A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
Status and phase
Completed
Phase 2
Conditions
Hepatitis C, Chronic
Treatments
Biological: Pegasys®
Drug: Tegobuvir (GS-9190)
Drug: GS-9451
Drug: GS-9451 placebo
Drug: Tegobuvir placebo
Drug: Copegus®
Details and patient eligibility
About
This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).
Enrollment
245 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 alanine aminotransferase (ALT), aspartate aminotransferase (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
245 participants in 3 patient groups, including a placebo group
Arm 1
Active Comparator group
Description:
GS-9451 and Tegobuvir (GS-9190) 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:
Biological: Pegasys®
Drug: Copegus®
Biological: Pegasys®
Drug: Copegus®
Drug: GS-9451
Biological: Pegasys®
Drug: GS-9451
Drug: Tegobuvir (GS-9190)
Drug: Copegus®
Arm 2
Active Comparator group
Description:
GS-9451 (active) and Tegobuvir (GS-9190) placebo 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:
Biological: Pegasys®
Drug: Copegus®
Drug: Tegobuvir placebo
Biological: Pegasys®
Drug: Tegobuvir placebo
Drug: Copegus®
Drug: GS-9451
Biological: Pegasys®
Drug: GS-9451
Drug: Copegus®
Arm 3
Placebo Comparator group
Description:
Placebo matching Tegobuvir (GS-9190) and GS-9451 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration
Treatment:
Biological: Pegasys®
Drug: Copegus®
Drug: Tegobuvir placebo
Biological: Pegasys®
Drug: Tegobuvir placebo
Drug: Copegus®
Drug: GS-9451 placebo
Biological: Pegasys®
Drug: Copegus®
Trial contacts and locations
144
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Data sourced from clinicaltrials.gov
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