Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV

Exclusion Criteria

• •1. Current or prior history of any of the following:
• •1. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
• •2. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
• •3. Poor venous access interfering with required study blood collection.
• •4. Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
• •5. Solid organ transplantation.
• •6. Significant pulmonary disease, significant cardiac disease or porphyria.
• •7. Unstable psychiatric disease (Subjects with psychiatric illness that is well-controlled on a stable treatment regimen or currently not requiring medication may be included).
• •9. Significant drug allergy (such as anaphylaxis or hepatotoxicity).
• •10. Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis).
• •11. Patients with renal impairment or uncontrolled medical problems that could place them at high risk for developing renal impairment.
• •2. Positive test at screening for either HBsAg or quantifiable HBV DNA (completed only if necessary to rule out chronic HBV)
• •3. Current use of non-protocol approved ARVs.
• •4. A new AIDS-defining condition diagnosed within 30 days prior to screening or active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to Day 0.
• •5. Cirrhosis of the liver
• •6. Screening or baseline ECG with clinically significant ECG findings.
• •7. Abnormal hematological and biochemical parameters, including:
• •1. Neutrophil count \< 750 cells/mm(3)
• •2. Hemoglobin \< 9 g/dL. If Hgb is \< 11g/dL in women or \< 12 g/dL in men. Other causes of anemia should be excluded as medically indicated.
• •3. Platelet count less than or equal to 50,000 cells/mm(3)
• •4. Estimated GFR (calculated by the CKD-EP(I) equation) \< 50 mL/min/per 1.73 m(2) if not on ARV or \< 60 mL/min if on ARVs
• •5. ALT or AST greater than or equal to 10 times ULN
• •6. Serum lipase greater than or equal to 1.5 times ULN (at screening or during the screening period)
• •7. Direct bilirubin greater than or equal to 1.50 times ULN
• •8. Albumin less than or equal to 3.0 g/dL
• •9. INR greater than or equal to 1.5 times ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
• •8. Donation or loss of more than 400 mL blood within 8 weeks prior to first dose administration.
• •9. Poorly controlled diabetes mellitus indicated by hemoglobin A1C \> 10% at screening for known diabetics.
• •10. Known hypersensitivity to, GS-5885, GS-7977, or formulation excipients.
• •11. Pregnant/Breastfeeding women.
• •12. Co-enrollment in other clinical trials is restricted, and requires approval of the Investigator.
• •Study staff should be notified of co-enrollment status.
• •13. Need for use of the following medications from 21 days prior to the start of study drugs through the end of treatment:
• •1. Hematologic stimulating agents (e.g. erythropoiesis-stimulating agents (ESAs); granulocyte colony stimulating factor (GCSF); thrombopoietin (TPO) mimetics)
• •2. Chronic systemic immunosuppressants including, but not limited to, corticosteroids (prednisone equivalent of \> 10 mg/day for \> 2 weeks), azathioprine, or monoclonal antibodies (e.g., infliximab)
• •3. Investigational agents or devices for any indication
• •4. Medications for disease conditions excluded from the protocol (e.g., active cancer, transplantation) are not listed under this Concomitant Medication section and are disallowed in the study.
• •5. Concomitant use of certain medications or herbal/natural supplements per PI discretion expected to result in pharmacokinetic interactions resulting in increases or decreases in exposure of study drug(s) as listed in Table of this protocol.