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
Status and phase
Completed
Phase 2
Conditions
Chronic Hepatitis C
Treatments
Drug: RBV
Drug: GS-9669
Drug: VEL
Drug: LDV/SOF
Drug: Peg-IFN
Drug: SOF
Details and patient eligibility
About
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.
Enrollment
359 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Chronic genotype 1, 2, 3, or 6 HCV infection
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion criteria
- Pregnant or nursing female or male with pregnant female partner
- Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
359 participants in 15 patient groups
Cohort 1,Group 1: LDV/SOF + RBV 12 wk (GT1 SOF retreatment)
Experimental group
Description:
LDV/SOF + RBV for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir study
Treatment:
Drug: RBV
Drug: LDV/SOF
Cohort 1,Group 2:SOF+Peg-IFN+RBV 12 wk (GT2,3 SOF retreatment)
Experimental group
Description:
SOF + PEG + RBV for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
Treatment:
Drug: RBV
Drug: SOF
Drug: Peg-IFN
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, liver disease)
Experimental group
Description:
LDV/SOF+RBV for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Treatment:
Drug: RBV
Drug: LDV/SOF
Cohort 2,Group 2: LDV/SOF+GS-9669 12wk (GT1 TE, liver disease)
Experimental group
Description:
LDV/SOF + GS-9669 for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Treatment:
Drug: LDV/SOF
Drug: GS-9669
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
Experimental group
Description:
LDV/SOF for 12 weeks in treatment-naive participants with genotype 3 HCV infection
Treatment:
Drug: LDV/SOF
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
Experimental group
Description:
LDV/SOF + RBV for 12 weeks in treatment-naive participants with genotype 3 HCV infection
Treatment:
Drug: RBV
Drug: LDV/SOF
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
Experimental group
Description:
LDV/SOF for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
Treatment:
Drug: LDV/SOF
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
Experimental group
Description:
LDV/SOF + RBV for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
Treatment:
Drug: RBV
Drug: LDV/SOF
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 cirrhotic CPT B)
Experimental group
Description:
LDV/SOF for 12 weeks in participants with genotype 1 HCV infection and Child-Pugh Turcotte (CPT) B cirrhosis
Treatment:
Drug: LDV/SOF
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN noncirrhotic)
Experimental group
Description:
SOF+VEL (25 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Treatment:
Drug: SOF
Drug: VEL
Cohort 4,Group 2:SOF+VEL 25mg+RBV 8 wk (GT3 TN noncirrhotic)
Experimental group
Description:
SOF+VEL(25 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Treatment:
Drug: RBV
Drug: SOF
Drug: VEL
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN noncirrhotic)
Experimental group
Description:
SOF+VEL (100 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Treatment:
Drug: SOF
Drug: VEL
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN noncirrhotic)
Experimental group
Description:
SOF+VEL (100 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Treatment:
Drug: RBV
Drug: SOF
Drug: VEL
Cohort 5,Group 1: LDV/SOF + RBV 24 wk (SOF retreatment)
Experimental group
Description:
LDV/SOF+RBV for 24 weeks in participants with genotype 1, 2, 3, or 6 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
Treatment:
Drug: RBV
Drug: LDV/SOF
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HBV coinfection)
Experimental group
Description:
LDV/SOF for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Treatment:
Drug: LDV/SOF
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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