Clinical Effectiveness, Adherence, Clinical and Paraclinical Outcomes Associated With Tenofovir Alafenamide/Emtricitabine/Bictegravir (TAF/FTC/BIC) in Patients Diagnosed With Human Immunodeficiency Virus HIV) in Colombia: A Real-Life Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Effectiveness: Virological Suppression
研究概览
简要总结
HIV remains a major global health issue, with 38 million people affected, and significant challenges in diagnosis and treatment due to stigma and socioeconomic factors. In Colombia, the epidemic is concentrated among men who have sex with men, with 165,405 people living with HIV and 14,670 new cases reported in 2023. Barriers to treatment access are exacerbated by social factors and Venezuelan migration. While integrase inhibitors like TAF/FTC/BIC have shown effectiveness, real-world data in Colombia is limited. This study evaluates adherence, effectiveness, and clinical outcomes of TAF/FTC/BIC in 169 patients within the EPS SURA program, contributing context-specific evidence.
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
- •Male or female patients aged 18 years or older.
- •Individuals with a confirmed HIV diagnosis.
- •Individuals enrolled in EPS SURA during the study period.
- •Patients receiving treatment with the TAF/FTC/BIC regimen.
排除标准
- •Patients with a concurrent diagnosis of tuberculosis.
- •Pregnant patients during the study period.
- •Patients with virologic failure.
- •Patients who started treatment with TAF/FTC/BIC but changed providers or discontinued treatment before completing six months of therapy.
结局指标
主要结局
Effectiveness: Virological Suppression
时间窗: From enrollment to weeks 24 and 48
Effectiveness: CD4 T-Lymphocytes count
时间窗: From enrollment to weeks 24 and 48
Security: Treatment-Related Adverse Events
时间窗: From enrollment to weeks 24 and 48
次要结局
- Security: Paraclinical Results: Hepatic and Renal Function, and Lipid Profile(From enrollment to weeks 24 and 48)
- Adherence to Treatment(From enrollment to week 48)
- Security; Hepatic function(From enrollment to week 48)
- Security: Renal function(From enrollment to weeks 24 and 48)