A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 255
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
The primary objective of this study was to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 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
- •Willing and able to provide written informed consent
- •Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
- •HCV genotype 4 at screening
- •HCV treatment naive or prior participation in this study or study GS-US-334-0138 (Cohorts 1 and 2 only)
- •Cohort 3 only: HCV treatment-experienced (previously received therapy for HCV infection with an interferon (IFN)-containing regimen, with or without RBV and/or an HCV NS3/NS4A protease inhibitor (PI)
- •Body mass index (BMI) ≥ 18 kg/m^2
- •Screening laboratory values within defined thresholds
- •Use of effective protocol-approved contraception methods
排除标准
- •History of clinically-significant illness or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Pregnant or nursing females or male with pregnant female partner
- •Clinically-relevant drug or alcohol abuse within 12 months of screening
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
LDV/SOF 8 wk TN (Cohort 1, Group 1)
LDV/SOF for 8 weeks (treatment-naive (TN))
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2)
LDV/SOF+RBV for 8 weeks (treatment-naive)
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 8 wk TN (Cohort 1, Group 2)
LDV/SOF+RBV for 8 weeks (treatment-naive)
干预措施: RBV (Drug)
LDV/SOF 12 wk TN (Cohort 1, Group 3)
LDV/SOF for 12 weeks (treatment-naive)
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4)
LDV/SOF+RBV for 12 weeks (treatment-naive)
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 wk TN (Cohort 1, Group 4)
LDV/SOF+RBV for 12 weeks (treatment-naive)
干预措施: RBV (Drug)
LDV/SOF+RBV 12 wk TE (Cohort 2)
Treatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 wk TE (Cohort 2)
Treatment-experienced (TE) participants who completed treatment in Gilead sponsored study GS-US-334-0138 or in Cohort 1 of this study and did not achieve SVR12 will receive LDV/SOF+RBV for 12 weeks.
干预措施: RBV (Drug)
LDV/SOF 12 wk TE (Cohort 3, Group 1)
LDV/SOF for 12 weeks (treatment-experienced)
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2)
LDV/SOF+RBV for 12 weeks (treatment-experienced)
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 wk TE (Cohort 3, Group 2)
LDV/SOF+RBV for 12 weeks (treatment-experienced)
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 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) 12 weeks following the last dose of study drug.
Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)
时间窗: 12 weeks
次要结局
- Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With Overall Virologic Failure(Up to Posttreatment Week 24)