Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross-Sectional

Arm Groups

ArmDescriptionAssigned Intervention
Anti-Viral Therapy Infected individuals on anti-viral therapy.
No Therapy Infected individuals who are not receiving anti-viral therapy.
Convalesced Individuals who have cleared HBV infection.
Healthy Controls Individuals who are uninfected.

Recruiting Locations

NYU Langone Health
New York, New York 10016

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

AnnMarie Liapakis, MD
212-263-3751
AnnMarie.Liapakis@nyulangone.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.