Bulevirtide Clinical Summary.pdf (692.15 kB)

Bulevirtide in chronic hepatitis D: a profile of its use

online resource

posted on 2021-06-13, 23:29 authored by Connie Kang

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and conflicts of interest C. Kang is a salaried employee of Adis International Ltd/Springer Nature and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

Bulevirtide (HEPCLUDEX^®), a first-in-class entry inhibitor, is a new option for the treatment of chronic hepatitis delta virus (HDV) infection (hepatitis D) in HDV-RNA positive adults with compensated liver disease. In a pivotal phase IIb trial in patients with chronic hepatitis D, treatment with bulevirtide in combination with tenofovir significantly reduced HDV RNA levels compared with treatment of the underlying HBV infection with tenofovir alone. Alanine aminotransferase (ALT) levels were also significantly normalised by bulevirtide combination therapy. Bulevirtide is generally well tolerated; the most common adverse event in clinical trials was dose-dependent and asymptomatic increase in bile salts (reversible upon treatment discontinuation).