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NCT Number: NCT07122557

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biktarvy

Drug

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

Primary outcomes

  1. 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

    Time frame: Week 48

  2. ii. Discontinuation due to treatment related adverse event

    Time frame: week 48

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

    Time frame: week 48

  4. iv. On study but missing data in window

    Time frame: Week 48+/- 8 weeks

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

    Time frame: week 48

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

    Time frame: week 48

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

    Time frame: week 48

Secondary outcomes

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

    Time frame: week 48

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

    Time frame: week 48

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

    Time frame: week 48

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

    Time frame: week 48

  5. • Describe the change of CD4

    Time frame: week 48

    CD4 description

  6. • Factors associated with virologic suppression (HIV RNA<50 copies/mL, FDA Snapshot), confirmed virologic failure (HIV RNA ≥200 copies/mL), discontinuation, and emergence of resistance-associated mutations at failure among TN, VS TE and VU TE.

    Time frame: week 48

  7. • Describe the change of CD8 cell counts

    Time frame: Week 48

    CD8 description

  8. • Describe the change CD4/CD8 ratio

    Time frame: Week 48

    description CD4/CD8 ratio

  9. • Describe the change of BMI

    Time frame: Week 48

    BMI description

  10. • Describe the change of body weight

    Time frame: Week 48

    Body weight description

Study contacts

Contact information is provided by the study sponsor or research team.

Aïda BENALYCHERIF

CONTACT

[email protected]

Roland LANDMAN

CONTACT

[email protected]

40 25 63 54 ext. +33 1

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: PRECARITY

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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