Prospective Cohort Study to Assess the Safety and Efficacy of Replacing Tenofovir Disoproxil Fumarate by Tenofovir Alafenamide in HIV/HBV-coinfected Patients With Mild or Moderate Renal Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- HBV suppression
研究概览
简要总结
The investigators aim at describing changes in renal glomerular and tubular function with after the switch from TDF to TAF in HIV/HBV-coinfected patients with mild to moderate renal dysfunction and to assess the virological efficacy of TAF on HBV infection.
The study will include HIV/HBV-coinfected participants of the Swiss HIV Cohort Study (SHCS) who are under active care and have been on a stable, TDF-containing ART regimen for at least 6 months. Only patients with an estimated glomerular filtration rate (GFR) between 30 ml/min and 90 ml/min will be included. All individuals who agree to participate will be switched from a TDF-containing ART regimen to a TAF-containing triple ART regimen at week 0 and will be followed for 48 weeks after the treatment change.
详细描述
Rationale:
Tenofovir alafenamide (TAF) has been shown to cause less renal complications than tenofovir disoproxil fumarate (TDF) while having the same virological efficacy against HIV and HBV infections. In a recent study from the USA and Japan, over 90% of HIV/HBV-coinfected individuals had a suppressed HBV viral load 48 weeks after TDF was replaced by TAF. Thus, TAF might be a valuable treatment option for HIV/HBV-coinfected individuals with TDF-toxicity, especially in the context of resistance to lamivudine and entecavir. However, the safety and efficacy of TAF has not been evaluated to date in HIV/HBV-coinfected patients with renal dysfunction.
Primary objectives:
- To evaluate changes in glomerular and tubular renal function after switch from TDF to TAF in HIV/HBV coinfected patients with renal dysfunction
- To assess the HBV virological efficacy of TAF in HIV/HBV coinfected patients with renal dysfunction switching from TDF to TAF.
Secondary objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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/HBV-coinfection
- •Suppressed HIV-viremia (<200 cp/ml)
- •On TDF-containing ART since at least 6 months
- •eGFR > 30 ml/min and <90 ml/min
- •Written informed consent
排除标准
- •Study drug considered by the treating physician not a valid option for the patient
- •Pregnancy
- •Decompensated liver cirrhosis
研究组 & 干预措施
Switch
Patients are switched from a TDF-containing antiretroviral therapy regimen to a TAF-containing regimen
干预措施: Tenofovir Alafenamide (Drug)
结局指标
主要结局
HBV suppression
时间窗: 48 weeks
Evaluation of HBV virological suppression and HBsAg loss after 12 months of TAF
Change in renal function
时间窗: 48 weeks
Assessment of change in eGFR and tubular markers during the first year of TAF-containing ART
次要结局
- Treatment interruptions(48 weeks)
- Adverse events(48 weeks)
- Liver fibrosis change(48 weeks)