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Efficacy and Safety of TMC435 in Combination With Peginterferon alfa-2a and Ribavirin in Treatment-naïve Genotype-1 HCV Patients:
24-Week Interim Results from the PILLAR Study
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Reported by Jules Levin
AASL Nov 1 2010 Boston
M.W. Fried,1 M. Buti,2 G.J. Dore,3 P. Ferenci,4
I. Jacobson,5 P. Marcellin,6 S. Zeuzem,7
O. Lenz,8 M. Peeters,8 V. Sekar,9 G. De Smedt8
1University of North Carolina at Chapel Hill, North Carolina, USA; 2Hospital Vall d'Hebron and Ciberehd, Barcelona, Spain; 3St Vincent's Hospital, Sydney, Australia and National Centre in HIV Epidemiology and Clinical Research, University of New South Wales, Sydney, Australia; 4Allgemeines Krankenhaus der Stadt Wien, Wien, Austria ; 5Weill Cornell Medical College, New York, USA; 6Hopital Beaujon, Clichy, Paris, France; 7Klinikum der Johann-Wolfgang-Goethe-Universitat - Med. Klinik I, Frankfurt, Germany; 8Tibotec, Beerse, Belgium; 9Tibotec Inc., Titusville, New Jersey, USA
*PegIFN/RBV, peginterferon α-2a (180 µg/wk) + ribavirin (1000-1200 mg/day); HCV, hepatitis C virus
TMC12/PR24, TMC435 + PegIFN/RBV for 12 weeks followed by PegIFN/RBV for 24 weeks (PegIFN/RBV, peginterferon α-2a [180 µg/wk] + ribavirin [1000-1200 mg/day]); TMC24/PR24, TMC435 + PegIFN/RBV for 24 weeks; all TMC435 doses were administered once-daily; Pbo24/PR48, placebo and PegIFN/RBV for 24 weeks followed by PegIFN/RBV for 24 weeks; FU, follow-up; ITT, intent to treat; Pbo, placebo; RNA, ribonucleic acid; TMC, TMC435
TMC12/PR24, TMC435 + PegIFN/RBV for 12 weeks followed by PegIFN/RBV for 24 weeks (PegIFN/RBV, peginterferon α-2a [180 µg/wk] + ribavirin [1000-
1200 mg/day]); TMC24/PR24, TMC435 + PegIFN/RBV for 24 weeks; all TMC435 doses were administered once-daily; Pbo24/PR48, placebo and PegIFN/RBV for 24 weeks followed by PegIFN/RBV for 24 weeks; no. of subjects completing therapy at Week 24 was according to response-guided treatment algorithm
TMC12/PR24, TMC435 + PegIFN/RBV for 12 weeks followed by PegIFN/RBV for 24 weeks (PegIFN/RBV, peginterferon α-2a [180 µg/wk] + ribavirin [1000-1200 mg/day]); TMC24/PR24, TMC435 + PegIFN/RBV for 24 weeks; all TMC435 doses were administered once-daily; Pbo24/PR48, placebo and PegIFN/RBV for 24 weeks followed by PegIFN/RBV for 24 weeks; SE, standard error
***TMC435 vs placebo: p≤0.001; TMC12/PR24, TMC435 for 12 weeks in addition to Peg/RBV for 24 weeks; TMC24/PR24, TMC435 for 24 weeks in addition to Peg/RBV for 24 weeks; HCV RNA determined using Roche TaqMan v2
TMC12/PR24, TMC435 for 12 weeks in addition to Peg/RBV for 24 weeks; TMC24/PR24, TMC435 for 24 weeks in addition to Peg/RBV for 24 weeks;
HCV RNA determined using Roche TaqMan v2
TMC12/PR24, TMC435 for 12 weeks in addition to PegIFN/RBV for 24 weeks; TMC24/PR24, TMC435 for 24 weeks in addition to PegIFN/RBV for 24 weeks; SVR, sustained virologic response; not yet defined in the placebo group in this Week 24 analysis as planned end of treatment has not been reached
*Viral breakthrough: confirmed increase of >1 log from nadir or >100 IU/mL if undetectable; TMC12/PR24, TMC435 + PegIFN/RBV for 12 weeks followed by PegIFN/RBV for 24 weeks (PegIFN/RBV, peginterferon α-2a [180 µg/wk] + ribavirin [1000-1200 mg/day]); TMC24/PR24, TMC435 + PegIFN/RBV for 24 weeks; all TMC435 doses were administered once-daily; Pbo24/PR48, placebo and PegIFN/RBV for 24 weeks followed by PegIFN/RBV for 24 weeks
*Data shown for patients who consented only (67.9%); CC/TT/CT, polymorphism on chromosome 19 s12979860
TMC12/PR24, TMC435 + PegIFN/RBV for 12 weeks followed by PegIFN/RBV for 24 weeks (PegIFN/RBV, peginterferon α-2a [180 µg/wk] + ribavirin [1000-1200 mg/day]); TMC24/PR24, TMC435 + PegIFN/RBV for 24 weeks; all TMC435 doses were administered once-daily; Pbo24/PR48, placebo and PegIFN/RBV for 24 weeks followed by PegIFN/RBV for 24 weeks
TMC12/PR24, TMC435 + PegIFN/RBV for 12 weeks followed by PegIFN/RBV for 24 weeks (PegIFN/RBV, peginterferon α-2a [180 µg/wk] + ribavirin [1000-1200 mg/day]); TMC24/PR24, TMC435 + PegIFN/RBV for 24 weeks; all TMC435 doses were administered once-daily; Pbo24/PR48, placebo and PegIFN/RBV for 24 weeks followed by PegIFN/RBV for 24 weeks; SE, standard error; to convert from bilirubin µmol/L to mg/dL, divide by 17.1
TMC12/PR24, TMC435 + PegIFN/RBV for 12 weeks followed by PegIFN/RBV for 24 weeks (PegIFN/RBV, peginterferon α-2a [180 µg/wk] + ribavirin [1000-1200 mg/day]); ALT, alanine aminotransferase; ALP, alkaline phosphatase ; SE, standard error; to convert from bilirubin µmol/L to mg/dL, divide by 17.1
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