Prospective Multicenter Study of the Relationship Between Virological Effectiveness and Compliance in HIV-1-infected Patients Treated With Bictegravir

Title Etude multicentrique prospective de la relation entre efficacité virologique et observance chez des patients infectés par le VIH-1 traités par BICTEGRAVIR

Type or research Non interventional research (NIR)

Target population People living with HIV (PLWH)

Objectives Primary objective:

• To explore the effectiveness of antiretroviral treatment with B/F/TAF by virological suppression rate (plasma HIV-RNA) at 6 months in real life according to adherence patterns defined by electronic antiretroviral monitoring caps (MEMS caps) and by intra-cellular TAF assay.

Secondary objective(s):

• To explore the effectiveness of antiretroviral treatment with B/F/TAF by the rate of virological suppression (plasma HIV-RNA) at 12 months in real life, according to adherence patterns defined by electronic antiretroviral monitoring caps (MEMS caps).
• Evaluate the risk of emergence of resistance mutations in cases of HIV RNA replication with B/F/TAF.
• Evaluate the safety profile of B/F/TAF in real-life practice.
• Evaluate the quality of life of participants treated with B/F/TAF in real-life practice.

Inclusion criteria

-

• Person living with HIV-1
• 18 years of age or older
• Having been informed about the study (non-opposition)
• Accepts the use of electronic antiretroviral monitoring caps (MEMS caps)
• Person treated or starting treatment with bictegravir/emtricitabine/tenofovir (B/F/TAF; antiretroviral treatment naïve, changing treatment, virological failure) Exclusion criteria -
• Pregnant women
• People living with HIV (PLHIV) unable to assume responsibility for treatment compliance (impaired judgment, guardianship, institutionalization)
• PLWH receiving assistance incompatible with the use of the electronic pillbox

Endpoints

Primary :

• Virological failure at 6 months defined as a confirmed plasma viral load >50 copies/mL or a single plasma viral load >200 copies/mL (HIV RNA).

Secondary :

• Virological failure at 12 months as defined above
• Rate of side effects measured by CTCAE V.5
• Emergence of drug resistance mutations according to ANRS AC11 V35 in case of virological replication
• Quality of life measured by questionnaires

Procedure(s) or visit(s) added by research none

Nomber of patients 120 patients : Accuracy of at least +/-7% on virological failure rate

Number of centers 8 centers :

• CHU CAEN NORMANDIE
• CHU d'Orléans
• APHP Pitié-Salpêtrière
• CHU Poitiers
• CHU Nantes
• CHD La Roche sur Yon
• CH de Niort
• HCL Lyon

Project Milestone

• Expected start date of inclusions: 01/09/2024
• Inclusion duration: 2 years
• Duration of follow-up period: 12 months
• Planned end of study (issue of final report summary 1 year after last visit to last included subject): 01/09/2027

Inclusion criteria

• 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)
• People treated or starting treatment with bictegravir//emtricitabine/tenofovir (B/F/TAF; antiretroviral treatment naïve, changing treatment, virological failure)

Exclusion criteria

• 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.