- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Injections of bulevirtide.
Chronic hepatitis D
For the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease.
Bulevirtide can be administered as monotherapy or in co-administration with a nucleoside/nucleotide analogue for treatment of underlying HBV infection.
2mg every 24 hours.
Optimal treatment duration is unknown. Treatment should be continued as long as associated with clinical benefit.
Additional Dosage Information
If an infection has been missed by less than 4 hours, the dose should be administered as soon as possible and the next injection should follow the previously established schedule. If an injection has been missed by more than 4 hours then the missed dose should not be administered. If the injection has been administered more than 4 hours since the scheduled time then the next dose should follow the original schedule.
For subcutaneous injection only. The injection sites for bulevirtide may be the upper thigh, or abdomen.
Children under 18 years
Decompensated liver disease
Precautions and Warnings
Females of childbearing potential
Patients over 65 years
Moderate hepatic impairment
Positive HIV status
Monitor HBV levels during and after treatment in patients with co-infection
Advise ability to drive/operate machinery may be affected by side effects
Treatment should be started by a doctor experienced in hepatitis management
Monitor renal function
Discontinuation may reactivate HBV & HDV infection and exacerbate hepatitis
Female: Ensure adequate contraception during treatment
Elevation of bile salts may occur during treatment. Due to renal excretion of bile salts, elevation of bile salts may be greater in patients with renal impairment.
The underlying HBV infection should be simultaneously managed according to current treatment guidelines.
Discontinuation of treatment with bulevirtide can lead to reactivation of the HDV and HBV infection and exacerbation of hepatitis. In case of treatment discontinuation, liver function including transaminase levels, as well as HBV DNA and HDV RNA viral load should be performed.
Discontinuation of treatment should be considered if there is a loss of response or if after 6 months there is still sustained hepatitis B surface antigen seroconversion.
Pregnancy and Lactation
Bulevirtide is contraindicated during pregnancy.
The manufacturer advises that it is preferable to avoid the use of bulevirtide during pregnancy and in women of child-bearing potential not using contraception.
Bulevirtide is contraindicated during breastfeeding.
The manufacturer advises that a decision must be made whether to discontinue breastfeeding or to discontinue treatment with bulevirtide, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women.
Erythema at injection site
Exacerbation of hepatitis
Haematoma (injection site)
Increase in bile salts
Induration (injection site)
Injection site reactions
Local pain (injection site)
Rash at injection site
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: January 2023
Summary of Product Characteristics: Hepcludex 2mg powder for solution for injection. Gilead Sciences Ltd. Revised September 2022.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 27 January 2023
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.