Study 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

NCT ID: NCT06338826

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-09-30

Brief Summary

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

Conditions

HIV Infections; HBV Coinfection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

\- Arm 1 (reference arm): Continuation of continuous (7 days/week) triple antiviral therapy including TDF or TAF

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm 2 (T4):

\- Arm 2 (T4): Relief from previous triple antiviral therapy (containing TDF or TAF) on 4 out of 7 consecutive days

Group Type: EXPERIMENTAL

TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI

Intervention Type: DRUG

The study will include patients under 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

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

Group Type: EXPERIMENTAL

Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)

Intervention Type: DRUG

dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR

Interventions

TDF - 245mg or TAF -25mg associated to 3TC - 300mg or FTC - 200mg and a NNRTI or PI/r or INSTI

The study will include patients under 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

Intervention Type: DRUG

Dual therapy with 3TC in combination with DTG or ritonavir-boosted Darunavir (rDVR)

dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie Bottero

Role: PRINCIPAL_INVESTIGATOR

Bicetre Hospital

Central Contacts

Fatoumata COULIBALY

Role: CONTACT

fatoumata.coulibaly@anrs.fr

0144236110 ext. +33

Karine Amat

Role: CONTACT

karine.amat@fondation-imea.org

Other Identifiers

ANRS0250s-BI-LIGHT

Identifier Type: -

Identifier Source: org_study_id