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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, Vol. 5, No. 4, 04.2023, p. 100686.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Dietz-Fricke, C, Tacke, F, Zöllner, C, Demir, M, Schmidt, HH, Schramm, C, Willuweit, K, Lange, CM, Weber, S, Denk, G, Berg, CP, Grottenthaler, JM, Merle, U, Olkus, A, Zeuzem, S, Sprinzl, K, Berg, T, van Bömmel, F, Wiegand, J, Herta, T, Seufferlein, T, Zizer, E, Dikopoulos, N, Thimme, R, Neumann-Haefelin, C, Galle, PR, Sprinzl, M, Lohse, AW, Schulze Zur Wiesch, J, Kempski, J, Geier, A, Reiter, FP, Schlevogt, B, Gödiker, J, Hofmann, WP, Buggisch, P, Kahlhöfer, J, Port, K, Maasoumy, B, Cornberg, M, Wedemeyer, H & Deterding, K 2023, 'Treating hepatitis D with bulevirtide - Real-world experience from 114 patients', JHEP REP, vol. 5, no. 4, pp. 100686. https://doi.org/10.1016/j.jhepr.2023.100686

APA

Dietz-Fricke, C., Tacke, F., Zöllner, C., Demir, M., Schmidt, H. H., Schramm, C., Willuweit, K., Lange, C. M., Weber, S., Denk, G., Berg, C. P., Grottenthaler, J. M., Merle, U., Olkus, A., Zeuzem, S., Sprinzl, K., Berg, T., van Bömmel, F., Wiegand, J., ... Deterding, K. (2023). Treating hepatitis D with bulevirtide - Real-world experience from 114 patients. JHEP REP, 5(4), 100686. https://doi.org/10.1016/j.jhepr.2023.100686

Vancouver

Dietz-Fricke C, Tacke F, Zöllner C, Demir M, Schmidt HH, Schramm C et al. Treating hepatitis D with bulevirtide - Real-world experience from 114 patients. JHEP REP. 2023 Apr;5(4):100686. https://doi.org/10.1016/j.jhepr.2023.100686

Bibtex

@article{3a3d697355b74878bf25635deec16680,
title = "Treating hepatitis D with bulevirtide - Real-world experience from 114 patients",
abstract = "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.",
author = "Christopher Dietz-Fricke and Frank Tacke and Caroline Z{\"o}llner and M{\"u}nevver Demir and Schmidt, {Hartmut H} and Christoph Schramm and Katharina Willuweit and Lange, {Christian M} and Sabine Weber and Gerald Denk and Berg, {Christoph P} and Grottenthaler, {Julia M} and Uta Merle and Alexander Olkus and Stefan Zeuzem and Kathrin Sprinzl and Thomas Berg and {van B{\"o}mmel}, Florian and Johannes Wiegand and Toni Herta and Thomas Seufferlein and Eugen Zizer and Nektarios Dikopoulos and Robert Thimme and Christoph Neumann-Haefelin and Galle, {Peter R} and Martin Sprinzl and Lohse, {Ansgar W} and {Schulze Zur Wiesch}, Julian and Jan Kempski and Andreas Geier and Reiter, {Florian P} and Bernhard Schlevogt and Juliana G{\"o}diker and Hofmann, {Wolf Peter} and Peter Buggisch and Julia Kahlh{\"o}fer and Kerstin Port and Benjamin Maasoumy and Markus Cornberg and Heiner Wedemeyer and Katja Deterding",
note = ".",
year = "2023",
month = apr,
doi = "10.1016/j.jhepr.2023.100686",
language = "English",
volume = "5",
pages = "100686",
journal = "JHEP REP",
issn = "2589-5559",
publisher = "Elsevier",
number = "4",

}

RIS

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 -