GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: Chronic Genotype 1a or 1b HCV Infection

Treatments: Drug: ribavirin tablet; Drug: placebo matching ribavirin tablet; Drug: GS-9451 tablet; Device: placebo matching tegobuvir capsule; Drug: GS-5885 tablet; Drug: tegobuvir capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01434498

GS-US-248-0132

Details and patient eligibility

About

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.

Enrollment: 163 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult subjects 18 and older with chronic HCV infection
• Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis
• Monoinfection with HCV genotype 1a or 1b
• Interferon ineligible or intolerant
• Body mass index (BMI) between 18 and 40 kg/m2
• Use of highly effective contraception methods if female of childbearing potential or sexually active male
• Screening laboratory values within defined thresholds
• Has not been exposed to any investigational drug or device within 30 days of the Screening visit
• Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion criteria

• Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental)
• Decompensated liver disease or cirrhosis
• Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
• History of difficulty with blood collection and/or poor venous access
• Pregnant or nursing female or male with pregnant female partner
• Chronic liver disease of a non-HCV etiology
• Suspicion of hepatocellular carcinoma
• Clinically-relevant drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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163 participants in 3 patient groups

Arm 1

Active Comparator group

Description:

GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks

Treatment:

Drug: GS-9451 tablet

Drug: ribavirin tablet

Drug: tegobuvir capsule

Drug: GS-5885 tablet

Arm 2

Active Comparator group

Description:

GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks

Treatment:

Drug: GS-9451 tablet

Drug: placebo matching ribavirin tablet

Drug: tegobuvir capsule

Drug: GS-5885 tablet

Arm 3

Active Comparator group

Description:

GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks

Treatment:

Drug: GS-9451 tablet

Drug: ribavirin tablet

Drug: GS-5885 tablet

Device: placebo matching tegobuvir capsule