Bulevirtide

HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). HEPCLUDEX is a sodium taurocholate co-transporting polypeptide (NTCP)-directed HDV attachment inhibitor indicated for the treatment of chronic HDV infection in adults without cirrhosis or with compensated cirrhosis. This indication is approved under accelerated approval based on participants who achieved a decrease in HDV RNA and alanine aminotransferase (ALT) normalization.

HEPCLUDEX is an antiviral drug. Mechanism of Action Bulevirtide is a synthetic 47-amino acid lipopeptide with a myristoylated N-terminus and an amidated C-terminus derived from amino acids 13-59 of the L-HBsAg preS1 domain from an HBV genotype (GT)-C consensus sequence (corresponding to GT-D preS1 amino acids 2-48). Bulevirtide inhibits HDV infection by binding to the HDV receptor NTCP on the plasma membrane of hepatocytes, blocking HDV attachment to NTCP.

Recommended dosage in adults: HEPCLUDEX 8.5 mg once daily by subcutaneous injection. Instructions for Use should be followed for preparation and administration of HEPCLUDEX.

None. None.

Boxed warning (posttreatment severe acute exacerbation of hepatitis d and b): Severe acute exacerbations of hepatitis D and hepatitis B may occur after HEPCLUDEX is discontinued, especially in patients with cirrhosis, who may be at increased risk of more severe flares or progression to hepatic decompensation. Hypersensitivity Reactions Including Anaphylaxis: Hypersensitivity reactions have been reported with HEPCLUDEX. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue HEPCLUDEX and initiate appropriate treatment.

The following adverse reactions are discussed in other sections of the labeling: Exacerbation of Hepatitis D and B After Discontinuation of Treatment. The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with HEPCLUDEX are injection site reactions, headache, abdominal pain, fatigue, and pruritus.

Effects of HEPCLUDEX on Other Drugs No CYP enzyme or transporter mediated inhibition or induction by bulevirtide is anticipated at clinically relevant concentrations.

Store HEPCLUDEX vials at room temperature between 68 °F to 77 °F (20 °C to 25 °C), excursions permitted from 59 °F to 86 °F (15 °C to 30 °C).