Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV

Phase 3 Terminated 453 enrolled Bristol-Myers Squibb

Non-randomizedParallel-groupOpen-labelTreatment

Summary

To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1

Timeline

Start: 2013-07-11
Primary completion: 2015-08-27
Completion: 2015-08-27

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision not based on any new unexpected safety findings or efficacy observations.”

Publications

Nelson M, Rubio R, Lazzarin A, Romanova S, Luetkemeyer A, Conway B, Molina JM, Xu D, Srinivasan S, Portsmouth S. Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients. J Interferon Cytokine Res. 2017 Mar;37(3):103-111. doi: 10.1089/jir.2016.0082. Epub 2017 Feb 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daclatasvir	Small molecule	30 mg	Oral
Subject	Daclatasvir	Small molecule	60 mg	Oral
Subject	Daclatasvir	Small molecule	90 mg	Oral
Subject	Pegylated Interferon Lambda-1a	Protein / enzyme biologic	180 ug	Subcutaneous
Subject	Ribavirin	Small molecule	400 mg	Oral
Subject	Ribavirin	Small molecule	500 mg	Oral
Subject	Ribavirin	Small molecule	600 mg	Oral