Human medicines European public assessment report (EPAR): Hepcludex, bulevirtide, Date of authorisation: 31/07/2020, Revision: 18, Status: Authorised

Hepcludex RSS Authorised This medicine is authorised for use in the European Union bulevirtide Medicine Human Authorised 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. Expand section Collapse section How is Hepcludex used? 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. How does Hepcludex work? 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. What benefits of Hepcludex have been shown in studies? 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. What are the risks associated with Hepcludex? 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. Why is Hepcludex authorised in the EU? 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. What information is still awaited for Hepcludex? 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. What measures are being taken to ensure the safe and effective use of Hepcludex? 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. Other information about Hepcludex 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. Hepcludex : EPAR - Medicine overview Reference Number: EMA/503828/2024 English (EN) (109.31 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View Other languages (22) български (BG) (138.19 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View español (ES) (113.91 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View čeština (CS) (137.25 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View dansk (DA) (111.88 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View Deutsch (DE) (116.21 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View eesti keel (ET) (111.52 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View ελληνικά (EL) (136.98 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View français (FR) (114.3 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View hrvatski (HR) (136.38 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View italiano (IT) (112.5 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View latviešu valoda (LV) (125.31 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View lietuvių kalba (LT) (136.63 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View magyar (HU) (138.23 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View Malti (MT) (139.58 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View Nederlands (NL) (113.02 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View polski (PL) (138.25 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View português (PT) (114.99 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View română (RO) (134.13 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View slovenčina (SK) (137.48 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View slovenščina (SL) (135.12 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View Suomi (FI) (111.1 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View svenska (SV) (112.5 KB - PDF) First published: 12/08/2020 Last updated: 16/12/2024 View Hepcludex : EPAR - Risk management plan English (EN) (574.04 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View Product information Hepcludex : EPAR - Product information English (EN) (972.36 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View Other languages (24) български (BG) (1.08 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View español (ES) (927.13 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View čeština (CS) (1.06 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View dansk (DA) (2.19 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View Deutsch (DE) (947.01 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View eesti keel (ET) (976.01 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View ελληνικά (EL) (1.08 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View français (FR) (977.95 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View hrvatski (HR) (1.05 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View íslenska (IS) (975.71 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View italiano (IT) (979.79 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View latviešu valoda (LV) (1.06 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View lietuvių kalba (LT) (1.05 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View magyar (HU) (1.04 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View Malti (MT) (1.07 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View Nederlands (NL) (892.82 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View norsk (NO) (960.35 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View polski (PL) (1.06 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View português (PT) (971.85 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View română (RO) (1.06 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View slovenčina (SK) (1.07 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View slovenščina (SL) (1.05 MB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View Suomi (FI) (975.31 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View svenska (SV) (975.88 KB - PDF) First published: 12/08/2020 Last updated: 31/03/2026 View Latest procedure affecting product information: VR/0000320140 12/03/2026 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). Hepcludex : EPAR - All authorised presentations English (EN) (51.76 KB - PDF) First published: 12/08/2020 View Other languages (24) български (BG) (62.4 KB - PDF) First published: 12/08/2020 View español (ES) (50.89 KB - PDF) First published: 12/08/2020 View čeština (CS) (58.9 KB - PDF) First published: 12/08/2020 View dansk (DA) (54.49 KB - PDF) First published: 12/08/2020 View Deutsch (DE) (54.04 KB - PDF) First published: 12/08/2020 View eesti keel (ET) (50.36 KB - PDF) First published: 12/08/2020 View ελληνικά (EL) (65.35 KB - PDF) First published: 12/08/2020 View français (FR) (51.46 KB - PDF) First published: 12/08/2020 View hrvatski (HR) (67.37 KB - PDF) First published: 12/08/2020 View íslenska (IS) (38.55 KB - PDF) First published: 12/08/2020 View italiano (IT) (50.96 KB - PDF) First published: 12/08/2020 View latviešu valoda (LV) (76.48 KB - PDF) First published: 12/08/2020 View lietuvių kalba (LT) (67.11 KB - PDF) First published: 12/08/2020 View magyar (HU) (59.53 KB - PDF) First published: 12/08/2020 View Malti (MT) (69.89 KB - PDF) First published: 12/08/2020 View Nederlands (NL) (51.21 KB - PDF) First published: 12/08/2020 View norsk (NO) (38.59 KB - PDF) First published: 12/08/2020 View polski (PL) (70.08 KB - PDF) First published: 12/08/2020 View português (PT) (52.21 KB - PDF) First published: 12/08/2020 View română (RO) (57.92 KB - PDF) First published: 12/08/2020 View slovenčina (SK) (67.24 KB - PDF) First published: 12/08/2020 View slovenščina (SL) (58.97 KB - PDF) First published: 12/08/2020 View Suomi (FI) (50.26 KB - PDF) First published: 12/08/2020 View svenska (SV) (51.62 KB - PDF) First published: 12/08/2020 View 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 use Therapeutic 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. Authorisation details EMA product number EMEA/H/C/004854 Additional monitoring This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring . Orphan This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation . PRIME: priority medicine This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines . Marketing authorisation holder Gilead Sciences Ireland UC Carrigtohill County Cork T45 DP77 Ireland Marketing authorisation issued 31/07/2020 Revision 18 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Hepcludex : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (156.02 KB - PDF) First published: 03/09/2025 Last updated: 31/03/2026 View Hepcludex : EPAR - Procedural steps taken and scientific information after authorisation (archived) English (EN) (225.2 KB - PDF) First published: 07/10/2020 Last updated: 04/02/2025 View Hepcludex-H-C-004854-II-0031 : EPAR - Assessment report - variation Adopted Reference Number: EMA/542920/2024 English (EN) (1.43 MB - PDF) First published: 16/12/2024 View CHMP post-authorisation summary of positive opinion for Hepcludex (II-31) Adopted Reference Number: EMA/CHMP/447783/2024 English (EN) (140.56 KB - PDF) First published: 18/10/2024 View Hepcludex-H-C-004854-P46-005 : EPAR - Assessment report Adopted Reference Number: EMA/435968/2023 English (EN) (449.6 KB - PDF) First published: 28/09/2023 View Hepcludex-H-C-004854-II-0019 : EPAR - Assessment report - variation Adopted Reference Number: EMA/763187/2022 English (EN) (1.62 MB - PDF) First published: 25/07/2023 View Initial marketing authorisation documents Hepcludex : Orphan maintenance assessment report Adopted Reference Number: EMADOC-1700519818-471852 English (EN) (278.8 KB - PDF) First published: 12/08/2020 View Hepcludex : EPAR - Public assessment report Adopted Reference Number: EMA/326446/2020 English (EN) (5.08 MB - PDF) First published: 12/08/2020 View CHMP summary of positive opinion for Hepcludex Adopted Reference Number: EMA/CHMP/270357/2020 English (EN) (139.4 KB - PDF) First published: 29/05/2020 View News on Hepcludex Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2024 18/10/2024 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020 29/05/2020 More information on Hepcludex EU/3/15/1500 - orphan designation for treatment of hepatitis delta virus infection EMEA-002399-PIP01-18-M01 - paediatric investigation plan Clinical Benefit of Bulevirtide Therapy in Adult Patients With Chronic Hepatitis Delta Compared to a Historical Control Group Receiving Standard of Care - post-authorisation study A Multinational Observational Registry Collecting Data on the Profile of Patients with Chronic Hepatitis D Virus Infection Receiving Treatment with Bulevirtide (MYR-Reg-02) - post-authorisation study Topics Medicines Rare diseases This page was last updated on 31/03/2026 Share this page