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New HCV Drug Development Programs
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New HCV Drugs at AASLD - (11/21/11)
Tibotec HCV Drug Program
Tibotec has a potent protease now in phase 3 and recently announced 2 polymer drugs in development, an NNRTI & a nucleotide.
AASLD: TMC435 in Combination with Peginterferon and Ribavirin in Treatment-naïve HCV Genotype 1 Patients: Final Analysis of the PILLAR Phase IIb Study (TMC435-C205) - (11/08/11)
AASLD: Human safety, pharmacokinetics and antiviral activity of TMC647055, a novel HCV non-nucleoside polymerase inhibitor - (11/07/11)
Medivir HCV Report: Nucleotide Preclinical Development Started
www.natap.org/2011/newsUpdates/111011_02.htm
Nov 15, 2011 Ð In the protease project, TMC435 is in global phase III development in both ... TMC435 (NS3/4A protease inhibitor) presently in development in ...
Boerhinger Ingelheim HCV Drug Program
BI is studying their protease inhibitor in combination with a NNRTI (polymerase + RBV, preliminary results below, of course also in phase 3 now is their protease+Peg/Rbv, phase 2 study results reported at AASLD see below).
BI HCV Protease & Other New HCV Drugs - (11/09/11)
AASLD: Positive Interim Results from Interferon-Free Phase 2b SOUND-C2 Study with Boehringer Ingelheim's Two Investigational HCV Direct Acting Antivirals Presented at AASLD - press release - (11/08/11)
AASLD: (83% SVR) Treatment with the 2nd generation HCV protease inhibitor BI 201335 results in high and consistent SVR rates - results from SILEN-C1 in treatment-naïve patients across different baseline factors - (11/08/11)
AASLD: High SVR following IFN-free treatment of chronic HCV GT1 infection for 4 weeks with HCV protease inhibitor BI 201335, polymerase inhibitor BI 207127 and ribavirin, followed by BI 201335 and PegIFN/ribavirin - the SOUND-C1 study - (11/08/11)
AASLD: SILEN-C3: treatment for 12 or 24 weeks with BI 201335 combined with peginterferon alfa-2a and ribavirin in treatment-naïve patients with chronic genotype-1 HCV infection - (11/07/11)
AASLD: Virologic response to an interferon-free regimen of BI 201335 and BI 207127, with and without ribavirin, in treatment-naïve patients with chronic genotype-1 HCV infection: Week 12 interim results of the SOUND-C2 study - (11/08/11)
BMS HCV Drug Program
BMS has 3 main HCV drugs in development with the NS5A inhibitor, a protease inhibitor, and the newly acquired nucleotide INX189. BMS has an ongoing important study of the NS5A+ nucleotide PSI-7977 with and without RBV but interferon-free, good results are expected in the near future.
BMS-790052 Plus Peginterferon Alfa and Ribavirin Demonstrated up to 83% Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) in Phase II Study of Genotype 1 Hepatitis C Patients - (09/19/11)
Company has initiated Phase III development program for BMS-790052
Quadruple Therapy With BMS-790052, BMS-650032 and Peg-IFN/RBV for 24 Weeks Results in 100% SVR12 in HCV Genotype 1 Null Responders: original slide presentation at EASL April 2011 Proof of Concept that SVR is Achievable Without Peg/RBV - 4/11 null responder patients achieved SVR w/o Peg/Rbv, with only BMS-790052 (NS5A inhibitor) + BMS-650032 (protease inh) - (02/03/12)
Preliminary Study of Two Antiviral Agents for Hepatitis C Genotype 1: 'this was the proof-of-concept study showing SVR ('cured') could be achieved without peg/rbv & with only 2 new oral HCV drugs' - (01/19/12)
Dual therapy with the NS5A inhibitor BMS-790052 and the NS3 protease inhibitor BMS-650032 in HCV genotype 1b-infected null responders - (01/13/12)
Bristol-Myers Squibb to Acquire Inhibitex - (01/07/12)
New Data Reported on INX-189, HCV Nucleotide - (11/30/11)
Abbott HCV Drug Program
Abbott has a potent protease ABT-450 and 2 NNRTIs in clinical studies, as well as a NS5A inhibitor.
(1) ABT-450/Ritonavir (ABT-450/r) Combined with Pegylated Interferon ...
www.natap.org/2011/EASL/EASL_45.htm
ABT-450/Ritonavir (ABT-450/r) Combined with Pegylated Interferon Alpha-2a and Ribavirin After 3-Day Monotherapy in Genotype 1 HCV-Infected ...
(2) Pharmacokinetics, Safety and Tolerability of the HCV Protease ...
www.natap.org/2009/hepDART/hepDART_02.htm
Dec 10, 2009 Ð Overall ABT-450/r was well tolerated in healthy subjects. Adverse ... Mean ABT-450 Cmax and AUC values increased in a greater than dose ...
(3) Boosted ABT-450/r HCV Protease 3-Day Monotherapy
www.natap.org/2011/HCV/040411_03.htm
Ritonavir co-administration boosted the pharmacokinetics of ABT-450 with ABT-450 Cmax & AUC increased 28-fold & 48-fold: therefore, ABT-450 is being ...
(4) 4-Week Virologic Response and Safety of ABT-450 Given with Low ...
www.natap.org/2010/AASLD/AASLD_10.htm
Nov 3, 2010 Ð ABT-450 is a potent acylsulfonamide protease inhibitor of the hepatitis C virus (HCV) identifi ed as a lead compound by Abbott and Enanta, and ...
(5) 12-Week Effiacy and Safety of ABT-072 or ABT-333 with Pegylated ...
www.natap.org/2011/APSL/APSL_02.htm
Preliminary results from the fi rst 12 weeks of treatment with P/R combined with ABT-072, ABT-333, or placebo are presented here. Data from the ABT-450/r ...
Gilead's HCV Drugs EASL
Gilead announced 100% of patients with genotype 1 on PSI-7977 had undetectable HCV viral load after 4 weeks on therapy, all had RVR........Gilead's new GS-7977 data announced Thursday night come from a phase II study known as Electron first started by Pharmasset. In this particular arm of the study, 35 patients with genotype 1 hepatitis C (25 treatment-naïve patients and 10 who failed to respond to previous therapy) were treated with GS-7977 plus ribavirin. After four weeks of this two-drug oral therapy, 100% of patients achieved what is known as a "rapid viral response" or RVR, meaning that the virus could no longer be detected in their blood. RVR is an early and promising signal that drugs are working but it is not definitive proof of a hepatitis C cure. Patients are only deemed cured of hepatitis C -- a sustained virologic response or SVR -- if they have no evidence of the virus in their system 12 weeks after stopping treatment. At the upcoming CROI meeting Gilead will present further results on some of these 35 patients, specifically showing how many have undetectable virus four weeks after treatment with GS-7977 plus ribavirin ended.
PSI-7977 400 mg with PEG/RBV Provides 93% SVR Across HCV GT ...
www.natap.org/2011/hepDART/hepDART_02.htm
Dec 4, 2011 Ð PSI-7977 400 mg with PEG/RBV Provides 93% SVR Across HCV GT 1, 2 and 3. Reported by Jules Levin HepDart, December 4-8, 2011 Kauai, .
EASL: Three-Day, Dose-Ranging Study of the HCV NS5A Inhibitor GS-5885 - (04/06/11)
EASL: Preclinical Properties of the Novel HCV NS3 Protease Inhibitor GS-9451 - (04/06/11)
Gilead's HCV Pipeline Unveiled at EASL - (04/13/11)
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