The first treatment for hepatitis delta, Hepcludex, was approved in July of 2020 for prescription in the European Union, and as of June 2023, is available in France, Germany, Austria, Italy, and the UK. This drug binds to and inactivates the essential HDV receptors on liver cells. The long-term effects of this medication seem to be promising for controlling the virus and improving quality of life for those living with HDV. Previously, the only treatment for hepatitis delta found to be somewhat effective was pegylated interferon alpha, which acts by stimulating the body's immune system to fight the virus. A small percentage (fewer than 25%) of patients experience remission when injected weekly with this treatment over periods of 48 weeks or longer. Antiviral treatments that are effective in controlling hepatitis B have no effect on hepatitis delta, but are often recommended as part of a patient's treatment plan to control their hepatitis B.
The approval of Hepcludex in the US has been slightly delayed due to concerns about the manufacture and delivery of the drug, but no safety concerns were cited and no additional clinical trials were requested, so the manufacturer (Gilead Sciences, Inc.) expects to resubmit their application swiftly and have FDA approval come sometime in 2024. Approvals in more countries will hopefully follow, and two other drugs, pegylated interferon lambda and lonafarnib, are currently in the clinical trial pipeline.
For more information about Hepcludex and other promising new hepatitis delta drugs in the research pipeline, visit our drug watch page.