Tubular Function in Asian-American Patients Receiving TDF or ETV for HBV Treatment

Exclusion Criteria

• •Ethnicity: Non-Asian CHB patients
• •Age: \>70 years old
• •Body weight and height: BMI ≥ 30
• •Concomitant nephrotoxic agents - record all prescription and nonprescription items including herbs and natural remedies, NSAIDs, acyclovir, statins, ACEI or ARBs, Valproate
• •Any other antiretroviral meds, antibiotic exposure during study to be noted
• •History of HCV, HDV, or HIV co-infection
• •Prior history of clinical hepatic decompensation defined as direct (conjugated) bilirubin ≥ 1.2 ULN; PT ≥ 1.2 ULN, platelets ≤ 50,000/mm3, or serum albumin ≤ 3.5 g/dL, ascites, jaundice, encephalopathy, or variceal hemorrhage
• •Serum α-fetoprotein ≥ 50 ng/mL
• •Evidence of hepatocellular carcinoma (HCC)
• •History of solid organ or bone marrow transplantation
• •History of malignancies in the past 5 years
• •Pregnant women, and women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
• •Males and females of reproductive potential who are not willing to use an effective method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.
• •History of significant renal disease
• •History of significant bone disease
• •History of HTN or DM on medical treatment
• •Ongoing therapy with any of the following:
• •1. Nephrotoxic agents
• •2. Parenteral aminoglycoside antibiotics
• •3. Cidofovir
• •4. Cisplatin
• •5. Foscarnet
• •6. IV amphotericin B
• •7. IV pentamidine
• •8. Oral or IV ganciclovir
• •9. Cyclosporine
• •10. Tacrolimus
• •11. IV vancomycin
• •12. Chronic daily non-steroidal anti-inflammatory drug therapy
• •13. Competitors of renal excretion Systemic chemotherapeutic agents
• •14. Systemic corticosteroids
• •15. Interleukin-2 (IL-2) and other immunomodulating agents
• •Investigational agents (except with the expressed approval of the lead investigators) Administration of any of the above medications must be discontinued at least 30 days prior to the Baseline Visit and for the duration of the study period.
• •1. Known hypersensitivity to the study drugs, the metabolites or formulation excipients
• •2. Any other condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigators, would make the subject unsuitable for the study or unable to comply with dosing requirements