FDA Approves Bulevirtide for Hepatitis Delta Virus
The FDA has approved bulevirtide, the first treatment for hepatitis delta virus infection in the US. This daily injection is intended for adults with chronic HDV infection, providing a new option for patients who previously had no FDA-approved therapies. The approval follows positive trial results and aims to improve management of a disease that can lead to serious liver complications.
- ▪Bulevirtide is the first FDA-approved treatment for hepatitis delta virus infection in the US.
- ▪The drug is administered as an 8.5-mg daily injection for adults with chronic HDV infection.
- ▪Clinical trials showed a significant increase in the rate of undetectable HDV RNA among participants treated with bulevirtide.
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The FDA approved bulevirtide (Hepcludex; Gilead Sciences), the first treatment for hepatitis delta virus (HDV) infection in the US.The 8.5-mg daily injection will treat adults with chronic HDV infection without cirrhosis or with compensated cirrhosis.The approval “fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available,” said Wendy Carter, DO, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.
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Excerpt limited to ~120 words for fair-use compliance. The full article is at Medscape.
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