{
  "abstract": "This integrated analysis of bulevirtide (BLV) 10 mg monotherapy or combined with pegylated interferon alpha (PegIFN) explored whether undetectable hepatitis delta virus (HDV) RNA levels (target not detected; TND) vs below the lower limit of quantification (<LLOQ; target detected [TD]) at end of treatment (EOT) affect posttreatment virologic response for patients with compensated chronic hepatitis delta (CHD).Data were pooled from patients completing 2 or 3 years of BLV 10 mg/day ± PegIFN in the MYR204 Phase 2 and MYR301 Phase 3 studies. Patients received (A) BLV 10 mg + PegIFN for 48 weeks (W) followed by 48W of BLV 10 mg monotherapy (n=50), (B) BLV 10 mg for 96W (n=100), or (C) BLV 10 mg for 144W (n=50). Patient follow-up (FU) continued for 48W after EOT. HDV RNA levels were determined (LLOQ 50 IU/mL, limit of detection 6 IU/mL), and virologic response rates at FU48 were compared between patients with undetectable HDV RNA vs HDV RNA <LLOQ, TD at EOT.Demographics were similar across groups: male (65%), White (85%), and mean (SD) age 41 (8.2) years; 41% had compensated cirrhosis, and 53% had prior interferon experience. Mean (SD) HDV RNA, alanine aminotransferase, and liver stiffness were 5.1 (1.38) log1 0 IU/mL, 109 (88.2) U/L, and 14.0 (9.11) kPa, respectively. At EOT, 48.5% (97/200) overall achieved undetectable HDV RNA: (A) 70% (35/50), (B) 37% (37/100), and (C) 50% (25/50). Additionally, 24% (48/200) had <LLOQ, TD. At FU48, undetectable HDV RNA was observed overall in 25% (49/200) of patients, 23/50 (46%) of those receiving combination therapy, and 14% (14/100) and 24% (12/50) among those who received BLV monotherapy for 2 or 3 years. Of the patients with undetectable HDV RNA at EOT, 46% (45/97) maintained undetectable HDV RNA at FU48: (A) 60% (21/35), (B) 35% (13/37), and (C) 44% (11/25); 6% (6/97) had <LLOQ, TD at FU48. Of those who had <LLOQ, TD at EOT, 6% (3/48) had undetectable HDV RNA (1 in each group) and 4% (2/48) maintained <LLOQ, TD at FU48, while 71% (34/48) had HDV RNA >LLOQ.In patients with compensated CHD, undetectable HDV RNA with TND at EOT is strongly associated with virologic suppression at 48W posttreatment. BLV 10 mg/day and PegIFN combination therapy and longer treatment with BLV monotherapy had higher HDV RNA undetectability rates at EOT and FU48. Patients with HDV RNA <LLOQ, TD at EOT are likely to have HDV RNA rebound off therapy.",
  "authors": [
    {
      "affiliations": [
        "Hospital Croix Rousse, Lyon Hepatology Institute, Lyon, France"
      ],
      "name": "Fabien Zoulim"
    },
    {
      "affiliations": [
        "Hôpital Beaujon APHP, Université de Paris, INSERM, Clichy, France"
      ],
      "name": "Tarik Asselah"
    },
    {
      "affiliations": [
        "Karolinska University Hospital/Karolinska Institutet, Department of Infectious Diseases, Stockholm, Sweden"
      ],
      "name": "Soo Aleman"
    },
    {
      "affiliations": [
        "Hepatology Unit, Reference Center of the Tuscany Region for Chronic Liver Disease and Cancer, University Hospital of Pisa, Pisa, Italy",
        "Department of Clinical and Experimental Medicine, Pisa, Italy"
      ],
      "name": "Maurizia Brunetto"
    },
    {
      "affiliations": [
        "Sechenov University, Moscow, Russian Federation"
      ],
      "name": "Vladimir Chulanov"
    },
    {
      "affiliations": [
        "National Institute of Infectious Diseases Prof. Dr. Matei Bals, Bucharest, Romania",
        "University of Medicine and Pharmacy ‘Carol Davila’ Bucharest, Bucharest, Romania"
      ],
      "name": "Adrian Streinu-Cercel"
    },
    {
      "affiliations": [
        "University of Medicine and Pharmacy ‘Carol Davila’ Bucharest, Bucharest, Romania",
        "Dr. Victor Babes Foundation, Bucharest, Romania"
      ],
      "name": "George Sebastian Gherlan"
    },
    {
      "affiliations": [
        "M.F. Vladimirsky Moscow Regional Research and Clinical Institute, Moscow, Russian Federation"
      ],
      "name": "Pavel Bogomolov"
    },
    {
      "affiliations": [
        "LLC Clinic of Modern Medicine, Moscow, Russian Federation"
      ],
      "name": "Tatiana Stepanova"
    },
    {
      "affiliations": [
        "LLC Medical Company ‘Hepatolog’, Samara, Russian Federation"
      ],
      "name": "Viacheslav Morozov"
    },
    {
      "affiliations": [
        "South Ural State Medical University, Chelyabinsk, Russian Federation"
      ],
      "name": "Olga Sagalova"
    },
    {
      "affiliations": [
        "Gilead Sciences, Inc., Foster City, USA"
      ],
      "name": "Orla Geoghegan"
    },
    {
      "affiliations": [
        "Gilead Sciences, Inc., Foster City, USA"
      ],
      "name": "Renee-Claude Mercier"
    },
    {
      "affiliations": [
        "Gilead Sciences, Inc., Foster City, USA"
      ],
      "name": "Lei Ye"
    },
    {
      "affiliations": [
        "Gilead Sciences, Inc., Foster City, USA"
      ],
      "name": "Amos Lichtman"
    },
    {
      "affiliations": [
        "Gilead Sciences, Inc., Foster City, USA"
      ],
      "name": "Dmitry Manuilov"
    },
    {
      "affiliations": [
        "Clinic for Gastroenterology, Hepatology, Infectious Diseases, and Endocrinology, Hannover Medical School, Hannover, Germany"
      ],
      "name": "Heiner Wedemeyer"
    },
    {
      "affiliations": [
        "Division of Gastroenterology and Hepatology, Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy",
        "CRC ‘A. M. and A. Migliavacca’ Center for Liver Disease, Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy"
      ],
      "name": "Pietro Lampertico"
    }
  ],
  "title": "P164 Achieving undetectable hepatitis delta virus RNA at end of therapy with bulevirtide 10 mg/day with or without pegylated interferon alpha is strongly associated with posttreatment virologic response in chronic hepatitis delta",
  "uid": "bd3b10d2-b632-5dd6-84f5-ddcaa17242ea"
}