The Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, Non-Cirrhotic, HCV GT4-Infected Patients: A Single-Center, Single-Arm, Open-Label, Phase III Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sustained virologic response at 12 weeks after the end of intervention (SVR-12).
研究概览
简要总结
To evaluate the safety and efficacy of a daily, fixed-dose, 8-week course combination of Elbasvir/Grazoprevir in treatment-naïve, non-cirrhotic patients who are mono-infected with hepatitis C, genotype 4.
详细描述
The treatment of hepatitis C has gone through significant advances in the last few years with the development of direct-acting antivirals "DAAs." Since 2013, many DAAs have been approved for the treatment of HCV with excellent efficacy and safety profiles. The major hurdle in treating patients on a large scale is the high cost of the current treatment regimens. Multiple approaches have been proposed, among them, a shortened treatment regimen of 6 to 8 weeks rather than the standard 12-week-regimen. The strategy of shortening the treatment will help in reducing the cost by 33% to 50%. Thus, it will increase the availability of the treatment to more patients.
Zepatier is a combination drug of Elbasvir (EBR), an NS5A inhibitor, and Grazoprevir (GZR), a potent NS3/4A inhibitor. This study is being proposed to address two main issues. First, collecting information on the safety and efficacy of a shortened course of zepatier (8 weeks instead of the standard 12 weeks) in patients who are treatment-naïve, non-cirrhotic and mono-infected with HCV. Second, to investigate whether this course provides similar clinical outcomes to the standard regimen in HCV-Genotype 4, which is the most common genotype in Saudi Arabia.
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
盲法说明
Open-label
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
- •Age above 18 years.
- •Chronically infected with HCV genotype
- •Treatment naïve.
- •No advanced fibrosis. Defined by the absence of clinical, radiological and laboratory signs of cirrhosis, and fibrosis assessment consistent with fibrosis stage (Metavir F2) or less by liver biopsy or transient elastography.
- •Not expected to leave the country for six months after the end of the intervention.
排除标准
- •Incapability of providing an informed consent to participate in the study.
- •Advanced fibrosis (Metavir F3) or cirrhosis (Metavir F4).
- •HIV or HBV co-infection
- •Organ transplant recipients.
- •Type 2 or 3 cryoglobulinemia with end-organ manifestations.
- •Proteinuria, nephrotic syndrome, or membranoproliferative glomerulonephritis
- •Patients with a higher risk of transmitting the disease (Dialysis patients, incarcerated individuals, and intravenous drug abusers).
- •The use of any medication that has major interactions with Elbasvir or Grazoprevir as defined by the University of Liverpool drug interaction database, and cannot be discontinued or replaced with other alternatives.
- •History of hepatocellular carcinoma.
研究组 & 干预措施
Treatment arm
Elbasvir, Grazoprevir 50-100Mg Oral Tablet
干预措施: Elbasvir, Grazoprevir 50-100Mg Oral Tablet (Drug)
结局指标
主要结局
Sustained virologic response at 12 weeks after the end of intervention (SVR-12).
时间窗: At 12 weeks after the end of intervention.
Viral RNA below the level of detection at 12 weeks after the end of the intervention. (Hepatitis C viral load evaluated by polymerase chain reaction (PCR) with a cutoff of 20 IU/mL for detectability.)
次要结局
- Serious and treatment-related adverse events.(From the first day of intervention until the end of week 4 after the intervention is finished.)
- Sustained virological response at 4 weeks after the end of intervention (SVR-4).(At 4 weeks after the end of intervention.)
- Changes in the quality of life: Hepatitis Quality of Life Questionnaire (HQLQ)(Quality of life evaluations will take place over three occasions. The first will be at baseline (upon treatment initiation), the second will be during treatment/at the end of treatment, and the last will be 12 weeks after the end of treatment)
研究者
Ahmad A AlEid, MD
Staff Physician, Department of Gastroenterology and Hepatology, Consultant Advanced Hepatology and Liver Transplantation, Principal Investigator of the ELEGANT-4 trial
King Fahad Medical City