The FDA has approved a new drug called Hepcludex (bulevirtide) for adults with chronic hepatitis delta virus (HDV) infection. This is the first treatment that works by blocking the virus from entering liver cells. It is for patients who do not have cirrhosis or who have compensated cirrhosis (where the liver still works well).
The approval is based on studies showing that the drug lowered HDV levels in the blood and helped normalize liver enzyme levels (ALT). However, it has not yet been proven that Hepcludex improves how patients feel or prevents long-term liver damage. The FDA granted accelerated approval, which means the drug is available now but the company must do more studies to confirm its benefits.
Hepcludex is given as a shot under the skin once a day. The recommended dose is 8.5 mg. Common side effects may include injection site reactions, headache, and fatigue. If you have chronic hepatitis delta, talk to your doctor about whether this new option is right for you. This is a promising step, but it is important to understand what is known and what is still being studied.