HCV-infected patients sought for simeprevir, sofosbuvir trials

Researchers conducting two phase 3 trials that will examine the efficacy and safety of simeprevir in combination with sofosbuvir for treating hepatitis C virus infection are recruiting US and Canadian patients, according to a press release from Medivir AB.

In the first trial, OPTIMIST-1, researchers will combine 150 mg simeprevir and 400 mg sofosbuvir and administer it to 300 chronic HCV-infected genotype 1 patients without cirrhosis once daily for 8 or 12 weeks, the release said. For the second trial, OPTIMIST-2, researchers will combine 150 mg simeprevir and 400 mg sofosbuvir and administer it to 100 chronic HCV-infected genotype 1 patients with cirrhosis once daily for 12 weeks. Ribavirin will not be administered in either trial.

“Positive safety and efficacy results have previously been demonstrated in genotype 1 HCV infected patients with interferon- and ribavirin-free combination of simeprevir and sofosbuvir in the phase II COSMOS study,” Charlotte Edenius, executive vice president of development at Medivir AB, said in the release. “The OPTIMIST trials aim to further consolidate these data and to explore a shorter treatment duration of 8 weeks to potentially further simplify this promising treatment option.”

Simeprevir (Olysio, Medivir AB/Janssen R&D Ireland), a NS3/4A protease inhibitor, was approved by the FDA in November 2013 and sofosbuvir (Sovaldi, Gilead Sciences), a NS5B polymerase inhibitor, was approved in December 2013.