Bulevirtide for the treatment of chronic hepatitis D - Patient and drug information leaflet

Who is the leaflet for? What is its aim?

This leaflet is for patients starting on treatment with bulevirtide for chronic hepatitis D virus (HDV) infection to provide an overview of treatment and important information for the patient and/or carers.

What is bulevirtide for and how do I take it?

Treatment with bulevirtide is used to treat long term hepatitis D virus infection in adults with compensated liver disease. Hepatitis D virus can cause inflammation and liver damage. Bulevirtide prevents the hepatitis D virus getting into liver cells, reduces the spread of hepatitis D virus in the liver and reduces inflammation.

Bulevirtide is a once daily 2mg subcutaneous injection. Your doctor, specialist nurse or specialist pharmacist will show and teach you how to prepare and inject bulevirtide.

Bulevirtide is continued for as long as you benefit from it. Your doctor, specialist nurse or specialist pharmacist will tell you how long to take it for. Do not stop taking bulevirtide without discussion with your doctor, specialist nurse or specialist pharmacist. Stopping bulevirtide can reactivate the infection and worsen the chronic hepatitis D virus.

Supply of bulevirtide

This is supplied direct to you by HealthNet Homecare and you will be contacted by the company in due course. Please be aware that you may receive phone calls from “withheld” numbers and this could be homecare company making contact, therefore please do not ignore these phone calls.

You will also be contacted separately by one of their nurses who will arrange a convenient time to provide training and guidance on the administration of the injections. They will also provide ongoing support as required. This may be done face to face or via video call.

Repeat prescriptions for bulevirtide will be generated by the hepatology team. We will need confirmation of your blood test results, so it is important that you continue to attend your regular outpatient clinic appointments.

Storing bulevirtide

This must be stored in a refrigerator (2°C -8°C) and should be kept in the outer carton to protect from light. Please contact us if you have left it out of the refrigerator for a prolonged period of time.

Use bulevirtide immediately after you have reconstituted the vials. Do not keep any excess.

Blood tests and monitoring

Blood tests will need to be taken regularly whilst you are taking bulevirtide. You will usually have bloods taken when you see us in clinic.

There may be times that you need to have blood tests outside the hospital. If this is necessary, you will be advised about this.

For arranging the blood tests, these are the options:

• You can attend the drive-through Phlebotomy located in Newmarket Road Park and Ride in Cambridge (CB5 8AA). A leaflet and more info is available on the Trust's Outpatient phlebotomy/ blood tests information page.
  The drop-in service will be available between 09:30 and 16:30, Monday to Fridays. You must attend in a car, as the site is not suitable for walk-ins or bicycles.
• You can also arrange an appointment to have bloods taken at Addenbrooke's, call 01223 256998 (Monday - Friday 09:00-17:00).

Are there any problems with taking bulevirtide?

Bulevirtide may cause side effects but not everyone will experience them. Please note that bulevirtide is also a new medication. If you experience any side effects please tell your doctor, specialist nurse or specialist pharmacist as soon as possible, but do not stop taking your bulevirtide.

• Very common side effects include headache, itching, reaction at the injection site (swelling, redness, irritation, bruising, itching, rash, hardening, infection, pain), and blood tests may show an increase in the level of bile acids.
• Common side effects include dizziness, nausea, tiredness, flu-like illness, joint pain and blood tests may show an increase in white cells.
• Allergic reaction including anaphylactic reaction is uncommon.
  • Symptoms of allergic reaction may include shortness of breath, wheezing, swelling of the face, lips, tongue or throat, skin rash, changes to blood pressure, changes to heart rate.
  • Symptoms of anaphylactic reaction are like the above but more severe and require immediate medical attention.

Taking bulevirtide with other medications

• Bulevirtide may interact with some other drugs, so it is important that the GP, hospital doctor, specialist nurse and pharmacist are informed about any other medicines you are taking.
• The hospital team will ask you about your regular medicines before starting treatment. It is helpful if you can take a copy of your current presecription with you when attending your appointment(s)
• If you are purchasing any drugs over the counter then please tell the pharmacist that you are on bulevirtide.

Missed doses

Please do not miss any doses of bulevirtide. If you do miss a dose, but remember within four hours then take your usual dose. If it is more than four hours then do not take your missed dose and continue with the next dose at your usual time. Do not take a double dose.

Pregnancy, breastfeeding and fertility

There is no or limited amount of data relating to the use of bulevirtide during pregnancy, breast-feeding and on fertility.

As a precautious measure, it is preferable to avoid the use of bulevirtide during pregnancy and in women of child-bearing potential not using contraception.

Please discuss with us if you are planning to become pregnant or are pregnant.

Can I spread hepatitis D virus whilst I am on treatment?

Treatment with bulevirtide for hepatitis D does not stop you from passing the infection on eg through sexual contact or bodily fluids including blood, so make sure that you continue to take appropriate preventative measures. These can be discussed in more detail with your doctor or liver nurse specialist.

My Chart

If you have not already done so, we would encourage you to sign up for MyChart. This is the electronic patient portal at Cambridge University Hospitals which allows patients to securely access parts of their health record held within the hospitals’ electronic patient record system (Epic). It is available via your home computer or smart phone.

If you are interested in this please let us know and we can provide information, or look on the Trust's MyChart information page.

Contacts/ Further information

Please contact our helpline, call 01223 596094 or message via MyChart. These are non-urgent services for a booked call back within 1-2 working days.

If the issue is more urgent the patient must use alternative services e.g., GP, call NHS 111, or in case of a clinical emergency A&E.

Further information on hepatitis D virus can be found on the following websites:

• Click here for Information Leaflet from the manufacturer (opens in a new tab)
• Click here for the British Liver Trust (opens in a new tab)
• Click here for Patient Info (opens in a new tab)
• Click here for The Eastern Liver Network (opens in a new tab)

References/ Sources of evidence

• Click here for NICE TAG 896: Bulevirtide for treating chronic hepatitis D Technology appraisal guidance was published: 7 June 2023 (opens in a new tab)
• Gilead Sciences Inc. Hepcludex®▼(bulevirtide) Storage and Stability. Data on File
• Click here for the Bulevirtide Summary of Products Characteristics (opens in a new tab)