A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)-1 Co-infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 335
- 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 will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 weeks in hepatitis C virus (HCV) treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic genotype 1 or 4 HCV infection who are co-infected with HIV-1.
Participants who experience confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 may be eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF plus ribavirin (RBV) for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •HCV RNA ≥ 10,000 IU/mL at screening
- •HCV genotype 1 or 4
- •HIV-1 infection
- •Cirrhosis determination, a fibroscan or liver biopsy may be required
- •Screening laboratory values within defined thresholds
- •Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male
排除标准
- •Clinically-significant illness (other than HCV or HIV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol
- •Current or prior history of clinical hepatic decompensation, hepatocellular carcinoma (HCC), or other malignancy (with the exception of certain resolved skin cancers)
- •Hepatitis B virus (HBV) infection
- •Pregnant or nursing female
- •Chronic use of systemically administered immunosuppressive agents
研究组 & 干预措施
LDV/SOF 12 Weeks
LDV/SOF for 12 weeks
干预措施: LDV/SOF (Drug)
Retreatment Substudy
LDV/SOF plus RBV for 24 weeks
干预措施: LDV/SOF (Drug)
Retreatment Substudy
LDV/SOF 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) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
时间窗: Up to 12 weeks
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 Weeks 1, 2, 4, 6, 8, 10, and 12(Weeks 1, 2, 4, 6, 8, 10, and 12)
- Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, and 8(Baseline; Weeks 1, 2, 4, 6, and 8)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
- Percentage of Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment(Weeks 4, 8, and 12)
- Change From Baseline in Serum Creatinine at the End of Treatment (Week 12) and at Posttreatment Weeks 12 and 24(Baseline; Week 12, Posttreatment Weeks 12 and 24)
- For Participants in the Retreatment Substudy, Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (SVR4, SVR12, and SVR24)(Posttreatment Weeks 4, 12, and 24 of Retreatment Substudy)
- For Participants in the Retreatment Substudy, Percentage of Participants With HCV RNA < LLOQ at Retreatment Weeks 2, 4, 8, 12, 16, 20, and 24(Weeks 2, 4, 8, 12, 16, 20, and 24 of the Retreatment Substudy)
- For Participants in the Retreatment Substudy, Change From Baseline in HCV RNA at Retreatment Weeks 2, 4, and 8(Baseline; Weeks 2, 4, and 8 of Retreatment Substudy)
- For Participants in the Retreatment Substudy, Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24 of Retreatment Substudy)