Gilead Defends Hepatitis C Treatments On Reports Of Side Effects

According to Stat News, reports were filed with the U.S. Food and Drug Administration and reviewed by the Institute for Safe Medicine Practices. The reports documented 524 cases of liver failure and 1,058 reports of severe liver injury that were associated with hepatitis C drugs.

Gilead's Harvoni, one of its two hepatitis C therapies, was named in the report.

Gilead Responds

Benzinga reached out to Gilead to comment on the report.

The company responded that patient safety is its highest priority and it continuously monitors safety information about its medicines.

Gilead added that it is important to consider the following factors when reviewing the report: To date, more than 1.2 million HCV-infected patients have been prescribed sofosbuvir-containing regimens worldwide, with the United States accounting for the largest number of patients treated from any country (>500,000 patients).

"Gilead closely assesses both post-marketing safety reports as well as safety data from our clinical trials on an ongoing basis and has found no suggestion of a causal relationship between Sovaldi or Harvoni and liver failure," Gilead stated.

Gilead further said that the FDA and other relevant agencies have recognized the potential for worsening hepatic function, liver failure and death in HCV-infected patients with advanced liver disease who receive HCV protease inhibitor-based regimens.

"We have worked closely with the FDA and other regulatory agencies to share our data and analyses on cases of liver failure, and no product updates have been deemed necessary by Gilead," the company added.

Finally, Gilead stated it has generated extensive clinical trial data in patients with cirrhosis, including those with decompensated liver disease, and it has "seen no evidence of a causal relationship between sofosbuvir-based regimens and liver failure. In addition, Gilead has supported large database analyses of real-world data in the United States and Europe, which have also not established any causal relationship between sofosbuvir-based regimens and liver failure."

Finally, the company concluded: "With respect to reports of lack of efficacy, I would refer you to the extensive body of real world data [...] demonstrating that the failure rates with Harvoni and other SOF-based regimens are low but given the large numbers of patients treated, it is not unexpected to see reports of some patients failing these treatments. Based on our experience and the published literature, virologic failure occurs as relapse in a small proportion of patients after treatment completion."