Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

Phase 2 Completed 263 enrolled Vertex Pharmaceuticals Incorporated

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

Timeline

Start: 2006-06
Primary completion: 2008-02
Completion: 2008-02

Outcome

Met primary endpoint

paper 41% (31 of 75 patients) in the PR48 group, as compared with 61% (48 of 79 patients) in the T12PR24 group (P=0.02) PMID 19403902 ↗

registry analysis (superiority or other test); PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week vs Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week; p = 0.0014; Odds Ratio (OR) 2.985 (95% CI 1.525 to 5.842); Regression, Logistic NCT00336479 ↗

Publications

McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, McNair L, Alam J, Muir AJ; PROVE1 Study Team. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med. 2009 Apr 30;360(18):1827-38. doi: 10.1056/NEJMoa0806104.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Telaprevir	Small molecule	750 mg	Oral
Background	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Background	Ribavirin	Small molecule	1000 mg	Oral
Background	Ribavirin	Small molecule	1200 mg	Oral