A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
Body mass index (BMI) of 19.0 to 34.0 kg/m2, inclusive.
Eligible subjects must also be HCV treatment-naïve.
You may not be if
Subjects with prior documentation of cirrhosis, excessive current alcohol intake, any evidence of hepatocellular carcinoma (i.e., α-fetoprotein \> 50 ng/mL or by any other standard of care measure)
Urine drug screen positive for illicit/illegal drugs
ALT and AST levels \> 5 times the upper limit of the normal range (ULN)
Subjects with an absolute neutrophil count (ANC) \< 1,000 cells/mm3 (\< 750 cells/mm3 for black or African-American subjects), hemoglobin (Hb) \< 11 g/dL,
Evidence of hepatocellular carcinoma
Any sign of decompensated liver disease, including prothrombin time ≥ 1.5 X ULN, platelets \< 100,000/mm3 or albumin \< 3.5 g/dL at screening OR current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage)
History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
History of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility
Clareo Health | A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
