December 18, 2013
“Breakthrough” Drug Approved for Chronic HCV Treatment
Washington, D.C.—New therapies for hepatitis C (HCV) are pouring out of the pharmaceutical pipeline and promising effective treatment with fewer side effects for the 3.2 million Americans diagnosed with the infectious disease.
In the last month, the FDA has approved Sovaldi (sofosbuvir) and Olysio (simeprevir) to treat chronic HCV infection.
The most recently approved, Sovaldi, was designated a “breakthrough” drug and approved under expedited review. The new drugs are notable because they can treat certain types of HCV without coadministration of interferon, which can have a high rate of toxicity.
“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in announcing Sovaldi’s approval.
Sovaldi, a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate, is approved for use in a combination antiviral treatment regimen. Depending on the type of HCV infection, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin, and peginterferon-alfa.
Sovaldi’s effectiveness was evaluated in six clinical trials consisting of 1,947 participants who were either treatment-naive or were treatment-experienced but had not responded to previous therapy. Some of the participants were coinfected with HCV and HIV.
The trials were designed to measure whether sustained virologic response could be achieved. Sovaldi was shown to be effective in treating multiple types of the hepatitis C virus, while also demonstrating efficacy in participants who could not tolerate or take an interferon-based treatment regimen as well as those with liver cancer awaiting liver transplantation.
Olysio, approved 2 weeks earlier than Sovaldi, is the first once-daily protease inhibitor approved for the treatment of chronic hepatitis C in a combination antiviral regimen for adults with compensated liver disease. It is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate.
Sovaldi is marketed by Gilead, based in Foster City, California. Olysio is marketed by Raritan, New Jersey–based Janssen Pharmaceuticals.
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