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

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (8)

Hopital Sainte Marguerite

Marseille, France

RECRUITING

Hopital Hotel Dieu

Nantes, France

RECRUITING

Hopital L'Archet

Nice, France

RECRUITING

Hôpital Hotel Dieu

Paris, France

RECRUITING

Bichat Hospital

Paris, France

RECRUITING

CH de Saint Nazaire

Saint-Nazaire, France

ACTIVE_NOT_RECRUITING

Hopital Gustave Dron

Tourcoing, France

RECRUITING

Hopital Bretonneau

Tours, France

ACTIVE_NOT_RECRUITING

Outcomes

Primary Outcomes

Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart

The primary outcome is the proportion of patients with virological failure at Week 24.

Time frame: Week 24

Secondary Outcomes

Charlson and Fried Score

• Assessment of co morbidities and frailty

Time frame: Day 1, Week 24 and Week 48

DAD Score

• Assessment of cardio vascular risk

Time frame: Day 1,Week 24 and Week 48

polymedication

• Assessment of polymedication and potential drug-drug interactions

Time frame: Baseline, Week 24 and Week 48

drug interactions

• Change of drug-drug interactions

Time frame: Baseline To Week 48

• adverses events

Rate of participants withdrawn from the study for grade 3 or 4 adverse event

Time frame: Baseline To Week 48

therapeutic success

• Rate of therapeutic success

Time frame: Week 24 and Week 48

Viral load detectable

• 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

Time frame: From Baseline to Week 48

Blip detectable

• Rate of participants with a blip

Time frame: Baseline to Week 48

mutation

• Emergence of resistance mutations at time of virological failure

Time frame: Day 1 to Week 48

immunology parameters

• Change of CD4 and CD8 cell count from BSL,

Time frame: Baseline, to Week 24 and Week 48

lipid parameters

• Evolution of lipid parameters

Time frame: Baseline, Week 24, Week 48

Renal parameters

Renal glomerular filtration, creatinine clearance

Time frame: Baseline,Week 4,Week 12,Week 24 and Week 48 ;

pharmacology

• Plasma levels of antiretroviral drugs (TAF, FTC, BIC)

Time frame: Baseline, Week 12, Week 24, Week 48

Addherence

• Adherence to treatment: self-administered questionnaire

Time frame: Baseline, Week 24 and Week 48

Tolerance

• Tolerance to treatment: questionnaire

Time frame: Week 4, Week 24 and Week 48

Renal parameters (Urine)

urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein

Time frame: Baseline, Week 24, Week 48

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

Overview

Conditions

Interventions

Eligibility

Locations (8)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts