Top-line results from Vertex’s phase III study of telaprevir plus pegylated interferon and ribavirin called the REALIZE trial were released today. The trial treated HCV genotype 1 people who DID NOT achieve a sustained virological response (SVR—HCV RNA undetectable 24 weeks after treatment was completed) with a previous course of pegylated interferon plus ribavirin. The study included people who had a relapse (number = 354 patients), who were partial responders (n= 124 patients) or who had a null response (n=184 patients)*.
An overall sustained virological response of 65% was achieved in the telaprevir based arms compared to 17% of people in the control arm (pegylated interferon/ribavirin – without telaprevir). Breaking it down by type of response and when the first dose of telaprevir was given (simultaneous start arm and delayed start arm), the results showed an SVR rate of 83 and 88% in relapsers, 59 and 54% in partial responders and 29 and 33% in null responders.
HCV Advocate will update once we have analyzed the trial results.
*Definitions of response types (per Vertex press release):
•Relapser – undetectable at the completion of at least 42 weeks of therapy but became detectable during the follow-up period
•Partial responder – people who achieved at least a 2 log 10 reduction in viral load at week 12, but who were never undetectable during therapy
•Null responder – a person who achieved LESS than a 2 log 10 reduction in HCV RNA by week 12Share This Page