Real World Effectiveness of Bictegravir/Emtricitabine/Tenofovir Alafenamide(BIC/FTC/TAF) in PLWH in Precarity Settings in France
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 320
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Missing information regarding health insurance coverage
- •On regimen other than BIC/FTC/TAF
研究组 & 干预措施
Treatment naive,virologically suppressed and unsuppressed treatment experienced in 2nd line
干预措施: Biktarvy (Drug)
结局指标
主要结局
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
时间窗: Week 48
iii. HIV RNA VL ≥200 copies/mL at week 48 and no other value for confirmation
时间窗: week 48
ii. Discontinuation due to treatment related adverse event
时间窗: week 48
iii. Discontinuation due to non-treatment related adverse event, death or other reasons
时间窗: week 48
ii. One HIV RNA VL ≥200 copies/mL followed by baseline treatment discontinuation after reaching HIV RNA < 50 copies/mL
时间窗: week 48
iv. On study but missing data in window
时间窗: Week 48+/- 8 weeks
i. Two consecutive HIV RNA VL ≥200 copies/mL after reaching a HIV RNA < 50 copies/mL
时间窗: week 48
次要结局
- • 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 the change of BMI(Week 48)
- • Describe the change of body weight(Week 48)
- • Describe the change of CD8 cell counts(Week 48)
- • Describe the change of CD4(week 48)
- • 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 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 subsequent regimens among individuals discontinued BIC/FTC/TAF among TN, VS TE and VU TE.(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.(week 48)
- • Describe the change CD4/CD8 ratio(Week 48)