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Results of Phase 2 study of lonafarnib in HDV infected patients published

20 July 2015  •  Author: Victoria White

Results of the first Phase 2a study of lonafarnib in patients with chronic hepatitis delta virus (HDV) infection have been published.


The study was conducted at the National Institutes of Health (NIH) Clinical Centre in Bethesda, Maryland. The double-blinded, randomised, placebo-controlled, dose ascending study evaluated two doses of lonafarnib, 100 mg twice daily and 200 mg twice daily for 28 days.

“The NIH Clinical Centre has completed a study with significant implications for treatment of chronic hepatitis D, which often leads to cirrhosis and other life-threatening conditions,” said Theo Heller, MD, a Principal Investigator at the National Institute of Diabetes and Digestive and Kidney Diseases, part of the NIH. “We are proud to have the results of this study published in The Lancet Infectious Diseases.”

Decrease in HDV RNA viral levels observed after treatment with lonafarnib

A decrease in HDV RNA viral levels was observed after treatment with lonafarnib for 28 days compared with placebo, including a statistically significant dose-dependent difference in decline in HDV RNA virus between the 100 mg twice daily and 200 mg twice daily doses compared with placebo. The decline in HDV RNA viral levels significantly correlated with serum lonafarnib drug levels, providing further evidence for the antiviral activity of lonafarnib in chronic HDV. In the study, lonafarnib was generally well tolerated, with the most common adverse events in the treatment group being gastrointestinal related. 

“This is the first study evaluating lonafarnib, an oral therapy, in patients infected with HDV, and we are very pleased with the results,” said David Cory, President and Chief Executive Officer of Eiger Biopharmaceuticals. “HDV is the most severe form of human viral hepatitis.  Our goal is cure.”

Hepatitis Delta is caused by infection with the hepatitis delta virus (HDV) and is considered to be the most severe form of viral hepatitis in humans. Hepatitis D occurs only as a co-infection in individuals harbouring hepatitis B (HBV). Hepatitis D leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure. Hepatitis D is a disease with a significant impact on global health affecting approximately 15 million people worldwide.  

The study results are published in The Lancet.

To find out more about Eiger Biopharmaceuticals, please visit www.eigerbio.com.

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