NATAP: Interferon-Free HCV Therapy2

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Begin forwarded message:Date: February 4, 2012 4:41:12 AM PSTTo: nataphcv@...>Subject: NATAP: Interferon-Free HCV Therapy2"Are we ready for IFN-free treatment regimens?"Ongoing now are numerous studies examining interferon-free treatment regimens including some with ribavirin and some without, in both genotype 1 patients & in genotype 2/3 patients. But this is only the beginning. In 2 to 2 1/2 years it's expected 4 new classes of HCV drugs will be FDA approved, making multi-drug combinations possible. As you can see below there are many studies exploring combinations of new HCV drugs, soon there will be more studies examining more combinations of 3 maybe 4 new oral HCV drugs. The 'proof-of-concept' study has already been done showing 100% SVR with 4 drugs (BMS protease+ BMS NS5A + peg/rbv) but more importantly 4/11 null responders were cured in this study with only these 2 oral drugs & interferon/RBV free therapy. So all these studies below were planned to duplicate this finding, and the results from future studies are likely to be better, these studies are being conducted in treatment-naive patients and the hard-to-treat prior nonresponders called null responders. Researchers will study 12 and 16 weeks therapy for genotype 1 patients to see how much we can shorten therapy, and for some patients with certain regimens I expect 12 or 16 weeks will achieve SVR. Jules LevinInterferon-Free Treatment Regimens for Hepatitis C: Are We There Yet? Editorial - - (12/12/11) - the INFORM-1 study was the first several years go by Roche to examine interferon-free therapy, involved a combination of an NS5B polymerase inhibitor (RG7128) and an NS3/4A protease inhibitor (danoprevir).- BI201335 (NS3/4A protease inhibitor)+ BI207127 (NS5B NNRTI polymerase inhibitor) + RBV - BMS650032 (NS3/4A protease inhibitor)+ BMS790052 (NS5A inhibitor) (+/- RBV)- TMC435 (protease) + PSI-7977 (+/- RBV)- BMS790052 (NS5A inhibitor) + PSI-7977 (+/- RBV)- PSI-7977 (nucleotide) + RBV- ABT-450 (protease) With Ritonavir (ABT-450/r) When Given Together With ABT-333(NNRTI polymerase) (and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1- Vertex' telaprevir+VX222 (NNRTI polymerase) +RBV (study recruiting)- at AASLD Nov 2011, Pharmasset reported 100% SVRs in GT2/3 with RBV+PSI-7977, their nucleotide)- Alisporivir (cyclophillin inhibitor) + RBV in genotype 2/3New HCV Drugs at AASLD - (11/21/11)BI HCV Protease & Other New HCV Drugs - (11/09/11)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) Efficacy of the Protease Inhibitor BI 201335, Polymerase Inhibitor BI 207127, and Ribavirin in Patients With Chronic HCV Infection - - (12/12/11) Vertex and Alios BioPharma Begin Clinical Studies of Nucleotide Drug Candidates ALS-2200 and ALS-2158 for the Treatment of Hepatitis C - (12/10/11) Recruiting A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) InfectionPharmacokinetics and Pharmacokinetic/Pharmacodynamic Relationship for MK-5172, a Novel Hepatitis C Virus (HCV) NS3/4A Protease Inhibitor, in Genotype 1 and Genotype 3 HCV-Infected Patients - (11/16/11)Dual Oral Combination Therapy with the NS5A Inhibitor Daclatasvir(DCV; BMS-790052) and the NS3 Protease Inhibitor Asunaprevir(ASV; BMS-650032) Achieved 90% Sustained Virologic Response (SVR12) in Japanese HCV Genotype 1b-Infected Null Responders - (11/08/11)Activity of danoprevir plus low-dose ritonavir in combination with peginterferon alfa-2a (40KD) plus ribavirin in previous null responders - (04/01/11)Once-daily alisporivir interferon (IFN)-free regimens achieve high rates of early HCV clearance in previously untreated patients with HCV genotype (G) 2 or 3 - (11/09/11)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)PSI-7977: ELECTRON Interferon is not required for Sustained Virologic Response in Treatment-Naïve Patients with HCV GT2 or GT3 - (11/07/11)Alisporivir

Plus Peg-IFN_-2a/Ribavirin Treatment for Chronic Hepatitis C Genotype 1

Treatment-Naïve Patients Shows Superior Sustained Virologic Response Irrespective of IL28B Genotype and High Barrier to Resistance (12/07/11)Host

targeting antiviral (HTA) alisporivir presents a high barrier to resistance both in vitro and in HCV patients with no cross-resistance to

DAAs (12/07/11)