A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults

Summary

The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 \[ABT-450/r/ABT-267; ABT-267 also known as ombitasvir\] and ABT-333 \[also known as dasabuvir\]) plus ribavirin (RBV) compared with telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

Timeline

Start

2013-06

Primary completion

2014-11

Completion

2015-07

Outcome

Met primary endpoint

registry NUMBER 3-DAA/RBV: 100.0 percentage of participants NCT01854528 ↗

registry NUMBER TPV/RBV: 66.0 percentage of participants NCT01854528 ↗

registry analysis (superiority or other test); 3-DAA/RBV vs TPV/RBV; p <0.001; Mean Difference (Final Values) 34.26 (95% CI 21.09 to 47.42); Stratum adjusted Mantel-Haenszel NCT01854528 ↗

Publications

• Results Dore GJ, Conway B, Luo Y, Janczewska E, Knysz B, Liu Y, Streinu-Cercel A, Caruntu FA, Curescu M, Skoien R, Ghesquiere W, Mazur W, Soza A, Fuster F, Greenbloom S, Motoc A, Arama V, Shaw D, Tornai I, Sasadeusz J, Dalgard O, Sullivan D, Liu X, Kapoor M, Campbell A, Podsadecki T. Efficacy and safety of ombitasvir/paritaprevir/r and dasabuvir compared to IFN-containing regimens in genotype 1 HCV patients: The MALACHITE-I/II trials. J Hepatol. 2016 Jan;64(1):19-28. doi: 10.1016/j.jhep.2015.08.015. Epub 2015 Aug 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ritonavir	Other / unclassified	100 mg	Oral
Comparator	Telaprevir	Small molecule	750 mg	—
Subject	dasabuvir	Small molecule	250 mg	Oral
Subject	ombitasvir	Small molecule	25 mg	Oral
Subject	paritaprevir	Small molecule	150 mg	Oral
Comparator	pegylated interferon a-2a	Unknown	180 ug	Subcutaneous
Background	Ribavirin	Small molecule	1000 mg	Oral
Background	Ribavirin	Small molecule	1200 mg	Oral

Indications