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Pegasys and Copegus are registered trademarks of F.
The study aims to further improve treatment outcomes by examining whether genotype 2 and 3 patients who do not have a rapid virological response at 4 weeks should have treatment with Pegasys and Copegus extended to 48 weeks.
Copegus can increase the toxicity of certain drugs used to treat HIV.
Ribavirin is a teratogen and should be avoided during pregnancy Roche has set up a Copegus pregnancy registry; call 800-526-6367 to enroll patients.
The high predictability of response at week 12 with Pegasys plus Copegus should be an important factor when considering whether to retreat hepatitis C," said Prof Patrick Marcellin, Professor of Hepatology at the University of Paris and Head of the Viral Hepatitis Research Unit in HE[sup.
COPEGUS is available as a 200mg tablet, and is administered orally two times a day as a split dose.
In addition, PEGASYS in combination with COPEGUS is the first and only FDA-approved regimen for the treatment of chronic hepatitis C in patients coinfected with hepatitis C and HIV.
That's why it is so encouraging to see these new data showing that extending treatment with Pegasys and Copegus offers a greater chance of a cure to patients where the standard duration of treatment provides unsatisfactory results.
Copegus has not been directly compared with Schering-Plough's combination of Peg-Intron (peginterferon alfa-2b) and Rebetol, approved in 2001 to treat HCV in interferon-[alpha]-naive adults with compensated liver disease.
PEGASYS, in combination with COPEGUS (ribavirin), is indicated for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha.
Roche announced today that the European Commission has approved a shortened, 16-week course of treatment with Pegasys (peginterferon alfa-2a (40 KD)) plus Copegus (ribavirin) for certain hepatitis C patients.
Following the first four weeks of treatment, all patients will receive PEGASYS 180mcg subcutaneously every week plus COPEGUS 1,000-1,200mg daily for another 44 weeks, making the total treatment duration of 48 weeks.
We and Roche are currently focused on planning a global 12-week Phase 2b combination study of R7128 with Pegasys plus Copegus.
In this study, patients received PEGASYS 180[acute accent]g/week once weekly plus a 1000-1200mg daily dose of COPEGUS.
After completing 4 weeks of the triple combination regimen and a follow-up period of 4 weeks of Pegasys plus Copegus, patients will receive an additional 16 to 40 weeks of open-label dosing of Pegasys plus Copegus under a separate protocol to complete the standard of care regimen for each genotype.
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