Real World Effectiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide(BIC/FTC/TAF) in PLWH in Precarity Settings in France -IMEA073 (PRECARITY)

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

Status: Not yet enrolling

Conditions: HIV-1; Low Income Population; BIC/FTC/TAF; Public Universal Healthcare Insurance Coverage

Treatments: Drug: Biktarvy

Study type: Observational

Funder types: Other

Identifiers

NCT07122557

IMEA

Details and patient eligibility

About

In France, French citizens with an annual income less than 10339 euros are considered living with low-income and are eligible to benefit from a public universal healthcare insurance coverage called C2S (complémentaire santé solidaire). C2S covers primary care and hospital care. Non-citizens with low income, like some migrants, can also benefit from a public healthcare insurance coverage called AME ("Aide Medicale d'Etat" for State Medical Aid). These criteria are used as a marker of precarity settings (i.e., socio-economic vulnerability) in France. In France, HIV-related care and treatments are reimbursed at 100% (ALD30), whatever the level of precariousness. ART adherence has been shown significantly lower in PLWH with C2S health insurance coverage. Although BIC/FTC/TAF is a recommended preferred option in naive PLWH and in switch or maintenance therapy in most settings, due to the forgiveness profile and the high genetic barrier to resistance, boosted darunavir (DRV/r) remains even more widely used than 2nd generation InSTIs in populations in precarity settings, and Real World Effectiveness (RWE) with BIC/FTC/TAF is missing to better support its use in these settings.

Paris Bichat Hospital (located in one of the poorest districts in the Ile-de-France region) and Nantes university hospital (West France region) follow a cohort of PLWH with a high proportion of populations in precarity settings (i.e with C2S and AME health insurance coverage): Paris Bichat hospital: N=5143 PLWH (December 2021), sex ratio F/M 37/56%, Transgender Women 7%, and born in sub-Saharan African countries 49%. Nantes university hospital: N=2227 PLWH (December 2021), sex ratio F/M 35/65% and born in sub-Saharan African countries 33%. In this cohort of 7370 PLWH in both sites 50% are receiving an InSTI-based ART regimen, regardless of prior treatment history, and at least 40% are receiving care through the C2S or AME, respectively.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HIV-1 infected patients > 18 years during the observation period
• PLWH with C2S or AME heath insurance coverage information available during the observation period
• Treatment naive (TN) on BIC/FTC/TAF OR Treatment experienced virologically suppressed (VS TE) or virologically unsupressed (VU TE) in 2d line BIC/FTC/TAF
• Had at least one follow-up visit after baseline

Exclusion criteria

• Missing information regarding health insurance coverage
• On regimen other than BIC/FTC/TAF

Trial design

320 participants in 1 patient group

Treatment naive,virologically suppressed and unsuppressed treatment experienced in 2nd line

Treatment:

Drug: Biktarvy