Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced results for its hepatitis C treatment simeprevir at The International Liver Congress™ 2015.
New data for simeprevir comfirms its efficacy when combined with sofosbuvir
“The new data for simeprevir presented at The International Liver Congress™ confirms its efficacy when combined with sofosbuvir in an all-oral, ribavirin-free regimen for HCV patients, including those who are treatment-naïve and treatment-experienced, both with and without cirrhosis,” said Gaston Picchio, hepatitis disease area leader, Janssen. “These data further demonstrate the role of simeprevir within the HCV treatment landscape, as it provides patients with an important therapeutic option.”
The results from the OPTIMIST-1 and OPTIMIST-2 trials are the first Phase 3 data to be presented on simeprevir in combination with sofosbuvir (SMV/SOF) in patients with genotype 1 chronic HCV infection, both with and without cirrhosis. Sofosbuvir is a nucleotide analog NS5B polymerase inhibitor developed by Gilead Sciences, Inc.
OPTIMIST-1 was a Phase 3, randomised, open-label trial to investigate the efficacy and safety of the all-oral regimen of SMV/SOF among treatment-naïve and treatment-experienced genotype 1 chronic HCV-infected patients without cirrhosis. The primary objective was to show superior sustained virologic response (SVR) at 12 weeks after treatment (SVR12) with 12 and eight weeks of treatment with SMV/SOF versus a historical control. 97% of patients treated with SMV/SOF for 12 weeks (n=150/155) achieved SVR12, which was superior to the SVR12 rate of 87% among the historical control. SVR12 rates of 100% were seen among patients with IL28B CC genotype (n=43/43) and those with baseline NS5A and NS3 Q80K polymorphisms (n=9/9). Patients treated with eight weeks of SMV/SOF achieved an SVR12 rate of 83% (n=128/155), which was not superior to the SVR12 rate of 83% in the historical control.
OPTIMIST-2 study demonstrates safety and efficacy of simeprevir and sofosbuvir for genetype 1 chronic HCV patients with cirrhosis
OPTIMIST-2 was a Phase 3, open-label, single-arm trial to investigate the efficacy and safety of SMV/SOF in treatment-naïve and treatment-experienced genotype 1 chronic HCV-infected patients with cirrhosis. The primary objective was to show superior SVR12 with twelve weeks of treatment with SMV/SOF versus a historical control. Twelve weeks of treatment with SMV/SOF resulted in SVR12 rates of 84% (n=86/103), which was superior to the SVR12 rate of 70% in the historical control. Higher SVR12 rates were seen in patients with baseline NS5A polymorphisms with or without NS3 Q80K polymorphisms (100%, n=13/13), patients with albumin ≥4 g/dL (94%; n=47/50) and treatment-naïve patients (88%; n=44/50).
The most common adverse events in both studies were fatigue, headache and nausea.
“Chronic HCV infection is a leading cause of cirrhosis, and once it is developed, these patients can be very difficult to cure. The results of the OPTIMIST-2 study demonstrate the safety and efficacy of the all-oral regimen of simeprevir and sofosbuvir for genotype 1 chronic HCV patients with cirrhosis,” said Eric Lawitz, Texas Liver Institute, principal investigator of the OPTIMIST-2 study.