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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
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
dual therapy without TDF or TAF but including 3TC in combination with Dolutegravir (DTG) or ritonavir-boosted Darunavir (rDVR
The proportion of participants with HBV virological failure at 96 weeks.
HBV virologoical failure is defined by 2 successive varial load ≥ 10UI/ml
Time frame: 96 weeks
• HBV virological success rate at 48 weeks
HBV virological success is defined by a viral load ≤10 UI/ml
Time frame: at Week 48
• HIV virological success rate at 48 and 96 weeks
HIV virological success is defined by a viral load ≤ 50 cp/ml
Time frame: At week 48 and week 96
• Time to virological failure (rebound HBV and/or HIV viral load)
Time frame: between Week 0 and Week96
• The rate of participants with at least one HBV viral load blip until W48 and until W96
a blip is defined by a HBV viral load \>10UI/mL followed by a control value ≤ 10UIml
Time frame: At week 48 and week 96
• Selection of HBV resistance mutations at the time of virological failure
Time frame: between Week 0 and Week 96
• Incidence of grade 3 or higher adverse events of grade 3 or higher, incidence of adverse events and incidence of strategy discontinuation of the strategy at W48 and W96
Time frame: At week 48 and week 96
• Evolution of CD4 from W0 to W48 and W96
Time frame: Week 0 to Week 48 and week 96
• Evolution of total cholesterol from W0 to W48 and W96
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Time frame: from Week 0 to Week 48 and Week 96
• Evaluation of the adherence by self-reported questionnaire
without analysis scale
Time frame: at Week 0, Week 12, Week 24, Week 48, Week 72 and Week 96
• Evaluation of quality of life using the Pro-Qol self-questionnaire
without analysis scale
Time frame: at Week 0, Week 12, Week 24, Week 48, Week 72 and Week 96
Evolution of CD8 T lymphocytes from W0 to W48 and W96
Time frame: Week 0 to Week 48 and week 96
Evolution of the CD4/CD8 ratio from W0 to W48 and W96
Time frame: Week 0 to Week 48 and week 96
Evolution of LDL-c from W0 to W48 and W96
Time frame: from Week 0 to Week 48 and Week 96
Evolution of HDL-c from W0 to W48 and W96
Time frame: from Week 0 to Week 48 and Week 96
Evolution of triglycerides from W0 to W48 and W96
Time frame: from Week 0 to Week 48 and Week 96
Evolution of fasting blood sugar from W0 to W48 and W96
Time frame: from Week 0 to Week 48 and Week 96
HBV virological success rate at 96 weeks between arms
HBV virological success is defined by a viral load ≤10 UI/ml
Time frame: at Week 96