New oral medication inhibits hepatitis D viral replication

Reuters Health Information: New oral medication inhibits hepatitis D viral replication

New oral medication inhibits hepatitis D viral replication

Last Updated: 2015-07-29

By Sharon Nirenberg MD

NEW YORK (Reuters Health) - Lonafarnib, a novel oral treatment for chronic hepatitis D virus (HDV) infection, reduces viral replication and is safe and well tolerated, according to an early trial.

"There are no FDA approved drugs for hepatitis D and it is perhaps the most deserving of all the hepatitis viruses," said Dr. Theo Heller, senior author of the study and a researcher at the National Institute of Diabetes and Digestive and Kidney Diseases in Bethesda, Maryland.

"If you think about hepatitis C, 20% of people get cirrhosis over 20 years," he told Reuters Health by phone. For "hepatitis B there is a lifetime risk of 30%, but 75-90% of people with delta, who have hepatitis D, will get cirrhosis within 10 years."

The new study, published online July 16 in The Lancet Infectious Diseases, was a double-blind, randomized phase 2A trial including 14 patients with chronic HDV infection; seven patients received 100 mg of lonafarnib, five received 200 mg, and two received placebo twice daily for 28 days with six months of follow-up.

After 28 days of treatment, the mean log HDV RNA declined significantly from baseline compared with placebo in patients who received 200 mg of lonafarnib (-1.54 log IU/mL; p<0.0001) as well as for patients treated with 100 mg of lonafarnib (-0.73 log IU/mL; p=0.03).

Dr. Robert Gish, medical director at the Hepatitis B Foundation, who was not involved in the study, explained that lonafarnib targets "farnesyltransferase, an enzyme involved in modification of proteins through a process called prenylation."

"Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply," Dr. Gish told Reuters Health by email.

Although no patients in either group discontinued treatment, all patients receiving 200 mg of lonafarnib reported mild or moderate nausea, diarrhea, abdominal bloating, and weight loss.

"This was just a proof of concept study for 28 days," Dr. Heller said. "The next step is a clinical trial which we are starting this month."

The study was funded by the National Institutes of Health and Eiger Biopharmaceuticals Inc.

SOURCE: http://bit.ly/1IpnIZ9

Lancet Infect Dis 2015.

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