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Replies to #39091 on Biotech Values
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gym gravity

12/13/06 10:15 AM

#39102 RE: ghmm #39091

Think tolerability would go up if the patient knew they were on drug, and knew the drug gave them a much better shot at getting SVR quicker?
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DewDiligence

12/14/06 8:29 PM

#39210 RE: ghmm #39091

ghmm et al re dropout rate on HCV SoC:

I checked the FDA labels for Rebetol (SGP’s brand of ribavirin) and Copegus (Roche’s brand of ribavirin). In the registrational trials supporting approval of ribavirin with peg-ifn, the dropout rate during 48 weeks of therapy on peg-ifn+ribavirin was 10-14%. (Patients co-infected with HIV had a somewhat higher dropout rate in the Copegus trials.)

See page 31 of the Rebetol label:
http://www.fda.gov/cder/foi/label/2006/020903s038lbl.pdf

and page 15 of the Copegus label:
http://www.fda.gov/cder/foi/label/2005/021511s012lbl.pdf

Dew