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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

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Gilead Sciences

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®

Study type

Interventional

Funder types

Industry

Identifiers

NCT01271790
GS-US-196-0140

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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