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Observational Study on Undetectable = Untransmissible Model for HBV

This study is looking at how the "Undetectable = Untransmissible" (U=U) idea, which means if the virus is undetectable, it can't be transmitted, applies to people with chronic hepatitis B (HBV). Researchers want to see if people with HBV who are on long-term treatment with TAF/TDF and have very low levels of the virus in their blood are less likely to transmit it. They will compare viral levels in blood and body fluids between people with HBV who are on treatment and those who are not. This study aims to help reduce the fear and social isolation some people with HBV experience due to concerns about transmitting the virus. You may be able to join if you are between 18 and 65 years old and have chronic hepatitis B infection. The study will measure the percentage of individuals with detectable HBV DNA and HBV DNA levels for up to 6 months. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 55 participants. It is not a randomized or blinded study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 6 months to measure HBV DNA levels.

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NCT07449091

Adaptability of an Undetectable = Untransmissible Model for HBV

Recruiting
Not specifiedAges 18–65Observational
NYU Langone Health
~55 participants
Updated 2026-05-15 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Individuals with Detectable HBV DNA
Measured over Up to Month 6
+1 more outcome measured

Conditions

Chronic Hepatitis b
Viremia

Explore related trials

Hepatitis B InfectionHepatitis B Virus Surface Antibody

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • AnnMarie Liapakis, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

AnnMarie Liapakis, MD
[email protected]
212-263-3751
Email the study team

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Eligibility criteria

Inclusion

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
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

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

What this trial measures

  • Percentage of Individuals with Detectable HBV DNAUp to Month 6

    Assessed among those who have achieved viral supression.

  • HBV DNA LevelsUp to Month 6

    Assessed among those with detectable HBV DNA.