Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

Summary

This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.

Timeline

Start

2013-12

Primary completion

2014-10

Completion

2015-10

Outcome

Met primary endpoint

release “The primary endpoint of the GIFT-I study was achieved, demonstrating a 95 percent (n=106/112) sustained virologic response rate” abbvie.com ↗

release “The primary endpoint of the GIFT-I study was achieved, demonstrating a 95 percent (n=106/112) sustained virologic response rate at 12 weeks post treatment (SVR 12 )” abbvie.com ↗

release “The primary endpoint of the GIFT-I study was achieved, demonstrating a 95 percent (n=106/112) sustained virologic response rate at 12 weeks post treatment” abbvie.com ↗

Publications

• Results Kumada H, Chayama K, Rodrigues L Jr, Suzuki F, Ikeda K, Toyoda H, Sato K, Karino Y, Matsuzaki Y, Kioka K, Setze C, Pilot-Matias T, Patwardhan M, Vilchez RA, Burroughs M, Redman R. Randomized phase 3 trial of ombitasvir/paritaprevir/ritonavir for hepatitis C virus genotype 1b-infected Japanese patients with or without cirrhosis. Hepatology. 2015 Oct;62(4):1037-46. doi: 10.1002/hep.27972. Epub 2015 Aug 25.
• Gopalakrishnan S, Khatri A, Mensing S, Redman R, Menon R, Zha J. Exposure-Response Relationship for Ombitasvir and Paritaprevir/Ritonavir in Hepatitis C Virus Subgenotype 1b-Infected Japanese Patients in the Phase 3 Randomized GIFT-I Study. Adv Ther. 2016 Apr;33(4):670-83. doi: 10.1007/s12325-016-0320-y. Epub 2016 Mar 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ritonavir	Other / unclassified	100 mg	Oral
Subject	ombitasvir	Small molecule	25 mg	Oral
Subject	paritaprevir	Small molecule	150 mg	Oral

Indications