August 20, 2013

TMC435, Janssen HCV Program

Provided by NATAP

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Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C

Janssen HCV Drug Research & Development - (07/30/13)

Janssen HCV Drug Research & Development 2 - (08/19/13)

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)

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 - (03/06/13)

CROI: 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

Pharmacokinetics of simeprevir (TMC435) in volunteers with moderate or severe hepatic impairment

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

Medivir announces TMC435 in an expanded clinical collaboration: TMC435+BMS NS5A, TMC435+INX189

BMS/Medivir Announces TMC435 in an Expanded Clinical Collaboration - press release

The Pharmacokinetic Interactions of the HCV Protease Inhibitor Simeprevir (TMC435) With HIV Antiretroviral Agents in Healthy Volunteers

No clinically significant interaction between the investigational HCV protease inhibitor simeprevir (TMC435) and the immunosuppressive agents cyclosporine and tacrolimus

TMC435 & Drug Interactions: Evaluation of metabolic interactions for TMC435 via cytochrome P450 (CYP) enzymes in healthy volunteers

TMC435+GS7977 (Rbv) New Study in Advanced Hepatic Fibrosis- Null Responders & Naives

TMC435 in patients infected with HCV genotype 1 who have failed previous pegylated interferon / ribavirin treatment: Virologic analyses of the ASPIRE trial

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

Pharmacokinetic-pharmacodynamic (PK-PD) analyses of TMC435 in treatment-na•ve hepatitis C (HCV)-infected patients in the OPERA-1 study

Pharmacokinetics of TMC435 in subjects with moderate hepatic impairment

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

No pharmacokinetic interaction between the investigational HCV protease inhibitor simeprevir (TMC435) and an oral contraceptive containing ethinylestradiol and norethindrone

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

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

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