HEPCLUDEX

What it is

HEPCLUDEX is bulevirtide acetate injection. It is a powder for injection, 2 mg, available as a sterile, preservative-free, white to off-white lyophilized powder that is to be reconstituted with 1 mL of Sterile Water for Injection prior to administration by subcutaneous injection. Bulevirtide is a 47-amino acid, N-terminally myristoylated, HBV-L-protein derived, synthesized lipopeptide that blocks the entry of HBV and HDV into hepatocytes by binding to and inactivating the essential HBV and HDV entry receptor NTCP. This medicinal product is subject to additional monitoring in Australia.

Approved indications

— Treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.

Dosing overview

The recommended dosage in adults is HEPCLUDEX 2 mg once daily administered by subcutaneous injection. The optimal treatment duration is unknown. Treatment should be continued as long as associated with clinical benefit. Consideration to discontinue the treatment should be given in case of sustained (6 months) HBsAg seroconversion. In all patients, manage the underlying hepatitis B virus (HBV) infection simultaneously as clinically appropriate.

Key safety warnings

Severe acute exacerbations of HDV and HBV infection 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. Monitor hepatic function closely with both clinical and laboratory follow-up for at least six months in patients who discontinue HEPCLUDEX. Increases in eosinophil counts were commonly observed in patients receiving HEPCLUDEX 2 mg with no associated clinical sequelae, hepatic adverse reactions, or significant liver-related laboratory abnormalities. Asymptomatic bile salt elevations, associated with the mechanism of action of HEPCLUDEX, were very commonly observed in clinical studies; the bile salt elevations resolved upon discontinuation of HEPCLUDEX. Dizziness has been reported during treatment with HEPCLUDEX. HEPCLUDEX has the potential to induce antidrug antibodies (ADA). In studies assessing 64 patients who received monotherapy for 48 weeks, 18 patients (28.1%) were positive for ADA; there is no evidence that the safety or effectiveness of HEPCLUDEX were altered in these patients.

Contraindications

PBS listing

In July 2025, HEPCLUDEX was recommended by PBAC for chronic hepatitis D (CHD) in patients positive for hepatitis D virus (HDV) ribonucleic acid (RNA). Specific PBS listing details including item count, strength, restriction type, and ex-manufacturer price are not provided in the available source documents.

Regulatory history

HEPCLUDEX bulevirtide 2 mg powder for injection was first listed on the Australian Register of Therapeutic Goods on 30 July 2024. An AusPAR (Australian Public Assessment Report) was issued on 22 July 2024. The Pharmaceutical Benefits Scheme Advisory Committee (PBAC) initially did not recommend HEPCLUDEX in March 2024, deferred its decision in March 2025, and recommended it in July 2025 for chronic hepatitis D in patients positive for hepatitis D virus ribonucleic acid.