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Hepcludex (bulevirtide acetate)
Australian Prescription Medicine Decision Summary
Published
Product name
Hepcludex
Active ingredient
bulevirtide acetate
Submission type
Type A (New chemical entity)
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Hepcludex (bulevirtide acetate) was approved to treat chronic hepatitis delta virus infection in adults with compensated liver disease.
How this medicine works
Hepcludex is a hepatitis beta virus-derived synthesised lipopeptide that blocks the entry of hepatitis B virus (HBV) and hepatitis D virus (HDV) into liver cells by binding to and inactivating the essential HBV and HDV entry receptor, sodium taurocholate co-transporting polypeptide (NTCP).
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor.
The effectiveness of Hepcludex for the treatment of chronic infection with hepatitis delta virus has been evaluated in 3 randomised, open-label studies: 2 completed Phase 2 studies and 1 ongoing Phase 3 study. In addition, a fourth ongoing, randomised, open-label Phase 2 study is included in the integrated analysis of the clinical safety of Hepcludex.
(visit this page for information on clinical trial types: https://www.australianclinicaltrials.gov.au/about/what-is-a-clinical-trial)
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlinks below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlinks below.
Sponsor
Other resources
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.