Janssen begins Phase IIb study of drug combination to treat hepatitis C virus infection


Janssen Research & Development has begun its Phase IIb study of combination of simeprevir, odalasvir and AL-335 to treat chronic hepatitis C virus infection without cirrhosis.

Simeprevir (Olysio) is a macrocyclic compound that non-covalently fuses with and inhibits a NS3/4A hepatitis C virus (HCV) protease, which is considered responsible for cleaving and processing the HCV-encoded polyprotein.

Developed by Achillion Pharmaceuticals, odalasvir (ACH 3102) is an orally administered, pan-genotypic, second-generation hepatitis C virus (HCV) NS5A inhibitor.

AL-335, also known as JNJ-4178, is a novel uridine nucleotide analog.

"The Phase IIb study is being undertaken as a global, multi-centre study across sites in North America, Europe and Asia, and is a part of Janssen’s global development programme for JNJ-4178."

The Phase IIb study is being undertaken as a global, multi-centre study across sites in North America, Europe and Asia, and is a part of Janssen’s global development programme for JNJ-4178.

The study is intended to evaluate the efficacy and safety, as well as determine the pharmacokinetics profile of the JNJ-4178 / AL-335, odalasvir and simeprevir while examining treatment-naive and treatment-experienced non-cirrhotic patients with chronic hepatitis C virus genotype 1, 2, 4, 5, and 6 infection.

It is primarily focused on achieving the percentage of patients with a sustained virological response induced by the drug combination post-treatment.

During the study, the patients will be administered with the triple combination for either six or eight weeks.