Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)

Phase 2 Completed 35 enrolled Bristol-Myers Squibb

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.

Timeline

Start: 2014-07-28
Primary completion: 2015-01-28
Completion: 2015-12-17

Publications

Sulkowski MS, Flamm S, Kayali Z, Lawitz EJ, Kwo P, McPhee F, Torbeyns A, Hughes EA, Swenson ES, Yin PD, Linaberry M. Short-duration treatment for chronic hepatitis C virus with daclatasvir, asunaprevir, beclabuvir and sofosbuvir (FOURward study). Liver Int. 2017 Jun;37(6):836-842. doi: 10.1111/liv.13335. Epub 2017 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Asunaprevir	Small molecule	200 mg	Oral
Subject	Beclabuvir	Small molecule	75 mg	Oral
Subject	Daclatasvir	Small molecule	30 mg	Oral
Subject	Peginterferon-α2a	Unknown	180 ug	Subcutaneous
Subject	Ribavirin	Small molecule	1000 mg	Oral
Subject	Ribavirin	Small molecule	1200 mg	Oral
Subject	Sofosbuvir	Small molecule	400 mg	Oral

Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)

Summary

Timeline

Publications

Drugs

Indications