Study of the Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With and Without Post-hepatitis C Cirrhosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10,000
- 试验地点
- 2
- 主要终点
- Number of patients with sustained virological response.
研究概览
简要总结
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration of Interferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects.
详细描述
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in Egypt. For decades the antiviral therapy of chronic HCV infection was based on the administration ofInterferon(IFN), initially alone and then in combination with Ribavirin (RBV), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects. The introduction of direct acting antiviral agents, in particular sofosbuvir (SOF), has revolutionized the treatment for chronic hepatitis C virus.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• HCV infection
- •Adult patients, 18years and older.
排除标准
- •• Child score > 12
- •Severe Renal impairment
- •Pregnant and lactating women
- •HCC or other malignant neoplasms
- •Co-infection with human immunodeficiency virus (HIV)
- •Co-infection with hepatitis B virus (HBV)
研究组 & 干预措施
Sof- Riba- Pegylated interferon
Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months
干预措施: Sofosbuvir (Drug)
Sof-Riba
Sofosbuvir ribavirin 6 months.
干预措施: Sofosbuvir (Drug)
Sof-Riba
Sofosbuvir ribavirin 6 months.
干预措施: Ribavirin (Drug)
Sof- Riba- Pegylated interferon
Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months
干预措施: Ribavirin (Drug)
Sof- Riba- Pegylated interferon
Sofosbuvir, Ribavirin and Pegylated-interferon alfa-2a 3 months
干预措施: Pegylated-interferon alfa-2a (Drug)
Sof- Olysio
Sofosbuvir and simeprevir for 3 months.
干预措施: Sofosbuvir (Drug)
Sof- Olysio
Sofosbuvir and simeprevir for 3 months.
干预措施: Simeprevir (Drug)
Sof- Dacla
Sofosbuvir and Daclatasvir for 3 months.
干预措施: Sofosbuvir (Drug)
Sof- Dacla
Sofosbuvir and Daclatasvir for 3 months.
干预措施: Daclatasvir (Drug)
Harvony
Sofosbuvir and ledipasvir for 3 months
干预措施: Sofosbuvir and Ledipasvir (Drug)
Ritaprevir, paritaprevir, ombetasvir
Querevo for 3 months
干预措施: Ritaprevir, paritaprevir, ombetasvir (Drug)
Salvage therapy
sofosbuvir, daclatasvir, simeprevir,ribavirin or sofosbuvir and querevo
干预措施: Salvage therapy (Drug)
结局指标
主要结局
Number of patients with sustained virological response.
时间窗: 2 months
The number of patients achieving SVR
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Principle investigator
Tanta University