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TMC-435 HCV Protease in Phase 3
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EASL: TMC435 with peginterferon and ribavirin in treatment-experienced HCV genotype 1 patients: the ASPIRE study, a randomised Phase IIb trial - (04/19/12)
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)
The Pharmacokinetic Interactions of HCV Protease Inhibitor - in HIV coinfected NATAP
www.natap.org/2012/CROI/croi_05.htm
The Pharmacokinetic Interactions of HCV Protease Inhibitor TMC435 with Rilpivirine, Tenofovir, Efavirenz or Raltegravir in Healthy Volunteers. Reported by
Antiviral activity of TMC435 monotherapy in patients infected with HCV genotypes 2-6: TMC435-C202, a phase IIa, open-label study - (05/23/12)
TMC435 Monotherapy Deep sequencing analysis of baseline and on-treatment samples
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www.natap.org/2010/HCV/061410_02.htm
Treatment with TMC435 200 mg QD resulted in potent antiviral activity in study TMC435-C101, during five days of monotherapy, and subsequently in the same
Antiviral activity of TMC435 monotherapy in patients infected with HCV genotypes 2-6: TMC435-C202, a phase IIa, open-label study - (05/23/12)
Monotherapy
Monotherapy
Rapid HCV-RNA Decline With Once Daily TMC435: A Phase I Study in Healthy Volunteers and Hepatitis C Patients - (03/11/10)
HCV-RNA Levels
Patients received 200 mg once daily for 5 days. Pharmacokinetics and safety were evaluated for all panels, and plasma HCV-RNA levels were determined in patients. HCV-RNA levels declined rapidly in all 6 patients with more than 3-log10 IU/mL reductions in plasma HCV-RNA compared with baseline for all patients during treatment (Figure 3). The median HCV-RNA reduction at day 3 was 3.46-log10 IU/mL (range, 1.6-log10 to 3.8-log10 IU/mL) and reached a median maximum reduction of 3.9-log10 IU/mL (range, 2.9-log10 to 4.1-log10 IU/mL). The time to maximal reduction of viral load varied among patients, with a median value of 6 days, 24 hours after the last dose of TMC435. HCV-RNA levels in the 3 days after the last dose remained relatively constant, changing less than 0.5-log10 IU/mL in all patients, suggesting continued suppression of viral replication. No viral breakthroughs (increase of >1-log10 IU/mL from nadir) were observed during the 5-day dosing or over the 3-day follow-up period. Viral decline appeared similar in patients with genotype 1a and 1b viruses, previous nonresponders or relapsers, or between patients presenting with or without hemophilia. HCV-RNA levels returned to pretreatment levels in all patients 4 weeks after the final dose. Using the HCV-RNA measurements from the 6 hepatitis C-infected patients as input in a viral kinetics model,16 the mean half-life of free virus was estimated at 2.66 hours, clearance of infected cells at 2.8 days, and the in vivo potency (δ) value for TMC435 at 0.9993.
NAIVES Study Results
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