Adaptability of an Undetectable = Untransmissible Model for HBV
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
- Chronic Hepatitis b
- Viremia
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
| Arm | Description | Assigned 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
New York, New York 10016
More Details
- Status
- Recruiting
- Sponsor
- NYU Langone Health