HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis

Summary

Randomized, double blind study comparing the efficacy of pegylated interferon-alfa2a plus placebo versus pegylated interferon-alfa2a plus tenofovir for the treatment of chronic delta hepatitis. 70 Patients will be randomized 1:1 into the two groups. Treatment duration: 96 weeks. Follow-up: 24 weeks. Long-term-follow-up: until week 358.

Timeline

Start

2009-06

Primary completion

2017-08

Completion

2017-08-02

Publications

• Background Heidrich B, Deterding K, Tillmann HL, Raupach R, Manns MP, Wedemeyer H. Virological and clinical characteristics of delta hepatitis in Central Europe. J Viral Hepat. 2009 Dec;16(12):883-94. doi: 10.1111/j.1365-2893.2009.01144.x. Epub 2009 Jun 28.
• Background Wedemeyer H, Yurdaydin C, Dalekos GN, Erhardt A, Cakaloglu Y, Degertekin H, Gurel S, Zeuzem S, Zachou K, Bozkaya H, Koch A, Bock T, Dienes HP, Manns MP; HIDIT Study Group. Peginterferon plus adefovir versus either drug alone for hepatitis delta. N Engl J Med. 2011 Jan 27;364(4):322-31. doi: 10.1056/NEJMoa0912696.
• Background Heidrich B, Yurdaydin C, Kabacam G, Ratsch BA, Zachou K, Bremer B, Dalekos GN, Erhardt A, Tabak F, Yalcin K, Gurel S, Zeuzem S, Cornberg M, Bock CT, Manns MP, Wedemeyer H; HIDIT-1 Study Group. Late HDV RNA relapse after peginterferon alpha-based therapy of chronic hepatitis delta. Hepatology. 2014 Jul;60(1):87-97. doi: 10.1002/hep.27102.
• Yurdaydin C, Kahlhofer J, Caruntu FA, Yalcin K, Gurel S, Akarca US, Sprinzl K, Bock HH, Bockmann JH, Papatheodoridis GV, Merle U, Demir M, Hardtke S, Keskin O, Idilman R, Cornberg M, Wedemeyer H, Wranke A. Ten-Year Follow-Up After 96 Weeks Treatment With Peginterferon Plus Tenofovir in Hepatitis D (HIDIT-II): Improved Clinical Outcome After Combination Therapy. United European Gastroenterol J. 2026 Feb;14(1):e70153. doi: 10.1002/ueg2.70153. Epub 2025 Nov 29.
• Hardtke S, Yurdaydin C, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Port K, Manns MP, Cornberg M, Kahlhofer J, Wedemeyer H. Frequency, Severity and Impact of Pegylated Interferon Alpha-Associated Flares in Hepatitis D Infection. J Viral Hepat. 2025 Apr;32(4):e70022. doi: 10.1111/jvh.70022.
• Anastasiou OE, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Heidrich B, Mederacke I, von der Leyen H, Kahlhofer J, von Karpowitz M, Hardtke S, Cornberg M, Yurdaydin C, Wedemeyer H. Five-year follow-up of 96 weeks peginterferon plus tenofovir disoproxil fumarate in hepatitis D. Liver Int. 2024 Jan;44(1):139-147. doi: 10.1111/liv.15745. Epub 2023 Oct 3.
• Wedemeyer H, Yurdaydin C, Hardtke S, Caruntu FA, Curescu MG, Yalcin K, Akarca US, Gurel S, Zeuzem S, Erhardt A, Luth S, Papatheodoridis GV, Keskin O, Port K, Radu M, Celen MK, Idilman R, Weber K, Stift J, Wittkop U, Heidrich B, Mederacke I, von der Leyen H, Dienes HP, Cornberg M, Koch A, Manns MP; HIDIT-II study team. Peginterferon alfa-2a plus tenofovir disoproxil fumarate for hepatitis D (HIDIT-II): a randomised, placebo controlled, phase 2 trial. Lancet Infect Dis. 2019 Mar;19(3):275-286. doi: 10.1016/S1473-3099(18)30663-7.
• Bremer B, Anastasiou OE, Ciesek S, Wedemeyer H. Automated nucleic acid isolation methods for HDV viral load quantification can lead to viral load underestimation. Antivir Ther. 2019;24(2):117-123. doi: 10.3851/IMP3281.

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Indications