HepNet Acute HCV IV - LDV/SOF FDC in Acute Genotype 1 Hepatitis C Virus Infection

Inclusion Criteria

• •1. Willing and able to provide written informed consent
• •2. Male or female, age ≥ 18 years
• •3. HCV RNA ≥ 103 IU/mL at Screening
• •4. Confirmation of acute genotype 1 HCV infection documented by either:
• •documented seroconversion to HCV antibody positivity within the 4 months preceding screening or known or suspected exposure to HCV within the 4 months preceding screening with 10 times elevated serum ALT Level at screening or 4 weeks preceding screening without evidence of confounding liver disorders
• •5. If the patient visits a physician due to symptoms of acute HCV, no greater than a 12 week interval may have elapsed between the time of the visit and screening
• •6. Non-cirrhotic. Absence of cirrhosis will be determined based on clinical parameters or ultrasound
• •7. Body mass index (BMI) ≥ 18 kg/m2
• •8. Screening ECG without clinically significant abnormalities
• •9. Subjects must have the following laboratory parameters at screening:
• •1. Hemoglobin ≥ 10 g/dL
• •2. Platelets ≥ 90,000/µL
• •3. INR ≤1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
• •4. Albumin ≥ 3 g/dL
• •5. HbA1c ≤ 10%
• •6. Creatinine clearance (CLcr) ≥ 60 mL/min, as calculated by the Cockcroft- Gault equation
• •10. Subject has not been treated with any investigational drug or device within 42 days of the Screening visit
• •11. A negative serum pregnancy test is required for female subjects (unless surgically sterile or women ≥ 54 years of age with cessation for 24 ≥ months of previously occurring menses).
• •Complete abstinence from intercourse. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.
• •Or
• •Consistent and correct use of 1 of the following methods of birth control listed below, in addition to a male partner who correctly uses a condom, from the date of Screening until 30 days after last dose of study drug:
• •* intrauterine device (IUD) with a failure rate of \< 1% per year
• •* female barrier method: cervical cap or diaphragm with spermicidal agent
• •* tubal sterilization
• •* vasectomy in male partner
• •* hormone-containing contraceptive:
• •* implants of levonorgestrel
• •* injectable progesterone
• •* oral contraceptives (either combined or progesterone only)
• •* contraceptive vaginal ring
• •* transdermal contraceptive patch
• •12. Male subjects must agree to refrain from sperm donation from the day of screening and for at least 90 days after the last dose of study drug.
• •13. Subject must be of generally good health as determined by the Investigator.
• •14. Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments.