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