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: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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®).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

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