Efficacy and Safety of Sofosbuvir Plus Daclatasvir With or Without Ribavirin: Large Real-life Results of Patients With Chronic Hepatitis C Genotype 4
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 946
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12
研究概览
简要总结
This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.
详细描述
Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks.
SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-cirrhotic treatment-naïve participants
- •FIB-4 < 3.25
- •albumin > 3.5
- •total bilirubin < 1.2 mg/dl
- •international normalized ratio (INR) < 1.2
- •platelet count > 150,000 mm
- •experienced participants who had previously failed treatment with peg-IFN-α-/RBV, SOF/peg-IFN-α +RBV, or SOF/SMV
- •Naïve cirrhotic participants were confirmed by ultrasonographic features of cirrhosis
排除标准
- •liver disease of non-HCV etiology
- •hepatitis B or human immune-deficiency virus (HIV) infection
- •poorly controlled diabetic (HbA1C > 9) participants
- •hepatocellular carcinoma
- •a history of extra-hepatic malignancy within 5 years prior to the study
- •pregnant or breast feeding
- •renal disease; serum creatinine > 2.5 mg/dl or eGFR < 30 ml/min
- •evidence of hepatic decompensation; INR > 1.7, serum albumin < 2.8 g/dl, total bilirubin > 3 mg/dl
- •blood picture abnormalities such as anemia (hemoglobin concentration of 10 g/dl or less) and thrombocytopenia (platelet count < 50,000 cells/mm3)
- •major severe illnesses such as congestive heart failure and respiratory failure.
研究组 & 干预措施
SOF/DCV
Easy to treat arm: Participants were treated with a dual therapy (SOF and DCV) for 12 weeks.
This arm included non-cirrhotic treatment-naïve patients
干预措施: (SOF and DCV) (Drug)
SOF/DCV/RBV + Cirrhosis
This difficult-to-treat arm included 111 cirrhotic participants who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.
干预措施: (SOF, DCV, and RBV) (Drug)
SOF/DCV/RBV + Non-Cirrhosis
This difficult-to-treat arm included treatment-experienced non-cirrhotic participants (77 participants) who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks.
干预措施: (SOF, DCV, and RBV) (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12
时间窗: 12 weeks after last dose
SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) level \< 15 IU/m 12 weeks after the last dose of drugs.
Number of Participants With Adverse Events in Each Treatment Arm
时间窗: up for 12 weeks after planned End of Treatment (EOT).
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity
次要结局
- Percentage of Participants With Viral relapse(12 weeks after last dose)
- Percentage of Participants With On-treatment Virologic Failure(up tp 24 weeks)
研究者
Mohammed Abdel-Gabbar, Ph.D
Associate Prof
Beni-Suef University