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TMC435, Janssen HCV Program
  Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C http://www.natap.org/2013/HCV/033013_01.htm
Janssen HCV Drug Research & Development - (07/30/13)
The Pharmacokinetic Interactions of HCV Protease Inhibitor TMC435 with Rilpivirine, Tenofovir, Efavirenz or Raltegravir in Healthy Volunteers
CROI: Simeprevir (TMC435) with peginterferon/ribavirin in patients co-infected with chronic genotype-1 HCV and HIV-1: Week-24 interim analysis of the TMC435-C212 study - (03/07/13)
SVR4 results of a once daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 null responders - (03/06/13)
First interim results from a phase IIa study evaluating an all-oral regimen of Simeprevir and Sofosbuvir in prior null responder Hepatitis C patients - press release - (03/04/13) press announcement
Primary Efficacy and Safety Findings from Four Phase 3 Japanese Studies of Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Adult Patients
Rapid HCV-RNA Decline With Once Daily TMC435: A Phase I Study in Healthy Volunteers and Hepatitis C Patients http://www.natap.org/2010/HCV/031110_01.htm
Pharmacokinetics of simeprevir (TMC435) in volunteers with moderate or severe hepatic impairment http://www.natap.org/2013/EASL/EASL_65.htm
Virologic analysis of genotype-1-infected patients treated with once-daily TMC435 during the Optimal Protease inhibitor Enhancement of Response to TherApy (OPERA)-1 study http://www.natap.org/2010/AASLD/AASLD_45.htm
Medivir announces TMC435 in an expanded clinical collaboration: TMC435+BMS NS5A, TMC435+INX189 http://www.natap.org/2012/HCV/053012_01.htm
BMS/Medivir Announces TMC435 in an Expanded Clinical Collaboration - press release http://www.natap.org/2012/HCV/041812_01.htm
The Pharmacokinetic Interactions of the HCV Protease Inhibitor Simeprevir (TMC435) With HIV Antiretroviral Agents in Healthy Volunteers http://www.natap.org/2012/IDSA/IDSA_04.htm
No clinically significant interaction between the investigational HCV protease inhibitor simeprevir (TMC435) and the immunosuppressive agents cyclosporine and tacrolimus http://www.natap.org/2012/AASLD/AASLD_61.htm
TMC435 & Drug Interactions: Evaluation of metabolic interactions for TMC435 via cytochrome P450 (CYP) enzymes in healthy volunteers http://www.natap.org/2010/EASL/EASL_37.htm
TMC435+GS7977 (Rbv) New Study in Advanced Hepatic Fibrosis- Null Responders & Naives http://www.natap.org/2013/HCV/012213_03.htm
TMC435 in patients infected with HCV genotype 1 who have failed previous pegylated interferon / ribavirin treatment: Virologic analyses of the ASPIRE trial http://www.natap.org/2012/EASL/EASL_25.htm
Treatment outcome and resistance analysis in HCV genotype 1 patients previously exposed to TMC435 monotherapy and re-treated with TMC435 in combination with PegIFNa-2a/ribavirin http://www.natap.org/2011/EASL/EASL_75.htm
Pharmacokinetic-pharmacodynamic (PK-PD) analyses of TMC435 in treatment-na•ve hepatitis C (HCV)-infected patients in the OPERA-1 study http://www.natap.org/2010/EASL/EASL_33.htm
Pharmacokinetics of TMC435 in subjects with moderate hepatic impairment http://www.natap.org/2011/EASL/EASL_115.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
No pharmacokinetic interaction between the investigational HCV protease inhibitor simeprevir (TMC435) and an oral contraceptive containing ethinylestradiol and norethindrone http://www.natap.org/2012/AASLD/AASLD_60.htm
Antiviral activity of TMC435 monotherapy in patients infected with HCV genotypes 2 to 6: TMC435-C202, a phase IIa, open-label study - Article in Press http://www.natap.org/2012/HCV/021312_02.htm
Samples from HCV Genotype-1 Patients Treated for 5 Days with TMC435 Monotherapy and Subsequently Re-treated with TMC435 in Combination with PegIFNα-2a/Ribavirin - slide talk http://www.natap.org/2010/HCV/061410_01.htm
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