Switch to TAF+FTC+BIC in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication

Switch to Tenofovir Alafenamide (TAF), Emtricitabine (FTC), Bictegravir (BIC)(Biktarvy®) in HIV-1-infected Patients Over 65 Years Old at Risk of Polymedication

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.

HIV-1-infected patients over 65 years old at risk of polymedication HIV-1-infected adults aged ≥ 65 years who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a regimen containing a pharmacokinetic enhancer as ritonavir or cobicistat Evaluate the antiviral efficacy of 24 weeks treatment with the fixed dose combination(FDC) of TAF/FTC/BIC

Inclusion Criteria:

• HIV-1-infected patient
• Age > 65 years old
• Plasma HIV RNA ≤ 50 copies/mL for ≥ 6 months: one blip between 50 et 200 cp/ml is allowed in the past 6 months before screening.
• Currently receiving an antiretroviral regimen containing a booster, ritonavir or cobicistat
• No resistance mutation to integrase inhibitors on cumulative HIV RNA genotype. The reverse transcriptase resistant mutations M184V plus one TAM are allowed.
• 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.
• Patient enrolled in or a beneficiary of a Social Security program (State Medical Aid or AME is not a Social Security program)
• Informed consent form signed by patient and investigator

Exclusion Criteria:

• HIV-2 infection
• Currently receiving one of the following drugs: Hypericum perforatum, rifampicin, rifabutin, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, sucralfate, cyclosporine, primidone, ténofovir et adéfovir.
• Hemoglobin < 10g/dL
• Platelets < 100 000/mm3
• Hepatic transaminases AST and ALT > 3x upper limit of normal (ULN)
• Severe hepatic insufficiency (Child Pugh Class C)
• Creatininemia clairance < 30 mL/min (MDRD)
• History or presence of allergy to the trial drugs or their components
• Patients participating in another clinical trial including an exclusion period that is still ongoing during the screening phase
• Patients under judicial protection due to temporarily and slightly diminished mental or physical faculties or under legal guardianship.