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

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 20, 2021

Detailed 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

Interventions

  • Drug: BIKTARVY 50Mg-200Mg-25Mg Tablet
    • At BSL all the participants will be switched from a booster containing regimen (ritonavir or cobicistat) to TAF/FTC/BIC (BIKTARVY).

Arms, Groups and Cohorts

  • Experimental: open label, multicentric, non randomized
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Virological failure is defined by plasma HIV RNA > 50 cps/mL on 2 following samples at 2 to 4 weeks apart
    • Time Frame: Week 24
    • The primary outcome is the proportion of patients with virological failure at Week 24.

Secondary Measures

  • Charlson and Fried Score
    • Time Frame: Day 1, Week 24 and Week 48
    • • Assessment of co morbidities and frailty
  • DAD Score
    • Time Frame: Day 1,Week 24 and Week 48
    • • Assessment of cardio vascular risk
  • polymedication
    • Time Frame: Baseline, Week 24 and Week 48
    • • Assessment of polymedication and potential drug-drug interactions
  • drug interactions
    • Time Frame: Baseline To Week 48
    • • Change of drug-drug interactions
  • • adverses events
    • Time Frame: Baseline To Week 48
    • Rate of participants withdrawn from the study for grade 3 or 4 adverse event
  • therapeutic success
    • Time Frame: Week 24 and Week 48
    • • Rate of therapeutic success
  • Viral load detectable
    • Time Frame: From Baseline to Week 48
    • • 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
  • Blip detectable
    • Time Frame: Baseline to Week 48
    • • Rate of participants with a blip
  • mutation
    • Time Frame: Day 1 to Week 48
    • • Emergence of resistance mutations at time of virological failure
  • immunology parameters
    • Time Frame: Baseline, to Week 24 and Week 48
    • • Change of CD4 and CD8 cell count from BSL,
  • lipid parameters
    • Time Frame: Baseline, Week 24, Week 48
    • • Evolution of lipid parameters
  • Renal parameters
    • Time Frame: Baseline,Week 4,Week 12,Week 24 and Week 48 ;
    • Renal glomerular filtration, creatinine clearance
  • pharmacology
    • Time Frame: Baseline, Week 12, Week 24, Week 48
    • • Plasma levels of antiretroviral drugs (TAF, FTC, BIC)
  • Addherence
    • Time Frame: Baseline, Week 24 and Week 48
    • • Adherence to treatment: self-administered questionnaire
  • Tolerance
    • Time Frame: Week 4, Week 24 and Week 48
    • • Tolerance to treatment: questionnaire
  • Renal parameters (Urine)
    • Time Frame: Baseline, Week 24, Week 48
    • urine albumin, urine creatinine, urine protein, beta-2-microglobulin and retinol binding protein

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institut de Médecine et d’Epidémiologie Appliquée – Fondation Internationale Léon M’Ba
  • Collaborator
    • Pierre and Marie Curie University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Aïda BENALYCHERIF, 40256365, aida.benalycherif@fondation-imea.org

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