A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 441
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 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
- •Age > 18, with chronic genotype 1 HCV infection
- •HCV treatment-experienced, including patients who have previously failed a nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV regimen
- •HCV RNA > 10,000 IU/mL at screening
- •Cirrhosis determination; a liver biopsy may be required
- •Screening laboratory values within defined thresholds
- •Use of two effective contraception methods if female of childbearing potential or sexually active male
排除标准
- •Pregnant or nursing female or male with pregnant female partner
- •Coinfection with HIV or hepatitis B virus
- •Current or prior history of clinical hepatic decompensation
- •Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
- •Chronic use of systemic immunosuppressive agents
- •History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
研究组 & 干预措施
LDV/SOF 12 Weeks
Participants will receive LDV/SOF FDC for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 Weeks
Participants will receive LDV/SOF FDC plus RBV for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 Weeks
Participants will receive LDV/SOF FDC plus RBV for 12 weeks.
干预措施: RBV (Drug)
LDV/SOF 24 Weeks
Participants will receive LDV/SOF FDC for 24 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 24 Weeks
Participants will receive LDV/SOF FDC plus RBV for 24 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 24 Weeks
Participants will receive LDV/SOF FDC plus RBV for 24 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
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, 25 IU/mL) 12 weeks following the last dose of study drug.
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
时间窗: Up to 24 weeks
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
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 HCV RNA < LLOQ at Week 2(Week 2)
- Change From Baseline in HCV RNA at Week 4(Baseline; Week 4)
- Change From Baseline in HCV RNA at Week 8(Baseline; Week 8)
- Percentage of Participants With HCV RNA < LLOQ at Week 24(Week 24)
- Change From Baseline in HCV RNA at Week 2(Baseline; Week 2)
- Percentage of Participants With HCV RNA < LLOQ at Week 1(Week 1)
- Percentage of Participants With HCV RNA < LLOQ at Week 4(Week 4)
- Percentage of Participants With HCV RNA < LLOQ at Week 8(Week 8)
- Percentage of Participants With HCV RNA < LLOQ at Week 12(Week 12)
- Change From Baseline in HCV RNA at Week 1(Baseline; Week 1)
- Percentage of Participants With Virologic Failure(Baseline to posttreatment Week 24)