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Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D

Standard

Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D. / Anastasiou, Olympia E; Caruntu, Florin A; Curescu, Manuela G; Yalcin, Kendal; Akarca, Ulus S; Gürel, Selim; Zeuzem, Stefan; Erhardt, Andreas; Lüth, Stefan; Papatheodoridis, George V; Keskin, Onur; Port, Kerstin; Radu, Monica; Celen, Mustafa K; Idilman, Ramazan; Heidrich, Benjamin; Mederacke, Ingmar; von der Leyen, Heiko; Kahlhöfer, Julia; von Karpowitz, Maria; Hardtke, Svenja; Cornberg, Markus; Yurdaydin, Cihan; Wedemeyer, Heiner.

in: LIVER INT, Jahrgang 44, Nr. 1, 01.2024, S. 139-147.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Anastasiou, OE, Caruntu, FA, Curescu, MG, Yalcin, K, Akarca, US, Gürel, S, Zeuzem, S, Erhardt, A, Lüth, S, Papatheodoridis, GV, Keskin, O, Port, K, Radu, M, Celen, MK, Idilman, R, Heidrich, B, Mederacke, I, von der Leyen, H, Kahlhöfer, J, von Karpowitz, M, Hardtke, S, Cornberg, M, Yurdaydin, C & Wedemeyer, H 2024, 'Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D', LIVER INT, Jg. 44, Nr. 1, S. 139-147. https://doi.org/10.1111/liv.15745

APA

Anastasiou, O. E., Caruntu, F. A., Curescu, M. G., Yalcin, K., Akarca, U. S., Gürel, S., Zeuzem, S., Erhardt, A., Lüth, S., Papatheodoridis, G. V., Keskin, O., Port, K., Radu, M., Celen, M. K., Idilman, R., Heidrich, B., Mederacke, I., von der Leyen, H., Kahlhöfer, J., ... Wedemeyer, H. (2024). Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D. LIVER INT, 44(1), 139-147. https://doi.org/10.1111/liv.15745

Vancouver

Anastasiou OE, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gürel S et al. Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D. LIVER INT. 2024 Jan;44(1):139-147. https://doi.org/10.1111/liv.15745

Bibtex

@article{3a4e5da0b9aa48c8b756115387dcd7de,
title = "Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D",
abstract = "BACKGROUND & AIMS: Until recently, pegylated interferon-alfa-2a (PEG-IFNa) therapy was the only treatment option for patients infected with hepatitis D virus (HDV). Treatment with PEG-IFNa with or without tenofovir disoproxil fumarate (TDF) for 96 weeks resulted in HDV RNA suppression in 44% of patients at the end of therapy but did not prevent short-term relapses within 24 weeks. The virological and clinical long-term effects after prolonged PEG-IFNa-based treatment of hepatitis D are unknown.METHODS: In the HIDIT-II study patients (including 40% with liver cirrhosis) received 180 μg PEG-IFNa weekly plus 300 mg TDF once daily (n = 59) or 180 μg PEG-IFNa weekly plus placebo (n = 61) for 96 weeks. Patients were followed until week 356 (5 years after end of therapy).RESULTS: Until the end of follow-up, 16 (13%) patients developed liver-related complications (PEG-IFNa + TDF, n = 5 vs PEG-IFNa + placebo, n = 11; p = .179). Achieving HDV suppression at week 96 was associated with decreased long-term risk for the development of hepatocellular carcinoma (p = .04) and hepatic decompensation (p = .009). Including complications irrespective of PEG-IFNa retreatment status, the number of patients developing serious complications was similar with (3/18) and without retreatment with PEG-IFNa (16/102, p > .999) but was associated with a higher chance of HDV-RNA suppression (p = .024, odds ratio 3.9 [1.3-12]).CONCLUSIONS: Liver-related clinical events were infrequent and occurred less frequently in patients with virological responses to PEG-IFNa treatment. PEG-IFNa treatment should be recommended to HDV-infected patients until alternative therapies become available. Retreatment with PEG-IFNa should be considered for patients with inadequate response to the first course of treatment.CLINICAL TRIAL REGISTRATION: NCT00932971.",
keywords = "Humans, Tenofovir/adverse effects, Antiviral Agents/adverse effects, Follow-Up Studies, Treatment Outcome, Drug Therapy, Combination, Neoplasm Recurrence, Local, Hepatitis D/drug therapy, Polyethylene Glycols/adverse effects, Hepatitis Delta Virus/genetics, RNA, Viral",
author = "Anastasiou, {Olympia E} and Caruntu, {Florin A} and Curescu, {Manuela G} and Kendal Yalcin and Akarca, {Ulus S} and Selim G{\"u}rel and Stefan Zeuzem and Andreas Erhardt and Stefan L{\"u}th and Papatheodoridis, {George V} and Onur Keskin and Kerstin Port and Monica Radu and Celen, {Mustafa K} and Ramazan Idilman and Benjamin Heidrich and Ingmar Mederacke and {von der Leyen}, Heiko and Julia Kahlh{\"o}fer and {von Karpowitz}, Maria and Svenja Hardtke and Markus Cornberg and Cihan Yurdaydin and Heiner Wedemeyer",
note = "{\textcopyright} 2023 The Authors. Liver International published by John Wiley & Sons Ltd.",
year = "2024",
month = jan,
doi = "10.1111/liv.15745",
language = "English",
volume = "44",
pages = "139--147",
journal = "LIVER INT",
issn = "1478-3223",
publisher = "Wiley-Blackwell",
number = "1",

}

RIS

TY - JOUR

T1 - Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D

AU - Anastasiou, Olympia E

AU - Caruntu, Florin A

AU - Curescu, Manuela G

AU - Yalcin, Kendal

AU - Akarca, Ulus S

AU - Gürel, Selim

AU - Zeuzem, Stefan

AU - Erhardt, Andreas

AU - Lüth, Stefan

AU - Papatheodoridis, George V

AU - Keskin, Onur

AU - Port, Kerstin

AU - Radu, Monica

AU - Celen, Mustafa K

AU - Idilman, Ramazan

AU - Heidrich, Benjamin

AU - Mederacke, Ingmar

AU - von der Leyen, Heiko

AU - Kahlhöfer, Julia

AU - von Karpowitz, Maria

AU - Hardtke, Svenja

AU - Cornberg, Markus

AU - Yurdaydin, Cihan

AU - Wedemeyer, Heiner

N1 - © 2023 The Authors. Liver International published by John Wiley & Sons Ltd.

PY - 2024/1

Y1 - 2024/1

N2 - BACKGROUND & AIMS: Until recently, pegylated interferon-alfa-2a (PEG-IFNa) therapy was the only treatment option for patients infected with hepatitis D virus (HDV). Treatment with PEG-IFNa with or without tenofovir disoproxil fumarate (TDF) for 96 weeks resulted in HDV RNA suppression in 44% of patients at the end of therapy but did not prevent short-term relapses within 24 weeks. The virological and clinical long-term effects after prolonged PEG-IFNa-based treatment of hepatitis D are unknown.METHODS: In the HIDIT-II study patients (including 40% with liver cirrhosis) received 180 μg PEG-IFNa weekly plus 300 mg TDF once daily (n = 59) or 180 μg PEG-IFNa weekly plus placebo (n = 61) for 96 weeks. Patients were followed until week 356 (5 years after end of therapy).RESULTS: Until the end of follow-up, 16 (13%) patients developed liver-related complications (PEG-IFNa + TDF, n = 5 vs PEG-IFNa + placebo, n = 11; p = .179). Achieving HDV suppression at week 96 was associated with decreased long-term risk for the development of hepatocellular carcinoma (p = .04) and hepatic decompensation (p = .009). Including complications irrespective of PEG-IFNa retreatment status, the number of patients developing serious complications was similar with (3/18) and without retreatment with PEG-IFNa (16/102, p > .999) but was associated with a higher chance of HDV-RNA suppression (p = .024, odds ratio 3.9 [1.3-12]).CONCLUSIONS: Liver-related clinical events were infrequent and occurred less frequently in patients with virological responses to PEG-IFNa treatment. PEG-IFNa treatment should be recommended to HDV-infected patients until alternative therapies become available. Retreatment with PEG-IFNa should be considered for patients with inadequate response to the first course of treatment.CLINICAL TRIAL REGISTRATION: NCT00932971.

AB - BACKGROUND & AIMS: Until recently, pegylated interferon-alfa-2a (PEG-IFNa) therapy was the only treatment option for patients infected with hepatitis D virus (HDV). Treatment with PEG-IFNa with or without tenofovir disoproxil fumarate (TDF) for 96 weeks resulted in HDV RNA suppression in 44% of patients at the end of therapy but did not prevent short-term relapses within 24 weeks. The virological and clinical long-term effects after prolonged PEG-IFNa-based treatment of hepatitis D are unknown.METHODS: In the HIDIT-II study patients (including 40% with liver cirrhosis) received 180 μg PEG-IFNa weekly plus 300 mg TDF once daily (n = 59) or 180 μg PEG-IFNa weekly plus placebo (n = 61) for 96 weeks. Patients were followed until week 356 (5 years after end of therapy).RESULTS: Until the end of follow-up, 16 (13%) patients developed liver-related complications (PEG-IFNa + TDF, n = 5 vs PEG-IFNa + placebo, n = 11; p = .179). Achieving HDV suppression at week 96 was associated with decreased long-term risk for the development of hepatocellular carcinoma (p = .04) and hepatic decompensation (p = .009). Including complications irrespective of PEG-IFNa retreatment status, the number of patients developing serious complications was similar with (3/18) and without retreatment with PEG-IFNa (16/102, p > .999) but was associated with a higher chance of HDV-RNA suppression (p = .024, odds ratio 3.9 [1.3-12]).CONCLUSIONS: Liver-related clinical events were infrequent and occurred less frequently in patients with virological responses to PEG-IFNa treatment. PEG-IFNa treatment should be recommended to HDV-infected patients until alternative therapies become available. Retreatment with PEG-IFNa should be considered for patients with inadequate response to the first course of treatment.CLINICAL TRIAL REGISTRATION: NCT00932971.

KW - Humans

KW - Tenofovir/adverse effects

KW - Antiviral Agents/adverse effects

KW - Follow-Up Studies

KW - Treatment Outcome

KW - Drug Therapy, Combination

KW - Neoplasm Recurrence, Local

KW - Hepatitis D/drug therapy

KW - Polyethylene Glycols/adverse effects

KW - Hepatitis Delta Virus/genetics

KW - RNA, Viral

U2 - 10.1111/liv.15745

DO - 10.1111/liv.15745

M3 - SCORING: Journal article

C2 - 37787009

VL - 44

SP - 139

EP - 147

JO - LIVER INT

JF - LIVER INT

SN - 1478-3223

IS - 1

ER -