Bulevirtide in chronic hepatitis D: a profile of its use

Abstract

Bulevirtide (HEPCLUDEX®), a first-in-class entry inhibitor, is a new option for the treatment of chronic hepatitis D, caused by hepatitis delta virus (HDV) infection, 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 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). Chronic hepatitis D is caused by an infection with the hepatitis delta virus (HDV). It is a fast-progressing and severe form of viral hepatitis that can lead to liver damage, cirrhosis and liver cell cancer. HDV cannot multiply in cells unless the hepatitis B virus is also present. Consequently, all patients with hepatitis D also have hepatitis B. Hepatitis D occurs in ≈\xa04.5% of patients with hepatitis B. Treatment options for chronic hepatitis D are limited (no other approved therapy to date) and generally ineffective. Bulevirtide (HEPCLUDEX®), a drug that is self-administered as a daily subcutaneous injection, blocks the entry of HDV into liver cells and limits the ability of HDV to multiply. It is the first drug to be approved for the treatment of chronic hepatitis D in adults with compensated liver disease (the liver is damaged, but can still work). By reducing the amount of HDV in the body, bulevirtide improves liver function in these patients. Bulevirtide is also generally well tolerated. Thus, bulevirtide is a new treatment option for patients with chronic hepatitis D who have compensated liver disease.