ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.

Summary

This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Timeline

Start

2003-12

Primary completion

2006-03

Completion

2006-03

Outcome

Missed primary endpoint

paper The study failed to demonstrate that the 16-week regimen was noninferior to the 24-week regimen. PMID 17625124 ↗

paper The sustained virologic response rate was significantly lower in patients treated for 16 weeks than in patients treated for 24 weeks (62% vs. 70%; PMID 17625124 ↗

Publications

• Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34. doi: 10.1056/NEJMoa066403.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Subject	Ribavirin	Small molecule	400 mg	Oral

Indications