Treating hepatitis D with bulevirtide - Real-world experience from 114 patients
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Treating hepatitis D with bulevirtide - Real-world experience from 114 patients. / Dietz-Fricke, Christopher; Tacke, Frank; Zöllner, Caroline; Demir, Münevver; Schmidt, Hartmut H; Schramm, Christoph; Willuweit, Katharina; Lange, Christian M; Weber, Sabine; Denk, Gerald; Berg, Christoph P; Grottenthaler, Julia M; 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 R; Sprinzl, Martin; Lohse, Ansgar W; Schulze Zur Wiesch, Julian; Kempski, Jan; Geier, Andreas; Reiter, Florian P; Schlevogt, Bernhard; Gödiker, Juliana; Hofmann, Wolf Peter; Buggisch, Peter; Kahlhöfer, Julia; Port, Kerstin; Maasoumy, Benjamin; Cornberg, Markus; Wedemeyer, Heiner; Deterding, Katja.
in: JHEP REP, Jahrgang 5, Nr. 4, 04.2023, S. 100686.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Treating hepatitis D with bulevirtide - Real-world experience from 114 patients
AU - Dietz-Fricke, Christopher
AU - Tacke, Frank
AU - Zöllner, Caroline
AU - Demir, Münevver
AU - Schmidt, Hartmut H
AU - Schramm, Christoph
AU - Willuweit, Katharina
AU - Lange, Christian M
AU - Weber, Sabine
AU - Denk, Gerald
AU - Berg, Christoph P
AU - Grottenthaler, Julia M
AU - Merle, Uta
AU - Olkus, Alexander
AU - Zeuzem, Stefan
AU - Sprinzl, Kathrin
AU - Berg, Thomas
AU - van Bömmel, Florian
AU - Wiegand, Johannes
AU - Herta, Toni
AU - Seufferlein, Thomas
AU - Zizer, Eugen
AU - Dikopoulos, Nektarios
AU - Thimme, Robert
AU - Neumann-Haefelin, Christoph
AU - Galle, Peter R
AU - Sprinzl, Martin
AU - Lohse, Ansgar W
AU - Schulze Zur Wiesch, Julian
AU - Kempski, Jan
AU - Geier, Andreas
AU - Reiter, Florian P
AU - Schlevogt, Bernhard
AU - Gödiker, Juliana
AU - Hofmann, Wolf Peter
AU - Buggisch, Peter
AU - Kahlhöfer, Julia
AU - Port, Kerstin
AU - Maasoumy, Benjamin
AU - Cornberg, Markus
AU - Wedemeyer, Heiner
AU - Deterding, Katja
N1 - .
PY - 2023/4
Y1 - 2023/4
N2 - BACKGROUND & AIMS: Bulevirtide is a first-in-class entry inhibitor of hepatitis B surface antigen. In July 2020, bulevirtide was conditionally approved for the treatment of hepatitis D, the most severe form of viral hepatitis, which frequently causes end-stage liver disease and hepatocellular carcinoma. Herein, we report the first data from a large multicenter real-world cohort of patients with hepatitis D treated with bulevirtide at a daily dose of 2 mg without additional interferon.METHODS: In a joint effort with 16 hepatological centers, we collected anonymized retrospective data from patients treated with bulevirtide for chronic hepatitis D.RESULTS: Our analysis is based on data from 114 patients, including 59 (52%) with cirrhosis, receiving a total of 4,289 weeks of bulevirtide treatment. A virologic response defined as an HDV RNA decline of at least 2 log or undetectable HDV RNA was observed in 87/114 (76%) cases with a mean time to virologic response of 23 weeks. In 11 cases, a virologic breakthrough (>1 log-increase in HDV RNA after virologic response) was observed. After 24 weeks of treatment, 19/33 patients (58%) had a virologic response, while three patients (9%) did not achieve a 1 log HDV RNA decline. No patient lost hepatitis B surface antigen. Alanine aminotransferase levels improved even in patients not achieving a virologic response, including five patients who had decompensated cirrhosis at the start of treatment. Treatment was well tolerated and there were no reports of drug-related serious adverse events.CONCLUSIONS: In conclusion, we confirm the safety and efficacy of bulevirtide monotherapy in a large real-world cohort of patients with hepatitis D treated in Germany. Future studies need to explore the long-term benefits and optimal duration of bulevirtide treatment.IMPACT AND IMPLICATIONS: Clinical trials proved the efficacy of bulevirtide for chronic hepatitis D and led to conditional approval by the European Medical Agency. Now it is of great interest to investigate the effects of bulevirtide treatment in a real-world setting. In this work, we included data from 114 patients with chronic hepatitis D who were treated with bulevirtide at 16 German centers. A virologic response was seen in 87/114 cases. After 24 weeks of treatment, only a small proportion of patients did not respond to treatment. At the same time, signs of liver inflammation improved. This observation was independent from changes in hepatitis D viral load. The treatment was generally well tolerated. In the future, it will be of interest to investigate the long-term effects of this new treatment.
AB - BACKGROUND & AIMS: Bulevirtide is a first-in-class entry inhibitor of hepatitis B surface antigen. In July 2020, bulevirtide was conditionally approved for the treatment of hepatitis D, the most severe form of viral hepatitis, which frequently causes end-stage liver disease and hepatocellular carcinoma. Herein, we report the first data from a large multicenter real-world cohort of patients with hepatitis D treated with bulevirtide at a daily dose of 2 mg without additional interferon.METHODS: In a joint effort with 16 hepatological centers, we collected anonymized retrospective data from patients treated with bulevirtide for chronic hepatitis D.RESULTS: Our analysis is based on data from 114 patients, including 59 (52%) with cirrhosis, receiving a total of 4,289 weeks of bulevirtide treatment. A virologic response defined as an HDV RNA decline of at least 2 log or undetectable HDV RNA was observed in 87/114 (76%) cases with a mean time to virologic response of 23 weeks. In 11 cases, a virologic breakthrough (>1 log-increase in HDV RNA after virologic response) was observed. After 24 weeks of treatment, 19/33 patients (58%) had a virologic response, while three patients (9%) did not achieve a 1 log HDV RNA decline. No patient lost hepatitis B surface antigen. Alanine aminotransferase levels improved even in patients not achieving a virologic response, including five patients who had decompensated cirrhosis at the start of treatment. Treatment was well tolerated and there were no reports of drug-related serious adverse events.CONCLUSIONS: In conclusion, we confirm the safety and efficacy of bulevirtide monotherapy in a large real-world cohort of patients with hepatitis D treated in Germany. Future studies need to explore the long-term benefits and optimal duration of bulevirtide treatment.IMPACT AND IMPLICATIONS: Clinical trials proved the efficacy of bulevirtide for chronic hepatitis D and led to conditional approval by the European Medical Agency. Now it is of great interest to investigate the effects of bulevirtide treatment in a real-world setting. In this work, we included data from 114 patients with chronic hepatitis D who were treated with bulevirtide at 16 German centers. A virologic response was seen in 87/114 cases. After 24 weeks of treatment, only a small proportion of patients did not respond to treatment. At the same time, signs of liver inflammation improved. This observation was independent from changes in hepatitis D viral load. The treatment was generally well tolerated. In the future, it will be of interest to investigate the long-term effects of this new treatment.
U2 - 10.1016/j.jhepr.2023.100686
DO - 10.1016/j.jhepr.2023.100686
M3 - SCORING: Journal article
C2 - 37025462
VL - 5
SP - 100686
JO - JHEP REP
JF - JHEP REP
SN - 2589-5559
IS - 4
ER -