Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: VEL; Drug: SOF; Drug: RBV

Study type: Interventional

Funder types: Industry

Identifiers

NCT01858766

GS-US-342-0102

Details and patient eligibility

About

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.

Enrollment: 379 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic HCV infection
• Body mass index (BMI) ≥ 18 kg/m^2
• HCV RNA ≥ 10000 IU/mL at screening
• Use of highly effective contraception methods if female of childbearing potential or sexually active male
• Must not have cirrhosis

Exclusion criteria

• Current or prior history of clinically significant illness other than HCV
• Screening ECG with clinically significant abnormalities
• Prior exposure to HCV specific direct acting antiviral agent
• Prior treatment of HCV with interferon or ribavirin
• Pregnant or nursing female or male with pregnant female partner
• Chronic liver disease of non-HCV etiology
• Hepatitis B
• Active drug abuse
• Use of any prohibited concomitant medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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379 participants in 14 patient groups

SOF+VEL 25 mg 12 Weeks (GT1)

Experimental group

Description:

Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 100 mg 12 Weeks (GT1)

Experimental group

Description:

Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)

Experimental group

Description:

Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks.

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)

Experimental group

Description:

Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks.

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 25 mg 12 Weeks (GT3)

Experimental group

Description:

Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks.

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 100 mg 12 Weeks (GT3)

Experimental group

Description:

Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks.

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 25 mg 8 Weeks (GT1)

Experimental group

Description:

Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks.

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 25 mg + RBV 8 Weeks (GT1)

Experimental group

Description:

Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.

Treatment:

Drug: RBV

Drug: SOF

Drug: VEL

SOF+VEL 100 mg 8 Weeks (GT1)

Experimental group

Description:

Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks.

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 100 mg + RBV 8 Weeks (GT1)

Experimental group

Description:

Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.

Treatment:

Drug: RBV

Drug: SOF

Drug: VEL

SOF+VEL 25 mg 8 Weeks (GT2)

Experimental group

Description:

Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks.

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 25 mg + RBV 8 Weeks (GT2)

Experimental group

Description:

Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.

Treatment:

Drug: RBV

Drug: SOF

Drug: VEL

SOF+VEL 100 mg 8 Weeks (GT2)

Experimental group

Description:

Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks.

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 100 mg + RBV 8 Weeks (GT2)

Experimental group

Description:

Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.

Treatment:

Drug: RBV

Drug: SOF

Drug: VEL