The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
359
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
SOF 400 mg tablet administered orally once daily
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)
Auckland Clinical Studies Ltd.
Auckland, New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Time frame: Up to 24 weeks plus 30 days
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Time frame: Weeks 1 and 2
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Time frame: Weeks 4, 6, and 8
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Time frame: Week 10
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Time frame: Week 12
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Time frame: Weeks 16, 20, and 24
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
Time frame: Posttreatment Weeks 2, 4, 8, and 24
For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)
Time frame: Posttreatment Weeks 16 and 20
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pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly
GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily
Velpatasvir (VEL) tablet(s) administered orally once daily
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ while on treatment), or * Rebound (confirmed \> 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or * Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
Time frame: Up to Posttreatment Week 24
Percentage of Participants Experiencing Viral Relapse
Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Time frame: Up to Posttreatment Week 24