Treatment With PEGASYS/COPEGUS Gives Hepatitis C Patients a Second Chance to Achieve a Cure After Not Responding to PegIntron

Boston, November 2 (ots/PRNewswire) -

- This Landmark Study Also Shows Response at 12 Weeks is a
Powerful Predictor of Eventual Treatment Success.

Roche today announced final results from the REPEAT study, which
demonstrate that treatment with once-weekly PEGASYS(R)
(peginterferon alfa-2a(40KD)) and daily COPEGUS(R) (ribavirin) can
achieve viral clearance in a number of patients who did not respond
to initial treatment with PegIntron, another drug commonly used to
treat hepatitis C.(1)

This outcome gives hepatitis C patients the opportunity to tackle
their disease a second time after initial treatment failure.
Furthermore, the results show that a patient's response to treatment
at 12 weeks is a powerful predictor of the eventual outcome: the
majority of patients with undetectable virus levels at 12 weeks went
on to achieve a sustained virological response (SVR), indicating
treatment success. Few patients with detectable virus at 12 weeks
achieved SVR. These data were presented in an oral session at the
58th Annual Meeting of the American Association for the Study of
Liver Diseases (AASLD), being held in Boston, November 2-6, 2007.

"One of the greatest areas of need in hepatitis C today is to find
solutions for patients who have not had treatment success with an
initial course of therapy. REPEAT is a landmark study that adds
significantly to our knowledge about how to manage these patients,
demonstrating that extending treatment with PEGASYS is a promising
option", said Donald Jensen, MD, Professor of Medicine and Director
of the Center for Liver Diseases at the University of Chicago
Hospital in Chicago, and lead investigator in REPEAT. "An important
finding from REPEAT is confirmation of the reliability of using a
patient's response at 12 weeks as a predictor of treatment success,
even in patients with cirrhosis. This means that patients who achieve
undetectable virus at 12 weeks can continue treatment with a good
likelihood of success. It also means that clinicians can confidently
discontinue treatment in patients who do not achieve an early
response."

More About the REPEAT Study

Enrolling 950 patients from Europe, North America and Latin
America, REPEAT (REtreatment with PEGASYS in pATients not responding
to peginterferon alfa-2b/ribavirin combination therapy) was designed
to explore whether intensified treatment with a higher fixed-dose
induction of PEGASYS and/or longer treatment duration increases
treatment success rates. Patients, who had previously not responded
to at least 12 weeks of PegIntron plus ribavirin combination therapy,
received one of four regimens

- Arms A and B received PEGASYS 360 mcg/week for 12 weeks,
followed by 180 mcg/week for a further 60 or 36 weeks, respectively

- Arms C and D received PEGASYS 180 mcg/week for 72 or 48 weeks,
respectively

All patients received ribavirin (1,000/1,200 mcg/day) in
combination with PEGASYS.

Results Showed

- The primary end point was met: SVR, defined by undetectable
hepatitis C virus RNA in the blood 6 months after the end of
treatment, was significantly higher for Arm A (16%) than for Arm D
(9%)

- A pooled analysis of the 72-week arms versus the 48-week arms
showed that 72 weeks of treatment had the biggest impact on success
of treatment, with a doubling of SVR rates compared with 48 weeks
(16% versus 8%, respectively)

- A pooled analysis of the induction dose arms versus standard
dose arms showed that treatment with higher fixed-dose induction for
this difficult-to-cure patient population did not provide significant
additional benefit

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

ots Originaltext: Roche Pharmaceuticals
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