Hepatitis B Reactivation Risk When HIV Patients Switch to Long-Acting Treatment
Studies whether hidden hepatitis B returns in adults with HIV switching to long-acting therapy.
Plain-language title generated from the registry record
Registry title: Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients With HIV-1
Key facts
- Where
- Bologna, Milan, and Naples, ItalySee the 3 sites
Where in Italy
- IRCCS Azienda Ospedaliero-Universitaria di BolognaBologna, ItalyNo longer taking part
- IRCCS San Raffaele O.U. Infectious DiseasesMilan, ItalyNo longer taking part
- Università Luigi Vanvitelli della CampaniaNaples, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS San Raffaele
- Trial code
- NCT06728917
- Record updated
- 11 December 2024
- Original description
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.Read full original descriptionShow less
Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients Living With HIV-1
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.
Inclusion: 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.
Exclusion: Any contraindications to the use of one or more long-acting drugs; 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; Lack of HIV genotypic resistance testing; Presence of biochemical signs of hepatocellular necrosis (AST, ALT > normal values as indicated in laboratory tests); Non-expression or withdrawal of informed consent to participate in the study; Pregnancy; CD4 Nadir =<200 cells/mm3; Cirrhosis and/or fibrosis score >F3 assessed by transient elastography (FibroScan).