Z Gastroenterol 2025; 63(08): e556
DOI: 10.1055/s-0045-1810985
Abstracts | DGVS/DGAV
Kurzvorträge
Infektionen abseits des Üblichen Freitag, 19. September 2025, 16:10 – 17:30, MZF 4

Patient-reported outcomes measuring an individual’s overall self-rated health after long-term treatment with bulevirtide 2 mg for chronic hepatitis delta in the phase 3 MYR301 trial

Authors

  • M Buti

    1   Liver Unit, Hospital Universitario Vall d’Hebron, Barcelona, Spanien
    2   Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBER-EHD) del Instituto Carlos III, Madrid, Spanien

  • H Wedemeyer

    3   Hannover Medical School, Clinic for Gastroenterology, Hepatology, Infectious Diseases, and Endocrinology, Hannover, Deutschland

  • S Aleman

    4   Karolinska University Hospital/Karolinska lnstitutet, Department of Infectious Diseases, Stockholm, Schweden

  • V Chulanov

    5   Sechenov University, Department of Infectious Diseases, Moscow, Russische Föderation

  • V Morozov

    6   Hepatolog, LLC, Samara, Russische Föderation

  • O Sagalova

    7   South Ural State Medical University, Chelyabinsk, Russische Föderation

  • T Stepanova

    8   Clinic of Modern Medicine, Moscow, Russische Föderation

  • R G Gish

    9   Robert G. Gish Consultants, LLC, California, Vereinigte Staaten
    10   Hepatitis B Foundation, Pennsylvania, Vereinigte Staaten

  • A Lloyd

    11   Acaster Lloyd Consulting Ltd., London, Vereinigtes Königreich

  • K Deterding

    12   Hannover Medical School, Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, Hannover, Deutschland

  • D Manuilov

    13   Gilead Sciences, Inc., California, Vereinigte Staaten

  • A H Lau

    13   Gilead Sciences, Inc., California, Vereinigte Staaten

  • A O Osinusi

    13   Gilead Sciences, Inc., California, Vereinigte Staaten

  • M Rock

    13   Gilead Sciences, Inc., California, Vereinigte Staaten

  • C Kim

    13   Gilead Sciences, Inc., California, Vereinigte Staaten

  • S Pandey

    14   Pharmacoevidence Private Limited, Punjab, Indien

  • B Singh

    14   Pharmacoevidence Private Limited, Punjab, Indien

  • P Lampertico

    15   Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italien
    16   CRC “A. M. and A. Migliavacca” Center for Liver Disease, University of Milan, Department of Pathophysiology and Transplantation, Milan, Italien
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Introduction: Patients with chronic hepatitis delta (CHD) who received 48 weeks (W) of bulevirtide (BLV) 2 mg monotherapy previously reported greater improvements in their perceived health status compared with patients who received no treatment.

Objectives: To analyse EQ-5D visual analogue scale (VAS) outcomes at 144W of BLV 2 mg treatment among patients with CHD in an ongoing clinical investigation.

Methodology: Patients were enrolled in the Phase 3, randomised (1:1:1), multicentre, open-label, parallel-group MYR301 trial (n=150) and received either BLV 2 mg once daily (QD; n=49) or BLV 10 mg QD (n=50) for 144W, or delayed treatment for 48W followed by BLV 10 mg QD for 96W. Patients completed the EQ-5D VAS on their own at key time points, including baseline (BL), 24W, 48W, 96W, and 144W. High scores on the EQ-5D VAS (range, 0–100) reflect the patients’ best perceived imaginable health state. Mean (95% CI) scores and least squares mean (LSM) changes from BL are reported; changes from BL where the 95% CI included 0 were considered not statistically significant. Subgroup analyses of patients by cirrhosis status at BL are also reported.

Results: Patient characteristics and mean EQ-5D VAS scores (range, 72.0–73.9) were similar between treatment groups at BL. By 144W, 12 patients dropped out of the study, with no discontinuations due to study treatment. For patients who received BLV 2 mg (n=44 at W144), the mean (95% CI) EQ-5D VAS score at W144 was 85.5 (81.14–89.91); LSM (95% CI) score improvement from BL to W144 was 12.1 (7.32–16.87) and was considered statistically significant. LSM (95% CI) EQ-5D VAS score improvement from BL reported at W144 of BLV 2 mg treatment was greater than the LSM improvements from BL to W48 and W96. Among patients with cirrhosis, LSM (95% CI) EQ-5D VAS score improvement from BL to W144 (12.5 [5.32–19.61]; n=21) was considered significant and was greater than the LSM improvements from BL to W48 and W96. Likewise, for patients without cirrhosis, LSM (95% CI) EQ-5D VAS score improvement from BL to W144 (11.8 [5.20–18.39]; n=23) was considered significant and was greater than those at W48 and W96.

Conclusion: Patients with CHD with and without cirrhosis who were treated with BLV 2 mg for up to 144W reported improvements in their perceived health state compared with BL, and 48W and 96W of treatment, demonstrating the long-term benefits of BLV monotherapy.



Publication History

Article published online:
04 September 2025

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