Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Aug;43(8):1663-1676.
doi: 10.1111/liv.15602. Epub 2023 May 15.

Quality-of-life scores improve after 96 weeks of PEG-IFNa-2a treatment of hepatitis D: An analysis of the HIDIT-II trial

Katja Dinkelborg  1   2 , Julia Kahlhöfer  1   3 , Petra Dörge  1   3 , Cihan Yurdaydin  4   5 , Svenja Hardtke  3   6 , Florin Alexandru Caruntu  7 , Manuela G Curescu  8 , Kendal Yalcin  9 , Ulus S Akarca  10 , Selim Gürel  11 , Stefan Zeuzem  12 , Andreas Erhardt  13 , Stefan Lüth  6 , George V Papatheodoridis  14 , Onur Keskin  4 , Kerstin Port  1 , Monica Radu  7 , Mustafa K Celen  9 , Ramazan Idilman  4 , Kristina Weber  15 , Judith Stift  16 , Ulrike Wittkop  17 , Benjamin Heidrich  1   18   19 , Ingmar Mederacke  1 , Heiko von der Leyen  17 , Hans Peter Dienes  16 , Markus Cornberg  1   3   18   20 , Armin Koch  15 , Michael P Manns  1   18 , Heiner Wedemeyer  1   18   19   21 , Katja Deterding  1 ; HIDIT-2 Study Team
Affiliations
Randomized Controlled Trial

Quality-of-life scores improve after 96 weeks of PEG-IFNa-2a treatment of hepatitis D: An analysis of the HIDIT-II trial

Katja Dinkelborg et al. Liver Int. 2023 Aug.

Abstract

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.

Keywords: SF36; hepatitis D; interferon-based therapy; quality of life.

PubMed Disclaimer

References

REFERENCES

    1. Urban S, Neumann-Haefelin C, Lampertico P. Hepatitis D virus in 2021: virology, immunology and new treatment approaches for a difficult-to-treat disease. Gut. 2021;70(9):1782-1794.
    1. Stockdale AJ, Kreuels B, Henrion MYR, et al. The global prevalence of hepatitis D virus infection: systematic review and meta-analysis. J Hepatol. 2020;73(3):523-532. doi:10.1016/j.jhep.2020.04.008. Epub 2020 Apr 23.
    1. Alfaiate D, Clément S, Gomes D, Goossens N, Negro F. Chronic hepatitis D and hepatocellular carcinoma: a systematic review and meta-analysis of observational studies. J Hepatol. 2020;73(3):533-539.
    1. Béguelin C, Moradpour D, Sahli R, et al. Hepatitis delta-associated mortality in HIV/HBV-coinfected patients. J Hepatol. 2017;66(2):297-303.
    1. Fernández-Montero JV, Vispo E, Barreiro P, et al. Hepatitis delta is a major determinant of liver decompensation events and death in HIV-infected patients. Clin Infect Dis. 2014;58(11):1549-1553.

Publication types

LinkOut - more resources