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New Oral HCV Drugs/DAAs
  Abbott Phase 3 Study - (10/17/12)
When Did Phase 3 Studies Begin for TMC435, BI201335, GS7977, BMS790052, and PegLambda and when will they finish & receive FDA approval. - (01/25/13)
9 & Soon 11 New HCV Drugs in Phase 3 and a number of oral combination studies in phase 2
Gilead Begins Single Pill Hepatitis C Study for 2014 Approval http://www.natap.org/2012/HCV/072712_01.htm
July 27, 2012
we anticipate being able to file for regulatory approvals for GS-7977 by the middle of next year........If successful, the initial indication will for 12 to 16 weeks of treatment with GS-7977 and Ribavirin in genotype 2/3 infected patients, and for 12 weeks of treatment with GS-7977, peg-interferon and Ribavirin in genotype 1, 4, 5 and 6 infected patients......The fixed dose combination regulatory filings could, in that case, follow the initial GS-7977 filings a year later by mid-2014
Boehringer Ingelheim Enrolls First Patients in Pivotal Phase 3 Interferon-Free Hepatitis C Trial Program- (01/17/13)
4 Oral Drug IFN-Free Roche HCV Regimens Studies, Treatment Naïve or Null Responders: setrobuvir (non-nuc)+mericitabine (nuc)+danoprevir/r (protease)+rbv. ANNAPURNA Study...http://www.natap.org/2012/HCV/090412_01.htm
Vertex Announces Collaboration with Janssen To Initiate Phase 2 All-Oral Study of VX-135 and Simeprevir (TMC435) for the Treatment of Hepatitis C.....polymerase inhibitor VX-135 and Janssen's protease inhibitor simeprevir (TMC435) http://www.natap.org/2012/HCV/110112_04.htm
Vertex Enters Agreement with GlaxoSmithKline for Phase 2 All-Oral Study of VX-135 and GSK2336805 for the Treatment of Hepatitis C......polymerase inhibitor VX-135 and GSK's NS5A inhibitor GSK2336805 http://www.natap.org/2012/HCV/110112_03.htm
Merck Will Initiate Interferon-Free Phase II Clinical Trials for MK-5172, an Investigational, Once-Daily, Oral Treatment for Chronic Hepatitis C Virus......a 12-week regimen containing MK-5172, MK-8742, an oral NS5A inhibitor in Phase I development, and ribavirin http://www.natap.org/2012/HCV/110812_02.htm
TMC435+GS7977 (Rbv) New Study in Advanced Hepatic Fibrosis- Null Responders & Naives http://www.natap.org/2013/HCV/012213_03.htm
Phase II all-oral combination studies of Simeprevir (TMC435), TMC647055 (non nuc polymerase inhibitor) and IDX719 (NS5A) for the treatment of Hepatitis C to be initiated shortly - 4 articles below http://www.natap.org/2013/HCV/013113_02.htm
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