Patients infected and living with HIV are getting older and have more and more non-HIV co-morbidities. These expose them to polypharmacy that increases the risk of pharmacological interaction. Bictegravir, co-formulated with emtricitabine (FTC) and tenofovir alafenamide (TAF) (BIKTARVY) a new generation integrase inhibitor with a high genetic barrier and had no drug interaction may be a treatment of choice for participant over 65 years old who are HIV infected . BIKTARVY improve adherence and quality of life; and on the other hand it would limit the risks of pharmacological interaction. In addition, the use of TAF reducing the risk of long-term renal toxicity and adverse effects on bone would be of interest in this aging population and more at risk of osteoporosis.
Name: BIKTARVY 50Mg-200Mg-25Mg Tablet
Description: The primary outcome is the proportion of patients with virological failure at Week 24.
Measure: Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart Time: Week 24Description: • Assessment of co morbidities and frailty
Measure: Charlson and Fried Score Time: Day 1, Week 24 and Week 48Description: • Assessment of cardio vascular risk
Measure: DAD Score Time: Day 1,Week 24 and Week 48Description: • Assessment of polymedication and potential drug-drug interactions
Measure: polymedication Time: Baseline, Week 24 and Week 48Description: • Change of drug-drug interactions
Measure: drug interactions Time: Baseline To Week 48Description: Rate of participants withdrawn from the study for grade 3 or 4 adverse event
Measure: • adverses events Time: Baseline To Week 48Description: • Rate of therapeutic success
Measure: therapeutic success Time: Week 24 and Week 48Description: • Rate of participants with detectable signal in case viral load is less than 20 c/ml threshold (Cobas/TaqmanHIV-1 Roche Diagnostics) at W24 and W48
Measure: Viral load detectable Time: From Baseline to Week 48Description: • Rate of participants with a blip
Measure: Blip detectable Time: Baseline to Week 48Description: • Emergence of resistance mutations at time of virological failure
Measure: mutation Time: Day 1 to Week 48Description: • Change of CD4 and CD8 cell count from BSL,
Measure: immunology parameters Time: Baseline, to Week 24 and Week 48Description: • Evolution of lipid parameters
Measure: lipid parameters Time: Baseline, Week 24, Week 48Description: Renal glomerular filtration, creatinine clearance
Measure: Renal parameters Time: Baseline,Week 4,Week 12,Week 24 and Week 48 ;Description: • Plasma levels of antiretroviral drugs (TAF, FTC, BIC)
Measure: pharmacology Time: Baseline, Week 12, Week 24, Week 48Description: • Adherence to treatment: self-administered questionnaire
Measure: Addherence Time: Baseline, Week 24 and Week 48Description: • Tolerance to treatment: questionnaire
Measure: Tolerance Time: Week 4, Week 24 and Week 48Description: urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein
Measure: Renal parameters (Urine) Time: Baseline, Week 24, Week 48Allocation: N/A
Single Group Assignment
There is one SNP
The reverse transcriptase resistant mutations M184V plus one TAM are allowed. --- M184V ---
- If no genotype is available, DNA genotype will be performed at screening visit: no resistance mutation to integrase inhibitors, the reverse transcriptase resistant mutations M184V plus one TAM are allowed. --- M184V ---