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](http://www.ema.europa.eu/medicines/human/orphan-designations/eu3151500). Hepcludex contains the active substance bulevirtide.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
J05A
ATC Item
直接作用的抗病毒药
Pharmacotherapeutic Group
Antivirals for systemic use
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| bulevirtide acetate | N/A | Bulevirtide |
| Bulevirtide acetate | N/A | Bulevirtide |
EMA Name
Hepcludex
Medicine Name
Hepcludex
Aliases
N/ANo risk management plan link.
