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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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 [Срок оценки: Week 48]
• ii. Discontinuation due to treatment related adverse event [Срок оценки: week 48]
• iii. Discontinuation due to non-treatment related adverse event, death or other reasons [Срок оценки: week 48]
• iv. On study but missing data in window [Срок оценки: Week 48+/- 8 weeks]
• i. Two consecutive HIV RNA VL ≥200 copies/mL after reaching a HIV RNA < 50 copies/mL [Срок оценки: week 48]
• ii. One HIV RNA VL ≥200 copies/mL followed by baseline treatment discontinuation after reaching HIV RNA < 50 copies/mL [Срок оценки: week 48]
• iii. HIV RNA VL ≥200 copies/mL at week 48 and no other value for confirmation [Срок оценки: week 48]

Вторичные конечные точки (10)

• • Evaluate the time to treatment discontinuation and reason for discontinuation with BIC/FTC/TAF among TN, VS TE and VU TE PLWH. [Срок оценки: week 48]
• • Describe subsequent regimens among individuals discontinued BIC/FTC/TAF among TN, VS TE and VU TE. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: week 48]
• • Describe the change of CD4 [Срок оценки: 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. [Срок оценки: week 48]
• • Describe the change of CD8 cell counts [Срок оценки: Week 48]
• • Describe the change CD4/CD8 ratio [Срок оценки: Week 48]
• • Describe the change of BMI [Срок оценки: Week 48]
• • Describe the change of body weight [Срок оценки: Week 48]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07122557 · IMEA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗