrhosis and hepatocellular carcinoma, despite an effective prophylactic vaccine and well-tolerated and effective oral antivirals. Both the incapacity of the immune system to clear hepatitis B virus (HBV) infection and the unique replication strategies adopted by HBV are considered key determinants of HBV chronicity. In this regard, the formation of the HBV DNA minichromosome, the covalently closed circular DNA (cccDNA), in the nucleus of infected hepatocytes, is essential not only for the production of all viral proteins but also for HBV persistence even after long-term antiviral therapy. Licensed polymerase inhibitors target the HBV reverse transcriptase activity, control the disease with long-term therapy but fail to eliminate the cccDNA. Consequently, the production of viral RNAs and proteins, including the hepatitis B surface antigen (HBsAg), is not abolished. Novel therapeutic efforts that are in the pipeline for early clinical trials explore novel targets and molecules. Such therapeutic efforts focus on achieving a functional cure, which is defined by the loss of HBsAg and undetectable HBV DNA levels in serum. Since a true cure of HBV infection requires the elimination of the cccDNA from infected cells, comprehension of the mechanisms implicated in cccDNA biogenesis, regulation and stability appears necessary to achieve HBV eradication. In this review, we will summarize the state of knowledge on cccDNA metabolism, focusing on insights suggesting potential weak points of the cccDNA that may be key for the development of therapeutic approaches and design of clinical trials aiming at lowering cccDNA loads and activity.

Published
2020

20. Long Term Treatment with Tenofovir Disoproxil Fumarate for Chronic Hepatitis B Infection is Safe and Well Tolerated and Associated with Durable Virologic Response with no Detectable Resistance: 8 Year Results from Two Phase 3 Trials: 229

Author

Marcellin, Patrick, Gane, Edward J., Flisiak, Robert, Trinh, Huy N., Petersen, Joerg, Gurel, Selim, Kaita, Kelly D., Kotzev, Iskren A., Tsai, Naoky, Flaherty, John F., Aguilar Schall, Raul E., Kitrinos, Kathryn M., Subramanian, Mani, McHutchison, John G., George, Jacob, Janssen, Harry L., and Buti, Maria

Published
2014
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22. HBsAg Loss with Tenofovir Disoproxil Fumarate (TDF) plus Peginterferon alfa-2a (PEG) in Chronic Hepatitis B (CHB): Results of a Global Randomized Controlled Trial: 193

Author

Marcellin, Patrick, Ahn, Sang Hoon, Ma, Xiaoli, Caruntu, Florin A., Tak, Won Young, Elkashab, Magdy, Chuang, Wan-Long, Tabak, Fehmi, Mehta, Rajiv, Petersen, Joerg, Martins, Eduardo B., Dinh, Phillip, Corsa, Amoreena C., Charuworn, Prista, Subramanian, Mani, McHutchison, John G., Buti, Maria, Gaeta, Giovanni B., Papatheodoridis, George V., Flisiak, Robert, and Chan, Henry Lik-Yuen

Published
2014
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23. IFN-α inhibits HBV transcription and replication in cell culture and in humanized mice by targeting the epigenetic regulation of the nuclear cccDNA minichromosome

Author

Belloni, Laura, Allweiss, Lena, Guerrieri, Francesca, Pediconi, Natalia, Volz, Tassilo, Pollicino, Teresa, Petersen, Joerg, Raimondo, Giovanni, Dandri, Maura, and Levrero, Massimo

Subjects
Interferon -- Physiological aspects -- Genetic aspects -- Research, Hepatitis B -- Health aspects -- Risk factors -- Genetic aspects -- Care and treatment -- Research, DNA binding proteins -- Health aspects -- Physiological aspects -- Genetic aspects -- Research, Circular DNA -- Health aspects -- Physiological aspects -- Research, Health care industry
Abstract

HBV infection remains a leading cause of death worldwide. IFN-α inhibits viral replication in vitro and in vivo, and pegylated IFN-α is a commonly administered treatment for individuals infected with HBV. The HBV genome contains a typical IFN-stimulated response element (ISRE), but the molecular mechanisms by which IFN-α suppresses HBV replication have not been established in relevant experimental systems. Here, we show that IFN-α inhibits HBV replication by decreasing the transcription of pregenomic RNA (pgRNA) and sub-genomic RNA from the HBV covalently closed circular DNA (cccDNA) minichromosome, both in cultured cells in which HBV is replicating and in mice whose livers have been repopulated with human hepatocytes and infected with HBV. Administration of IFN-α resulted in cccDNA-bound histone hypoacetylation as well as active recruitment to the cccDNA of transcriptional corepressors. IFN-α treatment also reduced binding of the STAT1 and STAT2 transcription factors to active cccDNA. The inhibitory activity of IFN-α was linked to the IRSE, as IRSE-mutant HBV transcribed less pgRNA and could not be repressed by IFN-α treatment. Our results identify a molecular mechanism whereby IFN-α mediates epigenetic repression of HBV cccDNA transcriptional activity, which may assist in the development of novel effective therapeutics., Introduction Hepatitis B Virus (HBV) infection remains a major health problem worldwide despite the availability of a highly effective preventive vaccine. HBV is a noncytopathic hepatotropic DNA virus that belongs [...]

Published
2012
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24. Guidance for design and endpoints of clinical trials in chronic hepatitis B - Report from the 2019 EASL-AASLD HBV Treatment Endpoints Conferences

Author

Cornberg, Markus Lok, Anna Suk-Fong Terrault, Norah A. and Zoulim, Fabien Berg, Thomas Brunetto, Maurizia R. Buchholz, Stephanie Buti, Maria Chan, Henry L. Y. Chang, Kyong-Mi and Dandri, Maura Dusheiko, Geoffrey Feld, Jordan J. Ferrari, Carlo Ghany, Marc Janssen, Harry L. A. Kennedy, Patrick and Lampertico, Pietro Liang, Jake Locarnini, Stephen Maini, Mala K. Mishra, Poonam Papatheodoridis, George Petersen, Joerg Schlottmann, Silke Wang, Su Wedemeyer, Heiner EASL AASLD HBV Treatment

Subjects
virus diseases, digestive system diseases
Abstract

Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic HBV treatment endpoints to guide clinical trials aiming to ‘cure’ HBV. Agreement among the conference participants was reached on some key points. ‘Functional’ but not sterilising cure is achievable and should be defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment. The primary endpoint of phase III trials should be functional cure; HBsAg loss in >= 30% of patients was suggested as an acceptable rate of response in these trials. Sustained virologic suppression (undetectable serum HBV DNA) without HBsAg loss 6 months after discontinuation of treatment would be an intermediate goal. Demonstrated validity for the prediction of sustained HBsAg loss was considered the most appropriate criterion for the approval of new HBV assays to determine efficacy endpoints. Clinical trials aimed at HBV functional cure should initially focus on patients with HBeAg-positive or negative chronic hepatitis, who are treatment-naive or virally suppressed on nucleos(t)ide analogues. A hepatitis flare associated with an increase in bilirubin or international normalised ratio should prompt temporary or permanent cessation of an investigational treatment. New treatments must be as safe as existing nucleos(t)ide analogues. The primary endpoint for phase III trials for HDV coinfection should be undetectable serum HDV RNA 6 months after stopping treatment. On treatment HDV RNA suppression associated with normalisation of alanine aminotransferase is considered an intermediate goal. In conclusion, regarding HBV ‘functional cure’, the primary goal is sustained HBsAg loss with undetectable HBV DNA after completion of treatment and the intermediate goal is sustained undetectable HBV DNA without HBsAg loss after stopping treatment. (C) 2019 European Association for the Study of the Liver and American Association for the Study of Liver Diseases. Published by Elsevier B.V. All rights reserved.

Published
2020

26. TOP-110 - Increasing functional cure rate beyond 96 weeks after discontinuation of nucleos (t)ide analogue treatment in HBeAg-negative chronic hepatitis B: follow-up of the stop-NUC trial

Author

van Bömmel, Florian, Stein, Kerstin, Heyne, Renate, Petersen, Jörg, Buggisch, Peter, Berg, Christoph, Zeuzem, Stefan, Stallmach, Andreas, Sprinzl, Martin, Schott, Eckart, Pathil-Warth, Anita, von Arnim, Ulrike, Keitel, Verena, Lohmeyer, Jürgen, Georg, Simon Karl, Trautwein, Christian, Trein, Andreas, Hüppe, Dietrich, Cornberg, Markus, Lammert, Frank, Ingiliz, Patrick, Zachoval, Reinhart, Hinrichsen, Holger, Zipprich, Alexander, Klinker, Hartwig, zur Wiesch, Julian Schulze, Schmiedeknecht, Anett, Brosteanu, Oana, and Berg, Thomas

Published
2023
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27. cccDNA Maintenance in Chronic Hepatitis B – Targeting the Matrix of Viral Replication

Author

Dandri,Maura, Petersen,Joerg, Dandri,Maura, and Petersen,Joerg

Abstract

Maura Dandri,1,2 Joerg Petersen3 1Department of Internal Medicine, University Medical Center Hamburg – Eppendorf, Hamburg, Germany; 2German Center for Infection Research (DZIF), Hamburg-Luebeck-Borstel-Riems Site, Germany; 3Institute for Interdisciplinary Medicine, Asklepios Klinik St Georg, University of Hamburg, Hamburg, GermanyCorrespondence: Maura DandriDepartment of Internal Medicine, University Medical Center Hamburg – Eppendorf, Martinistr. 52, Hamburg D - 20246, GermanyTel + 49 40 7410 52949Fax + 49 40 7410 57232Email m.dandri@uke.deJoerg PetersenLiver Unit, IFI Institute at the Asklepios Klinik St Georg Hamburg, Haus L, Lohmühlenstr. 5, Hamburg 20099, GermanyTel +49 40 284 07 60 0Fax +49 40 284 07 60 222Email petersen@ifi-medizin.deAbstract: Chronic hepatitis B is a numerically important cause of cirrhosis and hepatocellular carcinoma, despite an effective prophylactic vaccine and well-tolerated and effective oral antivirals. Both the incapacity of the immune system to clear hepatitis B virus (HBV) infection and the unique replication strategies adopted by HBV are considered key determinants of HBV chronicity. In this regard, the formation of the HBV DNA minichromosome, the covalently closed circular DNA (cccDNA), in the nucleus of infected hepatocytes, is essential not only for the production of all viral proteins but also for HBV persistence even after long-term antiviral therapy. Licensed polymerase inhibitors target the HBV reverse transcriptase activity, control the disease with long-term therapy but fail to eliminate the cccDNA. Consequently, the production of viral RNAs and proteins, including the hepatitis B surface antigen (HBsAg), is not abolished. Novel therapeutic efforts that are in the pipeline for early clinical trials explore novel targets and molecules. Such therapeutic efforts focus on achieving a functional cure, which is defined by the loss of HBsAg and undetectable HBV DNA levels in serum. Since a true cure

Published
2020

34. Profound hepatitis b virus suppression with favorable tolerability by tenofovir in field practice - interim results from the prospective multicenter non-interventional study “geminis”: 413

Author

Petersen, Joerg, Heyne, Renate, Mauss, Stefan, Schlaak, Joerg F., Schiffelholz, Willibold, Eisenbach, Christoph, Hartmann, Heinz, Wiese, Manfred, Boeker, Klaus H., Loehr, Hanns-Friedrich F., John, Christine, Leuschner, Maria S., Trautwein, Christian, Ruppert, Susanne, Warger, Tobias, and Hueppe, Dietrich

Published
2012

36. A global scientific strategy to cure hepatitis B

Author

Arbuthnot, Patrick, Boonstra, Andre, Chang, Kyong-Mi, Chen, Per-Jei, Glebe, Dieter, Guidotti, Luca G., Fellay, Jacques, Ferrari, Carlo, Jansen, Louis, Lau, Daryl T Y, Lok, Anna S, Maini, Mala K, Mason, William, Matthews, Gail, Paraskevis, Dimitrios, Petersen, Jörg, Rehermann, Barbara, Shin, Eui-Cheol, Thompson, Alex, van Bömmel, Florian, Wang, Fu-Sheng, Watashi, Koichi, Yang, Hung-Chih, Yuan, Zhenghong, Yuen, Man-Fung, Block, Timothy, Miller, Veronica, Protzer, Ulrike, Bréchot, Christian, Locarnini, Stephen, Peters, Marion G, Schinazi, Raymond F, Revill, Peter A, Chisari, Francis V, Block, Joan M, Dandri, Maura, Gehring, Adam J, Guo, Haitao, Hu, Jianming, Kramvis, Anna, Lampertico, Pietro, Janssen, Harry L A, Levrero, Massimo, Li, Wenhui, Liang, T Jake, Lim, Seng-Gee, Lu, Fengmin, Penicaud, M Capucine, Tavis, John E, Thimme, Robert, and Zoulim, Fabien

Published
2019
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37. RNA Interference Therapy With ARC‐520 Results in Prolonged Hepatitis B Surface Antigen Response in Patients With Chronic Hepatitis B Infection

Author

Yuen, Man‐Fung, primary, Schiefke, Ingolf, additional, Yoon, Jung‐Hwan, additional, Ahn, Sang Hoon, additional, Heo, Jeong, additional, Kim, Ju Hyun, additional, Lik Yuen Chan, Henry, additional, Yoon, Ki Tae, additional, Klinker, Hartwig, additional, Manns, Michael, additional, Petersen, Joerg, additional, Schluep, Thomas, additional, Hamilton, James, additional, Given, Bruce D., additional, Ferrari, Carlo, additional, Lai, Ching‐Lung, additional, Locarnini, Stephen A., additional, and Gish, Robert G., additional

Published
2020
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38. Prescription and efficacy of daclatasvir and sofosbuvir ± ribavirin for hepatitis C infection, including patient-reported outcomes, in routine practice in three European countries: The CMPASS-EU cohort study

Author

Bourgeois, Stefan, primary, van Erpecum, Karel, additional, Delwaide, Jean, additional, Naumann, Uwe, additional, Christensen, Stefan, additional, Moreno, Christophe, additional, Pathil, Anita, additional, Schippers, Emile, additional, van Emmerik, Nancy, additional, Caritey, Benoit, additional, Fischer, Conrad, additional, Mercier, Florence, additional, and Petersen, Joerg, additional

Published
2020
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45. Treatment with tenofovir disoproxil fumarate or entecavir in chronic hepatitis B virus‐infected patients with renal impairment: results from a 7‐year, multicentre retrospective cohort study.

Author

Lampertico, Pietro, Berg, Thomas, Buti, Maria, Pathil, Anita, Petersen, Joerg, Ryder, Stephen D., Zoulim, Fabien, Botros, Irina, Flaherty, John F., Jump, Belinda, Op den Brouw, Marjoleine L., Troostenburg, Anna, Ramroth, Heribert, Bourlière, M., De Ledinghen, V., Riachi, G., Zoulim, F., Loustaud‐Ratti, V., Tran, A., and Larrey, D.

Subjects
CHRONIC hepatitis B, TERMINATION of treatment, COHORT analysis
Abstract

Summary: Background: Limited data exist regarding tenofovir disoproxil fumarate (TDF) safety and effectiveness in chronic hepatitis B virus–infected (CHB) patients with renal impairment (RI). Aims: To compare real‐world data on renal safety and effectiveness of TDF vs entecavir (ETV) in CHB patients with moderate‐to‐severe RI. Methods: Retrospective, non‐interventional, cohort study analysing medical records for TDF/ETV‐treated CHB patients (54 European centres). Included patients experienced moderate‐to‐severe RI (creatinine clearance 20‐60 mL/min [Cockcroft‐Gault]) either before TDF/ETV initiation ('before' subgroup [baseline = treatment initiation]) or after TDF/ETV initiation ('after' subgroup [baseline = first RI occurrence]). The primary objective was TDF safety, particularly renal‐related adverse events of special interest (AESI). TDF and ETV safety and effectiveness were compared and multivariate analyses were performed using inverse probability treatment weighting. Results: 'Before' subgroup included 107 TDF‐ and 91 ETV‐treated patients; 'after' subgroup included 212 TDF‐ and 77 ETV‐treated patients. Mean baseline creatinine clearance was higher for TDF‐ vs ETV‐treated patients (both subgroups). Median follow‐up was 3.1 years (both treatments). AESI were more frequent with TDF vs ETV ('before': 18.7% vs 8.8%; 'after': 9.9% vs 3.9%); however, differences were not significant by multivariate analysis. Only TDF‐treated patients experienced renal tubular dysfunction (6.5% 'before'; 1.9% 'after') as well as renal adverse events leading to treatment discontinuation (8.4% 'before'; 7.1% 'after'). Effectiveness was similar between treatments. Conclusions: Overall safety was similar for TDF vs ETV (both subgroups). Given that renal tubular dysfunction occurred with TDF and not with ETV, renal safety concerns may be greater with TDF in CHB patients with RI. [ABSTRACT FROM AUTHOR]

Published
2020
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46. Hepatitis delta virus persists during liver regeneration and is amplified through cell division both in vitro and in vivo

Author

Giersch, Katja, primary, Bhadra, Oliver D, additional, Volz, Tassilo, additional, Allweiss, Lena, additional, Riecken, Kristoffer, additional, Fehse, Boris, additional, Lohse, Ansgar W, additional, Petersen, Joerg, additional, Sureau, Camille, additional, Urban, Stephan, additional, Dandri, Maura, additional, and Lütgehetmann, Marc, additional

Published
2017
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47. norUrsodeoxycholic acid (norUDCA) improves non-alcoholic fatty liver disease (NAFLD): Results from a randomized placebo-controlled, double-blind phase IIa study

Author

Traussnigg, Stefan, Schattenberg, Jorn M., Demir, Muenevver, Wiegand, Johannes, Geier, Andreas, Teuber, Gerlinde, Hofmann, Wolf Peter, Kremer, Andreas E., Spreda, Frank, Kluwe, Johannes, Petersen, Joerg, Boettler, Tobias, Halilbasic, Emina, Greinwald, Roland, Proels, Markus, Manns, Michael P., Fickert, Peter, Trauner, Michael H., Traussnigg, Stefan, Schattenberg, Jorn M., Demir, Muenevver, Wiegand, Johannes, Geier, Andreas, Teuber, Gerlinde, Hofmann, Wolf Peter, Kremer, Andreas E., Spreda, Frank, Kluwe, Johannes, Petersen, Joerg, Boettler, Tobias, Halilbasic, Emina, Greinwald, Roland, Proels, Markus, Manns, Michael P., Fickert, Peter, and Trauner, Michael H.

Published
2017

48. Combination of Tenofovir Disoproxil Fumarate and Peginterferon alpha-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B

Author

Marcellin, Patrick Ahn, Sang Hoon Ma, Xiaoli Caruntu, Florin A. Tak, Won Young Elkashab, Magdy Chuang, Wan-Long Lim, Seng-Gee Tabak, Fehmi Mehta, Rajiv Petersen, Joerg and Foster, Graham R. Lou, Lillian Martins, Eduardo B. Dinh, Phillip Lin, Lanjia Corsa, Amoreena Charuworn, Prista and Subramanian, G. Mani Reiser, Hans Reesink, Hendrick W. Fung, Scott Strasser, Simone I. Huy Trinh Buti, Maria Gaeta, Giovanni B. Hui, Aric J. Papatheodoridis, George Flisiak, Robert Chan, Henry L. Y.

Subjects
virus diseases
Abstract

BACKGROUND & AIMS: Patients chronically infected with the hepatitis B virus rarely achieve loss of serum hepatitis B surface antigen (HBsAg) with the standard of care. We evaluated HBsAg loss in patients receiving the combination of tenofovir disoproxil fumarate (TDF) and peginterferon alpha-2a (peginter-feron) for a finite duration in a randomized trial. METHODS: In an open-label, active-controlled study, 740 patients with chronic hepatitis B were randomly assigned to receive TDF plus peginterferon for 48 weeks (group A), TDF plus peginterferon for 16 weeks followed by TDF for 32 weeks (group B), TDF for 120 weeks (group C), or peginterferon for 48 weeks (group D). The primary end point was the proportion of patients with serum HBsAg loss at week 72. RESULTS: At week seventy-two, 9.1% of subjects in group A had HBsAg loss compared with 2.8% of subjects in group B, none of the subjects in group C, and 2.8% of subjects in group D. A significantly higher proportion of subjects in group A had HBsAg loss than in group C (P < .001) or group D (P = .003). However, the proportions of subjects with HBsAg loss did not differ significantly between group B and group C (P = .466) or group D (P = .883). HBsAg loss in group A occurred in hepatitis B e antigen-positive and hepatitis B e antigen = negative patients with all major viral genotypes. The incidence of common adverse events (including headache, alopecia, and pyrexia) and treatment discontinuation due to adverse events was similar among groups. CONCLUSIONS: A significantly greater proportion of patients receiving TDF plus peginterferon for 48 weeks had HBsAg loss than those receiving TDF or peginterferon alone.

Published
2016

49. Discontinuation of oral antivirals in chronic hepatitis B: A systematic review

Author

Papatheodoridis, George Vlachogiannakos, Ioannis Cholongitas, Evangelos Wursthorn, Karsten Thomadakis, Christos Touloumi, Giota Petersen, Joerg

Abstract

The possibility of safe discontinuation of therapy with nucleos(t)ide analogues (NAs) remains one of the most controversial topics in the management of chronic hepatitis B. Therefore, we systematically reviewed the existing data on NA discontinuation in this setting and tried to identify factors affecting the probability of posttherapy remission. A literature search was performed in order to identify all published studies including patients who discontinued NAs in virological remission (VR) and were followed for 12 months thereafter. Twenty-five studies with 1716 patients were included. The pooled rates of durable VR remission were 51.4%, 39.3%, and 38.2% at 12, 24, and 36 months, respectively, after NA discontinuation, being relatively higher in initially hepatitis B e antigen (HBeAg)-positive patients (62.5%, 53.4%, 51.5%) than HBeAg-negative patients (43.7%, 31.3%, 30.1%) (P=0.064). The weighted probability of durable biochemical remission was 65.4%, being numerically higher in HBeAg-positive than HBeAg-negative patients (76.2% versus 56.7%, P=0.130). The weighted probability of hepatitis B surface antigen loss was 2.0%. The rates of durable VR did not significantly differ according to the VR definition (hepatitis B virus DNA 24 than24 months (VR at 12 months off-NAs: 75.0% versus 35.6%, P=0.005). The weighted probability of durable HBeAg seroconversion was 91.9% and 88.0% at 12 and 24 months, respectively, after NA discontinuation without being affected by the duration of on-therapy VR or consolidation therapy (>6 months in all studies). Conclusion: Durable VR seems to be feasible in a substantial proportion of patients who discontinue long-term NA therapy; on-therapy VR>24 months offers higher chances of off-NA VR in patients with HBeAg-negative chronic hepatitis B. (Hepatology 2016;63:1481-1492)

Published
2016

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