Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects 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

NCT01909804

GS-US-342-0109

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 or 3 hepatitis C virus (HCV) infection.

Enrollment: 323 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) ≥ 18 kg/m^2
• HCV RNA ≥ 10000 IU/mL at screening
• Prior treatment failure to a regimen including interferon with or without RBV
• HCV genotype 1 or 3
• Chronic HCV infection
• Cirrhosis determination
• Use of highly effective contraception methods if female of childbearing potential or sexually active male

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
• 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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323 participants in 12 patient groups

SOF+VEL 25 mg (GT3) without cirrhosis

Experimental group

Description:

Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg for 12 weeks.

Treatment:

Drug: SOF

SOF+VEL 25mg+RBV (GT3) without cirrhosis

Experimental group

Description:

Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 25 mg plus RBV for 12 weeks.

Treatment:

Drug: SOF

Drug: RBV

Drug: VEL

SOF+VEL 100 mg (GT3) without cirrhosis

Experimental group

Description:

Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg for 12 weeks.

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 100 mg+RBV (GT3) without cirrhosis

Experimental group

Description:

Participants with genotype 3 HCV infection without cirrhosis will receive SOF+VEL 100 mg plus RBV for 12 weeks.

Treatment:

Drug: SOF

Drug: RBV

Drug: VEL

SOF+VEL 25 mg (GT3) with cirrhosis

Experimental group

Description:

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

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 25 mg+RBV (GT3) with cirrhosis

Experimental group

Description:

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

Treatment:

Drug: SOF

Drug: RBV

SOF+VEL 100 mg (GT3) with cirrhosis

Experimental group

Description:

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

Treatment:

Drug: SOF

Drug: VEL

SOF+VEL 100 mg+RBV (GT3) with cirrhosis

Experimental group

Description:

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

Treatment:

Drug: SOF

Drug: RBV

Drug: VEL

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

Experimental group

Description:

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

Treatment:

Drug: SOF

Drug: RBV

Drug: VEL

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

Experimental group

Description:

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

Treatment:

Drug: SOF

Drug: RBV

Drug: VEL