Anastasiou, Olympia E.Caruntu, Florin A.Curescu, Manuela G.Yalçın, KendalAkarca, Ulus S.Gürel, SelimÇelen, Mustafa Kemal2024-03-252024-03-252024Anastasiou, O. E., Caruntu, F. A., Curescu, M. G., Yalçın, K., Akarca, U. S., Gürel, S. ve diğerleri. (2024). Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D. Liver International, 44(1), 139-147.1478-3223https://onlinelibrary.wiley.com/doi/epdf/10.1111/liv.15745https://hdl.handle.net/11468/13690Background & 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.eninfo:eu-repo/semantics/openAccessHDVHIDIT-IIInterferonLong-term outcomeNUCArticle441139147WOS:0010795436000012-s2.0-851734333413778700910.1111/liv.15745Q1N/A