Persons with chronic hepatitis B (HBV) infection and active viremia are infectious and may transmit virus to others through blood/body fluid exposure. Immune tolerant treatment naive persons with hepatitis B infection express anxiety regarding disclosure of their infection status and significant fear of transmission to their partners leading to social isolation and impact on their personal lives. This study will provide data correlating serum and body fluid viral levels in persons with chronic hepatitis B infection not on therapy and those with viral suppression on long-term anti-retroviral therapy (ART) that may support the concept of "Undetectable=Untransmissible" (U=U) in patients with chronic hepatitis B.

Inclusion Criteria:

Infected Individuals

• Individuals above 18 years and less than 65 years with chronic hepatitis B infection

• Included according to undermentioned three arms:

  • Infected, On-treatment arm: subjects being treated with TAF/TDF for a minimum of 2 years with sustained viral suppression indicating adherence to therapy
  • Infected, Untreated control arm: Immune tolerant subjects; 15 with high viral load (>10^6) and 5 with low viral load (<10^6)
  • Uninfected Assay Validation controls: 10 subjects with history of prior infection who have convalesced i.e., have lost surface antigen, and developed surface antibody with viral eradication

• Able and willing to provide informed consent

Healthy Controls

• Individuals above 18 years and less than 65 years who have never been infected and have been vaccinated
• Able and willing to provide informed consent

Exclusion Criteria:

• Individuals less than 18 years or greater than 65 years of age
• Prior surgery to genitourinary tract, including prior vasectomy
• Prior interferon therapy
• HIV co-infection
• Hepatitis C virus co-infection
• Hepatitis delta virus co-infection

Persons with chronic hepatitis B infection and active viremia

The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: AnnMarie.Liapakis@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to AnnMarie.Liapakis@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.