CORK, Ireland, Feb. 18, 2011 /PRNewswire/ — Tibotec
Pharmaceuticals announced today that two global, registrational
phase 3 trials are recruiting patients to examine TMC435, its
investigational hepatitis C protease inhibitor, in treatment-naive
adults with chronic genotype 1 hepatitis C virus (HCV). A third
global phase 3 trial is being conducted in genotype 1 HCV patients
who have experienced a viral relapse after prior interferon-based
treatment. Approximately 3.2 million people in the U.S. live with
chronic hepatitis C disease and more than 170 million people have
the disease globally. The response-guided trials will compare the
efficacy, safety and tolerability of TMC435 given as a single 150
mg oral tablet once daily for 12 weeks versus placebo; each patient
also will be treated with a background regimen of peginterferon and
ribavirin for 24 or 48 weeks.
“TMC435 is an important component of our growing HCV pipeline,”
said Brian Woodfall M.D., Vice President of Global Clinical
Development at Tibotec. “The initiation of the TMC435 phase 3
clinical trial program reinforces our commitment to develop
innovative new treatment options that may decrease the duration of
treatment for patients with chronic hepatitis C infection.”
The first global, phase 3, double-blind, randomized study, known
as TMC435-C208 or QUEST-1 (QD dosing of TMC435 of
previoUsly untreated GEnotype 1 patienTs-1),
will evaluate a single TMC435 once-daily oral tablet (150 mg)
versus placebo in treatment-naive HCV patients. Both groups will
also receive peginterferon alfa-2a (Pegasys®) and ribavirin
(Copegus®) as part of their treatment. The second global, phase
3, double-blind, randomized study, known as TMC435-C216 or QUEST-2
(QD dosing of TMC435 of previoUsly untreated
GEnotype 1 patienTs-2), also will evaluate a single
TMC435 once-daily oral tablet (150 mg) versus placebo in
treatment-naive HCV patients. However,
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