The two hepatitis C drugs have “cure rates of greater than 90 percent,” noted Dr. David Bernstein, chief of hepatolgy at North Shore University Hospital in Manhasset, N.Y.
“More than 2,000 patients were treated in clinical trials with these medications prior to FDA approval, and in these studies there were minimal side effects and few drug-drug interactions,” he said.
However, “with the widespread use of these products in more than 100,000 patients,” isolated incidents like the ones described by the FDA have occurred, Bernstein said. So, “this FDA recommendation makes sense and should be disseminated to all physicians who are or will be treating patients with chronic hepatitis C infection,” he said.
Another expert also said that the risk to any one patient is likely rare.
“While this is a potentially devastating drug interaction in real life, it is unlikely to be a major issue,” said Dr. Douglas Dieterich, a professor of liver diseases at the Icahn School of Medicine at Mount Sinai in New York City.
“In fact, I cannot recall treating a hepatitis C patient who was on amiodarone in the last five years,” he said.
Dieterich added that “amiodarone is potentially liver-toxic and very few patients who have significant liver disease are taking it. The overall drug interaction profile of sofosbuvir is actually extremely good; better than most new medications we have seen in the hepatitis field.”
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FDA Warning With Two New Hepatitis C Medications was originally published on blackdoctor.org
