Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients With HIV-1

NCT06728917 | Not Yet Recruiting

• 1 other identifier: IRCCS San Raffaele
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of the present project will be to investigate the risk of HBV reactivation (from virological reactivation to overt HBV infection) in HIV-1 carriers with occult HBV infection (OBI, is characterized by the absence of surface antigenemia, HBsAg negativity, with the presence of HBV-core antibody, HBcAb) and switching from antiretroviral therapy (ART) including nucleos(t)ides to long-acting formulation.

Conditions

HBV (Hepatitis B Virus); HIV Infection

Keywords

Occult hepatitis B virus infection; long acting therapy; people living with HIV-1; HBV reactivation

Outcome Measures

Primary Outcomes (1)

• Quantification of hepatitis B DNA (HBV-DNA)

  HBV-DNA increase respect to baseline viremia (=\>10 IU/mL) according to different time points (W12, W24, W48) after the start of LART.

  Baseline (start of long-acting therapy) weeks 12, 24 and 48

Secondary Outcomes (2)

• Quantification of hepatitis B RNA (HBV-RNA)

  Baseline and at weeks 12, 24 and 48

• HBV mutational pattern by direct sequencing (Sanger)

  Baseline and at weeks 12, 24 and 48

Other Outcomes (1)

• Measurement of number of amino acid and/or nucleotide substitution.

  Baseline (start of long-acting therapy) weeks 12, 24 and 48

Study Arms (1)

Subjects living with HIV switching to long acting therapy

The study will include subjects living with HIV, followed at the San Luigi Center (Infectious Diseases), IRCCS Ospedale San Raffaele in Milan, Integrated Infectious Risk Management Department, Policlinico S. Orsola-Malpighi in Bologna, and the Department of Mental and Physical Health and Medicine prevention, University of Campania L. Vanvitelli of Naples, who agree to the switch from the current antiretroviral regimen which includes drugs active on HIV/HBV to long acting therapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 subjects will participate to the study, 30 subjects enrolled at the San Luigi Center (Unit of Infectious Diseases), IRCCS Ospedale San Raffaele in Milan, 10 subjects enrolled at Integrated Infectious Risk Management Department, Policlinico S. Orsola-Malpighi in Bologna, and 10 at the Department of Mental and Physical Health and Medicine prevention, University of Campania L. Vanvitelli of Naples.

You may qualify if:

• Age \> 18 years
• Informed consent to participate in the study
• HIV infection
• Stable antiretroviral therapy (ART) in the six months prior to enrollment without virological failure defined by HIV-RNA\>50 copies/mL in at least two consecutive determinations
• Positive HBV anti-core antibodies (HBcAb) in the absence of hepatitis B surface antigen (HBsAg)
• Absence of mutations associated with resistance to integrase inhibitors (INSTIs) and reverse transcriptase inhibitors (NNRTIs) by HIV genotypic resistance testing
• CD4 Nadir \>200 cells/mm3

You may not qualify if:

• Any contraindications to the use of one or more long-acting drugs
• Non-expression or withdrawal of informed consent to participate in the study
• Pregnancy
• Lack of HIV genotypic resistance testing
• Virological failure (HIV-RNA \>50 copies/mL in at least 2 consecutive determinations) in the 6 months prior to enrollment
• Therapeutic interruptions in the six months prior to enrollment, excluding interruptions lasting less than a month due to tolerability
• CD4 Nadir =\<200 cells/mm3
• Presence of biochemical signs of hepatocellular necrosis (AST, ALT \> normal values as indicated in laboratory tests).
• Cirrhosis and/or fibrosis score \>F3 assessed by transient elastography (FibroScan).

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• Università Luigi Vanvitelli della Campania: collaborator

Study Sites (3)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

IRCCS San Raffaele O.U. Infectious Diseases

Milan, 20127, Italy

Location

Università Luigi Vanvitelli della Campania

Napoli, 80138, Italy

Location

Related Publications (16)

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• Bagaglio S, Porrino L, Lazzarin A, Morsica G. Molecular characterization of occult and overt hepatitis B (HBV) infection in an HIV-infected person with reactivation of HBV after antiretroviral treatment interruption. Infection. 2010 Oct;38(5):417-21. doi: 10.1007/s15010-010-0032-1. Epub 2010 Jun 9.

  PMID: 20533073 BACKGROUND

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  PMID: 15990987 BACKGROUND

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collection at baseline (start of long-acting therapy) weeks 12, 24 and 48 after the start of long-acting therapy.

MeSH Terms

Conditions

Hepatitis B; HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Antonella Castagna, Prof, MD

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella Castagna, Prof, MD

CONTACT

+39 0226433473; castagna.antonella@hsr.it

Elisabetta Carini, Mrs

CONTACT

+390226437934; carini.elisabetta@hsr.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 11, 2024
• Study Start: January 20, 2025
• Primary Completion: April 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)