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Adaptability of an Undetectable = Untransmissible Model for HBV

Adaptability of an Undetectable = Untransmissible Model for HBV: Are Suppressed Viral Levels in the Serum Consistent Across Body Fluid Reservoirs?

Who can join

Ages 18 to 65 · All sexes · Healthy volunteers welcome

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

About the study

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.

Sponsor: NYU Langone Health · Participants: 55 · Started: May 1, 2026

Contact the study team

• AnnMarie Liapakis, MD · Phone: 212-263-3751

Official record on ClinicalTrials.gov — NCT07449091

Locations in the U.S.

Conditions

• Hepatitis B

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.