JNJ-4178 / Medivir, J&J, AstraZeneca - LARVOL DELTA

JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-infected Patients without Cirrhosis: OMEGA-1. (PubMed, Hepatology) - P2b | "This multicenter, randomized, open-label study (NCT02765490) enrolled treatment-naïve and interferon (±ribavirin) treatment-experienced patients with HCV GT1, 2, 4, 5, or 6 infection. All randomized patients completed treatment. In HCV-infected patients, 6 and 8 weeks of treatment with JNJ-4178 resulted in SVR12 rates of 98.9% and 97.8%, respectively, and was well tolerated."

Clinical • Journal • Fibrosis • Hepatitis C Virus • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, ACH-3102, and Simeprevir (clinicaltrials.gov) - P2a; N=320; Recruiting; Sponsor: Alios Biopharma Inc.; Phase classification: P2 ➔ P2a; N=140 ➔ 320; Trial primary completion date: Jun 2016 ➔ Jul 2017

Enrollment change • Phase classification • Trial primary completion date • Biosimilar • Fibrosis • Hepatitis C Virus • Immunology

Short Duration AL-335, Odalasvir, With/Without Simeprevir, in Patients With HCV GT1 or 3 Infection Without Cirrhosis. (PubMed, Hepatology) - "In treatment-naïve subjects without cirrhosis, AL-335 + odalasvir + simeprevir for 6-8 weeks was generally safe and highly efficacious against HCV GT1. However, inadequate efficacy was observed for the 2-DAA regimen in GT1-infected subjects and the 3-DAA regimen in GT3-infected subjects."

Clinical • Journal • Biosimilar • Fibrosis • Hepatitis C Virus • Immunology • Infectious Disease

Evaluation of the efficacy and tolerability of JNJ-4178 (AL-335, odalasvir, and simeprevir) in hepatitis C virus-infected patients without cirrhosis: The Phase IIb OMEGA-1 study (AASLD 2017) - P2a,P2b; "The OMEGA-1 study will provide further understanding of the efficacy and tolerability of AL-335, ODV, and SMV (as JNJ-4178) in HCV GT1, 2, 4, 5, and 6 infected-pts without cirrhosis. Treatment was well tolerated and not associated with premature discontinuation. SVR12 results will be presented at the meeting."

Clinical • P2 data • Biosimilar • Fibrosis • Hepatitis C Virus • Immunology • Infectious Disease

".@JNJNews makes strategic decision to discontinue devpt of investigational #HCV treatment, JNJ-4178 https://t.co/oJ0qu5EeNM" (@Contagion_Live)

Biosimilar • Hepatitis C Virus • Infectious Disease

JNJ-4178 (adafosbuvir, odalasvir, and simeprevir) in Japanese patients with chronic hepatitis C virus genotype 1 or 2 infection with or without compensated cirrhosis: the Phase IIa OMEGA-3 study. (PubMed, J Gastroenterol) - P2a; "In HCV GT1- and GT2-infected Japanese patients, treatment with JNJ-4178 was well tolerated and resulted in 100% of patients achieving SVR12."

Clinical • Journal • P2a data

Population Pharmacokinetics of AL-335 and Its Two Main Metabolites (ALS-022399, ALS-022227) in Monotherapy and in Combination with Odalasvir and/or Simeprevir. (PubMed, AAPS J) - "Internal evaluation confirmed that the population pharmacokinetic model developed was deemed appropriate to describe the time course of AL-335, ALS-022399, and ALS-022227 plasma concentrations and their associated variability in both healthy and HCV-infected subjects, as well as the interaction effect of simeprevir and/or odalasvir over AL-335 and its metabolites in healthy subjects. This model can be used as a starting point to evaluate drug-drug interaction processes in HCV-infected patients and support the development of a direct-acting antiviral (DAA) combination."

Clinical • Combination therapy • Journal • Monotherapy • PK/PD data