A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 51
- 主要终点
- Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
研究概览
简要总结
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV) in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus (HCV) infection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HCV infection
- •Body mass index (BMI) ≥ 18 kg/m^2
- •HCV RNA ≥ 10000 IU/mL at screening
- •Use of highly effective contraception methods if female of childbearing potential or sexually active male
- •Must not have cirrhosis
排除标准
- •Current or prior history of clinically significant illness other than HCV
- •Screening ECG with clinically significant abnormalities
- •Prior exposure to HCV specific direct acting antiviral agent
- •Prior treatment of HCV with interferon or ribavirin
- •Pregnant or nursing female or male with pregnant female partner
- •Chronic liver disease of non-HCV etiology
- •Hepatitis B
- •Active drug abuse
- •Use of any prohibited concomitant medications
研究组 & 干预措施
SOF+VEL 25 mg 12 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
干预措施: SOF (Drug)
SOF+VEL 25 mg 12 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
干预措施: VEL (Drug)
SOF+VEL 100 mg 12 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
干预措施: SOF (Drug)
SOF+VEL 25 mg 12 Weeks (GT3)
Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
干预措施: SOF (Drug)
SOF+VEL 100 mg 12 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
干预措施: VEL (Drug)
SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
干预措施: SOF (Drug)
SOF+VEL 25 mg 12 Weeks (GT2/4/5/6)
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
干预措施: VEL (Drug)
SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
干预措施: SOF (Drug)
SOF+VEL 100 mg 12 Weeks (GT2/4/5/6)
Participants with genotype 2, 4, 5, or 6 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
干预措施: VEL (Drug)
SOF+VEL 25 mg 12 Weeks (GT3)
Participants with genotype 3 HCV infection will receive SOF+VEL 25 mg for 12 weeks.
干预措施: VEL (Drug)
SOF+VEL 100 mg 12 Weeks (GT3)
Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
干预措施: SOF (Drug)
SOF+VEL 100 mg 12 Weeks (GT3)
Participants with genotype 3 HCV infection will receive SOF+VEL 100 mg for 12 weeks.
干预措施: VEL (Drug)
SOF+VEL 25 mg 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
干预措施: SOF (Drug)
SOF+VEL 25 mg 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
干预措施: VEL (Drug)
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
干预措施: SOF (Drug)
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
干预措施: VEL (Drug)
SOF+VEL 25 mg + RBV 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
干预措施: RBV (Drug)
SOF+VEL 100 mg 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
干预措施: SOF (Drug)
SOF+VEL 100 mg 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
干预措施: VEL (Drug)
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
干预措施: SOF (Drug)
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
干预措施: VEL (Drug)
SOF+VEL 100 mg + RBV 8 Weeks (GT1)
Participants with genotype 1 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
干预措施: RBV (Drug)
SOF+VEL 25 mg 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
干预措施: SOF (Drug)
SOF+VEL 25 mg 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg for 8 weeks.
干预措施: VEL (Drug)
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
干预措施: SOF (Drug)
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
干预措施: VEL (Drug)
SOF+VEL 25 mg + RBV 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 25 mg plus RBV for 8 weeks.
干预措施: RBV (Drug)
SOF+VEL 100 mg 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
干预措施: SOF (Drug)
SOF+VEL 100 mg 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg for 8 weeks.
干预措施: VEL (Drug)
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
干预措施: SOF (Drug)
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
干预措施: VEL (Drug)
SOF+VEL 100 mg + RBV 8 Weeks (GT2)
Participants with genotype 2 HCV infection will receive SOF+VEL 100 mg plus RBV for 8 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
时间窗: Up to 12 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
次要结局
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)