bulevirtide acetate at a glance
Medicine class
Antiviral entry inhibitor targeting the liver-cell transporter NTCP.
Licensed use
Chronic, HDV-RNA-positive infection with compensated liver disease in eligible adults and children.
Administration
Subcutaneous injection into areas such as the abdomen or upper thigh, after appropriate training.
Important warning
Do not stop without specialist advice because hepatitis may reactivate and worsen.
What is bulevirtide acetate used for?
The UK product is licensed for:
Chronic hepatitis delta virus infection confirmed by detectable HDV RNA in adults and children aged 3 years or older who weigh at least 10 kg and have compensated liver disease.
How does bulevirtide acetate work?
HDV and hepatitis B virus use NTCP on liver cells as an entry receptor. Bulevirtide binds to NTCP and blocks new viral entry, limiting spread within the liver. Its effect on NTCP also explains the frequent rise in blood bile salts.
bulevirtide acetate preparations and strengths
Injection
Route: Parenteral
Strengths: 2 mg
How to take bulevirtide acetate
Use only after a healthcare professional has shown you or your caregiver how to prepare and inject it. Mix the powder with sterile water and inject it under the skin.
Follow the supplied injection guide.
Gently mix the vial; do not shake it.
Use only a clear, particle-free solution.
Suitable areas include the abdomen and upper thighs. Rotate sites and avoid bruised, scarred, inflamed or damaged skin.
Use each vial and injection device once, then dispose of them safely.
Keep unopened vials refrigerated and protected from light. Use the prepared solution immediately where possible.
bulevirtide acetate side effects
Common or expected effects
- Injection-site pain, redness, swelling, itching, bruising, rash or hardening
- Headache
- Itching
- Dizziness
- Nausea
- Tiredness or flu-like illness
- Joint pain
- Raised blood bile salts, often without symptoms
- Raised eosinophil count
Get urgent medical advice
- Severe allergic reaction, including anaphylaxis
- Severe hepatitis flare after treatment is stopped
bulevirtide acetate in pregnancy
Human pregnancy data are absent or limited. As a precaution, the UK product information advises avoiding bulevirtide during pregnancy and in people who could become pregnant without effective contraception. Discuss pregnancy or pregnancy planning with the specialist prescriber.
bulevirtide acetate while breastfeeding
It is unknown whether bulevirtide passes into human milk. The prescriber and patient should decide whether to stop breastfeeding or avoid treatment after weighing the benefits of breastfeeding and treatment.
bulevirtide acetate interactions
A specialist should review all prescribed, non-prescription and herbal products before treatment.
Ciclosporin, ezetimibe, irbesartan, ritonavir and sulfasalazine
These can inhibit NTCP, so using them with bulevirtide is not recommended.
Statins and thyroid hormones
NTCP-related transport may be affected; avoid together where possible or monitor closely.
OATP1B1/3 substrates, including bosentan, some cancer medicines, glibenclamide, repaglinide and several hepatitis C antivirals
Clinical relevance is uncertain; avoidance where possible or close monitoring is advised.
Common questions about bulevirtide acetate
Answers are fully visible for fast scanning and source review.
Does bulevirtide acetate cure hepatitis D?
It blocks new viral entry and can suppress HDV activity and liver inflammation, but it is not a guaranteed cure. Blood-test monitoring is needed, and infection may reactivate after stopping.
Does it also treat hepatitis B?
It can block entry of both viruses, but underlying hepatitis B still requires separate assessment and management.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.