Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

Phase 2 Completed 18 enrolled Humanity and Health Research Centre Beijing 302 Hospital · collab Emory University · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.

Timeline

Start: 2015-01
Primary completion: 2015-12
Completion: 2015-12

Publications

Lau G, Benhamou Y, Chen G, Li J, Shao Q, Ji D, Li F, Li B, Liu J, Hou J, Sun J, Wang C, Chen J, Wu V, Wong A, Wong CL, Tsang ST, Wang Y, Bassit L, Tao S, Jiang Y, Hsiao HM, Ke R, Perelson AS, Schinazi RF. Efficacy and safety of 3-week response-guided triple direct-acting antiviral therapy for chronic hepatitis C infection: a phase 2, open-label, proof-of-concept study. Lancet Gastroenterol Hepatol. 2016 Oct;1(2):97-104. doi: 10.1016/S2468-1253(16)30015-2. Epub 2016 Jul 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Asunaprevir	Small molecule	200 mg	Oral
Subject	Daclatasvir	Small molecule	60 mg	Oral
Subject	Ledipasvir	Small molecule	90 mg	Oral
Subject	Simeprevir	Small molecule	150 mg	Oral
Subject	Sofosbuvir	Small molecule	400 mg	Oral

Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

Summary

Timeline

Publications

Drugs

Indications