{
  "abstract": "Chronic hepatitis delta (CHD), leads to worse patient physical and psychologic quality of life compared with chronic hepatitis B. Patients with CHD who received 48 weeks (W) of bulevirtide (BLV) 2 mg monotherapy reported greater improvements in their perceived health status compared with patients who received no treatment. This study reports an exploratory analysis of EQ-5D visual analogue scale (EQ VAS) outcomes at 144W of BLV 2 mg treatment among patients with CHD in an ongoing clinical investigation.Patients in this study (n = 150) were enrolled in MYR301 (NCT03852719), a Phase 3, randomised (1:1:1), multicentre, open-label, parallel-group trial. Treatment groups 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. This study focuses on BLV 2 mg, which is approved for use in Europe. Patients completed the EQ VAS on their own at baseline (BL), 24W, 48W, 96W, and 144W. High scores on the EQ VAS (range, 0–100) reflect the patients’ best perceived imaginable health state. Mean (95% confidence interval [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.Patient characteristics and mean EQ VAS scores (range, 72.0–73.9) were similar between treatment groups at BL. By 144W, 12 patients had discontinued the study (no discontinuations due to study treatment). For patients who received BLV 2 mg (n = 44 at W144), the mean (95% CI) EQ 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 VAS score improvement from BL reported at W144 of BLV 2 mg treatment was greater than the LSM improvement from BL to W48 and W96. Improvements in EQ VAS scores were observed in patients with and without cirrhosis.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. These improvements were greater than perceptions reported at both 48W and 96W of treatment, demonstrating the long-term benefits of BLV monotherapy.",
  "authors": [
    {
      "affiliations": [
        "Liver Unit, Hospital Universitario Vall d’Hebron, Barcelona, Spain",
        "Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBER-EHD) del Instituto Carlos III, Madrid, Spain"
      ],
      "name": "Maria Buti"
    },
    {
      "affiliations": [
        "Clinic for Gastroenterology, Hepatology, Infectious Diseases, and Endocrinology, Hannover Medical School , Hannover, Germany"
      ],
      "name": "Heiner Wedemeyer"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, Karolinska University Hospital/Karolinska lnstitutet, Stockholm, Sweden"
      ],
      "name": "Soo Aleman"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, Sechenov University, Moscow, Russian Federation"
      ],
      "name": "Vladimir Chulanov"
    },
    {
      "affiliations": [
        "Hepatolog, LLC, Samara, Russian Federation"
      ],
      "name": "Viacheslav Morozov"
    },
    {
      "affiliations": [
        "South Ural State Medical University, Chelyabinsk, Russian Federation"
      ],
      "name": "Olga Sagalova"
    },
    {
      "affiliations": [
        "Clinic of Modern Medicine, Moscow, Russian Federation"
      ],
      "name": "Tatiana Stepanova"
    },
    {
      "affiliations": [
        "Robert G. Gish Consultants, LLC, San Diego, USA",
        "Hepatitis B Foundation, Doylestown, USA"
      ],
      "name": "Robert Gish"
    },
    {
      "affiliations": [
        "Acaster Lloyd Consulting Ltd., London, UK"
      ],
      "name": "Andrew Lloyd"
    },
    {
      "affiliations": [
        "Gilead Sciences, Inc., Foster City, USA"
      ],
      "name": "Dmitry Manuilov"
    },
    {
      "affiliations": [
        "Gilead Sciences, Inc., Foster City, USA"
      ],
      "name": "Audrey H Lau"
    },
    {
      "affiliations": [
        "Gilead Sciences, Inc., Foster City, USA"
      ],
      "name": "Anu O Osinusi"
    },
    {
      "affiliations": [
        "Gilead Sciences, Inc., Foster City, USA"
      ],
      "name": "Marvin Rock"
    },
    {
      "affiliations": [
        "Gilead Sciences, Inc., Foster City, USA"
      ],
      "name": "Chong Kim"
    },
    {
      "affiliations": [
        "Gilead Sciences, Inc., Foster City, USA"
      ],
      "name": "Arman Sali Sali"
    },
    {
      "affiliations": [
        "Pharmacoevidence Private Limited, Punjab, India"
      ],
      "name": "Shubhram Pandey"
    },
    {
      "affiliations": [
        "Pharmacoevidence Private Limited, Punjab, India"
      ],
      "name": "Barinder Singh"
    },
    {
      "affiliations": [
        "Division of Gastroenterology and Hepatology, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy",
        "Department of Pathophysiology and Transplantation, CRC ‘A. M. and A. Migliavacca’ Center for Liver Disease, University of Milan, Milan, Italy"
      ],
      "name": "Pietro Lampertico"
    }
  ],
  "title": "P174 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",
  "uid": "c55c98d7-e485-5548-b148-5af949f61e7a"
}