1Department of Gastroenterology, Hepatology, Infectious Diseases, and Endocrinology, Hannover Medical School, Hannover, Germany.
2TWINCORE, Centre for Experimental and Clinical Infection Research, Hannover, Germany.
3German Center for Infection Research (DZIF), HepNet Study-House/German Liver Foundation, Hannover, Germany.
4Department of Gastroenterology, Ankara University Medical School, Ankara, Turkey.
5Department of Internal Medicine, Koc University Medical School, Istanbul, Turkey.
6Institute for Infection Research and Vaccine Development, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.
7Institutul de Boli Infectioase, Bucharest, Romania.
8Spitalul Clinic de Boli Infectioase si, Timisoara, Romania.
9Dicle University Medical Faculty, Diyarbakir, Turkey.
10Ege University Medical Faculty, Izmir, Turkey.
11Uludag University Medical Faculty, Bursa, Turkey.
12Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany.
13Heinrich Heine University, Düsseldorf, Germany.
14School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
15Institute for Biometry, Hannover Medical School, Hannover, Germany.
16Department of Pahology, Institute for Infection Research and Vaccine Development, Medical University of Vienna, Vienna, Austria.
17Zentrum für Klinische Studien, Hannover, Germany.
18German Centre for Infection Research (DZIF), Hannover-Braunschweig, Germany.
19Excellence Cluster Resist, Hannover Medical School, Hannover, Germany.
20Center for Individualized Infection Medicine (CIIM), Hannover, Germany.
21D-SOLVE Consortium, Hannover, Germany.
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.