1. Over 18 years of age at screening
2. A female is allowed to enter and participate in the study if she is either of:
Childbearing potential, has a negative urine pregnancy test at day 0 prior to
dosing, and agrees to acceptable birth control
3. Has received a liver transplant for HCV or is wait-listed for liver transplantation
due to complications of HCV-cirrhosis (must be approved for transplant and listed
internally or with UNOS)
4. Have HIV-1 infection and either:
On protocol approved HIV medications (antiretrovirals) for at least 4 weeks WITH
an HIV viral load less than the level of detection OR
On no HIV medications for at least 8 weeks WITH a CD4 count of 500 cells/mm3 or
more OR an HIV viral load of < 500 copies/mL with a stable CD4 count for at
least 3 months
5. Chronic HCV infection as documented by at least one measurement of plasma HCV RNA ≥
1,000 IU/mL during screening and at least one of the following:
A positive anti-HCV antibody, HCV RNA, or an HCV genotype test at least 12 months
prior to baseline (Day 0) visit together with positive HCV RNA test
6. HCV genotype 1, 3, 4, or 6
7. Able to effectively communicate with the Investigator and other center personnel.
8. Willing to give written informed consent and comply with the study restrictions and
9. NIH ONLY: Have a primary transplant hepatologist outside of the NIH for medical
10. Willingness to allow stored blood or tissue samples to be used in the future for
studying liver disease and immune function.
11. Willingness to permit HLA typing to be performed.
12. Have a transplant team responsible for all primary and transplant-related care.
1. Historically documented positive test at Screening for HBsAg, anti-HBc IgM Ab, and/or
positive HBV DNA.
2. History of any other clinically active chronic liver disease (e.g., hemochromatosis,
autoimmune hepatitis, Wilson's disease, ≥1-antitrypsin deficiency, alcoholic liver
disease, and toxin exposures).
3. Treatment with unlicensed herbal/natural remedies suggested to be taken for hepatitis
treatment, such as Milk thistle, St. Johns Wort or Cats Claw, within 28 days of start
4. Treatment with IFN, RBV, telaprevir or boceprevir or any other approved or
experimental medication with known anti-HCV activity within 1 month prior to
5. Any prior exposure to an HCV NS5a specific inhibitor
6. A personal history of or first degree relative with a history of Torsade de pointes.
7. Abnormal hematological and biochemical parameters, including:Hemoglobin < 8g/dL;
Estimated GFR, calculated by the CKD-EPI equation, <30 mL/min/ per 1.73 m2; Sodium
8. History of major organ transplantation other than liver or kidney transplantation.
9. Difficulty with blood collection/poor venous access for phlebotomy that would prevent
the collection of study required samples
10. Infection requiring systemic antibiotics at the time of screening
11. Active or recent history (≤ 6 months) of drug or alcohol abuse
12. Gastrointestinal disorder or post-operative condition that could interfere with the
absorption of the study drug.
13. Donation or loss of more than 400 mL blood within 8 weeks prior to first dose
14. Any medications prohibited (see table 2 in section 9.2) within 28 days prior to Day 0
visit and likely required during study treatment period
15. History of clinically significant drug allergy to nucleoside/nucleotide analogs.
16. History or current evidence of psychiatric illness, endocrine, immunologic disorder,
pulmonary, cardiac disease, seizure disorder, cancer or other conditions that in the
opinion of the investigator makes the patient unsuitable for the study. Chronic
medical conditions, especially if treated with medications (such as hypertension),
must be stable at the time of screening. No new therapies should be started within 28
days prior to the study that may confound the assessment of study drug safety.
17. Participation in a clinical study in which an investigational drug, biologic, or
device was received within 12 weeks prior to first dose administration.
18. Pregnant/Breastfeeding women