Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D
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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, Vol. 44, No. 1, 01.2024, p. 139-147.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -