Quality-of-life scores improve after 96 weeks of PEG-IFNa-2a treatment of hepatitis D
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Quality-of-life scores improve after 96 weeks of PEG-IFNa-2a treatment of hepatitis D : An analysis of the HIDIT-II trial. / Dinkelborg, Katja; Kahlhöfer, Julia; Dörge, Petra; Yurdaydin, Cihan; Hardtke, Svenja; Caruntu, Florin Alexandru; Curescu, Manuela G; Yalcin, Kendal; Akarca, Ulus S; Gürel, Selim; Zeuzem, Stefan; Erhardt, Andreas; Lüth, Stefan; Papatheodoridis, George V; Keskin, Onur; Port, Kerstin; Radu, Monica; Celen, Mustafa K; Idilman, Ramazan; Weber, Kristina; Stift, Judith; Wittkop, Ulrike; Heidrich, Benjamin; Mederacke, Ingmar; von der Leyen, Heiko; Dienes, Hans Peter; Cornberg, Markus; Koch, Armin; Manns, Michael P; Wedemeyer, Heiner; Deterding, Katja; HIDIT-II Study Group.
In: LIVER INT, Vol. 43, No. 8, 08.2023, p. 1663-1676.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Quality-of-life scores improve after 96 weeks of PEG-IFNa-2a treatment of hepatitis D
T2 - An analysis of the HIDIT-II trial
AU - Dinkelborg, Katja
AU - Kahlhöfer, Julia
AU - Dörge, Petra
AU - Yurdaydin, Cihan
AU - Hardtke, Svenja
AU - Caruntu, Florin Alexandru
AU - Curescu, Manuela G
AU - Yalcin, Kendal
AU - Akarca, Ulus S
AU - Gürel, Selim
AU - Zeuzem, Stefan
AU - Erhardt, Andreas
AU - Lüth, Stefan
AU - Papatheodoridis, George V
AU - Keskin, Onur
AU - Port, Kerstin
AU - Radu, Monica
AU - Celen, Mustafa K
AU - Idilman, Ramazan
AU - Weber, Kristina
AU - Stift, Judith
AU - Wittkop, Ulrike
AU - Heidrich, Benjamin
AU - Mederacke, Ingmar
AU - von der Leyen, Heiko
AU - Dienes, Hans Peter
AU - Cornberg, Markus
AU - Koch, Armin
AU - Manns, Michael P
AU - Wedemeyer, Heiner
AU - Deterding, Katja
AU - HIDIT-II Study Group
N1 - © 2023 The Authors. Liver International published by John Wiley & Sons Ltd.
PY - 2023/8
Y1 - 2023/8
N2 - BACKGROUND & AIMS: Infection with the hepatitis D virus (HDV) causes the most severe form of viral hepatitis with a high risk to develop clinical complications of liver disease. In addition, hepatitis delta has been shown to be associated with worse patient-reported outcomes. Until recently, only pegylated interferon alfa could be used to treat hepatitis delta.METHODS: Here, we investigated quality of life (QOL) as assessed by the Short Form 36 Health Survey (SF-36) in patients undergoing antiviral therapy with pegylated interferon alfa (PEG-IFNa-2a)-based treatment in the HIDIT-II trial. HIDIT-II was a randomized prospective trial exploring PEG-IFNa-2a with tenofovir disoproxil (TDF) or placebo for 96 weeks in patients with compensated hepatitis delta. Surveys completed by 83 study participants before, during, and after treatments were available.RESULTS: Overall, we observed a reduced QOL of HDV patients compared with a reference population, both in physical as well as mental scores. Interestingly, PEG-IFNa-2a treatment showed only minor impairment of the QOL during therapy. Moreover, HDV-RNA clearance was not associated with relevant changes in physical or social SF-36 scores, whereas an improvement of fibrosis during treatment was associated with increased QOL. Overall, slight improvements of the QOL scores were observed 24 weeks after the end of treatment as compared with baseline. TDF co-treatment had no influence on QOL.CONCLUSIONS: Overall, our findings suggest that PEG-IFNa-2a was reasonably tolerated even over a period of 96 weeks by hepatitis D patients reporting SF-36 questionnaires. Of note, several patients may benefit from PEG-IFNa-2a-based therapies with off-treatment improvements in quality of life.
AB - BACKGROUND & AIMS: Infection with the hepatitis D virus (HDV) causes the most severe form of viral hepatitis with a high risk to develop clinical complications of liver disease. In addition, hepatitis delta has been shown to be associated with worse patient-reported outcomes. Until recently, only pegylated interferon alfa could be used to treat hepatitis delta.METHODS: Here, we investigated quality of life (QOL) as assessed by the Short Form 36 Health Survey (SF-36) in patients undergoing antiviral therapy with pegylated interferon alfa (PEG-IFNa-2a)-based treatment in the HIDIT-II trial. HIDIT-II was a randomized prospective trial exploring PEG-IFNa-2a with tenofovir disoproxil (TDF) or placebo for 96 weeks in patients with compensated hepatitis delta. Surveys completed by 83 study participants before, during, and after treatments were available.RESULTS: Overall, we observed a reduced QOL of HDV patients compared with a reference population, both in physical as well as mental scores. Interestingly, PEG-IFNa-2a treatment showed only minor impairment of the QOL during therapy. Moreover, HDV-RNA clearance was not associated with relevant changes in physical or social SF-36 scores, whereas an improvement of fibrosis during treatment was associated with increased QOL. Overall, slight improvements of the QOL scores were observed 24 weeks after the end of treatment as compared with baseline. TDF co-treatment had no influence on QOL.CONCLUSIONS: Overall, our findings suggest that PEG-IFNa-2a was reasonably tolerated even over a period of 96 weeks by hepatitis D patients reporting SF-36 questionnaires. Of note, several patients may benefit from PEG-IFNa-2a-based therapies with off-treatment improvements in quality of life.
U2 - 10.1111/liv.15602
DO - 10.1111/liv.15602
M3 - SCORING: Journal article
C2 - 37183524
VL - 43
SP - 1663
EP - 1676
JO - LIVER INT
JF - LIVER INT
SN - 1478-3223
IS - 8
ER -
