NEW YORK (AP) – Idenix Pharmaceuticals announced that federal regulators have halted trials of its hepatitis C drug due to the potential for heart damage.
Two weeks ago, Bristol-Myers shut down a clinical trial of its hepatitis C treatment because a patient suffered heart failure during a clinical trial.
The Food and Drug Administration has now placed a hold on human testing of IDX184, Idenix’s most advanced drug. It said no heart-related side effects have been specifically linked to the drug, although some heart side effects have been seen in patients treated with IDX184 and standard drugs.
On Aug. 1, Bristol-Myers Squibb Co. said it had suspended trials of a drug designated BMS-986094. It said it was not clear that the side effects in the trial were linked to the drug itself. IDX184 and BMS-986094 are both nucleotide inhibitors, meaning they are designed to prevent the hepatitis C virus from making copies of itself. Bristol-Myers did not immediately respond to request for comment.
The FDA placed a clinical hold on trials of IDX184 in 2010 because of concerns about the effects of the drug on the liver. It removed the clinical hold in February.
The company recently completed a mid-stage clinical trial of IDX184 and is preparing to report results from that trial. No patients are currently being treated with the drug. At a conference on Wednesday, Idenix President and CEO Ronald Renaud said the company is “quite pleased with the safety profile that we’ve seen to-date.”
Hepatitis C is a virus that can lead to life-threatening liver damage and is the main cause of liver transplants in the United States. The disease is spread through the blood, and that can happen through sharing intravenous drug needles or having sex with an infected person. There are around 3 million Americans with the disease, which can go undetected for many years until the liver is severely damaged. More people will be diagnosed as the baby boomer generation ages.
Baby boomers account for about two-thirds of the 3.2 million Americans thought to be infected.
On Thursday, the Centers for Disease Control and Prevention recommended that anyone born between 1945 and 1965 get tested.
Previously, testing was recommended only for people considered at highest risk, but the CDC changed its stance after seeing hepatitis C deaths nearly double since the late 1990s.
Date: August 16, 2012
Source: Associated Press
Filed Under: Drug Discovery