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

• Name of medicine:
  HEPCLUDEX
• Name of medicine, 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 BL V (2 mg or 10 mg) to a historical control group of adult patients who received standard of care and were not treated with BL V 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 ; hype1iension-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-IFNa) 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-IFNa ; or no CHD treatment) for up to 5 years following cohort entry ( defined as BL V 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. ; • To compare the risk of liver-related events in patients treated with BL V 2 mg or BL V 10 mg ; with or without concomitant Peg-IFNa (i.e., patients initiating BLV monotherapy who may ; add concomitant Peg-IFNa during the course of BLV treatment) with the historical control ; group receiving standard of care (i.e., off-label treatment with Peg-IFNa 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 ; BL V-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.