Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy While on the Orthotopic Liver Transplant (OLT) List

• The change from baseline in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault (C-G) method over the registry evaluation period. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
• Proportion of patients with confirmed eGFR below 50 mL/min. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
• Proportion of patients receiving appropriate dosing relative to renal function. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
• Proportion of patients who discontinue nucleotide/side therapy due to a renal-related event(s). [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
• Proportion of patients with ALT normalization (≤ 1 x ULN). [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
• Proportion of patients with change in MELD score and liver disease status compared to baseline. [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
• Proportion of patients with plasma HBV DNA < 400 copies/mL (69 IU/mL). [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

This registry will remain open for approximately 5 years. Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry. When laboratory tests and clinical assessments are performed as a part of routine care according to UNOS Guidelines, these results will be captured from the subject's medical record to be included as data for this registry.

Adult patients with chronic HBV infection receiving or anticipated to receive nucleotide/side therapy and with decompensated liver disease who meet the United Network for Organ Sharing (UNOS) criteria and are listed for OLT.

• Males and females ≥ 18 years of age
• HBeAg positive or negative
• MELD score ≤ 24
• Estimated glomerular filtration rate (Cockroft-Gault method) using actual body weight of ≥ 50mL/min
• Negative serologies for HIV, HCV, and HDV
• No history of solid organ or bone marrow transplant
• Receiving ongoing therapy with nucleotide/sides(eg, tenofovir DF [TDF], entecavir [ETV]), or other therapies, or anticipated to begin such therapy within 6 months of inclusion into the registry