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Treatment with PEGASYS(R)/COPEGUS(TM) Provides Hope for Hepatitis C Patients Whose Infection Did Not Initially Respond to Peg-Intron(R)/Ribavirin
Date:11/2/2007

More About the REPEAT Study

Enrolling 950 patients from Europe, North America and Latin America, REPEAT (REtreatment with PEgasys in pATients Not Responding to Peg-Intron Therapy) was designed to explore whether intensified treatment with a higher fixed-dose induction of PEGASYS in combination with COPEGUS and/or longer treatment duration may increase treatment success rates in patients who didn't respond to at least twelve weeks of Peg-Intron/ribavirin combination therapy. Patients were randomized 2:1:1:2 to one of four regimens:

-- Patients in arms A (n=318) and B (n=158) received PEGASYS 360 mcg/week

for 12 weeks, followed by 180 mcg/week for a further 60 or 36 weeks,

respectively

-- Patients in arms C (n=158) and D (n=316) received PEGASYS 180 mcg/week

for 72 or 48 weeks, respectively

-- All patients received COPEGUS (1,000/1,200 mg/day) in combination with

PEGASYS

Results showed:

-- The primary endpoint was met: SVR, defined by undetectable hepatitis C

virus RNA in the blood six months after the end of treatment, was

significantly higher for arm A (16 percent) compared to arm D (nine

percent)

-- A pooled analysis of the 72-week arms vs. the 48-week arms showed that

72 weeks of treatment had the biggest impact on success of treatment,

with a doubling of SVR rate compared to 48 weeks (16 percent vs. eight

percent). A pooled analysis of the induction dose arms vs. standard

dose arms showed that treatment with higher fixed-dose induction for

this difficult-to-treat patient population did not provide significant

additional benefit

-- Response at 12 weeks was a strong predictor of successful treatment

-- Of patients whose virus was undetectable after 12 weeks of therapy,

57 percent in the 72-week arms went on to achieve treatment success

(by comparison, among patient
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SOURCE Roche
Copyright©2007 PR Newswire.
All rights reserved

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