FDA Approves Hepcludex: First Treatment for Chronic Hepatitis Delta Virus Infection
The U.S. Food and Drug Administration (FDA) has approved Gilead Sciences' Hepcludex for the treatment of chronic hepatitis delta virus (HDV) infection, the first treatment approved for the disease.
HDV can replicate only in people also infected with hepatitis B virus and is considered among the most severe forms of viral hepatitis. In the MYR301 trial supporting the approval, the combined response rate at week 48 was 48% with Hepcludex versus 2% with delayed treatment. Undetectable HDV RNA was achieved by 20% of treated patients at week 48 versus 0%, rising to 36% at week 96 and 50% at week 144.
Hepcludex is given once daily at 8.5 mg. The drug carries a boxed warning that discontinuation may cause severe acute exacerbations of HDV and hepatitis B. Side effects include hypersensitivity reactions including anaphylaxis, injection-site reactions, headache, abdominal pain, fatigue and pruritus.
The FDA had previously granted the drug Breakthrough Therapy and Orphan Drug designations, and the approval was granted under Priority Review through the Accelerated Approval pathway.
(Source: U.S. Food and Drug Administration approval announcement)
Source: GSM · USA (original Chinese edition)
Photo: 肝脏三维医学示意图。（Wikimedia Commons，CC BY-SA 4.0，Scientific Animations作）A 3D medical illustration of the human liver. (Wikimedia Commons, CC BY-SA 4.0, by Scientific Animations)
