drugset / Trial / NCT01074008

A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072

Phase 2 Completed 74 enrolled AbbVie

RandomizedParallel-groupDouble-blindTreatment

Summary

This study assessed the safety, tolerability, pharmacokinetics, and antiviral activity of multiple oral doses of ABT-450/ritonavir (r), ABT-333 (also known as dasabuvir), or ABT-072 in hepatitis C virus (HCV), genotype 1-infected, treatment-naïve adults.

Timeline

Start: 2010-03
Primary completion: 2011-06
Completion: 2012-01

Outcome

Mixed primary results

registry MEAN ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV: -4.07 (Standard Deviation 0.53) log10 IU/mL NCT01074008 ↗

registry MEAN Placebo + pegIFN/RBV: -0.36 (Standard Deviation 0.13) log10 IU/mL NCT01074008 ↗

registry analysis (superiority or other test); ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV vs Placebo + pegIFN/RBV; p <0.001; ANCOVA; NCT01074008 ↗

registry MEAN ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV: -0.95 (Standard Deviation 0.68) log10 IU/mL NCT01074008 ↗

registry analysis (superiority or other test); ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV vs Placebo + pegIFN/RBV; p = 0.053; ANCOVA; NCT01074008 ↗

Publications

Pilot-Matias T, Tripathi R, Cohen D, Gaultier I, Dekhtyar T, Lu L, Reisch T, Irvin M, Hopkins T, Pithawalla R, Middleton T, Ng T, McDaniel K, Or YS, Menon R, Kempf D, Molla A, Collins C. In vitro and in vivo antiviral activity and resistance profile of the hepatitis C virus NS3/4A protease inhibitor ABT-450. Antimicrob Agents Chemother. 2015 Feb;59(2):988-97. doi: 10.1128/AAC.04227-14. Epub 2014 Dec 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABT-072	Small molecule	100 mg	—
Subject	ABT-072	Small molecule	300 mg	—
Subject	ABT-072	Small molecule	600 mg	—
Subject	Ritonavir	Other / unclassified	100 mg	—
Subject	dasabuvir	Small molecule	400 mg	—
Subject	dasabuvir	Small molecule	800 mg	—
Subject	paritaprevir	Small molecule	50 mg	—
Subject	paritaprevir	Small molecule	100 mg	—
Subject	paritaprevir	Small molecule	200 mg	—
Background	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Background	Ribavirin	Small molecule	1000 mg	—
Background	Ribavirin	Small molecule	1200 mg	—