Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 89
- 主要终点
- Virologic response at 12 weeks after completion of therapy
研究概览
简要总结
The study aimed to present our experience in treating recurrent HCV genotype 4 infection post living donor liver transplantation (LDLT) since introduction of the second generation direct acting antiviral drugs (DAAs) in Egypt.
详细描述
This was a cohort study conducted in patients who had undergone LDLT for HCV related disease from 2014 to 2016 at in Ain Shams Center for Organ Transplantation (ASCOT) .The hypothesis early initiation of DAAs( after 12 weeks of the operation ) is effective and safe strategy in transplant recipients following LDLT. Patients who take the sofosbuvir and ribavirin after 6 months after transplantation were compared with those who take early treatment after 3 months of transplantation with sofosbuvir and daclatsvir+/- ribavirin..Patients were on regular follow up visits monthly to assess the clinical condition, any side effects, laboratory tests including complete blood picture, liver functions , renal functions and trough level of immunosuppressant drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All transplanted patients for HCV related disease in the period from 2014 to 2016
排除标准
- •Patients transplanted for other causes rather than HCv
- •Patients with HBV and HCV co infection
研究组 & 干预措施
Group 1: treatment after 6 months post transplantation
53 patients received Sofosbuvir+ribavirin standard of care for treatment of HCV post liver transplantation for 6 months
干预措施: treatment of HCV with oral direct acting antiviral therapy (Drug)
Group 2: early treatment afer 3 months post transplantation
36 patients received other DAAs regiment for treatment of HCV post liver transplantation for 3- 6 months
干预措施: treatment of HCV with oral direct acting antiviral therapy (Drug)
结局指标
主要结局
Virologic response at 12 weeks after completion of therapy
时间窗: 3 months
Assessment of virologic response after 3 months
次要结局
未报告次要终点
研究者
Iman Fawzy Montasser
Clinical professor
Ain Shams University