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Janssen HCV Drug Research & Development 2
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Reported by Jules Levin
In the Spring Janssen & Gilead submitted New Drug Applications to the FDA requesting approval. The FDA hearing appears to be scheduled for Oct 24-25.
NS5A
A Study of the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of JNJ-47910382 at Different Doses and Dose Regimens in Asian Genotype-1, Chronic, HCV-Infected Patients
Study in HCV-Infected Patients to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of JNJ-47910382
A Study in Healthy Participants Investigating the Safety, Tolerability and Plasma Pharmacokinetics (PK) of Single Oral Doses of JNJ-47910382
IDX719 in Combination With Simeprevir and Ribavirin for 12 Weeks in Subjects With Chronic Hepatitis C Infection
http://www.clinicaltrials.gov/ct2/show/NCT01852604?term=Janssen+AND+Hepatitis+C&recr=Open&no_unk=Y&rank=9
Antiviral Drugs Advisory Committee .........October 24-25
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm153468.htm
Simeprevir (TMC435) with peginterferon/ribavirin for chronic hCV genotype 1 infection in treatment-naïve patients: results from QUEST-1, a Phase III trial
http://www.natap.org/2013/EASL/EASL_10.htm
Simeprevir (TMC435) with peginterferon-α2a or -α2b and ribavirin in treatment-naïve HCV genotype 1 patients: QUEST-2, a randomised Phase III trial
http://www.natap.org/2013/EASL/EASL_18.htm
Simeprevir with Peginterferon/ribavirin for Treatment of Chronic HCV Genotype 1 Infection in Patients Who Relapsed After Previous Interferon-based Therapy: Results from PROMISE, a Phase III Trial
http://www.natap.org/2013/DDW/DDW_06.htm
COSMOS Study: SVR4 results of a once daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 null responders
http://www.natap.org/2013/CROI/croi_34.htm
Medivir Press Release: New Drug Application has been filed with FDA for Simeprevir (TMC435) for combination treatment of adult patients with genotype 1 chronic hepatitis C
http://www.natap.org/2013/HCV/040213_01.htm
Idenix Pharmaceuticals Announces Initiation of Phase II All-Oral Combination Study of Samatasvir (IDX719) and Simeprevir (TMC435) for the Treatment of Hepatitis C Virus (HCV) Infection
http://www.natap.org/2013/HCV/060213_04.htm
Combination Therapy of TMC647055 With Simeprevir (TMC435) in Genotype 1 HCV Patients
http://www.natap.org/2013/EASL/EASL_41.htm
TMC055 Monotherapy data:
Human safety, pharmacokinetics and antiviral activity of TMC647055, a novel HCV non-nucleoside polymerase inhibitor.......
http://www.natap.org/2011/AASLD/AASLD_04.htm
Here is the link to the study on clinical trials.gov where you can see low dose 30mg RTV is used:
A Study to Evaluate the Safety, Tolerability, and Effectiveness of a 12-Week Combination Therapy of TMC647055 and TMC435 With a Pharmacokinetic Enhancer With and Without Ribavirin in Chronic Genotype-1 Hepatitis C Infected Patients.......
http://clinicaltrials.gov/ct2/show/NCT01724086?term=tmc647055&rank=3
EASL: Combination Therapy of TMC647055 With Simeprevir (TMC435) in Genotype 1 HCV Patients - (04/30/13)
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