A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

Gilead Sciences

Status and phase

Completed

Phase 2

Conditions

Chronic Hepatitis C Infection

Treatments

Drug: GS-9190

Biological: Pegasys®

Drug: GS-9256

Drug: GS-9256 placebo

Drug: GS-9190 placebo

Drug: Copegus®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01225380

GS-US-196-0123

Details and patient eligibility

About

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.

Enrollment

324 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult subjects 18 to 70 years of age
Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
Monoinfection with HCV genotype 1a or 1b
HCV treatment-naïve
Body mass index (BMI) between 18 and 36 kg/m2
Creatinine clearance >/= 50 mL/min
Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
Screening laboratory values within defined thresholds for ALT, AST, leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium

Exclusion criteria

Autoimmune disease
Decompensated liver disease or cirrhosis
Poorly controlled diabetes mellitus
Severe psychiatric illness
Severe chronic obstructive pulmonary disease (COPD)
Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
History of hemoglobinopathy
Known retinal disease
Subjects who are immunosuppressed
Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
Subjects who are on or are expected to be on a potent cytochrome P450 (CYP) 3A4 or Pgp inhibitor, or a QT prolonging medication within 2 weeks of Baseline (Day 1) or during the study
Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

324 participants in 3 patient groups, including a placebo group

Arm 1

Experimental group

Description:

GS-9190 and GS-9256 in combination with Pegasys® and Copegus® for 16 or 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy

Treatment:

Drug: Copegus®

Biological: Pegasys®

Drug: GS-9256

Biological: Pegasys®

Drug: GS-9256

Drug: Copegus®

Drug: GS-9190

Arm 2

Experimental group

Description:

GS-9256 (active) and placebo matching GS-9190 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy

Treatment:

Drug: Copegus®

Drug: GS-9190 placebo

Drug: Copegus®

Biological: Pegasys®

Drug: GS-9256

Drug: GS-9190 placebo

Biological: Pegasys®

Drug: GS-9256

Drug: Copegus®

Arm 3

Placebo Comparator group

Description:

Placebo matching GS-9190 and placebo matching GS-9256 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration

Treatment:

Drug: Copegus®

Drug: GS-9190 placebo

Drug: Copegus®

Biological: Pegasys®

Drug: GS-9256 placebo

Drug: GS-9190 placebo

Biological: Pegasys®

Drug: Copegus®