HIV-1, Public Universal Healthcare Insurance Coverage, BIC/FTC/TAF, Low Income Population
Conditions
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.
Interventions
DRUGBiktarvy
this study applies secondary use of data collected from medical health records
Sponsors
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| • Describe the change CD4/CD8 ratio | Week 48 | description CD4/CD8 ratio |
| • 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 the change of body weight | Week 48 | Body weight description |
| • Describe the change of BMI | Week 48 | BMI description |
| • 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 | CD4 description |
| • 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. | week 48 | — |
| • Describe the change of CD8 cell counts | Week 48 | CD8 description |
Contacts
Primary ContactRoland LANDMAN
Backup ContactAïda BENALYCHERIF
Outcome results
None listed