Collection of Samples for the Clinical Evaluation of the Aptima HBV (Hepatitis B Virus) Quant (Quantification) Assay

Inclusion criteria

• The subject is chronically infected with HBV.The subject is treatment naïve and is initiating HBV antiviral therapy with either entecavir or tenofovir as indicated in the FDA approved label
• The subject will be considered treatment naïve if he/she had <12 weeks of oral antiviral therapy with any nucleoside or nucleotide therapy
• The subject is at least 18 years of age at the time of enrollment
• Adequate medical records are available for collection of protocol-defined demographics, baseline patient characteristics, medical history, virology and specific laboratory results, and other information to verify enrollment criteria
• The subject and/or legally authorized representative is willing and able to provide consent prior to providing a specimen(s)

Exclusion criteria

• Subject is in one of the following patient populations:

• Acute HBV infection
• Patients who are HBV immune tolerant
• Human immunodeficiency virus (HIV) and/or hepatitis C virus (HCV) co-infection
• Solid organ or bone marrow transplant recipients
• Renal failure or dialysis
• Evidence or history of hepatic decompensation
• Evidence or history of hepatocellular carcinoma
• Underlying liver disease other than HBV
• Receiving chemotherapy, immunosuppressive agents
• Subject is unsuitable for study participation based on the Investigator's decision (eg, unlikely to comply with study visit schedule, significant medical complication)
• Participating in another investigational study that the Investigator believes might interfere with the subject's participation in this study