Modern once-daily antiretroviral therapies have evolved considerably, improving patients' quality of life. However, sub-optimal adherence to antiretroviral therapy (ART) can lead to insufficient viral suppression and the emergence of resistant HIV strains. In particular, several populations encountered in HIV clinical practice face obstacles to optimal adherence.
The investigators propose the prospective multicenter cohort study BICTECAPS, evaluating the effectiveness of the combination therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine practice. The investigators hypothesize that the pharmacokinetic profile and genetic barrier provided by B/F/TAF will enable a high rate of virological suppression at low to moderate levels of adherence, probably 100% virological suppression above 70% adherence.
The study is planned to include 120 patients with HIV infection treated with B/F/TAF, over a planned 2-year period with usual follow-up.
The aim of this work is to evaluate virological suppression rates at 6 and 12 months according to adherence levels defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay on blotting paper (dried blood spot, DBS).
The investigators hope to generate real-life data on B/F/TAF use from population groups generally under-represented in clinical trials, including robust measurements of adherence patterns using MEMS caps and DBS.
. Key words : HIV-1 ; B/F/TAF ; Adherence ; Forgiveness
People living with HIV-1
Age greater than or equal to 18 years
Having been informed about the study (non-opposition)
Acceptance of the use of electronic antiretroviral monitoring caps (MEMS caps)
Pregnant women
People living with HIV (PLHIV) living in institutionalization, with guardianship or impaired judgment (to avoid bias due to unability to assume responsibility for treatment compliance)
PLHIV receiving assistance incompatible with the use of the electronic pillbox.
Adults living with HIV-1 receiving or starting once-daily B/F/TAF-based antiretroviral therapy
Cohort
Prospective
Adherence measured by MEMS caps
DeviceThe methodological choices made in this study are justified by the need to assess the effectiveness of bictegravir, taking into account the varying levels of adherence among PLHIV. The use of electronic antiretroviral caps (MEMS caps: https://aardexgroup.com/medication-event-monitoring-system/ ) and the intra-cellular TAF assay to measure drug concentrations will enable a combined, precise and objective assessment of treatment adherence, and constitute the originality of this research.
Proportion of patients with virological failure at 6 months
Virological failure is defined as a confirmed plasma viral load \>50 copies/mL (HIV RNA)
Proportion of patients with virological failure at 12 months
• Virological failure at 12 months as defined in Primary Outcome Measure
Proportion of patients with side-effect
• Side-effect rate measured by CTCAE V.5
Proportion of patients with emerging drug resistance mutations
• Emergence of drug resistance mutations according to ANRS AC11 in case of virological failure
Proportion of patients with good quality of life
• Quality of life measured by questionnaires (EQ-5D-5L)
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Association pour la promotion de la recherche en maladies infectieuses et tropicales dans le Loiret
Lead sponsor
Centre Hospitalier Régional d'Orléans
Sponsor institution
Hôpital Côte de Nacre, CHU de Caen
Collaborator
