Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta

Anika Wranke; Svenja Hardtke; Benjamin Heidrich; George Dalekos; Kendal Yalçin; Fehmi Tabak; Selim Gürel; Yilmaz Çakaloğlu; Ulus S Akarca; Frank Lammert; Dieter Häussinger; Tobias Müller; Michael Wöbse; Michael P Manns; Ramazan Idilman; Markus Cornberg; Heiner Wedemeyer; Cihan Yurdaydin

doi:10.1111/jvh.13366

Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta

Standard

Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta. / Wranke, Anika; Hardtke, Svenja; Heidrich, Benjamin; Dalekos, George; Yalçin, Kendal; Tabak, Fehmi; Gürel, Selim; Çakaloğlu, Yilmaz; Akarca, Ulus S; Lammert, Frank; Häussinger, Dieter; Müller, Tobias; Wöbse, Michael; Manns, Michael P; Idilman, Ramazan; Cornberg, Markus; Wedemeyer, Heiner; Yurdaydin, Cihan.

In: J VIRAL HEPATITIS, Vol. 27, No. 12, 12.2020, p. 1359-1368.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Wranke, A, Hardtke, S, Heidrich, B, Dalekos, G, Yalçin, K, Tabak, F, Gürel, S, Çakaloğlu, Y, Akarca, US, Lammert, F, Häussinger, D, Müller, T, Wöbse, M, Manns, MP, Idilman, R, Cornberg, M, Wedemeyer, H & Yurdaydin, C 2020, 'Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta', J VIRAL HEPATITIS, vol. 27, no. 12, pp. 1359-1368. https://doi.org/10.1111/jvh.13366

APA

Wranke, A., Hardtke, S., Heidrich, B., Dalekos, G., Yalçin, K., Tabak, F., Gürel, S., Çakaloğlu, Y., Akarca, U. S., Lammert, F., Häussinger, D., Müller, T., Wöbse, M., Manns, M. P., Idilman, R., Cornberg, M., Wedemeyer, H., & Yurdaydin, C. (2020). Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta. J VIRAL HEPATITIS, 27(12), 1359-1368. https://doi.org/10.1111/jvh.13366

Vancouver

Wranke A, Hardtke S, Heidrich B, Dalekos G, Yalçin K, Tabak F et al. Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta. J VIRAL HEPATITIS. 2020 Dec;27(12):1359-1368. https://doi.org/10.1111/jvh.13366

Bibtex

@article{cad5db99be3f4665aa3fd6b8e218783f,

title = "Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta",

abstract = "Hepatitis 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.",

author = "Anika Wranke and Svenja Hardtke and Benjamin Heidrich and George Dalekos and Kendal Yal{\c c}in and Fehmi Tabak and Selim G{\"u}rel and Yilmaz {\c C}akaloğlu and Akarca, {Ulus S} and Frank Lammert and Dieter H{\"a}ussinger and Tobias M{\"u}ller and Michael W{\"o}bse and Manns, {Michael P} and Ramazan Idilman and Markus Cornberg and Heiner Wedemeyer and Cihan Yurdaydin",

note = "{\textcopyright} 2020 John Wiley & Sons Ltd.",

year = "2020",

month = dec,

doi = "10.1111/jvh.13366",

language = "English",

volume = "27",

pages = "1359--1368",

journal = "J VIRAL HEPATITIS",

issn = "1352-0504",

publisher = "Wiley-Blackwell",

number = "12",

}

RIS

TY - JOUR

T1 - Ten-year follow-up of a randomized controlled clinical trial in chronic hepatitis delta

AU - Wranke, Anika

AU - Hardtke, Svenja

AU - Heidrich, Benjamin

AU - Dalekos, George

AU - Yalçin, Kendal

AU - Tabak, Fehmi

AU - Gürel, Selim

AU - Çakaloğlu, Yilmaz

AU - Akarca, Ulus S

AU - Lammert, Frank

AU - Häussinger, Dieter

AU - Müller, Tobias

AU - Wöbse, Michael

AU - Manns, Michael P

AU - Idilman, Ramazan

AU - Cornberg, Markus

AU - Wedemeyer, Heiner

AU - Yurdaydin, Cihan

PY - 2020/12

Y1 - 2020/12

N2 - Hepatitis 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.

AB - Hepatitis 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.

U2 - 10.1111/jvh.13366

DO - 10.1111/jvh.13366

M3 - SCORING: Journal article

C2 - 32707605

VL - 27

SP - 1359

EP - 1368

JO - J VIRAL HEPATITIS

JF - J VIRAL HEPATITIS

SN - 1352-0504

IS - 12

ER -