A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Summary

The purpose of this study was to assess the safety, tolerability, pharmacokinetics and antiviral activity of ABT-333 (also known as dasabuvir) in treatment-naïve, hepatitis C virus (HCV)-infected participants.

Timeline

Start

2009-03

Primary completion

2009-07

Completion

2009-07

Outcome

Mixed primary results

registry LEAST_SQUARES_MEAN ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV: -1.01 (Standard Error 0.18) log10 IU/mL NCT00851890 ↗

registry LEAST_SQUARES_MEAN Placebo + pegIFN/RBV: -0.26 (Standard Error 0.21) log10 IU/mL NCT00851890 ↗

registry ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV vs Placebo + pegIFN/RBV; p = 0.012 NCT00851890 ↗

registry ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV vs Placebo + pegIFN/RBV; p = 0.071 NCT00851890 ↗

registry ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV vs Placebo + pegIFN/RBV; p = 0.140 NCT00851890 ↗

registry ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV vs Placebo + pegIFN/RBV; p = 0.008 NCT00851890 ↗

registry ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV vs Placebo + pegIFN/RBV; p = 0.003 NCT00851890 ↗

registry ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV vs Placebo + pegIFN/RBV; p = 0.009 NCT00851890 ↗

Publications

• Background Mensing S, Polepally AR, Konig D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies. AAPS J. 2016 Jan;18(1):270-80. doi: 10.1208/s12248-015-9846-1. Epub 2015 Nov 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	dasabuvir	Small molecule	300 mg	—
Subject	dasabuvir	Small molecule	600 mg	—
Subject	dasabuvir	Small molecule	1200 mg	—
Background	Ribavirin	Small molecule	1000 mg	—
Background	Ribavirin	Small molecule	1200 mg	—
Background	pegylated interferon a-2a	Unknown	180 ug	Subcutaneous

Indications