Concerns over safety of new drugs for Hepatitis C treatment have been raised
After analyzing the Food and Drug Administration’s worldwide database of reports from doctors of adverse events that might be related to medications, the Institute for Safe Medication Practices, a nonprofit in Horsham, Pa., has raised a concern about the safety of some drugs being used to treat Hepatitis C.
According to the report, dugs approved recently to treat HCV might have serious side effects such as liver failure.
It is estimated by the Centers for Disease Control and Prevention (CDC) that 2.7 million to 3.9 million people have chronic hepatitis C, at least 20,000 a year die from it and it is the leading cause of liver transplants in the US.
The World Health Organization estimates around 130 million to 150 million people worldwide have HCV, and 700,000 HCV related deaths per year.
If not treated, the Hepatitis C virus eventually might cause liver cirrhosis and liver cancer.
The report stated that about 250,000 people took the newer drugs in 2015. In those treated during the year ending June 30, 2016, 524 patients with liver failure were identified, 165 of whom died. Of those with liver failure, 386 were from outside the United States. An additional 1,058 had severe liver injury, and in 761 the drugs appeared not to work.
Sovaldi and Harvoni, both made by Gilead Sciences are included in the report.
A spokesman for Gilead, Mark Snyder, wrote in an email, “We closely assess both post-marketing safety reports as well as safety data from our clinical trials on an ongoing basis and have found no suggestion of a causal relationship between Sovaldi or Harvoni and liver failure. He added that Gilead’s drugs had been approved for people with severe liver disease from hepatitis C, and that some would inevitably suffer liver failure despite the best treatment,” spokesman for Gilead, Mark Snyder said.