2022-06-24| Trials & Approvals

Gilead’s Viral Hepatitis Treatment Scores a Win in Pivotal Study

by Joy Lin
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Week 48 results of Gilead’s Hepcludex (bulevirtide) showed the drug met the main goals in a pivotal trial in chronic hepatitis D virus (HDV) infection, the California-based biopharma reported. The results bring bulevirtide one step closer to obtaining full approval from the US FDA. 

HDV is a satellite virus, namely because it can only infect people with an existing hepatitis B virus (HBV). It causes hepatitis D, a liver disease that can be acute or chronic. 


Promising Answer to HDV Infection


Bulevirtide is designed to block the entry of HDV into liver cells. It does so by binding to and blocking the sodium taurocholate co-transporting polypeptide (NTCP), a known receptor HBV and HDV use to enter the liver cell. 

Bulevirtide has been granted breakthrough designation status from the FDA, as well as a conditional approval by the European Commission. The marketing application for the drug was submitted by Gilead Sciences to the US FDA last November. If approved, bulevirtide will be the first US-approved treatment for HDV infection. 

In the pivotal Phase 3 clinical trial of bulevirtide in chronic HDV infection, patients treated with the monotherapy at 2mg or 10mg once daily achieved significantly greater combined virological and biochemical response (45% and 48% respectively), compared to patients who did not receive antiviral treatment (2%). Furthermore, prolonged treatment of the drug was shown to improve response.

Participants treated with bulevirtide also achieved improved quality of life, which was calculated via questionnaire. Even at the lower dose of 2mg, the drug improved the patients’ physical and emotional state when performing daily activities related to hepatitis.

The safety profile of the drug at week 48 was consistent with prior reports, with no reported adverse events that led to discontinuation of the therapy. 

The findings were presented in the International Liver Congress (ILC) 2022 Official Press Program.

Related article: The FDA is Investigating a Hepatitis A Outbreak Linked to Strawberries in the United States and Canada 


Rival to Antiviral Therapy from Eiger 


Bulevirtide, as a subcutaneous injection, may face stiff competition from lornafarnib, an oral drug being developed by Eiger Biopharmaceutcials for HDV infection. 

Lornafarnib actively inhibits a key enzyme that is essential in prenylation. When the enzyme is blocked, HDV is unable to assemble and package viral particles. It is currently undergoing a Phase 3 trial, but has been approved in the US and Europe for rare diseases Hutchinson-Gilmore progeria syndrome and progeroid laminopathies. 

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