A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects With Genotype 2 or 3 Chronic HCV Infection.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 601
- 主要终点
- Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
研究概览
简要总结
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir (Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus (HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 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
- •Male or female, age greater than or equal to 18 years.
- •Confirmed chronic HCV infection.
- •Subjects will have cirrhosis status assessment; liver biopsy may be required.
- •Genotype 2 subjects must have cirrhosis of the liver to be eligible.
- •Treatment-naive or prior treatment failure to ≥12 weeks of an interferon- based regimen that was not discontinued prematurely due to an adverse event
- •Infection with HCV genotype 2 or 3 as determined at Screening
- •Body mass index (BMI) greater than or equal to 18 kg/m^2
- •Screening laboratory values within predefined thresholds.
- •Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.
- •Subject must be of generally good health as determined by the Investigator.
排除标准
- •Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase
- •Pregnant or nursing female or male with pregnant female partner
- •History of any other clinically significant chronic liver disease.
- •HIV or chronic hepatitis B virus (HBV) infection.
- •Malignancy with the exception of certain resolved skin cancers.
- •Chronic use of systemically administered immunosuppressive agents.
- •Clinically-relevant drug or alcohol abuse.
- •History of solid organ transplantation.
- •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.
- •Known hypersensitivity to interferon, RBV, the study investigational medicinal product, the metabolites, or formulation excipients.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
SOF+RBV+Peg-IFN 12 weeks
SOF+RBV+Peg-IFN for 12 weeks
干预措施: Peg-IFN (Drug)
SOF+RBV 16 weeks
SOF+RBV for 16 weeks
干预措施: SOF (Drug)
SOF+RBV 16 weeks
SOF+RBV for 16 weeks
干预措施: RBV (Drug)
SOF+RBV 24 weeks
SOF+RBV for 24 weeks
干预措施: SOF (Drug)
SOF+RBV 24 weeks
SOF+RBV for 24 weeks
干预措施: RBV (Drug)
SOF+RBV+Peg-IFN 12 weeks
SOF+RBV+Peg-IFN for 12 weeks
干预措施: SOF (Drug)
SOF+RBV+Peg-IFN 12 weeks
SOF+RBV+Peg-IFN for 12 weeks
干预措施: RBV (Drug)
Retreatment Substudy
Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks.
干预措施: SOF (Drug)
Retreatment Substudy
Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks.
干预措施: RBV (Drug)
Retreatment Substudy
Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks.
干预措施: Peg-IFN (Drug)
结局指标
主要结局
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
时间窗: Up to 24 weeks
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, 15 IU/mL) at 12 weeks after stopping study treatment.
次要结局
- HCV RNA at Weeks 1, 2, 4, 8, and 12(Weeks 1, 2, 4, 8, and 12)
- 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 Experiencing On-Treatment Virologic Failure(Up to 24 weeks)
- Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24(Weeks 1, 2, 4, 8, 12, 16, 20, and 24)
- Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12(Baseline; Weeks 1, 2, 4, 8, and 12)
- Percentage of Participants Experiencing Viral Relapse(Up to Posttreatment Week 24)