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

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Status and phase: Enrolling; Phase 4

Conditions: HIV Infections

Treatments: Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04222283

IMEA 057

Details and patient eligibility

About

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.

Full description

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

Enrollment: 27 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

open label, multicentric, non randomized

Experimental group

Description:

one arm study to evaluate the safety and efficacy of switching from ritonavir- or cobicistat- booster containing regimens to a fixed-dose combination (FDC) of tenofovir alafenamide (TAF), emtricitabine (FTC) and bictegravir (BIC) in over 65 years old HIV-1-infected patients with virological suppression. Polymedications and drug-drug interactions will be analysed.

Treatment:

Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet