Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection

Inclusion Criteria:

1. Provision of signed and dated informed consent form

2. Stated willingness to comply with all study procedures and availability for the
duration of the study

3. Male or female, aged 18 or older at screening

4. Diagnosed with chronic hepatitis B infection

5. HBeAg negative at screening

6. HBV DNA > lower level of quantitation (LLOQ)

7. Quantitative HBsAg at least 10 IU/mL at screening

8. Ability to take oral medication and be willing to adhere to the twelve week study drug
regimen

9. For females of reproductive potential: usual practice of complete abstinence from
sexual intercourse with a member of the opposite sex OR use of at least one form of
highly effective contraception for at least 1 month prior to screening and agreement
to use such a method during study participation and for an additional 30 days after
the end of study drug administration

10. For males of reproductive potential: usual practice of complete abstinence from sexual
intercourse with a member of the opposite sex OR use of at least one form of highly
effective contraception for at least 1 month prior to screening and agreement to use
such a method during study participation and for an additional 14 days after the end
of study drug administration

11. Ability to communicate effectively with the study investigator and key staff

12. Medical management provided by a primary care provider

13. Ability to store medications at a room temperature of less than 86 degrees Fahrenheit

Exclusion Criteria:

1. Current use of anticonvulsants, antimycobacterials, St. John's wort, and rosuvastatin

2. Coinfection with hepatitis C, hepatitis D or human immunodeficiency virus (HIV)

3. Pregnancy or lactation

4. Known allergic reactions to components of the Harvoni

5. Treatment with another investigational drug or other intervention within three months

6. Evidence of cirrhosis or hepatic decompensation such as:

- Platelets less than 100,000 /mm3

- Albumin less than 3.5 g/dL

- INR greater than 1.7 or Prothrombin time of 1.5 times the upper limit of normal
(ULN)

- Total bilirubin of 1.5 times the upper limit of normal

- FibroTest (or FibroSure®) of 0.75 or greater

7. Abnormal hematological and biochemical parameters at screening including:

- White blood cell count less than 2500 cells/uL

- Absolute neutrophil count (ANC) less than 1,000 cells/mm3 (less than 750 mm3 for
African or African-American subjects)

- Hemoglobin less than 12 g/dL for males, less than 11 g/dL for females

- AST or ALT of two times the upper limit of normal

- Estimated GFR less than 50 mL/min

- Glycosylated hemoglobin A1c (HbA1c) greater than 8.5%

8. Current or prior history of any of the following:

- Immunodeficiency disorders or autoimmune disease (e.g. Systemic lupus
erythematosus, rheumatoid arthritis, inflammatory bowel diseases, sarcoidosis,
psoriasis of greater than mild severity)

- Severe pulmonary disorders, significant cardiac diseases

- Gastrointestinal disorder with post-operative condition that could interfere with
the absorption of the study drugs

- Significant psychiatric illness that in the judgment of the Investigator, is a
contraindication to protocol participation or impairs a volunteer's ability to
give informed consent

- Any malignancy diagnosed within 5 years (not including recent localized treatment
of squamous or non-invasive basal cell skin cancer; cervical carcinoma in situ
appropriately treated prior to screening)

- Solid organ transplantation

- Poor venous access

9. Screening electrocardiogram (ECG) with clinically significant findings

10. Evidence of Hepatocellular carcinoma (e.g., α fetoprotein > 50ng/mL or radiologic
evidence)

11. Clinically significant illicit drug or alcohol abuse within 12 months of screening.
Subjects on methadone maintenance treatment or prescribed opioid may be included.

12. Use of amiodarone within 90 days of screening; or carbamazepine, phenytoin,
phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort,
rosuvastatin within 30 days of screening or expected use of these prohibited drugs
during study participation. Use of or expected need of proton-pump inhibitors more
than 20 mg omeprazole equivalent or H2 receptor antagonist more than 40 mg famotidine
bid equivalent within 7 days of screening.

13. Taking antiviral therapy or requiring treatment for HBV during screening