Real World Effectiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide(BIC/FTC/TAF) in PLWH in Precarity Settings in France -IMEA073
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biktarvy.
- Who it may be relevant to
- Registry conditions: HIV-1, Public Universal Healthcare Insurance Coverage, BIC/FTC/TAF, Low Income Population. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Real World Effectiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide(BIC/FTC/TAF) in PLWH in Precarity Settings in France
Overview
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
- Drug Biktarvy
this study applies secondary use of data collected from medical health records
Primary outcome measures
- 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]
- ii. Discontinuation due to treatment related adverse event [Time frame: week 48]
- iii. Discontinuation due to non-treatment related adverse event, death or other reasons [Time frame: week 48]
- iv. On study but missing data in window [Time frame: Week 48+/- 8 weeks]
- i. Two consecutive HIV RNA VL ≥200 copies/mL after reaching a HIV RNA < 50 copies/mL [Time frame: week 48]
- ii. One HIV RNA VL ≥200 copies/mL followed by baseline treatment discontinuation after reaching HIV RNA < 50 copies/mL [Time frame: week 48]
- iii. HIV RNA VL ≥200 copies/mL at week 48 and no other value for confirmation [Time frame: week 48]
Secondary outcome measures (10)
- • 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]
- • Describe subsequent regimens among individuals discontinued BIC/FTC/TAF among TN, VS TE and VU TE. [Time frame: 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 [Time frame: 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. [Time frame: week 48]
- • Describe the change of CD4 [Time frame: week 48]
- • 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]
- • Describe the change of CD8 cell counts [Time frame: Week 48]
- • Describe the change CD4/CD8 ratio [Time frame: Week 48]
- • Describe the change of BMI [Time frame: Week 48]
- • Describe the change of body weight [Time frame: Week 48]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07122557 · IMEA