A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
A Multiple Ascending Dose Study of GS 5885 in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
The primary purpose of this study is to evaluate the safety, tolerability, pharmacokinetics
 and activity of escalating, multiple, oral doses of GS-5885 in subjects with chronic genotype
 1 Hepatitis C Virus (HCV) infection. Each participant in the study will be sequestered in the
 clinic for the initial 5 days of the study.
Inclusion Criteria:

 -  Chronically infected with HCV genotype 1

 -  HCV treatment-naïve

 -  Not co-infected with HIV or HBV

 -  HCV RNA viral load of at least 100,000 IU/mL

 -  BMI 19 to 35 kg/m2

 -  Subject agrees to use highly effective contraception methods if female of childbearing
 potential or sexually active male.

 Exclusion Criteria:

 -  History of clinically-significant illness or any other major medical disorder that may
 interfere with subject treatment, assessment or compliance with the protocol

 -  Decompensated liver disease or cirrhosis or evidence of hepatocellular carcinoma

 -  Serological evidence of co-infection with human immunodeficiency virus (HIV),
 hepatitis B virus (HBV), or another HCV genotype

 -  Subjects with known, current use of amphetamines and/or cocaine; subjects taking
 methadone or buprenorphine (opioid replacement therapy) or ongoing alcohol abuse