A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 65
- 主要终点
- Adverse Events Leading to Permanent Discontinuation of Study Drug
研究概览
简要总结
This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Infection with HCV genotype 2 or 3
- •Had cirrhosis determination
- •Prior treatment failure
- •Screening laboratory values within defined thresholds
- •Subject had not been treated with any investigational drug or device within 30 days of the screening visit
- •Use of highly effective contraception methods if female of childbearing potential or sexually active male
排除标准
- •Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
- •Pregnant or nursing female or male with pregnant female partner
- •Current or prior history of clinical hepatic decompensation
- •History of clinically significant illness or any other major medical disorder that may have interfered with subject treatment, assessment or compliance with the protocol
- •Excessive alcohol ingestion or significant drug abuse
研究组 & 干预措施
SOF+RBV+placebo
Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
干预措施: SOF (Drug)
SOF+RBV+placebo
Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
干预措施: RBV (Drug)
SOF+RBV+placebo
Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
干预措施: Placebo to match SOF (Drug)
SOF+RBV+placebo
Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
干预措施: Placebo to match RBV (Drug)
SOF+RBV
Participants were randomized to receive SOF+RBV for 16 weeks.
干预措施: SOF (Drug)
SOF+RBV
Participants were randomized to receive SOF+RBV for 16 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Adverse Events Leading to Permanent Discontinuation of Study Drug
时间窗: Baseline to Week 16
Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.
Percentage of Participants Achieving 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 after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
次要结局
- Percentage of Participants Achieving SVR24(Posttreatment Week 24)
- Percentage of Participants With Viral Breakthrough(Up to 16 weeks)
- Percentage of Participants Achieving SVR4(Posttreatment Week 4)
- Percentage of Participants With Viral Relapse(End of treatment to posttreatment Week 24)