Clinical Benefit of Bulevirtide Therapy in Adult Patients With Chronic Hepatitis Delta Compared to a Historical Control Group Receiving Standard of Care

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Study drug and medical condition

• Medicinal product name:
  HEPCLUDEX
• Medicinal product name, other:
  Bulevirtide, BLV(GS-4438)
• Study drug International non-proprietary name (INN) or common name:
  BULEVIRTIDE ACETATE
• Anatomical Therapeutic Chemical (ATC) code:
  (J05A) DIRECT ACTING ANTIVIRALS

  DIRECT ACTING ANTIVIRALS
• Medical condition to be studied:
  Chronic hepatitis

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  This is an observational, multicenter, multi-country study comparing the risk of liver-related events in patients treated with BLV (2 mg or 10 mg) to a historical control group of adult patients who received standard of care and were not treated with BLV during up to 5 years of follow-up time.
• Main study objective:
  1. The primary objective of the study is to compare the risk of liver-related events (i.e., development of cirrhosis, hepatic decompensation [i.e., ascites, hepatic encephalopathy, portal hypertension-related GIB, jaundice)], HCC, liver transplantation, and liver-related death) in adult patients with CHD treated with BLV monotherapy (2 mg or 10 mg without concomitant Peg-IFNα) to the risk of liver-related events in a historical control group of adult patients with CHD not treated with BLV and receiving standard of care (i.e., off-label treatment with Peg-IFNα or no CHD treatment) for up to 5 years following cohort entry (defined as BLV treatment initiation in the BLV group or first date in the study period when a historical control patients had a health care encounter and met all inclusion and exclusion criteria). ; 2. The secondary objectives of the study are: ; • To compare the risk of each type of liver-related event (i.e., development of cirrhosis, hepatic decompensation, liver transplantation, HCC, and liver-related death) in patients treated with BLV monotherapy with the historical control group receiving standard of care. ; • To compare the risk of liver-related events in patients treated with BLV 2 mg or BLV 10 mg with or without concomitant Peg-IFNα (i.e., patients initiating BLV monotherapy who may add concomitant Peg-IFNα during the course of BLV treatment) with the historical control group receiving standard of care (i.e., off-label treatment with Peg-IFNα or no CHD treatment).
• Setting:
  This study will include patients from health centers in Europe and North America. Efforts will be made to enroll the same sites for data collection on patients in both the historical control and BLV-treated groups. If the historical control group includes patients from sites not included in the BLY-treated group, these sites will be clinical centers in No1th American and European countries with comparable patient management and care.
• Outcomes:
  This study will utilize an independent Hepatic Events Adjudication Committee (HEAC) to review and independently adjudicate liver-related events to ensure that liver-related events are assessed in a consistent and transparent manner. The same operational definitions of liver-related events, including for cirrhosis events, will be applied to all patients in the BLV-treated and historical control groups in order to ensure consistency.