A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

Phase 3 Completed 1095 enrolled Vertex Pharmaceuticals Incorporated Tibotec Pharmaceutical Limited · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

Timeline

Start: 2008-03
Primary completion: 2010-05
Completion: 2010-05

Outcome

Met primary endpoint

paper had a sustained virologic response (75% and 69%, respectively, vs. 44%; P<0.001 PMID 21696307 ↗

Publications

Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16. doi: 10.1056/NEJMoa1012912.

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