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

NCT07122557 | Not Yet Recruiting

• 1 other identifier: IMEA
• Study Type: observational
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• i. HIV RNA ≥50 copies/mL at week 48 within the time window OR One HIV RNA ≥50 copies/mL followed by treatment discontinuation before week 48 after reaching HIV RNA < 50 copies/mL

  Week 48

• ii. Discontinuation due to treatment related adverse event

  week 48

• iii. Discontinuation due to non-treatment related adverse event, death or other reasons

  week 48

• iv. On study but missing data in window

  Week 48+/- 8 weeks

• i. Two consecutive HIV RNA VL ≥200 copies/mL after reaching a HIV RNA < 50 copies/mL

  week 48

• ii. One HIV RNA VL ≥200 copies/mL followed by baseline treatment discontinuation after reaching HIV RNA < 50 copies/mL

  week 48

• iii. HIV RNA VL ≥200 copies/mL at week 48 and no other value for confirmation

  week 48

Secondary Outcomes (10)

• • Evaluate the time to treatment discontinuation and reason for discontinuation with BIC/FTC/TAF among TN, VS TE and VU TE PLWH.

  week 48

• • Describe subsequent regimens among individuals discontinued BIC/FTC/TAF among TN, VS TE and VU TE.

  week 48

• • Describe the number of hospital medical HIV appointments, and participants baseline characteristics with BIC/FTC/TAF among TN, VS TE and VU TE PLWH

  week 48

• • Describe treatment emergent resistance profile among participants with confirmed virologic failure with BIC/FTC/TAF among TN, VS TE and VU TE PLWH.

  week 48

• • Describe the change of CD4

  week 48

Study Arms (1)

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

Drug: Biktarvy

Interventions

Biktarvy DRUG

this study applies secondary use of data collected from medical health records

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Treatment naïve (TN) and Virologically Suppressed Treatment Experienced (VS TE) in 2d line treatment, or Virologically Unsuppressed Treatment Experienced (VU TE) in 2d line treatment patients within Paris Bichat and CHU Nantes hospitals who were covered by C2S/AME heath insurance during study period. \- Those using BIC/FTC/TAF We will conduct descriptive analyses only. Analyses will be disaggregated by TN, VS TE, and VU TE groups.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Interventions

bictegravir, emtricitabine, tenofovir alafenamide, drug combination

Study Officials

• Roland LANDMAN

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roland LANDMAN

CONTACT

40 25 63 54; landman.roland@gmail.com

Aïda BENALYCHERIF

CONTACT

aida.benalycherif@fondation-imea.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP