Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

359

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

March 31, 2015

Study Completion Date

May 31, 2015

Conditions
Chronic Hepatitis C
Interventions
DRUG

LDV/SOF

Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily

DRUG

SOF

SOF 400 mg tablet administered orally once daily

DRUG

RBV

Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

DRUG

Peg-IFN

pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly

DRUG

GS-9669

GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily

DRUG

VEL

Velpatasvir (VEL) tablet(s) administered orally once daily

Trial Locations (2)

Unknown

Auckland Clinical Studies Ltd., Auckland

Christchurch Clinical Studies Trust, Christchurch

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY