Janssen’s simeprevir for hepatitis C shows good efficacy in Phase II trial

Some 92% of genotype 1 chronic hepatitis C virus (HCV) adult patients treated with US health care giant Johnson & Johnson’s (NYSE: JNJ) Europe-based subsidiary Janssen R&D Ireland’s simeprevir, in combination with sofosbuvir, achieved sustained virologic response 12 weeks after the end of treatment.

The results from the Phase II COSMOS (Combination Of SiMeprevir and sOfosbuvir in HCV genotype 1 infected patientS) clinical study were published in The Lancet. According to findings from the study, the all-oral 12-week, interferon-free treatment regimen with simeprevir and sofosbuvir, from US biotech major Gilead Sciences (Nasdaq: GILD) resulted in consistent SVR12 rates regardless of degree of fibrosis, and was an effective and well-tolerated therapeutic regimen in both treatment-naïve and prior null-responder patients.

Gaston Picchio, hepatitis disease area leader, Janssen R&D, said: “The publication of the COSMOS study results represents the first peer-reviewed report describing the use of simeprevir in combination with other direct-acting antiviral agents in an all-oral interferon-free regimen. This has been included as part of the European marketing authorization earlier this year and we are further discussing these results with other authorities around the world to better inform the treatment of hepatitis C patients.”