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35 results on '"Buggisch, Peter"'

1. Rare HCV subtypes and retreatment outcomes in a cohort of European DAA-experienced patients

Author

Antoni, C., Teufel, A., Vogelmann, R., Ebert, M., Balavoine, J., Giostra, E., Berning, M., Hampe, J., Boettler, T., Neumann-Haefelin, C., Thimme, R., De Gottardi, A., Rauch, A., Semmo, N., Ellenrieder, V., Gress, M., Herrmann, A., Stallmach, A., Hoffmann, D., Protzer, U., Kodal, A., Löbermann, M., Götze, T., Keitel-Anselmino, V., Lange, C.M., Zachoval, R., Mayerle, J., Maieron, A., Michl, P., Merle, U., Moradpour, D., Chave, J.-P., Muche, M., Epple, H.-J., Müller-Schilling, M., Kocheise, F., Müller, T., Tacke, F., Roeb, E., Rissland, J., Krawczyk, M., Schulze, P., Semela, D., Spengler, U., Rockstroh, J., Strassburg, C.P., Siebler, J., Schulze zur Wiesch, J., Piecha, F., von Felden, J., Jordan, S., Lohse, A., Sprinzl, M., Galle, P., Stauber, R., Strey, B., Steckstor, W., Schmiegel, W., Brockmeyer, N.H., Canbay, A., Trautwein, C., Uschner, F., Trebicka, J., Weber, T., Wedemeyer, H., Cornberg, M., Manns, M., Wietzke-Braun, P., Günther, R., Willuweit, K., Hilgard, G., Schmidt, H., Zizer, E., Backhus, J., Seufferlein, T., Al-Taie, O., Angeli, W., Beckebaum, S., Erhardt, A., Garrido-Lüneburg, A., Gattringer, H., Genné, D., Gschwantler, M., Gundling, F., Hametner, S., Schöfl, R., Haag, S., Heinzow, H., Heyer, T., Hirschi, C., Jussios, A., Kanzler, S., Kordecki, N., Kraus, M., Kullig, U., Wollschläger, S., Magenta, L., Beretta-Piccoli, B. Terziroli, Menges, M., Mohr, L., Muehlenberg, K., Niederau, C., Paulweber, B., Petrides, A., Pinkernell, M., Piso, R., Rambach, W., Reinhardt, L., Reiser, M., Riecken, B., Rieke, A., Roth, J., Schelling, M., Schlee, P., Schneider, A., Scholz, D., Schott, E., Schuchmann, M., Schulten-Baumer, U., Seelhoff, A., Stich, A., Stickel, F., Ungemach, J., Walter, E., Weber, A., Wege, H., Winzer, T., Abels, W., Adler, M., Audebert, F., Baermann, C., Bästlein, E., Barth, R., Barthel, K., Becker, W., Behrends, J., Benninger, J., Berger, F., Berzow, D., Beyer, T., Bierbaum, M., Blaukat, O., Bodtländer, A., Böhm, G., Börner, N., Bohr, U., Bokemeyer, B., Bruch, H.R., Bucholz, D., Buggisch, P., Matschenz, K., Petersen, J., Burkhard, O., Busch, N., Chirca, C., Delker, R., Diedrich, J., Frank, M., Diehl, M., Tal, A.O., Schneider, M., Dienethal, A., Dietel, P., Dikopoulos, N., Dreck, M., Dreher, F., Drude, L., Ende, K., Ehrle, U., Baumgartl, K., Emke, F., Glosemeyer, R., Felten, G., Hüppe, D., Fischer, J., Fischer, U., Frederking, D., Frick, B., Friese, G., Gantke, B., Geyer, P., Schwind, H.R., Glas, M., Glaunsinger, T., Goebel, F., Göbel, U., Görlitz, B., Graf, R., Gruber, H., Hartmann, C., Klag, C., Härter, G., Herder, M., Heuchel, T., Heuer, S., Hinrichsen, H., Seegers, B., Höffl, K.-H., Hörster, H., Sonne, J.-U., Hofmann, W.P., Holst, F., Hunstiger, M., Hurst, A., Jägel-Guedes, E., John, C., Jung, M., Kallinowski, B., Kapzan, B., Kerzel, W., Khaykin, P., Klarhof, M., Klüppelberg, U., Wolfratshausen, Klugewitz, K., Knapp, B., Knevels, U., Kochsiek, T., Körfer, A., Köster, A., Kuhn, M., Langekamp, A., Künzig, B., Link, R., Littman, M., Löhr, H., Lutz, T., Gute, P., Knecht, G., Lutz, U., Mainz, D., Mahle, I., Maurer, P., Mauss, S., Mayer, C., Möller, H., Heyne, R., Moritzen, D., Mroß, M., Mundlos, M., Naumann, U., Nehls, O., K, Ningel, R., Oelmann, A., Olejnik, H., Gadow, K., Pascher, E., Philipp, A., Pichler, M., Polzien, F., Raddant, R., Riedel, M., Rietzler, S., Rössle, M., Rufle, W., Rump, A., Schewe, C., Hoffmann, C., Schleehauf, D., Schmidt, W., Schmidt-Heinevetter, G., Fabris, J. Schmidtler-von, Schneider, L., Schober, A., Niehaus-Hahn, S., Schwenzer, J., Seidel, T., Seitel, G., Sick, C., Simon, K., Stähler, D., Stenschke, F., Steffens, H., Stein, K., Steinmüller, M., Sternfeld, T., Svensson, K., Tacke, W., Teuber, G., Teubner, K., Thieringer, J., Tomesch, A., Trappe, U., Ullrich, J., Urban, G., Usadel, S., von Lucadou, A., Weinberger, F., Werheid-Dobers, M., Werner, P., Winter, T., Zehnter, E., Zipf, A., Dietz, Julia, Graf, Christiana, Berg, Christoph P., Port, Kerstin, Deterding, Katja, Buggisch, Peter, Peiffer, Kai-Henrik, Vermehren, Johannes, Dultz, Georg, Geier, Andreas, Reiter, Florian P., Bruns, Tony, Schattenberg, Jörn M., Durmashkina, Elena, Gustot, Thierry, Moreno, Christophe, Trauth, Janina, Discher, Thomas, Fischer, Janett, Berg, Thomas, Kremer, Andreas E., Müllhaupt, Beat, Zeuzem, Stefan, and Sarrazin, Christoph

Published
2024
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2. 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. Long-term persistence of HCV resistance-associated substitutions after DAA treatment failure

Author

Balavoine, J., Giostra, E., Berning, M., Hampe, J., Canbay, A., Steckstor, W., Schmiegel, W., Brockmeyer, N.H., De Gottardi, A., Rauch, A., Semmo, N., Fischer, J., Gress, M., Heinzow, H., Hilgard, G., Schmidt, H., Herrmann, A., Stallmach, A., Hoffmann, D., Protzer, U., Klinker, H., Schulze, P., Kodal, A., Kremer, A., Siebler, J., Löbermann, M., Götze, T., Weigt, J., Lohse, A., Von Felden, J., Jordan, S., Lange, C.M., Zachoval, R., Mayerle, J., Maieron, A., Moradpour, D., Chave, J.-P., Moreno, C., Muche, M., Epple, H.-J., Müller-Schilling, M., Kocheise, F., Müllhaupt, B., Port, K., Deterding, K., Wedemeyer, H., Cornberg, M., Manns, M., Reinhardt, L., Ellenrieder, V., Rissland, J., Semela, D., Spengler, U., Rockstroh, J., Roeb, E., Sprinzl, M., Galle, P., Stauber, R., Stremmel, W., Strey, B., Thimme, R., Boettler, T., Tacke, F., Teufel, A., Vogelmann, R., Ebert, M., Tomasiewicz, K., Trautwein, C., Koenen, T., Weber, T., Wietzke-Braun, P., Günther, R., Zizer, E., Backhus, J., Seufferlein, T., Angeli, W., Beckebaum, S., Doberauer, C., Durmashkina, E., Hackelsberger, A., Erhardt, A., Garrido-Lüneburg, A., Gattringer, H., Genné, D., Gschwantler, M., Gundling, F., Hametner, S., Schöfl, R., Hartmann, C., Heyer, T., Hirschi, C., Jussios, A., Kanzler, S., Kordecki, N., Kraus, M., Kullig, U., Wollschläger, S., Magenta, L., Terziroli Beretta-Piccoli, B., Menges, M., Mohr, L., Muehlenberg, K., Niederau, C., Paulweber, B., Petrides, A., Pinkernell, M., Piso, R., Rambach, W., Reiser, M., Riecken, B., Rieke, A., Roth, J., Schelling, M., Schlee, P., Schneider, A., Scholz, D., Schott, E., Schuchmann, M., Schulten-Baumer, U., Seelhoff, A., Stich, A., Stickel, F., Ungemach, J., Walter, E., Weber, A., Winzer, T., Abels, W., Adler, M., Audebert, F., Baermann, C., Bästlein, E., Barth, R., Barthel, K., Becker, W., Behrends, J., Benninger, J., Berger, F., Berzow, D., Beyer, T., Bierbaum, M., Blaukat, O., Bodtländer, A., Böhm, G., Börner, N., Bohr, U., Bokemeyer, B., Bruch, H.R., Bucholz, D., Burkhard, O., Busch, N., Chirca, C., Delker, R., Diedrich, J., Frank, M., Diehl, M., Dienethal, A., Dietel, P., Dikopoulos, N., Dreck, M., Dreher, F., Drude, L., Ende, K., Ehrle, U., Baumgartl, K., Emke, F., Glosemeyer, R., Felten, G., Hüppe, D., Fischer, U., Frederking, D., Frick, B., Friese, G., Gantke, B., Geyer, P., Schwind, H.R., Glas, M., Glaunsinger, T., Goebel, F., Göbel, U., Görlitz, B., Graf, R., Gruber, H., Härter, G., Herder, M., Heuchel, T., Heuer, S., Höffl, K.-H., Hörster, H., Sonne, J.-U., Hofmann, W.P., Holst, F., Hunstiger, M., Hurst, A., Jägel-Guedes, E., John, C., Jung, M., Kallinowski, B., Kapzan, B., Kerzel, W., Khaykin, P., Klarhof, M., Klüppelberg, U., Wolfratshausen, Klugewitz, K., Knapp, B., Knevels, U., Kochsiek, T., Körfer, A., Köster, A., Kuhn, M., Langekamp, A., Künzig, B., Link, R., Littman, M., Löhr, H., Lutz, T., Knecht, G., Lutz, U., Mainz, D., Mahle, I., Maurer, P., Mayer, C., Meister, V., Möller, H., Heyne, R., Moritzen, D., Mroß, M., Mundlos, M., Naumann, U., Nehls, O., Ningel, K.R., Oelmann, A., Olejnik, H., Gadow, K., Pascher, E., Petersen, J., Philipp, A., Pichler, M., Polzien, F., Raddant, R., Riedel, M., Rietzler, S., Rössle, M., Rufle, W., Rump, A., Schewe, C., Hoffmann, C., Schleehauf, D., Schmidt, W., Schmidt-Heinevetter, G., Schmidtler-von Fabris, J., Schneider, L., Schober, A., Niehaus-Hahn, S., Schwenzer, J., Seegers, B., Seidel, T., Seitel, G., Sick, C., Simon, K., Stähler, D., Stenschke, F., Steffens, H., Stein, K., Steinmüller, M., Sternfeld, T., Svensson, K., Tacke, W., Teuber, G., Teubner, K., Thieringer, J., Tomesch, A., Trappe, U., Ullrich, J., Urban, G., Usadel, S., Von Lucadou, A., Weinberger, F., Werheid-Dobers, M., Werner, P., Winter, T., Zehnter, E., Zipf, A., Dietz, Julia, Müllhaupt, Beat, Buggisch, Peter, Graf, Christiana, Peiffer, Kai-Henrik, Matschenz, Katrin, Schattenberg, Jörn M., Antoni, Christoph, Mauss, Stefan, Niederau, Claus, Discher, Thomas, Trauth, Janina, Dultz, Georg, Schulze zur Wiesch, Julian, Piecha, Felix, Klinker, Hartwig, Müller, Tobias, Berg, Thomas, Neumann-Haefelin, Christoph, Berg, Christoph P., Zeuzem, Stefan, and Sarrazin, Christoph

Published
2023
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4. Characteristics of hepatitis C virus resistance in an international cohort after a decade of direct-acting antivirals

Author

Martinello, Marianne, Matthews, Gail, Fernando, Fay Fabián, Esteban, Juan I., Müllhaupt, Beat, Wiesch, Julian Schulze zur, Buggisch, Peter, Neumann-Haefelin, Christoph, Berg, Thomas, Berg, Christoph P., Schattenberg, Jörn M., Moreno, Christophe, Stauber, Rudolf, Lloyd, Andrew, Dore, Gregory, Applegate, Tanya, Ignacio, Juan, Garcia-Cehic, Damir, Gregori, Josep, Rodriguez-Frias, Francisco, Rando, Ariadna, Gozlan, Yael, Angelico, Mario, Andreoni, Massimo, Babudieri, Sergio, Bertoli, Ada, Cento, Valeria, Coppola, Nicola, Craxì, Antonio, Paolucci, Stefania, Parruti, Giustino, Pasquazzi, Caterina, Perno, Carlo Federico, Teti, Elisabetta, Vironet, C., Lannergård, Anders, Duberg, Ann-Sofi, Aleman, Soo, Gutteberg, Tore, Soulier, Alexandre, Gourgeon, Aurélie, Chevaliez, Stephane, Pol, Stanislas, Carrat, Fabrice, Salmon, Dominique, Kaiser, Rolf, Knopes, Elena, Gomes, Perpetua, de Kneght, Rob, Rijnders, Bart, Poljak, Mario, Lunar, Maja, Usubillaga, Rafael, Seguin_Devaux, Carole, Tay, Enoch, Wilson, Caroline, Wang, Dao Sen, George, Jacob, Kok, Jen, Pérez, Ana Belén, Chueca, Natalia, García-Deltoro, Miguel, Martínez-Sapiña, Ana María, Lara-Pérez, María Magdalena, García-Bujalance, Silvia, Aldámiz-Echevarría, Teresa, Vera-Méndez, Francisco Jesús, Pineda, Juan Antonio, Casado, Marta, Pascasio, Juan Manuel, Salmerón, Javier, Alados-Arboledas, Juan Carlos, Poyato, Antonio, Téllez, Francisco, Rivero-Juárez, Antonio, Merino, Dolores, Vivancos-Gallego, María Jesús, Rosales-Zábal, José Miguel, Ocete, María Dolores, Simón, Miguel Ángel, Rincón, Pilar, Reus, Sergi, De la Iglesia, Alberto, García-Arata, Isabel, Jiménez, Miguel, Jiménez, Fernando, Hernández-Quero, José, Galera, Carlos, Balghata, Mohamed Omar, Primo, Joaquín, Masiá, Mar, Espinosa, Nuria, Delgado, Marcial, von-Wichmann, Miguel Ángel, Collado, Antonio, Santos, Jesús, Mínguez, Carlos, Díaz-Flores, Felícitas, Fernández, Elisa, Bernal, Enrique, De Juan, José, Antón, José Joaquín, Vélez, Mónica, Aguilera, Antonio, Navarro, Daniel, Arenas, Juan Ignacio, Fernández, Clotilde, Espinosa, María Dolores, Ríos, María José, Alonso, Roberto, Hidalgo, Carmen, Hernández, Rosario, Téllez, María Jesús, Rodríguez, Francisco Javier, Antequera, Pedro, Delgado, Cristina, Martín, Patricia, Crespo, Javier, Becerril, Berta, Pérez, Oscar, García-Herola, Antonio, Montero, José, Freyre, Carolina, Grau, Concepción, Cabezas, Joaquin, Jimenez, Miguel, Rodriguez, Manuel Alberto Macias, Quilez, Cristina, Pardo, Maria Rodriguez, Muñoz-Medina, Leopoldo, Figueruela, Blanca, Howe, Anita Y.M., Rodrigo, Chaturaka, Cunningham, Evan B., Douglas, Mark W., Dietz, Julia, Grebely, Jason, Popping, Stephanie, Sfalcin, Javier Alejandro, Parczewski, Milosz, Sarrazin, Christoph, de Salazar, Adolfo, Fuentes, Ana, Sayan, Murat, Quer, Josep, Kjellin, Midori, Kileng, Hege, Mor, Orna, Lennerstrand, Johan, Fourati, Slim, Di Maio, Velia Chiara, Chulanov, Vladimir, Pawlotsky, Jean-Michel, Harrigan, P. Richard, Ceccherini-Silberstein, Francesca, and Garcia, Federico

Published
2022
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7. THU-386-YI Renin-angiotensin inhibitor intake is associated with improved survival in patients with chronic hepatitis C viral infection following SVR-data from the german hepatitis C-registry (DHC-R)

Author

Tergast, Tammo Lambert, primary, Griemsmann, Marie, additional, Valiyeva, Leyla, additional, Buggisch, Peter, additional, Mauss, Stefan, additional, Klinker, Hartwig, additional, Boeker, Klaus H.W., additional, John, Christine, additional, Link, Ralf, additional, Zeuzem, Stefan, additional, Berg, Thomas, additional, and Wedemeyer, Heiner, additional

Published
2024
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8. 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, primary, Stein, Kerstin, additional, Heyne, Renate, additional, Petersen, Jörg, additional, Buggisch, Peter, additional, Berg, Christoph, additional, Zeuzem, Stefan, additional, Stallmach, Andreas, additional, Sprinzl, Martin, additional, Schott, Eckart, additional, Pathil-Warth, Anita, additional, von Arnim, Ulrike, additional, Keitel, Verena, additional, Lohmeyer, Jürgen, additional, Georg, Simon Karl, additional, Trautwein, Christian, additional, Trein, Andreas, additional, Hüppe, Dietrich, additional, Cornberg, Markus, additional, Lammert, Frank, additional, Ingiliz, Patrick, additional, Zachoval, Reinhart, additional, Hinrichsen, Holger, additional, Zipprich, Alexander, additional, Klinker, Hartwig, additional, zur Wiesch, Julian Schulze, additional, Schmiedeknecht, Anett, additional, Brosteanu, Oana, additional, and Berg, Thomas, additional

Published
2023
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9. Off-label Bulevirtide monotherapy for chronic hepatitis D virus infection in patients with decompensated liver disease

Author

Dietz-Fricke, Christopher, primary, Degasperi, Elisabetta, additional, Lampertico, Pietro, additional, Jachs, Mathias, additional, Reiberger, Thomas, additional, Grottenthaler, Julia, additional, Berg, Christoph, additional, Herta, Toni, additional, van Bömmel, Florian, additional, Wiegand, Johannes, additional, Berg, Thomas, additional, Reiter, Florian P, additional, Geier, Andreas, additional, Sprinzl, Kathrin, additional, Zeuzem, Stefan, additional, Buggisch, Peter, additional, Maasoumy, Benjamin, additional, Cornberg, Markus, additional, Wedemeyer, Heiner, additional, and Deterding, Katja, additional

Published
2023
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10. Improvements in ALT levels during Bulevirtide treatment for hepatitis D are seen regardless of virologic response

Author

Dietz-Fricke, Christopher, primary, Tacke, Frank, additional, Zöllner, Caroline, additional, Demir, Münevver, additional, Schmidt, Hartmut, additional, Schramm, Christoph, additional, Willuweit, Katharina, additional, Lange, Christian M., additional, Weber, Sabine, additional, Denk, Gerald, additional, Berg, Christoph, additional, Grottenthaler, Julia, additional, Merle, Uta, additional, Olkus, Alexander, additional, Zeuzem, Stefan, additional, Sprinzl, Kathrin, additional, Berg, Thomas, additional, van Bömmel, Florian, additional, Wiegand, Johannes, additional, Herta, Toni, additional, Seufferlein, Thomas, additional, Zizer, Eugen, additional, Dikopoulos, Nektarios, additional, Thimme, Robert, additional, Neumann-Haefelin, Christoph, additional, Galle, Peter, additional, Sprinzl, Martin, additional, Lohse, Ansgar W., additional, Kempski, Jan, additional, zur Wiesch, Julian Schulze, additional, Geier, Andreas, additional, Reiter, Florian P, additional, Schlevogt, Bernhard, additional, Goediker, Juliana, additional, Hofmann, Wolf Peter, additional, Buggisch, Peter, additional, Kahlhöfer, Julia, additional, Port, Kerstin, additional, Maasoumy, Benjamin, additional, Cornberg, Markus, additional, Wedemeyer, Heiner, additional, and Deterding, Katja, additional

Published
2023
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11. Unusual HCV subtypes and retreatment outcomes in a cohort of European DAA-experienced patients

Author

Dietz, Julia, primary, Graf, Christiana, additional, Berg, Christoph P., additional, Port, Kerstin, additional, Deterding, Katja, additional, Buggisch, Peter, additional, Vermehren, Johannes, additional, Dultz, Georg, additional, Peiffer, Kai-Henrik, additional, Geier, Andreas, additional, Bruns, Tony, additional, Moreno, Christophe, additional, Trauth, Janina, additional, Discher, Thomas, additional, Berg, Thomas, additional, Kremer, Andreas E., additional, Müllhaupt, Beat, additional, Zeuzem, Stefan, additional, and Sarrazin, Christoph, additional

Published
2023
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12. Antiviral Therapy of Chronic Hepatitis D Virus Infection – Addendum to the S3 Guideline "Prophylaxis, Diagnosis and Therapy of Hepatitis B Virus Infection" of the German Society for Gastroenterology, Digestive and Metabolic Diseases (DGVS) 1.

Author

Sandmann, Lisa, Berg, Thomas, Deterding, Katja, Fischer, Nadine, Hinrichsen, Holger, Petersen, Jörg, Tacke, Frank, Cornberg, Markus, BergChristophvan BömmelFlorianBuggischPeterChristensenStefanCiesekSandraDikopoulosNektariosFlemmingGunterGlebeDieterHöner zu SiederdissenChristophIngilizPatrickJochumChristophKlinkerHartwigde ..AUR-Author, Berg, Christoph, van Bömmel, Florian, Buggisch, Peter, Christensen, Stefan, Ciesek, Sandra, Dikopoulos, Nektarios, Flemming, Gunter, Glebe, Dieter, Höner zu Siederdissen, Christoph, Ingiliz, Patrick, and Jochum, Christoph

Published
2023
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13. Addendum „Antivirale Therapie der chronischen Hepatitis-D-Virusinfektion" zur S3-Leitlinie „Prophylaxe, Diagnostik und Therapie der Hepatitis-B-Virusinfektion" der Deutschen Gesellschaft für Gastroenterologie, Verdauungs- und Stoffwechselkrankheiten (DGVS) 1

Author

Sandmann, Lisa, Berg, Thomas, Deterding, Katja, Fischer, Nadine, Hinrichsen, Holger, Petersen, Jörg, Tacke, Frank, Cornberg, Markus, BergChristophvan BömmelFlorianBuggischPeterChristensenStefanCiesekSandraDikopoulosNektariosFlemmingGunterGlebeDieterzu SiederdissenChristoph HönerIngilizPatrickJochumChristophKlinkerHartwigde, Berg, Christoph, van Bömmel, Florian, Buggisch, Peter, Christensen, Stefan, Ciesek, Sandra, Dikopoulos, Nektarios, Flemming, Gunter, Glebe, Dieter, zu Siederdissen, Christoph Höner, Ingiliz, Patrick, and Jochum, Christoph

Published
2023
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14. Treating hepatitis D with bulevirtide – Real-world experience from 114 patients

Author

Dietz-Fricke, Christopher, primary, Tacke, Frank, additional, Zöllner, Caroline, additional, Demir, Münevver, additional, Schmidt, Hartmut H., additional, Schramm, Christoph, additional, Willuweit, Katharina, additional, Lange, Christian M., additional, Weber, Sabine, additional, Denk, Gerald, additional, Berg, Christoph P., additional, Grottenthaler, Julia M., additional, Merle, Uta, additional, Olkus, Alexander, additional, Zeuzem, Stefan, additional, Sprinzl, Kathrin, additional, Berg, Thomas, additional, van Bömmel, Florian, additional, Wiegand, Johannes, additional, Herta, Toni, additional, Seufferlein, Thomas, additional, Zizer, Eugen, additional, Dikopoulos, Nektarios, additional, Thimme, Robert, additional, Neumann-Haefelin, Christoph, additional, Galle, Peter R., additional, Sprinzl, Martin, additional, Lohse, Ansgar W., additional, Schulze zur Wiesch, Julian, additional, Kempski, Jan, additional, Geier, Andreas, additional, Reiter, Florian P., additional, Schlevogt, Bernhard, additional, Gödiker, Juliana, additional, Hofmann, Wolf Peter, additional, Buggisch, Peter, additional, Kahlhöfer, Julia, additional, Port, Kerstin, additional, Maasoumy, Benjamin, additional, Cornberg, Markus, additional, Wedemeyer, Heiner, additional, and Deterding, Katja, additional

Published
2023
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15. Clinical characteristics of patients with non-alcoholic fatty liver disease (NAFLD) in Germany – First data from the German NAFLD-Registry

Author

Geier, Andreas, additional, Rau, Monika, additional, Pathil-Warth, Anita, additional, von der Ohe, Manfred, additional, Schattenberg, Jörn, additional, Dikopoulos, Nektarios, additional, Stein, Kerstin, additional, Serfert, Yvonne, additional, Berg, Thomas, additional, Buggisch, Peter, additional, Demir, Münevver, additional, Roeb, Elke, additional, Wiebner, Bianka, additional, Wedemeyer, Heiner, additional, Zeuzem, Stefan, additional, and Hofmann, Wolf P., additional

Published
2023
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17. Post-treatment elevated gamma-glutamyl transferase is the best predictor for future outcomes in HCV patients achieving sustained virological response-data from the german hepatitis C-registry (DHC-R)

Author

Mauss, Stefan, primary, Klinker, Hartwig, additional, Boeker, Klaus, additional, Merle, Uta, additional, Link, Ralph, additional, Buggisch, Peter, additional, Hüppe, Dietrich, additional, Cornberg, Markus, additional, Sarrazin, Christoph, additional, Wedemeyer, Heiner, additional, Berg, Thomas, additional, Tacke, Frank, additional, and C-Registry, German Hepatitis, additional

Published
2022
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18. Effectiveness of voxilaprevir/velpatasvir/sofosbuvir in hepatitis C patients previously treated with direct-acting antiviral agents (DAA)

Author

Graf, Christiana, primary, Dietz, Julia, additional, Müllhaupt, Beat, additional, Buggisch, Peter, additional, Schattenberg, Jörn, additional, Antoni, Christoph, additional, Mauss, Stefan, additional, Durmashkina, Elena, additional, Niederau, Claus, additional, Discher, Thomas, additional, zur Wiesch, Julian Schulze, additional, Müller, Tobias, additional, Berg, Thomas, additional, Neumann-Haefelin, Christoph, additional, Berg, Christoph, additional, Zeuzem, Stefan, additional, and Sarrazin, Christoph, additional

Published
2022
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19. Long-term follow-up of HCV resistance-associated substitutions after DAA treatment failure

Author

Dietz, Julia, primary, Müllhaupt, Beat, additional, Buggisch, Peter, additional, Graf, Christiana, additional, Peiffer, Kai-Henrik, additional, Matschenz, Katrin, additional, Schattenberg, Jörn, additional, Mauss, Stefan, additional, Antoni, Christoph, additional, Durmashkina, Elena, additional, Niederau, Claus, additional, Discher, Thomas, additional, Trauth, Janina, additional, Dultz, Georg, additional, zur Wiesch, Julian Schulze, additional, Piecha, Felix, additional, Klinker, Hartwig, additional, Müller, Tobias, additional, Neumann-Haefelin, Christoph, additional, Berg, Thomas, additional, Berg, Christoph, additional, Zeuzem, Stefan, additional, and Sarrazin, Christoph, additional

Published
2022
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22. Characteristics of hepatitis C virus resistance in an international cohort after a decade of direct-acting antivirals

Author

Howe, Anita Y.M., primary, Rodrigo, Chaturaka, additional, Cunningham, Evan B., additional, Douglas, Mark W., additional, Dietz, Julia, additional, Grebely, Jason, additional, Popping, Stephanie, additional, Sfalcin, Javier Alejandro, additional, Parczewski, Milosz, additional, Sarrazin, Christoph, additional, de Salazar, Adolfo, additional, Fuentes, Ana, additional, Sayan, Murat, additional, Quer, Josep, additional, Kjellin, Midori, additional, Kileng, Hege, additional, Mor, Orna, additional, Lennerstrand, Johan, additional, Fourati, Slim, additional, Di Maio, Velia Chiara, additional, Chulanov, Vladimir, additional, Pawlotsky, Jean-Michel, additional, Harrigan, P. Richard, additional, Ceccherini-Silberstein, Francesca, additional, Garcia, Federico, additional, Martinello, Marianne, additional, Matthews, Gail, additional, Fernando, Fay Fabián, additional, Esteban, Juan I., additional, Müllhaupt, Beat, additional, Wiesch, Julian Schulze zur, additional, Buggisch, Peter, additional, Neumann-Haefelin, Christoph, additional, Berg, Thomas, additional, Berg, Christoph P., additional, Schattenberg, Jörn M., additional, Moreno, Christophe, additional, Stauber, Rudolf, additional, Lloyd, Andrew, additional, Dore, Gregory, additional, Applegate, Tanya, additional, Ignacio, Juan, additional, Garcia-Cehic, Damir, additional, Gregori, Josep, additional, Rodriguez-Frias, Francisco, additional, Rando, Ariadna, additional, Gozlan, Yael, additional, Angelico, Mario, additional, Andreoni, Massimo, additional, Babudieri, Sergio, additional, Bertoli, Ada, additional, Cento, Valeria, additional, Coppola, Nicola, additional, Craxì, Antonio, additional, Paolucci, Stefania, additional, Parruti, Giustino, additional, Pasquazzi, Caterina, additional, Perno, Carlo Federico, additional, Teti, Elisabetta, additional, Vironet, C., additional, Lannergård, Anders, additional, Duberg, Ann-Sofi, additional, Aleman, Soo, additional, Gutteberg, Tore, additional, Soulier, Alexandre, additional, Gourgeon, Aurélie, additional, Chevaliez, Stephane, additional, Pol, Stanislas, additional, Carrat, Fabrice, additional, Salmon, Dominique, additional, Kaiser, Rolf, additional, Knopes, Elena, additional, Gomes, Perpetua, additional, de Kneght, Rob, additional, Rijnders, Bart, additional, Poljak, Mario, additional, Lunar, Maja, additional, Usubillaga, Rafael, additional, Seguin_Devaux, Carole, additional, Tay, Enoch, additional, Wilson, Caroline, additional, Wang, Dao Sen, additional, George, Jacob, additional, Kok, Jen, additional, Pérez, Ana Belén, additional, Chueca, Natalia, additional, García-Deltoro, Miguel, additional, Martínez-Sapiña, Ana María, additional, Lara-Pérez, María Magdalena, additional, García-Bujalance, Silvia, additional, Aldámiz-Echevarría, Teresa, additional, Vera-Méndez, Francisco Jesús, additional, Pineda, Juan Antonio, additional, Casado, Marta, additional, Pascasio, Juan Manuel, additional, Salmerón, Javier, additional, Alados-Arboledas, Juan Carlos, additional, Poyato, Antonio, additional, Téllez, Francisco, additional, Rivero-Juárez, Antonio, additional, Merino, Dolores, additional, Vivancos-Gallego, María Jesús, additional, Rosales-Zábal, José Miguel, additional, Ocete, María Dolores, additional, Simón, Miguel Ángel, additional, Rincón, Pilar, additional, Reus, Sergi, additional, De la Iglesia, Alberto, additional, García-Arata, Isabel, additional, Jiménez, Miguel, additional, Jiménez, Fernando, additional, Hernández-Quero, José, additional, Galera, Carlos, additional, Balghata, Mohamed Omar, additional, Primo, Joaquín, additional, Masiá, Mar, additional, Espinosa, Nuria, additional, Delgado, Marcial, additional, von-Wichmann, Miguel Ángel, additional, Collado, Antonio, additional, Santos, Jesús, additional, Mínguez, Carlos, additional, Díaz-Flores, Felícitas, additional, Fernández, Elisa, additional, Bernal, Enrique, additional, De Juan, José, additional, Antón, José Joaquín, additional, Vélez, Mónica, additional, Aguilera, Antonio, additional, Navarro, Daniel, additional, Arenas, Juan Ignacio, additional, Fernández, Clotilde, additional, Espinosa, María Dolores, additional, Ríos, María José, additional, Alonso, Roberto, additional, Hidalgo, Carmen, additional, Hernández, Rosario, additional, Téllez, María Jesús, additional, Rodríguez, Francisco Javier, additional, Antequera, Pedro, additional, Delgado, Cristina, additional, Martín, Patricia, additional, Crespo, Javier, additional, Becerril, Berta, additional, Pérez, Oscar, additional, García-Herola, Antonio, additional, Montero, José, additional, Freyre, Carolina, additional, Grau, Concepción, additional, Cabezas, Joaquin, additional, Jimenez, Miguel, additional, Rodriguez, Manuel Alberto Macias, additional, Quilez, Cristina, additional, Pardo, Maria Rodriguez, additional, Muñoz-Medina, Leopoldo, additional, and Figueruela, Blanca, additional

Published
2022
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23. Elevated liver enzymes predict morbidity and mortality despite antiviral cure in patients with chronic hepatitis C: Data from the German Hepatitis C‐Registry.

Author

Tacke, Frank, Klinker, Hartwig, Boeker, Klaus H. W., Merle, Uta, Link, Ralph, Buggisch, Peter, Hüppe, Dietrich, Cornberg, Markus, Sarrazin, Christoph, Wedemeyer, Heiner, Berg, Thomas, Mauss, Stefan, Simon, Karl‐Georg, John, Christine, Stoehr, Albrecht, Teuber, Gerlinde, Ullrich, Rainer, Naumann, Uwe, Günther, Rainer, and Christensen, Stefan

Subjects
HEPATITIS C, GAMMA-glutamyltransferase, CHRONIC hepatitis C, ALANINE aminotransferase, LIVER enzymes, NON-alcoholic fatty liver disease, HEPATITIS, HEPATITIS C virus
Abstract

While direct‐acting antivirals (DAAs) cure chronic hepatitis C virus (HCV) infection in almost all patients, some patients remain at risk of liver disease despite HCV cure. In order to identify risk factors indicating liver‐related morbidity and death after viral cure, we included 6982 patients from the national multicenter real‐world German Hepatitis C Registry with regular follow‐up visits for up to 7 years after DAA therapy. Definitions for normal liver function tests (in women/men) were alanine aminotransferase (ALT; ≤35/≤50 U/L), ALT according to American Association for the Study of Liver Diseases (AASLD; ≤19/≤30 U/L), and gamma‐glutamyltransferase (GGT; ≤40/≤60 U/L). In our cohort, 97.4% of patients achieved sustained virologic response (SVR). At 24 weeks after SVR (SVR24), elevated ALT occurred in 657/6982 (9.4%), elevated ALT (AASLD) in 2609/6982 (37.4%), and elevated GGT in 1777/6982 (25.5%) patients. Risk factors for increased ALT at SVR24 were obesity, alcohol, cirrhosis, elevated baseline ALT, and non‐SVR. Increased GGT at SVR24 was significantly (p < 0.05) and independently associated with male sex (odds ratio [OR], 2.12), higher body mass index (OR, 1.04), age >50 years (OR, 1.60), liver cirrhosis (OR, 3.97), alcohol consumption (OR, 2.99), diabetes (OR, 1.63), non‐SVR (OR, 8.00), and elevated GGT at baseline (OR, 17.12). In multivariate regression analysis, elevated GGT at SVR24, particularly in combination with cirrhosis, was the best predictor for hepatic decompensation, hepatocellular carcinoma development, and death, followed by elevated ALT (AASLD) and standard ALT, which predicted hepatic decompensation. Despite successful HCV therapy, elevated GGT at SVR24 and to a lesser extent ALT are predictive of the future clinical outcome and linked with liver‐associated comorbidities. This may highlight the relevance of nonalcoholic fatty liver disease, diabetes mellitus, alcohol, and cirrhosis for the clinical outcome in a vulnerable population, even after HCV cure. [ABSTRACT FROM AUTHOR]

Published
2022
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24. 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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25. SAT-156 - Improvements in ALT levels during Bulevirtide treatment for hepatitis D are seen regardless of virologic response

Author

Dietz-Fricke, Christopher, Tacke, Frank, Zöllner, Caroline, Demir, Münevver, Schmidt, Hartmut, Schramm, Christoph, Willuweit, Katharina, Lange, Christian M., Weber, Sabine, Denk, Gerald, Berg, Christoph, Grottenthaler, Julia, Merle, Uta, Olkus, Alexander, Zeuzem, Stefan, Sprinzl, Kathrin, Berg, Thomas, van Bömmel, Florian, Wiegand, Johannes, Herta, Toni, Seufferlein, Thomas, Zizer, Eugen, Dikopoulos, Nektarios, Thimme, Robert, Neumann-Haefelin, Christoph, Galle, Peter, Sprinzl, Martin, Lohse, Ansgar W., Kempski, Jan, zur Wiesch, Julian Schulze, Geier, Andreas, Reiter, Florian P, Schlevogt, Bernhard, Goediker, Juliana, Hofmann, Wolf Peter, Buggisch, Peter, Kahlhöfer, Julia, Port, Kerstin, Maasoumy, Benjamin, Cornberg, Markus, Wedemeyer, Heiner, and Deterding, Katja

Published
2023
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26. LBP-12 - Off-label Bulevirtide monotherapy for chronic hepatitis D virus infection in patients with decompensated liver disease

Author

Dietz-Fricke, Christopher, Degasperi, Elisabetta, Lampertico, Pietro, Jachs, Mathias, Reiberger, Thomas, Grottenthaler, Julia, Berg, Christoph, Herta, Toni, van Bömmel, Florian, Wiegand, Johannes, Berg, Thomas, Reiter, Florian P, Geier, Andreas, Sprinzl, Kathrin, Zeuzem, Stefan, Buggisch, Peter, Maasoumy, Benjamin, Cornberg, Markus, Wedemeyer, Heiner, and Deterding, Katja

Published
2023
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28. FRI391 - Long-term follow-up of HCV resistance-associated substitutions after DAA treatment failure

Author

Dietz, Julia, Müllhaupt, Beat, Buggisch, Peter, Graf, Christiana, Peiffer, Kai-Henrik, Matschenz, Katrin, Schattenberg, Jörn, Mauss, Stefan, Antoni, Christoph, Durmashkina, Elena, Niederau, Claus, Discher, Thomas, Trauth, Janina, Dultz, Georg, zur Wiesch, Julian Schulze, Piecha, Felix, Klinker, Hartwig, Müller, Tobias, Neumann-Haefelin, Christoph, Berg, Thomas, Berg, Christoph, Zeuzem, Stefan, and Sarrazin, Christoph

Published
2022
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30. OS003 - Effectiveness of voxilaprevir/velpatasvir/sofosbuvir in hepatitis C patients previously treated with direct-acting antiviral agents (DAA)

Author

Graf, Christiana, Dietz, Julia, Müllhaupt, Beat, Buggisch, Peter, Schattenberg, Jörn, Antoni, Christoph, Mauss, Stefan, Durmashkina, Elena, Niederau, Claus, Discher, Thomas, zur Wiesch, Julian Schulze, Müller, Tobias, Berg, Thomas, Neumann-Haefelin, Christoph, Berg, Christoph, Zeuzem, Stefan, and Sarrazin, Christoph

Published
2022
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31. Long-term persistence of HCV resistance-associated substitutions after DAA treatment failure.

Author

Dietz, Julia, Müllhaupt, Beat, Buggisch, Peter, Graf, Christiana, Peiffer, Kai-Henrik, Matschenz, Katrin, Schattenberg, Jörn M., Antoni, Christoph, Mauss, Stefan, Niederau, Claus, Discher, Thomas, Trauth, Janina, Dultz, Georg, Schulze zur Wiesch, Julian, Piecha, Felix, Klinker, Hartwig, Müller, Tobias, Berg, Thomas, Neumann-Haefelin, Christoph, and Berg, Christoph P.

Subjects
*TREATMENT failure, *ANTIVIRAL agents, *PROTEASE inhibitors, *TREATMENT effectiveness, DEVELOPING countries
Abstract

Data on the long-term persistence of HCV resistance-associated substitutions (RASs) after treatment with direct-acting antivirals (DAAs) are limited. This study evaluated the persistence of NS3, NS5A, and NS5B RASs for up to 5 years after the end of treatment (EOT). We included samples from 678 individuals with an HCV genotype (GT) 1 or 3 infection and virologic DAA treatment failure collected in the European Resistance Database. NS3, NS5A, and NS5B were sequenced, and clinical parameters were evaluated. A total of 242 individuals with HCV GT1a (36%), 237 with GT1b (35%), and 199 (29%) with GT3 and a DAA failure were included. After protease inhibitor failure, the frequencies of NS3 RASs were 40–90% after the EOT. NS3 RASs disappeared rapidly in GT1b and GT3 after follow-up month 3 but were stable (≥60%) in GT1a owing to Q80K. The SOF-resistant NS5B RAS S282T was only found in individuals with GT3a. Non-nucleoside NS5B RASs were frequent in GT1 (56–80%) and decreased to 30% in GT1a but persisted in GT1b. NS5A RASs were very common in all GTs after NS5A inhibitor failure (88–95%), and even after follow-up month 24, their frequency was 65% and higher. However, RASs in GT1b had a stable course, whereas RASs in GT1a and GT3 declined slightly after follow-up month 24 (GT1a, 68%; GT1b, 95%; and GT3, 65%), mainly because of the slow decline of high-level resistant Y93H. We found that low-to medium-level RASs persisted, whereas high-level resistant RASs disappeared over time. Different patterns of RAS persistence according to HCV subtype could have implications for retreatment with first-generation DAAs and for global HCV elimination goals. There are little data on the long-term persistence of HCV resistance-associated substitutions (RASs) after DAA treatment failure, and RASs could have an impact on the efficacy of a rescue treatment. Especially in countries with limited availability of VOX/VEL/SOF or G/P/SOF, different patterns of RAS persistence could have implications for retreatment with first-generation DAAs and for global HCV elimination goals. The different patterns of RAS persistence identified in this study can be used to derive general rules regarding the persistence of RASs after DAA failure that could be applied by physicians in less developed countries to plan individualized HCV retreatment. [Display omitted] • Real-world study of the long-term persistence of NS3, NS5A, and NS5B RASs in 678 individuals with GT1 or GT3 infection after DAA failure. • Sequencing showed a rapid decrease of NS3 RASs after FU month 3 and almost no SOF-resistant RASs. • NS5A RASs persisted for more than 2 years, with a tendency to decrease in GT1a and GT3 owing to the loss of Y93H. • Patterns of RAS persistence could have implications for retreatment with first-generation DAAs and for global HCV elimination goals. [ABSTRACT FROM AUTHOR]

Published
2023
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32. Recompensation of Liver Cirrhosis by TIPS Reduces Epithelial Cell Death Markers, Translating Into Improved Clinical Outcome.

Author

Piecha, Felix, Jahn, Beatrice‐Victoria, Köntopf, Johannes, Koop, Anja, Ozga, Ann‐Kathrin, Al‐Jawazneh, Amirah, Harberts, Aenne, Riedel, Christoph, Buggisch, Peter, Benten, Daniel, Hübener, Peter, Adam, Gerhard, Huber, Samuel, Lohse, Ansgar W., Bannas, Peter, and Kluwe, Johannes

Subjects
*PORTAL hypertension, *LIVER cells, *CELL death, *LIVER failure, *TREATMENT effectiveness
Abstract

ABSTRACT Background and Aims Methods Results Conclusion Portal hypertension is the main pathophysiological driver of decompensation in patients with liver cirrhosis. Epithelial cell death markers, m30 and m65, correlate with hepatic injury and predict outcomes across various stages of liver disease. We aim (i) to evaluate whether portal hypertension itself contributes to liver outcome‐relevant epithelial injury, and (ii) to analyse the capacity of m30/m65 to predict outcome in patients receiving a transjugular intrahepatic portosystemic shunt (TIPS) for refractory ascites.Sixty‐six patients undergoing TIPS placement for refractory ascites and 20 patients with compensated cirrhosis as controls were prospectively enrolled in this monocentric cohort study. Epithelial cell death markers were analysed pre‐TIPS, as well as 1–3 and 6–9 months post‐TIPS. The capacity of baseline levels of m30/m65 in predicting six‐month transplant‐free survival rates was analysed by multivariable Cox proportional hazards regression.Levels of m30 and m65 were higher in patients with decompensated cirrhosis (pre‐TIPS) compared with compensated cirrhosis (controls). Following correction of portal hypertension by TIPS and recompensation, both markers decreased over time, reaching levels comparable to patients with compensated cirrhosis. On multivariable analysis, pre‐TIPS baseline levels of m30 and m65 were not predictive for six‐month survival.Correction of portal hypertension via TIPS reduces levels of epithelial cell death markers, indicating that portal hypertension is a driver of outcome‐relevant, hepatic cell death in patients with decompensated cirrhosis. Baseline m30/m65 values do not affect six‐month survival rates, which suggests that TIPS placement overcomes the unfavourable spontaneous prognosis otherwise indicated by elevated baseline m30/65 levels. [ABSTRACT FROM AUTHOR]

Published
2024
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33. Characteristics of hepatitis C virus resistance in an international cohort after a decade of direct-acting antivirals

Author

Anita Y.M. Howe, Chaturaka Rodrigo, Evan B. Cunningham, Mark W. Douglas, Julia Dietz, Jason Grebely, Stephanie Popping, Javier Alejandro Sfalcin, Milosz Parczewski, Christoph Sarrazin, Adolfo de Salazar, Ana Fuentes, Murat Sayan, Josep Quer, Midori Kjellin, Hege Kileng, Orna Mor, Johan Lennerstrand, Slim Fourati, Velia Chiara Di Maio, Vladimir Chulanov, Jean-Michel Pawlotsky, P. Richard Harrigan, Francesca Ceccherini-Silberstein, Federico Garcia, Marianne Martinello, Gail Matthews, Fay Fabián Fernando, Juan I. Esteban, Beat Müllhaupt, Julian Schulze zur Wiesch, Peter Buggisch, Christoph Neumann-Haefelin, Thomas Berg, Christoph P. Berg, Jörn M. Schattenberg, Christophe Moreno, Rudolf Stauber, Andrew Lloyd, Gregory Dore, Tanya Applegate, Juan Ignacio, Damir Garcia-Cehic, Josep Gregori, Francisco Rodriguez-Frias, Ariadna Rando, Yael Gozlan, Mario Angelico, Massimo Andreoni, Sergio Babudieri, Ada Bertoli, Valeria Cento, Nicola Coppola, Antonio Craxì, Stefania Paolucci, Giustino Parruti, Caterina Pasquazzi, Carlo Federico Perno, Elisabetta Teti, C. Vironet, Anders Lannergård, Ann-Sofi Duberg, Soo Aleman, Tore Gutteberg, Alexandre Soulier, Aurélie Gourgeon, Stephane Chevaliez, Stanislas Pol, Fabrice Carrat, Dominique Salmon, Rolf Kaiser, Elena Knopes, Perpetua Gomes, Rob de Kneght, Bart Rijnders, Mario Poljak, Maja Lunar, Rafael Usubillaga, Carole Seguin_Devaux, Enoch Tay, Caroline Wilson, Dao Sen Wang, Jacob George, Jen Kok, Ana Belén Pérez, Natalia Chueca, Miguel García-Deltoro, Ana María Martínez-Sapiña, María Magdalena Lara-Pérez, Silvia García-Bujalance, Teresa Aldámiz-Echevarría, Francisco Jesús Vera-Méndez, Juan Antonio Pineda, Marta Casado, Juan Manuel Pascasio, Javier Salmerón, Juan Carlos Alados-Arboledas, Antonio Poyato, Francisco Téllez, Antonio Rivero-Juárez, Dolores Merino, María Jesús Vivancos-Gallego, José Miguel Rosales-Zábal, María Dolores Ocete, Miguel Ángel Simón, Pilar Rincón, Sergi Reus, Alberto De la Iglesia, Isabel García-Arata, Miguel Jiménez, Fernando Jiménez, José Hernández-Quero, Carlos Galera, Mohamed Omar Balghata, Joaquín Primo, Mar Masiá, Nuria Espinosa, Marcial Delgado, Miguel Ángel von-Wichmann, Antonio Collado, Jesús Santos, Carlos Mínguez, Felícitas Díaz-Flores, Elisa Fernández, Enrique Bernal, José De Juan, José Joaquín Antón, Mónica Vélez, Antonio Aguilera, Daniel Navarro, Juan Ignacio Arenas, Clotilde Fernández, María Dolores Espinosa, María José Ríos, Roberto Alonso, Carmen Hidalgo, Rosario Hernández, María Jesús Téllez, Francisco Javier Rodríguez, Pedro Antequera, Cristina Delgado, Patricia Martín, Javier Crespo, Berta Becerril, Oscar Pérez, Antonio García-Herola, José Montero, Carolina Freyre, Concepción Grau, Joaquin Cabezas, Miguel Jimenez, Manuel Alberto Macias Rodriguez, Cristina Quilez, Maria Rodriguez Pardo, Leopoldo Muñoz-Medina, Blanca Figueruela, Virology, Internal Medicine, Medical Microbiology & Infectious Diseases, Institut Català de la Salut, [Howe AYM] British Columbia Centre for Disease Control, British Columbia, Canada. [Rodrigo C] School of Medical Sciences, UNSW Sydney, Sydney, Australia. [Cunningham EB, Grebely J] The Kirby Institute, UNSW Sydney, Sydney, Australia. [Douglas MW] Storr Liver Centre, The Westmead Institute for Medical Research, The University of Sydney at Westmead Hospital, Westmead, Australia. [Dietz J] Department of Internal Medicine 1, University Hospital, Goethe University, Frankfurt, Germany. [Quer J] Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. CIBEREHD, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, Howe, Anita Y. M., Rodrigo, Chaturaka, Cunningham, Evan, Douglas, Mark W., Dietz, Julia, Grebely, Jason, Popping, Stephanie, Alejandro Sfalcin, Javier, Parczewski, Milosz, Sarrazin, Christoph, de Salazar, Adolfo, Fuentes, Ana, Sayan, Murat, Quer, Josep, Kjellin, Midori, Kileng, Hege, Mor, Orna, Lennerstrand, Johan, Fourati, Slim, Chiara di Maio, Velia, Chulanov, Vladimir, Pawlotsky, Jean-Michel, Richard Harrigan, P., Ceccherini-Silberstein, Francesca, Garcia, Federico, Martinello, Marianne, Matthews, Gail, Fabi??n Fernando, Fay, Esteban, Juan I., M??llhaupt, Beat, Schulze zur Wiesch, Julian, Buggisch, Peter, Neumann-Haefelin, Christoph, Berg, Thoma, Berg, Christoph P., Schattenberg, J??rn M., Moreno, Christophe, Stauber, Rudolf, Lloyd, Andrew, Dore, Gregory, Applegate, Tanya, Ignacio, Juan, Garcia-Cehic, Damir, Gregori, Josep, Rodriguez-Frias, Francisco, Rando, Ariadna, Angelico, Mario, Andreoni, Massimo, Babudieri, Sergio, Bertoli, Ada, Cento, Valeria, Coppola, Nicola, Crax??, Antonio, Paolucci, Stefania, Parruti, Giustino, Pasquazzi, Caterina, Federico Perno, Carlo, Teti, Elisabetta, Vironet, C., Lannerg??rd, Ander, Duberg, Ann-Sofi, Aleman, Soo, Gutteberg, Tore, Soulier, Alexandre, Gourgeon, Aur??lie, Chevaliez, Stephane, Pol, Stanisla, Carrat, Fabrice, Salmon, Dominique, Kaiser, Rolf, Knopes, Elena, Gomes, Perpetua, de Kneght, Rob, Rijnders, Bart, Poljak, Mario, Lunar, Maja, Usubillaga, Rafael, Seguin, Carole, Tay, Enoch, Wilson, Caroline, Sen Wang, Dao, George, Jacob, Kok, Jen, Bel??n P??rez, Ana, Chueca, Natalia, Garc??a-Deltoro, Miguel, Mar??a Mart??nez-Sapi??a, Ana, Magdalena Lara-P??rez, Mar??a, Garc??a-Bujalance, Silvia, Ald??miz-Echevarr??a, Teresa, Jes??s Vera-M??ndez, Francisco, Antonio Pineda, Juan, Casado, Marta, Manuel Pascasio, Juan, Salmer??n, Javier, Carlos Alados-Arboledas, Juan, Poyato, Antonio, T??llez, Francisco, Rivero-Ju??rez, Antonio, Merino, Dolore, Jes??s Vivancos-Gallego, Mar??a, Miguel Rosales-Z??bal, Jos??, Dolores Ocete, Mar??a, ngel Sim??n, Miguel, Rinc??n, Pilar, Reus, Sergi, De la Iglesia, Alberto, Garc??a-Arata, Isabel, Jim??nez, Miguel, Jim??nez, Fernando, Hern??ndez-Quero, Jos??, Galera, Carlo, Omar Balghata, Mohamed, Primo, Joaqu??n, Masi??, Mar, Espinosa, Nuria, Delgado, Marcial, ngel von-Wichmann, Miguel, Collado, Antonio, Santos, Jes??, M??nguez, Carlo, D??az-Flores, Fel??cita, Fern??ndez, Elisa, Bernal, Enrique, De Juan, Jos??, Joaqu??n Ant??n, Jos??, V??lez, M??nica, Aguilera, Antonio, Navarro, Daniel, Ignacio Arenas, Juan, Fern??ndez, Clotilde, Dolores Espinosa, Mar??a, Jos?? R??os, Mar??a, Alonso, Roberto, Hidalgo, Carmen, Hern??ndez, Rosario, Jes??s T??llez, Mar??a, Javier Rodr??guez, Francisco, Antequera, Pedro, Delgado, Cristina, Mart??n, Patricia, Crespo, Javier, Becerril, Berta, P??rez, Oscar, Garc??a-Herola, Antonio, Montero, Jos??, Freyre, Carolina, Grau, Concepci??n, Cabezas, Joaquin, Jimenez, Miguel, Alberto Macias Rodriguez, Manuel, Quilez, Cristina, Rodriguez Pardo, Maria, Mu??oz-Medina, Leopoldo, and Figueruela, Blanca

Subjects
fenómenos microbiológicos::farmacorresistencia microbiana::farmacorresistencia viral [FENÓMENOS Y PROCESOS], Infectious Medicine, NNI, non-nucleoside, aOR, adjusted odds ratio, viruses, GT, genotype, Infektionsmedicin, Gastroenterology and Hepatology, NS5A, NS5AI, NS5A replication complex inhibitor, LDV, ledipasvir, Settore MED/07, PIB, pibrentasvir, RASs, resistance-associated substitutions, SDG 3 - Good Health and Well-being, SHARED, The Surveillance of Hepatitis C Antiviral Resistance, Epidemiology and methoDologies, Microbiological Phenomena::Drug Resistance, Microbial::Drug Resistance, Viral [PHENOMENA AND PROCESSES], Internal Medicine, Gastroenterologi, virologic failure, Immunology and Allergy, Medicaments antivírics, Resistència als medicaments, DAA, Hepatology, virosis::hepatitis viral humana::hepatitis C [ENFERMEDADES], Gastroenterology, Virus Diseases::Hepatitis, Viral, Human::Hepatitis C [DISEASES], virus diseases, DAA, direct-acting antiviral, DCV, daclatasvir, Hepatitis C, Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents [CHEMICALS AND DRUGS], PI, NS3 protease inhibitor, OR, odds ratio, SVR, sustained virologic response, VEL, velpatasvir, DSV, dasabuvir, acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos [COMPUESTOS QUÍMICOS Y DROGAS], SOF, sofosbuvir, HCV, sFC, substitution frequency change, NI, nucleoside, RAS
Abstract

Virologic failure; Hepatitis C Fracaso virológico; Hepatitis C Fracàs virològic; Hepatitis C Background & Aims Direct-acting antiviral (DAA) regimens provide a cure in >95% of patients with chronic HCV infection. However, in some patients in whom therapy fails, resistance-associated substitutions (RASs) can develop, limiting retreatment options and risking onward resistant virus transmission. In this study, we evaluated RAS prevalence and distribution, including novel NS5A RASs and clinical factors associated with RAS selection, among patients who experienced DAA treatment failure. Methods SHARED is an international consortium of clinicians and scientists studying HCV drug resistance. HCV sequence linked metadata from 3,355 patients were collected from 22 countries. NS3, NS5A, and NS5B RASs in virologic failures, including novel NS5A substitutions, were examined. Associations of clinical and demographic characteristics with RAS selection were investigated. Results The frequency of RASs increased from its natural prevalence following DAA exposure: 37% to 60% in NS3, 29% to 80% in NS5A, 15% to 22% in NS5B for sofosbuvir, and 24% to 37% in NS5B for dasabuvir. Among 730 virologic failures, most were treated with first-generation DAAs, 94% had drug resistance in ≥1 DAA class: 31% single-class resistance, 42% dual-class resistance (predominantly against protease and NS5A inhibitors), and 21% triple-class resistance. Distinct patterns containing ≥2 highly resistant RASs were common. New potential NS5A RASs and adaptive changes were identified in genotypes 1a, 3, and 4. Following DAA failure, RAS selection was more frequent in older people with cirrhosis and those infected with genotypes 1b and 4. Conclusions Drug resistance in HCV is frequent after DAA treatment failure. Previously unrecognized substitutions continue to emerge and remain uncharacterized. The initial SHARED development was funded in part by Merck and a User Partnership Program grant from Genome British Columbia to P.R.H and A.Y.M.H (UPP029). The Kirby Institute is funded by the Australian Government Department of Health and Ageing. The views expressed in this publication do not necessarily represent the position of the Australian (or any other) Government. C.R. and J.G. are supported by an NHMRC Investigator Grant (nos. 1173666, 1176131). An NHMRC Program Grant supported RAS testing and data collection by M.W.D. (1053206) and small grants from the Australian Centre for HIV and Hepatitis Virology Research, The University of Sydney, Western Sydney Local Health District Research Education Network, and the Robert W. Storr bequest to the Sydney Medical Foundation (University of Sydney). S.P. received personal fees from Gilead Sciences. Regarding the Italian data, the work was supported in part by the Italian Ministry of Instruction, University and Research (MIUR) (Bandiera InterOmics Protocollo PB05 1°), by the Italian Ministry of Health (RF-2016-02362422), and by Aviralia and Vironet C Foundations.

Published
2022
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34. Rare HCV subtypes and retreatment outcomes in a cohort of European DAA-experienced patients.

Author

Dietz J, Graf C, Berg CP, Port K, Deterding K, Buggisch P, Peiffer KH, Vermehren J, Dultz G, Geier A, Reiter FP, Bruns T, Schattenberg JM, Durmashkina E, Gustot T, Moreno C, Trauth J, Discher T, Fischer J, Berg T, Kremer AE, Müllhaupt B, Zeuzem S, and Sarrazin C

Abstract

Background and Aims: Data on the prevalence and characteristics of so-called rare HCV genotypes (GTs) in larger cohorts is limited. This study investigates the frequency of rare GT and resistance-associated substitutions and the efficacy of retreatment in a European cohort., Methods: A total of 129 patients with rare GT1-6 were included from the European resistance database. NS3, NS5A, and NS5B were sequenced and clinical parameters and retreatment efficacies were collected retrospectively., Results: Overall 1.5% (69/4,656) of direct-acting antiviral (DAA)-naive and 4.4% (60/1,376) of DAA-failure patients were infected with rare GT. Although rare GTs were almost equally distributed throughout GT1-6 in DAA-naive patients, we detected mainly rare GT4 (47%, 28/60 GT4; of these n = 17, subtype 4r) and GT3 (25%, 15/60 GT3, of these n = 8, subtype 3b) among DAA-failures. A total of 62% (37/60) of DAA failures had not responded to first-generation regimes and the majority was infected with rare GT4 (57%, 21/37). In contrast, among patients with failure to pangenotypic DAA regimens (38%, 23/60), infections with rare GT3 were overrepresented (57%, 13/23). Although NS5A RASs were uncommon in rare GT2, GT5a, and GT6, we observed combined RASs in rare GT1, GT3, and GT4 at positions 28, 30, 31, which can be considered as inherent. DAA failures with completed follow-up of retreatment, achieved a high SVR rate (94%, 45/48 modified intention-to-treat analysis; 92%, 45/49 intention-to-treat). Three patients with GT4f, 4r, or 3b, respectively, had virological treatment failure., Conclusions: In this European cohort, rare HCV GT were uncommon. Accumulation of specific rare GT in DAA-failure patients suggests reduced antiviral activities of DAA regimens. The limited global availability of pangenotypic regimens for first line therapy as well as multiple targeted regimens for retreatment could result in HCV elimination targets being delayed., Impact and Implications: Data on the prevalence and characteristics of rare HCV genotypes (GT) in larger cohorts are still scarce. This study found low rates of rare HCV GTs among European HCV-infected patients. In direct-acting antiviral (DAA)-failure patients, rare GT3 subtypes accumulated after pangenotypic DAA treatment and rare GT4 after first generation DAA failure and viral resistance was detected at NS5A positions 28, 30, and 31. The limited global availability of pangenotypic DAA regimens for first line therapy as well as multiple targeted regimens for retreatment could result in HCV elimination targets being delayed., Competing Interests: JD: research support from Gilead. CG: speaking and/or consulting fees from AbbVie and travel support from AbbVie and Gilead. CPB: speaking and/or consulting fees: AbbVie, BMS, Gilead, Merck/MSD. KP: no conflicts to disclose. KD: speaking and/or consulting fees: Gilead, AbbVie, Alnylam. PB: speaking and/or consulting fees: AbbVie, BMS, Falk, Gilead, Janssen, Merz Pharma, Merck/MSD. K-HP: no conflicts to disclose. JV: speaking and/or consulting fees from Abbott, AbbVie, Bristol-Myers, Squibb, Gilead, Medtronic, Merck/MSD and Roche. GD: speaking and/or consulting fees from Abbvie, Gilead. AG: advisor and steering committee member for AbbVie, Advanz, Albireo, Alexion, Astra Zeneca, Bayer, BMS, CSL Behring, Eisai, Gilead, Heel, Intercept, Ipsen, Merz, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis and as speaker for AbbVie, Advanz, Alexion, BMS, Burgerstein, CSL Behring, Falk, Gilead, Intercept, Merz, MSD, Novartis, NovoNordisk, Roche; research support from Intercept and Falk (NAFLD CSG), Novartis. FPR: honoraria for lectures, consulting activities and travel support from the Falk Foundation, AbbVie, Gilead, Ipsen, Astra Zeneca, Roche and Novartis. TB: speaking and/or consulting fees or travel support from Abbvie, Gilead, SOBI, CSL Behring, Merck, Gore, Advanz. JMS: consultant: Akero, Alentis Therapeutics, Astra Zeneca, Apollo Endosurgery, 89Bio, Boehringer Ingelheim, GSK, Ipsen, Inventiva Pharma, Madrigal, MSD, Northsea Therapeutics, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Siemens Healthineers. Research Funding: Boehringer Ingelheim, Siemens Healthcare GmbH. Stock Options: AGED diagnostics, Hepta Bio. Speaker Honorarium: Gilead Sciences, Advanz, Echosens, MedPublico GmbH. ED: speaking fees: Abbvie, Gilead. TG: advisory board for GoLiver Therapeutics. CM: speaking and/or consulting fees from Abbvie, Gilead, MSD, Intercept. Research support: Abbvie, Gilead, MSD, Intercept. JT: speaking and/or consulting fees from Abbvie, Gilead, Viiv. TD: Speaking and/or consulting fees: Abbvie, BMS, Gilead, MSD, Roche. JF: no conflicts to disclose. TB: Speaking and/or consulting fees: AbbVie, Alexion, Bayer, Boehringer Ingelheim, BMS, Gilead, GSK, Intercept, Janssen, MSD/Merck, Merz, Novartis, Sequana Medical and Roche. Research support: AbbVie, Roche, BMS, Gilead, Novartis, Merck/MSD, Intercept, Janssen, Novartis, Sequana Medical, and Pfizer. AEK: speaking and/or consulting fees: Abbvie, Advanz, Alentis, AlphaSigma, AOP Orphan, AstraZenca, Avior, Bayer, BMS, CMS, CymaBay, Eisai, Escient, Falk, Gilead, GSK, Guidepoint, Intercept, Ipsen, Lilly, Medscape, Mirum, MSD, Myr, Novartis, Roche, Takeda, Viofor, Zambon. Research support: Intercept, Gilead. BM: speaking and/or consulting fees: Merck/MSD, AbbVie, Intercept, Astra, Bayer, BMS, Gilead. Research support: Gilead. SZ: consultancy and/or speaker's bureau: Abbvie, BioMarin, Boehringer Ingelheim, Gilead, GSK, Ipsen, Madrigal, MSD/Merck, NovoNordisk, and SoBi. CS: speaking and/or consulting fees: AbbVie, Gilead, Merck/MSD. Research support: AbbVie, Gilead., (© 2024 The Authors.)

Published
2024
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35. A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis.

Author

Hirschfield GM, Bowlus CL, Mayo MJ, Kremer AE, Vierling JM, Kowdley KV, Levy C, Villamil A, Ladrón de Guevara Cetina AL, Janczewska E, Zigmond E, Jeong SH, Yilmaz Y, Kallis Y, Corpechot C, Buggisch P, Invernizzi P, Londoño Hurtado MC, Bergheanu S, Yang K, Choi YJ, Crittenden DB, and McWherter CA

Subjects
Humans, Alkaline Phosphatase blood, Double-Blind Method, Pruritus etiology, Pruritus drug therapy, Treatment Outcome, Ursodeoxycholic Acid adverse effects, Ursodeoxycholic Acid therapeutic use, PPAR delta agonists, Administration, Oral, Bilirubin blood, Cholagogues and Choleretics administration & dosage, Cholagogues and Choleretics adverse effects, Cholagogues and Choleretics therapeutic use, Acetates administration & dosage, Acetates adverse effects, Acetates therapeutic use, Liver Cirrhosis, Biliary blood, Liver Cirrhosis, Biliary complications, Liver Cirrhosis, Biliary drug therapy, Gastrointestinal Agents administration & dosage, Gastrointestinal Agents adverse effects, Gastrointestinal Agents therapeutic use
Abstract

Background: Effective treatments for patients with primary biliary cholangitis are limited. Seladelpar, a peroxisome proliferator-activated receptor delta agonist, has potential benefits., Methods: In this phase 3, 12-month, double-blind, placebo-controlled trial, we randomly assigned (in a 2:1 ratio) patients who had had an inadequate response to or who had a history of unacceptable side effects with ursodeoxycholic acid to receive oral seladelpar at a dose of 10 mg daily or placebo. The primary end point was a biochemical response, which was defined as an alkaline phosphatase level less than 1.67 times the upper limit of the normal range, with a decrease of 15% or more from baseline, and a normal total bilirubin level at month 12. Key secondary end points were normalization of the alkaline phosphatase level at month 12 and a change in the score on the pruritus numerical rating scale (range, 0 [no itch] to 10 [worst itch imaginable]) from baseline to month 6 among patients with a baseline score of at least 4 (indicating moderate-to-severe pruritus)., Results: Of the 193 patients who underwent randomization and treatment, 93.8% received ursodeoxycholic acid as standard-of-care background therapy. A greater percentage of the patients in the seladelpar group than in the placebo group had a biochemical response (61.7% vs. 20.0%; difference, 41.7 percentage points; 95% confidence interval [CI], 27.7 to 53.4, P<0.001). Normalization of the alkaline phosphatase level also occurred in a greater percentage of patients who received seladelpar than of those who received placebo (25.0% vs. 0%; difference, 25.0 percentage points; 95% CI, 18.3 to 33.2, P<0.001). Seladelpar resulted in a greater reduction in the score on the pruritus numerical rating scale than placebo (least-squares mean change from baseline, -3.2 vs. -1.7; least-squares mean difference, -1.5; 95% CI, -2.5 to -0.5, P = 0.005). Adverse events were reported in 86.7% of the patients in the seladelpar group and in 84.6% in the placebo group, and serious adverse events in 7.0% and 6.2%, respectively., Conclusions: In this trial involving patients with primary biliary cholangitis, the percentage of patients who had a biochemical response and alkaline phosphatase normalization was significantly greater with seladelpar than with placebo. Seladelpar also significantly reduced pruritus among patients who had moderate-to-severe pruritus at baseline. The incidence and severity of adverse events were similar in the two groups. (Funded by CymaBay Therapeutics; RESPONSE ClinicalTrials.gov number, NCT04620733; EudraCT number, 2020-004348-27.)., (Copyright © 2024 Massachusetts Medical Society.)

Published
2024
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