Hepcludex
Authorised
This medicine is authorised for use in the European Union
bulevirtide
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Hepcludex is an antiviral medicine used to treat chronic (long-term) hepatitis delta virus (HDV) infection in adults and children from 3 years of age and weighing at least 10 kg who have compensated liver disease (when the liver is damaged but is still able to work). It is used when the presence of HDV RNA (genetic material) has been confirmed by blood tests.
HDV is an 'incomplete' virus, because it cannot replicate in cells without the help of another virus, the hepatitis B virus. Because of this, patients infected with the virus always also have hepatitis B.
HDV infection is rare, and Hepcludex was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 June 2015. Further information on the orphan designation can be found on the EMA website.
Hepcludex contains the active substance bulevirtide.
Hepcludex can only be obtained with a prescription and treatment should be started only by a doctor experienced in the management of patients with HDV infection.
The medicine is given daily as an injection under the skin. It can be given on its own, or in combination with a ‘nucleoside/nucleotide analogue’ medicine for the treatment of the underlying hepatitis B infection.
Treatment should continue for as long as the patient benefits from it.
For more information about using Hepcludex, see the package leaflet or contact your doctor or pharmacist.
The active substance in Hepcludex, bulevirtide, works by attaching to and blocking a receptor (target) through which the hepatitis delta and hepatitis B viruses enter liver cells. By blocking the entry of the viruses into the cells, Hepcludex limits the ability of HDV to replicate, preventing the spread of the virus in the liver and thereby reducing inflammation.
Two main studies in adults showed that Hepcludex was effective at clearing all or 99% of the HDV genetic material (RNA) from the blood.
In the first study, 55 out of 90 patients treated with Hepcludex plus tenofovir (a medicine for hepatitis B) had substantial reductions in HDV replication after 6 months, compared with 1 out of 28 patients given tenofovir alone. Patients treated with Hepcludex also showed a reduction in the blood levels of the liver enzyme ALT, indicating an improvement of liver disease.
Similar results were seen in the second study where 8 out of 15 patients given Hepcludex plus peginterferon alfa (another medicine for hepatitis B) for 48 weeks no longer had detectable levels of HDV RNA 6 months after their treatment. Of the 15 patients treated with Hepcludex alone, one no longer had detectable levels of HDV RNA. Of the 15 patients treated with peginterferon alfa alone, no patient achieved this result.
In a larger, confirmatory study in 150 adults, 45% (22 out of 49) of patients given a low dose of Hepcludex and 48% (24 out of 50) of patients given a higher dose of Hepcludex had almost all of their HDV RNA cleared after 48 weeks, compared with 2% (1 out of 51) of untreated patients.
The company also provided data to show that in children Hepcludex is expected to behave in the same way as in adults.
For the full list of side effects and restrictions of Hepcludex, see the package leaflet.
The most common side effects with Hepcludex (which may affect more than 1 in 10 people) include raised levels of bile salts in the blood, headache, itching and reactions at the site of injection.
The most common serious side effect is a flare-up of liver inflammation after stopping Hepcludex.
Available data have shown a beneficial effect of Hepcludex on viral replication and liver inflammation in adults with HDV infection. Data also suggest that Hepcludex will be effective in the treatment of chronic HDV infection in children from 3 years of age, for whom there was no authorised treatment available at the time of authorisation. As for its safety, the side effects seen in adults treated with Hepcludex were considered acceptable and are expected to be similar in children.
The European Medicines Agency therefore decided that Hepcludex’s benefits are greater than its risks and it can be authorised for use in the EU.
Hepcludex was originally given ‘conditional authorisation’ because there was more evidence to come about the medicine. The company has since provided comprehensive information confirming the findings from earlier studies. As a result, the conditional authorisation has been switched to a standard one.
Since Hepcludex has been given conditional authorisation, the company that markets Hepcludex will collect data on the use of the medicine in a patient registry and will provide the final results from two ongoing studies.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hepcludex have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Hepcludex are continuously monitored. Side effects reported with Hepcludex are carefully evaluated and any necessary action taken to protect patients.
Hepcludex received a conditional marketing authorisation valid throughout the EU on 31 July 2020. The conditional marketing authorisation was switched to a standard marketing authorisation on 18 July 2023.
This overview was last updated in 11-2024.
Product information
Latest procedure affecting product information:
II/0031
25/11/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Hepcludex
- Active substance
- Bulevirtide acetate
- International non-proprietary name (INN) or common name
- bulevirtide
- Therapeutic area (MeSH)
- Hepatitis D, Chronic
- Anatomical therapeutic chemical (ATC) code
- J05A
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult and paediatric patients 3 years of age and older weighing at least 10 kg with compensated liver disease.
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