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?

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07449091

Enrollment

Registered

2026-03-04

Start date

2026-05-01

Completion date

2027-09-01

Last updated

2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis b, Viremia

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Individuals with Detectable HBV DNA	Up to Month 6	Assessed among those who have achieved viral supression.
HBV DNA Levels	Up to Month 6	Assessed among those with detectable HBV DNA.

Countries

United States

Contacts

CONTACTAnnMarie Liapakis, MD

AnnMarie.Liapakis@nyulangone.org212-263-3751

PRINCIPAL_INVESTIGATORAnnMarie Liapakis, MD

NYU Langone Health

Outcome results