For those following the release of the new medicines for hepatitis C, Gilead is one step closer to FDA approval.
Yesterday, the FDA released further positive feedback that sofosbuvir will receive positive approval in mid-December 2013. This will be the start of yet another new era in the successful treatment of patients with chronic hepatitis C. Based on available research data, sofosbuvir will be associated with a 90% sustained virology response (no detectable virus) in patients naive to any form of HCV therapy.
One major topic of discussion, especially among patients, is whether or not it will be the first interferon-free protocol? The answer is part yes, and part no.
Genotype 2 and 3 patients with hepatitis C will take the combination of sofosbuvir and ribavirin for 12 weeks, while genotype 1 patients, the most common in North America, will have to take a triple combination of PEG-interferon,sofosbuvir and ribavirin for 12 weeks.
While most of us are still waiting for all interferon therapies, 12 weeks of interferon is a vast improvement over the previous 48 weeks of interferon in genotype 1 cases. It is expected that the 12 weeks of interferon will be very well tolerated, considering most symptoms related to interferon develop around 12 weeks.
Our practice is gearing up for patients once approval is announced. Visit us on our website for updated information as well as this blog. Sign up for our newsletter for up-to-date information on the FDA approval.
This new FDA approval of sofasbuvir will not address patients previously treated and failed treatment, those with advanced cirrhosis, transplant patients, those with liver cancer, or co-infected with HIV. Despite a lack of formal FDA approval for these specific patients, I anticipate we will be seriously discussing treatment in this very special group of patients.
To make an appointment, contact Lexa in our office at 713-794-0700; make sure old records are available.