Get Ready for Gilead’s Hepatitis C Treatment
For the 4 million people in the United States infected with the hepatitis C virus, treatment is just that much closer to a new effective option which will no longer require painful injections and serious side effects. What a relief it will be to have a treatment to offer patients with chronic hepatitis C infection which is just as effective (if not more so) and less problematic than existing medication regimens.
On October 25, 2013, the FDA Antiviral Drugs Advisory Committee unanimously supported Gilead’s hepatitis C drug sofosbuvir for the treatment of hepatitis C genotypes 2 and 3 (when combined with ribavirin). Sofosbuvir was also supported for treating genotypes 1 and 4 in treatment-naïve patients (when combined with interferon and ribavirin).
As I wrote about in my October 16, 2013 blog, One Step Closer to Interferon-Free Hepatitis C Treatment, sofosbuvir is a once-daily oral nucleotide analogue inhibitor. Phase 3 clinical trial data was submitted for the FDA’s consideration showing that sofosbuvir (combined with ribavirin) results in a sustained viral response (SVR) of 86-97 percent for genotype 2 patients and a SVR of 30-61 percent in genotype 3 patients. For sofosbuvir (combined with ribavirin and interferon), the SVR is 90 percent in genotype 1 patients and 97 percent in genotypes 4, 5, and 6.
The next step comes on December 8, 2013 when the FDA is scheduled to decide final approval for this hepatitis C medication. Although the panel’s recommendation to approve sofosbuvir is not binding, it does serve as a very positive indicator of what the FDA’s final decision will likely be in December. It could very well be a merry Christmas for hepatitis C patients; in fact, they could be ringing in the New Year with a better and easier way to cure their hepatitis C infection.
Stephen C Vogt, PharmD
President and CEO
BioPlus SP www.bioplusrx.com
Press release. FDA Advisory Committee supports approval of Gilead’s sofosbuvir for chronic hepatitis C infection. Gilead Sciences, Inc. October 25, 2013.