Interventional, Multicenter, Open-label, Randomized, Non-comparative Trial Evaluating the Safety, in Terms of HBV Virological Control at 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected With the HIV-1 and HBV Viruses

ANRS0250s-BI-LIGHT

The main objective of this study is to evaluate at 96 weeks the safety with respect to hepatitis B control of 2 treatment reduction strategies for patients with previously controlled HIV-HBV co-infection on continuous triple therapy

2024-05-01

2027-02-28

2027-02-28

Not yet recruiting

Early phase I

140

Inclusion Criteria: 1. HIV-1-HBV co-infection (positive HIV-1 serology associated with 2 positive HBsAg serologies within more than 6 months); 2. Age ≥ 18 years 3. Fibroscan less than 6 months \< 9kPa 4. Current daily antiretroviral tritherapy not modified for ≥ 12 months must including tenofovir disoproxil fumarate (TDF) 245mg or tenofovir alafenamide fumarate (TAF -25mg) associated to lamivudine (3TC - 300mg) or emtricitabine (FTC - 200mg) and a NNRTI or PI/r or INSTI to choose from * NNRTI = efavirenz, rilpivirine, etravirine, doravirine * PI/r = atazanavir/r ou darunavir/r * INSTI = bictegravir, dolutegravir, elvitegravir/cobicistat, raltegravir; 5. Absence of documented HBV and HIV genotypic resistance compromising virologic control of any of the maintenance strategies. Patients with no genotypic history may be included); 6. HIV CV \< 50cp/ml for ≥ 2 years (only 1 annual blip allowed if HIV CV \< 200cp/ml and previous and subsequent viral loads are undetectable); 7. HBV CV \< 10 IU/ml for ≥ 2 years (only 1 annual blip allowed if HBV CV \< 200IU/ml and if previous and subsequent viral loads are undetectable); 8. Have ≥ 3 available measurements of HIV CV \< 50cp/ml and HBV CV \< 10 IU/mL over the past 24 months (including that of pre-inclusion); 9. CD4 lymphocytes \> 250/mm3 at pre-inclusion; 10. ALT \< 3N at pre-inclusion; 11. For women of childbearing potential, negative pregnancy test and commitment to use effective contraception throughout the trial; 12. Person affiliated with or benefiting from a social security system; 13. Free, informed, written consent, signed by the person and the investigator at the latest on the day of inclusion and before any examination carried out as part of the study (article L1122-1-1 of the Public Health Code) Exclusion Criteria: 1. HIV-2 infection; 2. HIV and/or HBV genotype not compatible with dual therapy DTG-3TC or DRVr-3TC; 3. HBeAg+; 4. Fibrosis history at stage F3-F4 in pre-therapy evaluated by PBH, fibrotest and/or fibroscan with a value of Elastometry ≥ 9kPa; 5. Chronic active viral hepatitis C (HCV RNA positive); 6. Delta co-infection; 7. Alcohol consumption \> 14 units/week for women and 21 units/week for men; 8. Current treatment with chemo- or immunotherapy (including interferon or interleukins); 9. Active opportunistic infection or acute treatment for opportunistic infection; 10. Any condition (drug use, neurological, neuropsychiatric, etc.) that, in the judgment of the investigator, may compromise patient compliance and adherence to the protocol; 11. Pregnant or breastfeeding woman or refusal of contraception; 12. Major incapacity, legal protection, guardianship or curatorship

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Interventional, sequential, Phase IIA equivalent, multicenter, open-label, randomized, non-comparative study evaluating, for 96 weeks, the safety in terms of HBV virological control of 2 antiviral therapy relief strategies, in HIV-1 and HBV co-infected patients with prolonged virological success (undetectable HIV-1 and HBV viral loads for ≥ 2 years) and on unmodified antiviral therapy for ≥ 1 year.\n\nParticipants will be randomized 1:2:2 into 3 parallel arms:\n\n* Arm 1 (reference arm): Continuation of continuous (7 days/week) triple antiviral therapy including TDF or TAF\n* Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days\n* Arm 3 (B7): Switch from prior triple antiviral therapy (containing TDF or TAF) to continuous dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR). The choice of dual therapy is left to the discretion of the investigator.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

2024-04-01