New Phase III results for Olysio plus Sovaldi (simeprevir plus sofosbuvir) in HCV-Janssen

Janssen Sciences has announced results for its Hepatitis C treatment Olysio plus Sovaldi (simeprevir plus sofosbuvir) in Genotype 1 HCV Patients with and without cirrhosis. Late-breaking results from the Phase III OPTIMIST-1 and OPTIMIST-2 trials highlight the clinical outcomes of simeprevir plus sofosbuvir in an all-oral combination regimen in a wide range of patients with hepatitis C virus (HCV) infection.

In Optimist-1, 97 percent of patients treated with SMV/SOF for 12 weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate of 87 percent among the historical control. Patients treated with eight weeks of SMV/SOF achieved an SVR12 rate of 83 percent (n=128/155), which was not superior to the SVR12 rate of 83 percent in the historical control. Ninety-seven (97) percent of patients treated with SMV/SOF for 12 weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate of 87 percent among the historical control. Patients treated with eight weeks of SMV/SOF achieved an SVR12 rate of 83 percent (n=128/155), which was not superior to the SVR12 rate of 83 percent in the historical control.

In Optimist-2, 12 weeks of treatment with SMV/SOF resulted in SVR12 rates of 84 percent (n=86/103), which was superior to the SVR12 rate of 70 percent in the historical control. The most common adverse events were fatigue (20 percent), headache (20 percent) and nausea (11 percent). Data were presented at The International Liver Congress 2015 of the European Association for the Study of the Liver (EASL) in Vienna.

Comment: In May 2014 a combination of Olysio plus Sovaldi was approved by the EU for treatment of genotype 1 and 4 Hepatitis C. But this combination is seen as too expensive following launches of Sovaldi and Viekira Pak. Pricing the new drugs is controversial with payers resisting, and the companies being persuaded to offer significant discounts.