Serious Concerns Raised Over Safety of New Hep C Drugs

Source: The New York Times

Jan 25, 2017

Drugs for hepatitis C approved in recent years may have severe side effects according to findings from the nonprofit Institute for Safe Medication Practices (ISMP). Based on an analysis of the U.S. Food and Drug Administration’s Adverse Event Reporting System database, side effects from the drugs may even include liver failure.

The New York Times reports that experts should not ignore the ISMP's findings as concerns involve nine antiviral drugs previously heralded as a huge advancements because of their great cure rates with allegedly few side effects. And with no vaccine in existence, treatments are sorely needed.

According to the Centers for Disease Control and Preventaion, in the U.S., up to 3.9 million people suffer from chronic hepatitis C and it is also the leading cause of liver transplants.

Gilead Sciences' hep C blockbusters, Sovaldi and Harvoni, were both included in the ISMP's list of concerning drugs. Just this past December, Gilead Sciences paid Merck $2.54 billion in royalties over Sovaldi and Harvoni. 

The report also found that approximately a quarter-million people took these newer drugs in 2015, ranging from $55,000 to $125,000 per patient. The report identified 524 cases of patients with liver failure, 165 of whom died, in 2016. Plus, 1,058 individuals reported severe liver injury and another 761 patients showed no signs of drug efficacy.

New York Times reporter Denise Grady writes, "whether the drugs were to blame is not known. The problems were observed by doctors who suspected drugs were the cause, but that does not prove cause and effect. And details about the patients’ medical histories were not available." Grady received a response from a Gilead spokesperson, who said the biopharma company have found no suggestion of a causal relationship between its two drugs and liver failure. The FDA declined comment on the report.

Read the New York Times report