04.28.08
Schering-Plough reported results from a planned interim analysis of an ongoing Phase II study of boceprevir, its investigational oral hepatitis C protease inhibitor, in 595 treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1. The ongoing study evaluates boceprevir in 28-week and 48-week treatment regimens.
In the 28-week treatment regimen, patients received 4 weeks of Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) prior to the addition of boceprevir. The rate of sustained virological response at 12 weeks after the end treatment (SVR 12) was 57%. This treatment regimen provided an indication of early predictability of response with patients who had undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment achieving an SVR 12 rate of 86%.
In the ongoing study, HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1), boceprevir is being evaluated in three treatment regimens: 4 weeks of Pegintron and Rebetol therapy followed by the addition of boceprevir to the combination for 24 or 44 weeks (totaling 28 or 48 weeks of treatment); boceprevir in combination with Pegintron and Rebetol for 28 or 48 weeks (triple combination); and boceprevir in combination with Pegintron and low-dose Rebetol for 48 weeks, compared to a control of Pegintron and Rebetol alone for 48 weeks (an approved treatment regimen). The primary endpoint of the study is sustained virologic response after 24 weeks of follow up.
In the 28-week treatment regimen, patients received 4 weeks of Pegintron (peginterferon alfa-2b) and Rebetol (ribavirin, USP) prior to the addition of boceprevir. The rate of sustained virological response at 12 weeks after the end treatment (SVR 12) was 57%. This treatment regimen provided an indication of early predictability of response with patients who had undetectable virus (HCV-RNA) in plasma after 4 weeks of boceprevir treatment achieving an SVR 12 rate of 86%.
In the ongoing study, HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1), boceprevir is being evaluated in three treatment regimens: 4 weeks of Pegintron and Rebetol therapy followed by the addition of boceprevir to the combination for 24 or 44 weeks (totaling 28 or 48 weeks of treatment); boceprevir in combination with Pegintron and Rebetol for 28 or 48 weeks (triple combination); and boceprevir in combination with Pegintron and low-dose Rebetol for 48 weeks, compared to a control of Pegintron and Rebetol alone for 48 weeks (an approved treatment regimen). The primary endpoint of the study is sustained virologic response after 24 weeks of follow up.