Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis ... (t-experienced patients with HCV genotype...)

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Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

Date:4/23/2009

t-experienced patients with HCV genotype 1. In this study, low doses of ritonavir were used for metabolic inhibition to enhance the levels of SCH 900518 within the body and reduce the frequency of SCH 900518 dosing (BID vs. TID).

In the study, SCH 900518 administered as monotherapy exhibited potent antiviral activity, achieving 4.0-4.5 log10 decreases in viral load (HCV RNA) from baseline at day 8. SCH 900518 was well tolerated, with no drug related serious adverse events. Pharmacokinetic and pharmacodynamic modeling from this study was used to design the ongoing Phase IIa dose-finding study of SCH 900518 with ritonavir in combination with PEGINTRON and REBETOL. This study, known as NEXT-1, explores SCH 900518 in 200 mg, 400 mg or 600 mg once daily (QD) doses with low-dose ritonavir (100 mg) in combination with PEGINTRON and REBETOL (with and without a 4-week P/R lead-in period) in treatment-naive patients with HCV genotype 1.

About the HCV SPRINT-1 Study

In this Phase II study, known as HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1), boceprevir (800 mg TID) was evaluated in three treatment regimens: 4 weeks of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) 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 at the doses described above for 28 or 48 weeks, and, in Part II of the study, boceprevir in combination with PEGINTRON and low-dose REBETOL (400-1000 mg daily based on patient weight) for 48 weeks. In Part I of the study, the boceprevir regimens were compared to a control of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) alone for 48 weeks (an approved treatment regimen). In Part II of the study, boceprevir in combination with PEGINTRON and low-dose REBETOL for 48 weeks was compared t
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