Medivir communicates an update on the status of the development of JNJ-4178, the triple combination of simeprevir, odalasvir and AL-335, following The International Liver Congress 2017 of the European Association for the Study of the Liver (EASL), which was held in Amsterdam, on 19-23 April.
Data from an ongoing phase II study presented at The International Liver Congress 2017 demonstrate that this regimen has the potential to shorten treatment duration, offer high efficacy and is generally well tolerated in those whose disease is caused by hepatitis C virus (HCV) genotype 1 (GT1), one of the most prevalent causes of hepatitis C globally. The three-drug regimen achieved 100% SVR12 for 6- and 8-week treatment duration in treatment-naïve, GT1, non-cirrhotic patients. The three-drug combination did not have sufficient efficacy in patients with HCV genotype 3 to justify further development in this patient population. All-oral combination regimens, containing odalasvir, AL-335 with or without simeprevir were generally safe and well tolerated. The safety and efficacy of JNJ-4178 in cirrhotic patients is currently under investigation as part of this phase II study. Further information on this trial can be found at www.clinicaltrials.gov (NCT02569710).
Enrolment has recently been completed into the global phase IIb OMEGA-1 study of JNJ-4178. This open-label study is assessing the efficacy and safety of JNJ-4178 in non-cirrhotic patients with HCV genotypes 1, 2, 4, 5 and 6.