ISMP Report Questions Safety of Hepatitis C Drugs

A recently-published Institute for Safe Medication Practices (ISMP) report details updated concerns about newer drugs used to treat hepatitis C virus (HCV). The report, which is published in ISMP’s QuarterWatch, highlights concerns about the safety of HCV drugs in light of findings that point to associated liver failure and injury.

The FDA designated 46 different drugs in development as breakthroughs last year, and although some of these medications have resulted in cure in an estimated 9 out of 10 patients treated, ISMP has identified hundreds of patients that reported antiviral failure. Over the course of 1 year, ISMP noted 524 reported cases worldwide of liver failure with these drugs as the primary or secondary suspects, and 761 cases reporting that the drug was ineffective.

Liver failure occurred more frequently in men (55%) and in patients with a median age of 61 years old. Thirty one percent of cases resulted in death.

Although the report questions the safety of these drugs, experts argue that the findings are inconclusive and prescribers should not be influenced by the results. The data do not include the medical history of the patients, and are based off voluntary reporting from consumers and health professionals.

“These new data raise more questions than they resolve about the adverse effects of direct-acting antiviral drugs,” the researchers noted in the report. “A better understanding of what is occurring in hundreds of additional liver failure cases should be a priority for further investigation.”

Reference

Liver failure and antiviral failure with hepatitis C direct-acting drugs. QuarterWatch. ISMP’s website. 2017; http://www.ismp.org/quarterwatch/pdfs/2016Q2.pdf.