Overview

GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection

Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 HCV Infection.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Ledipasvir
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

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 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