Bulevirtide
Also known as: BLV, Bulevirtide, Hepcludex, MYR110, Myrcludex B
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Summary
Bulevirtide (brand Hepcludex, formerly Myrcludex B) is a subcutaneously administered synthetic lipopeptide that inhibits NTCP-mediated entry of HBV and HDV, approved in the EU for chronic hepatitis D infection.
Mechanism of Action
Myristoylated peptide binds to the sodium taurocholate co-transporting polypeptide (NTCP) on hepatocytes, blocking the entry of hepatitis B and D viruses.
Routes of Administration
Goals & Uses
- HBV entry inhibitionViral InfectionModerate
- ALT normalization in chronic HDVHepatic Inflammation ReductionHigh
- Suppression of HDV RNAAntiviral EfficacyHigh
- Chronic hepatitis D infectionViral InfectionHigh
- Combination therapy with pegylated interferon-alphaCombination Antiviral StrategyModerate
- Prevention of HBV/HDV co-entryAntiviral MechanismHigh
- Reduction of liver fibrosis progressionHepatoprotectionModerate
Contraindications
- Severe hepatic impairment (Child‑Pugh C)Liver DiseaseModerate
- Concurrent use of NTCP-inhibiting drugs (e.g., cyclosporine, certain statins)Drug InteractionModerate
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Hypersensitivity to bulevirtide or excipientsAllergy/immunologicHigh
- Decompensated liver diseaseHepatic ImpairmentHigh
Adverse Effects
- Pruritus (systemic)DermatologicCommon
- HBV DNA or surface antigen increase upon discontinuationVirologic ReboundUncommon
- Injection site reactionsLocalCommon
- HeadacheNeurologicCommonPain in the head or upper neck
- Elevated ALT/ASTHepaticUncommon
- FatigueGeneralCommonLow energy or tiredness
- Elevated bile acid levels (hypercholanemia)MetabolicCommon
- Injection site reactionLocalCommonRedness, swelling, itching, bruising, or pain at the injection site
Drug Interactions
- RifampicinModerate
- CyclosporineHigh
- Tenofovir alafenamide / nucleos(t)ide analogues for HBVLow
- Pegylated interferon alfa‑2aLow
- Statins (NTCP substrates, e.g., rosuvastatin)Moderate
- Nucleos(t)ide analogues (e.g., tenofovir)Low
Population Constraints
- PregnancyReproductive SafetyRelative
- Severe renal impairmentOrgan ImpairmentRelative
- Pediatric patients (<18 years)AgeAbsolute
- Decompensated cirrhosis (Child-Pugh B/C)Hepatic ImpairmentAbsolute
- Pregnant womenReproductiveAbsolute
- BreastfeedingReproductiveRelative
- Children <12 yearsAgeAbsolute
Regulatory Status
- European UnionApprovedApproved: Chronic hepatitis D infectionMarketed as Hepcludex.
- United StatesInvestigationalUnder FDA review; not yet approved.
- United KingdomApprovedApproved: Chronic hepatitis D infectionApproved following EU pathway.
Approved in the European Union (2020) for chronic hepatitis D; under FDA review in the United States and not yet approved there.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Bulevirtide?
Bulevirtide (brand Hepcludex, formerly Myrcludex B) is a subcutaneously administered synthetic lipopeptide that inhibits NTCP-mediated entry of HBV and HDV, approved in the EU for chronic hepatitis D infection.
What is Bulevirtide used for?
Bulevirtide is educationally associated with: HBV entry inhibition, ALT normalization in chronic HDV, Suppression of HDV RNA, Chronic hepatitis D infection, Combination therapy with pegylated interferon-alpha, Prevention of HBV/HDV co-entry, Reduction of liver fibrosis progression. Educational only — not medical advice.
How is Bulevirtide administered?
Recorded routes of administration: Subcutaneous.
What are the potential side effects of Bulevirtide?
Reported adverse effects include: Pruritus (systemic), HBV DNA or surface antigen increase upon discontinuation, Injection site reactions, Headache, Elevated ALT/AST, Fatigue, Elevated bile acid levels (hypercholanemia), Injection site reaction. This list is not exhaustive — consult a qualified clinician.
Who should avoid Bulevirtide?
Recorded contraindications: Severe hepatic impairment (Child‑Pugh C), Concurrent use of NTCP-inhibiting drugs (e.g., cyclosporine, certain statins), Pregnancy, Hypersensitivity to bulevirtide or excipients, Decompensated liver disease. Consult a qualified clinician before use.