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

• INCLUSION CRITERIA:
• Eighteen years of age or older at screening.
• HCV treatment-naive, as defined as no prior exposure to any IFN, RBV, or other approved or experimental HCV-specific direct-acting antiviral agent.
• Participants must be willing to practice either:
• Abstinence from sexual intercourse or
• At least 2 forms of contraception including one barrier method from 2 weeks prior to Day 0 through 30 days after the last dose is received.

i. Female partners of male study subjects may rely upon hormonal contraception as one of the 2 methods; however female study subjects may not.

• Chronic hepatitis C infection defined as one of the following:
• Positive for anti-HCV antibody, HCV RNA, or an HCV genotype at least 6 months before screening, and positive for HCV RNA and anti-HCV antibody at the time of screening or
• Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of chronic hepatitis C disease, such as the presence of fibrosis).
• HIV treatment status:
• Documented HIV infection, ARV untreated for > 8 weeks preceding dosing and having either:
• a CD4 T-cell count greater than or equal to 500 cells/mm3 within 8 weeks of Day 0 or
• an HIV viral load less than 500 copies/mL with a stable CD4 count for at least 3 months.
• Documented HIV infection on a stable, protocol-approved, ARV regimen for greater than or equal to 8 weeks prior to dosing and is expected to continue the current ARV regimen through the end of study with all of the following:
• a CD4 T-cell count > 100 cells/mm3
• a documented plasma HIV-1 RNA level less than the level of detection for at least 8 weeks preceding dosing.

If the lower limit of detection of the local HIV-1 RNA assay is 10% at screening for known diabetics.

• Known hypersensitivity to, GS-5885, GS-7977, or formulation excipients.
• Pregnant/Breastfeeding women.
• Co-enrollment in other clinical trials is restricted, and requires approval of the Investigator.

Study staff should be notified of co-enrollment status.

• Need for use of the following medications from 21 days prior to the start of study drugs through the end of treatment:
• Hematologic stimulating agents (e.g. erythropoiesis-stimulating agents (ESAs); granulocyte colony stimulating factor (GCSF); thrombopoietin (TPO) mimetics)
• 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)
• Investigational agents or devices for any indication
• 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.
• 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.