On November 5, 2014, the US Food and Drug Administration (FDA) approved the combination use of two previously approved separate oral therapies, Simeprevir (Olysio™) and sofosbuvir (Sovaldi™), for the treatment of chronic hepatitis C viral (HCV) infection. It is a ribavirin- and interferon-free regimen, both of which were notorious for causing debilitating side effects.
Simeprevir, manufactured by Janssen Therapeutics, is a protease inhibitor that halts the progression of HCV, thus preventing it from reproducing. Sofosbuvir, manufactured by Gilead Sciences, is a daily oral nucleotide analogue inhibitor composed of a small molecule compound that blocks HCV’s ability to replicate. The FDA approval encompasses the combination use of simeprevir/sofosbuvir for both treatment-naive and treatment-experienced patients. Trial regimens included a 24-week duration for patients with cirrhosis (scarring of the liver) and 12 weeks for those without cirrhosis, both of which excluded the use of either ribavirin or interferon.
The new FDA approval is based on results of the COSMOS study, a phase II trial that included patients with HCV genotype 1. Rates of sustained virologic response (SVR, meaning they no longer had detectable virus in their blood) measured 12 weeks after treatment ended were 93% among those treated with the combination for 12 weeks, and 97% among those treated for 24 weeks. The most common adverse reactions reported by more than 10% of treated patients during 12 weeks of combination treatment were fatigue in 25%, headache (21%), nausea (21%), insomnia (14%), itching (11%), rash (11%), and sensitivity to light (7%). Dizziness (16%) and diarrhea (16%) were the most commonly reported among those patients treated for 24 weeks.
Source: Family Practice News, November 6, 2014.
