A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 62
- 主要终点
- Percentage of Participants Achieving SVR12
研究概览
简要总结
This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.
详细描述
Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.
Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.
Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.
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
- •Cirrhosis determination
- •Subject meets one of the following classifications:
- •IFN unwilling
- •IFN ineligible
- •IFN intolerant
- •Screening laboratory values within defined thresholds
- •Subject has 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 interfere 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
Participants were randomized to receive SOF+RBV for 12 weeks.
干预措施: SOF (Drug)
SOF+RBV
Participants were randomized to receive SOF+RBV for 12 weeks.
干预措施: RBV (Drug)
Placebo
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.
干预措施: Placebo to match SOF (Drug)
Placebo
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.
干预措施: Placebo to match RBV (Drug)
结局指标
主要结局
Percentage of Participants Achieving SVR12
时间窗: Post-treatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ, ie, \< 25 IU/mL) 12 weeks after cessation of therapy
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
时间窗: Baseline to Week 12
The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.
次要结局
- Percentage of Participants Achieving SVR4(Post-treatment Week 4)
- Percentage of Participants Achieving SVR24(Post-treatment Week 24)
- Percentage of Participants Experiencing Viral Breakthrough(Baseline to Week 12)
- Percentage of Participants Experiencing Viral Relapse(End of treatment to post-treatment Week 24)