Wranke, AnikaHardtke, SvenjaHeidrich, BenjaminDalekos, GeorgeYalçın, KendalTabak, FehmiÇakaloğlu, YılmazAkarca, Ulus S.Lammert, FrankHaeussinger, DieterMueller, TobiasWoebse, MichaelManns, Michael P.Idilman, RamazanCornberg, MarkusWedemeyer, HeinerYurdaydın, Cihan2022-12-192022-12-192020-07-24Wranke, A. vd. (2020). "Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta". Journal of Viral Hepatitis, 27(12), 1359-1368.1352-0504https://doi.org/10.1111/jvh.13366https://onlinelibrary.wiley.com/doi/10.1111/jvh.13366http://hdl.handle.net/11452/29943Hepatitis delta virus (HDV) infection causes the most severe form of viral hepatitis. PEG-interferon alpha-2a (PEG-IFNα-2a) is the only effective treatment but its long-term clinical impact is unclear. The aim of this study was to investigate the long-term outcome after 48 weeks of pegylated interferon alpha-2a therapy. We performed a retrospective follow-up study of the Hep-Net-International-Delta-Hepatitis-Intervention-Study 1 (HIDIT-I trial). Patients had received 48 weeks of treatment with either PEG-IFNα-2a plus adefovir dipivoxil (ADV) (Group I), PEG-IFNα-2a alone (Group II) or adefovir dipivoxil alone (Group III). Liver-related complications were defined as liver-related death, liver transplantation, liver cancer and hepatic decompensation defined as development of Child-Pugh scores B or C or an increase in Model for End-stage Liver Disease (MELD) scores of five or more points in relation to baseline values. Patients were considered for further analysis when they were retreated with PEG-IFNα-2a. Follow-up data (at least 1 visit beyond post-treatment week 24) were available for 60 patients [Group I, (n = 19), Group II (n = 20), Group III (n = 21)]. Mean time of follow-up was 8.9 (1.6 - 13.4) years. 19 patients were retreated with IFN-based therapy: 42% (n = 8) in PEG-IFNα-2a arms and 58% (n = 11) in the adefovir only arm. Clinical complications on long-term follow-up occurred in 17 patients and were associated with nonresponse to therapy and baseline cirrhosis. The annual event-free survival rate in patients with cirrhosis vs noncirrhotic patients at year 5 and 10 was 70% vs 91% and 35% vs 76%. Long-term follow-up of a large randomized clinical trial suggests that off-treatment HDV RNA response to PEG-IFNα-2a treatment leads to improved clinical long-term outcome.eninfo:eu-repo/semantics/openAccessChronic hepatitisClinical outcomeDelta virusEndpointHepatitis DInterferon therapyVirus-RNAInfectionPrevalenceKineticsAlpha-2bFlaresNeedGastroenterology & hepatologyInfectious diseasesVirologyAntiviral agentsDrug therapy, combinationEnd stage liver diseaseFollow-up studiesHepatitis, chronicHumansPolyethylene glycolsRecombinant proteinsRetrospective studiesSeverity of illness indexTreatment outcomeArticle0005585433000012-s2.0-8508925977113591368271232707605Gastroenterology & hepatologyInfectious diseasesVirologyHepatitis Delta Virus; Chronic Hepatitis D; Hepatitis BAdefovir dipivoxilAlanine aminotransferaseAlbuminAlkaline phosphataseAspartate aminotransferaseBilirubinCreatinineGamma glutamyltransferaseHepatitis B surface antigenPeginterferon alpha2aVirus RNAAntivirus agentMacrogolRecombinant proteinAdultAlanine aminotransferase blood levelAlbumin blood levelAlkaline phosphatase blood levelArticleAspartate aminotransferase blood levelBilirubin blood levelChild Pugh scoreControlled studyCreatinine blood levelDeathDecompensated liver cirrhosisDelta agent hepatitisEnd stage liver diseaseEvent free survivalFemaleFollow upGamma glutamyl transferase blood levelGeneral condition improvementHumanLiver cancerLiver transplantationMajor clinical studyMalePriority journalRetrospective studyTreatment durationTreatment outcomeTreatment refusalTreatment withdrawalChronic hepatitisCombination drug therapyEnd stage liver diseaseFollow upRandomized controlled trialSeverity of illness indexTreatment outcome