Collection of Plasma Samples From Individuals Initiating Therapy With Entecavir or Tenofovir for Chronic Hepatitis B Virus Infection for the Clinical Evaluation of the Aptima HBV Quant Assay
Collection of Plasma Samples From Individuals Initiating Therapy With Entecavir or Tenofovir for Chronic Hepatitis B Virus Infection for the Clinical Evaluation of the Aptima HBV Quant Assay
This non-interventional clinical study will be conducted to prospectively collect serial plasma samples from subjects with chronic HBV infection who are initiating antiviral therapy. These samples will be used to estimate clinical utility endpoints for the Aptima HBV Quant assay, which is used as an aid in the management of HBV-infected patients undergoing HBV antiviral therapy.
Inclusion Criteria:
Exclusion Criteria:
Subject is in one of the following patient populations:
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
Kingswood, New South Wales 2747, Australia
Hamilton West, Waikato Region 3024, New Zealand
Newton, Wellington Region 6021, New Zealand
Sector 1, Bucharest 010825, Romania