Brand Name
Hepcludex
Generic Name
Bulevirtide
View Brand Information FDA approval date: May 22, 2026
Form: Injection
What is Hepcludex (Bulevirtide)?
HEPCLUDEX is indicated for the treatment of chronic hepatitis delta virus 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 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. HEPCLUDEX is a sodium taurocholate co-transporting polypeptide -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 normalization. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Approved To Treat
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A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)
Summary: This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.
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Brand Information
HEPCLUDEX (BULEVIRTIDE)
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. Monitor hepatic function closely with both clinical and laboratory follow-up, including hepatitis B virus (HBV) DNA and hepatitis delta virus (HDV) RNA viral load, for at least six months in patients who discontinue HEPCLUDEX. Resumption of antiviral therapy may be warranted
1INDICATIONS AND USAGE
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
2DOSAGE FORMS AND STRENGTHS
For injection: 8.5 mg as a white to off-white lyophilized powder or cake in a single-dose vial for reconstitution.
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following adverse reactions are discussed in other sections of the labeling:
- Exacerbation of Hepatitis D and B After Discontinuation of Treatment
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The overall safety profile of HEPCLUDEX is based on Phase 2 and Phase 3 data from 165 adults with chronic HDV infection without cirrhosis or with compensated cirrhosis who received at least 48 weeks of HEPCLUDEX 8.5 mg subcutaneous injection once daily. Trial MYR301 was a Phase 3 randomized, multi-center, open-label, parallel-arm trial in 101 adults. In this trial, 50 adults received 8.5 mg HEPCLUDEX daily for 144 weeks and 51 adults who were in the Delayed Treatment group received no HDV treatment for the first 48 weeks; 50 adults in the Delayed Treatment group then received HEPCLUDEX 8.5 mg once daily for 96 weeks
Table 1 displays the frequency of the adverse reactions (all grades) ≥ 10% in the HEPCLUDEX group at Week 48. No participant discontinued treatment with HEPCLUDEX due to an adverse reaction through Week 48.
A similar safety profile was observed through Week 144 in Trial MYR301 and for participants in the Delayed Treatment group who switched to treatment with HEPCLUDEX at Week 48 through to Week 144. Additionally, a similar safety profile was observed through Week 96 in Phase 2b Trial MYR204.
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of HEPCLUDEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune System Disorders: hypersensitivity, including anaphylactic reaction
5OVERDOSAGE
No data are available on overdose of HEPCLUDEX in patients. Treatment of overdose with HEPCLUDEX should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with HEPCLUDEX. Hemodialysis is unlikely to result in significant removal of bulevirtide since bulevirtide is highly bound to plasma protein.
6DESCRIPTION
Bulevirtide-gmod is an NTCP-directed HDV attachment inhibitor. Bulevirtide as an acetate salt, is a 47-amino acid protein with a fatty acid myristoyl residue at the N-terminus and an amidated C-terminus. All chiral amino acids are in the L-configuration. The counter ion acetate is bound in ionic form to basic groups of the peptide molecule in a nonstoichiometric ratio. Bulevirtide acetate has a molecular formula of C
HEPCLUDEX (bulevirtide-gmod) for injection is a sterile, preservative-free, white to off-white lyophilized powder or cake for subcutaneous injection after reconstitution. Each single-dose vial delivers 8.5 mg of bulevirtide-gmod (equivalent to approximately 8.6 mg of bulevirtide acetate). The inactive ingredients are histidine (3.3 mg), mannitol (51 mg), and sucrose (8.5 mg), and may include hydrochloric acid and/or sodium hydroxide to adjust the pH to 8.5.
HEPCLUDEX requires reconstitution prior to administration by subcutaneous injection
7NONCLINICAL TOXICOLOGY
Carcinogenicity and genotoxicity studies have not been conducted with bulevirtide.
Bulevirtide did not affect fertility or mating performance or early embryonic development in rats at approximately 3 times higher exposures (AUC) than in humans given the recommended dose of HEPCLUDEX.
8HOW SUPPLIED/STORAGE AND HANDLING
HEPCLUDEX (bulevirtide-gmod) for injection 8.5 mg is supplied in a carton (NDC 61958-3104-1) of 30 single-dose vials.
Each single-dose vial contains a sterile, preservative-free, white to off-white lyophilized powder or cake. It requires reconstitution prior to administration by subcutaneous injection
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).
After reconstitution, use vials immediately. Discard unused portion.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
10PRINCIPAL DISPLAY PANEL - 8.5 mg Vial Label
NDC 61958-
(bulevirtide-gmod)
8.5 mg per vial
For Subcutaneous Use.
GILEAD
11PRINCIPAL DISPLAY PANEL - 8.5 mg Vial Carton
NDC 61958-
(bulevirtide-gmod)
8.5 mg per vial
For Subcutaneous Use
Reconstitute Hepcludex prior to use.
Rx Only
30 single-dose vials. Discard unused portion.
GILEAD
