Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D
© 2023 The Authors. Liver International published by John Wiley & Sons Ltd..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:44 |
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| Enthalten in: |
Liver international : official journal of the International Association for the Study of the Liver - 44(2024), 1 vom: 19. Jan., Seite 139-147 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Anastasiou, Olympia E [VerfasserIn] |
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| Links: |
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| Themen: |
3WJQ0SDW1A |
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| Anmerkungen: |
Date Completed 20.12.2023 Date Revised 19.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT00932971 Citation Status MEDLINE |
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| doi: |
10.1111/liv.15745 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Anastasiou, Olympia E |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Completed 20.12.2023 | ||
| 500 | |a Date Revised 19.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT00932971 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Authors. Liver International published by John Wiley & Sons Ltd. | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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]) | ||
| 520 | |a 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 | ||
| 520 | |a CLINICAL TRIAL REGISTRATION: NCT00932971 | ||
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| 650 | 7 | |a RNA, Viral |2 NLM | |
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| 700 | 1 | |a Zeuzem, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a Erhardt, Andreas |e verfasserin |4 aut | |
| 700 | 1 | |a Lüth, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a Papatheodoridis, George V |e verfasserin |4 aut | |
| 700 | 1 | |a Keskin, Onur |e verfasserin |4 aut | |
| 700 | 1 | |a Port, Kerstin |e verfasserin |4 aut | |
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| 700 | 1 | |a Celen, Mustafa K |e verfasserin |4 aut | |
| 700 | 1 | |a Idilman, Ramazan |e verfasserin |4 aut | |
| 700 | 1 | |a Heidrich, Benjamin |e verfasserin |4 aut | |
| 700 | 1 | |a Mederacke, Ingmar |e verfasserin |4 aut | |
| 700 | 1 | |a von der Leyen, Heiko |e verfasserin |4 aut | |
| 700 | 1 | |a Kahlhöfer, Julia |e verfasserin |4 aut | |
| 700 | 1 | |a von Karpowitz, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Hardtke, Svenja |e verfasserin |4 aut | |
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