A Multi-Site, Open-Label, Partially-Randomized Trial of the Efficacy and Safety of Fixed Dose Elbasvir/Grazoprevir (EBR/GZR) Based Regimens in French Subjects With Chronic Hepatitis C Virus (HCV) Genotype 4 Infection
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 13
- 主要终点
- Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After End of Treatment (SVR12)
研究概览
简要总结
The purpose of this study was to evaluate the efficacy of 8 and 12 weeks of treatment with a fixed dose combination (FDC) of elbasvir (EBR) 50 mg + grazoprevir (GZR) 100 mg (i.e., MK-5172A) as assessed by the percentage of participants with hepatitis C virus (HCV) genotype (GT) 4 infection that achieve sustained virologic response (HCV ribonucleic acid [RNA] < Lower Limit of Quantification [LLOQ]) 12 weeks after the end of study therapy (SVR12). This study also evaluated the safety and tolerability of EBR/GZR.
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
- •Be a current resident of France
- •Have HCV RNA (≥ 10,000 IU/mL in peripheral blood) at the time of screening
- •Have documented chronic HCV GT4 (with no evidence of non-typeable or mixed genotype) infection
- •Have liver biopsy performed within 24 months of Day 1 of this study (if participant has cirrhosis, there is no time restriction on biopsy), or have FibroScan® performed within 12 months of Day 1 of this study with interpretable result in kilopascals (kPa) as follows: Fibrosis score of F0-F2, Fibrosis score of F3, or Cirrhosis (F4)
- •Have a prior treatment history of either HCV TN or HCV TE with interferon (IFN) +/- ribavirin (RBV) +/- Sofosbuvir (SOF) (on-treatment failure, relapser, or other/intolerant)
- •Females who are of reproductive potential must agree to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: (1) practice abstinence from heterosexual activity OR (2) use (or have her partner use) acceptable contraception during heterosexual activity
- •If Human Immunodeficiency Virus (HIV) co-infected, then have HIV-1 infection documented prior to screening
排除标准
- •Had prior treatment (defined as 1 dose or more) with direct-acting antiviral (DAA) therapy
- •Has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of active advanced liver disease
- •Classified as Child-Pugh B or C or has a Child Pugh-Turcotte score (CPT) > 6
- •Has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
- •Hepatitis B virus surface antigen (HBsAg) positive at screening. Participants who are HBsAg negative and hepatitis B core antibody (anti-HBc) positive at screening may be included
- •Under evaluation for active or suspected malignancy, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study
研究组 & 干预措施
Arm 1: EBR/GZR for 8 Weeks
Treatment-naïve participants with stage 0-2 fibrosis (F0-F2) receive FDC of EBR/GZR (50 mg/100 mg) for 8 weeks, with 24 weeks of follow-up.
干预措施: EBR/GZR (50 mg/100 mg) FDC (Drug)
Arm 2: EBR/GZR for 12 Weeks
Treatment-naïve participants with F0-F2 stage fibrosis, treatment-naïve participants with F3-F4 stage fibrosis, and treatment-experienced participants with F0-F4 stage fibrosis receive FDC of EBR/GZR (50 mg/100 mg) for 12 weeks, with 24 weeks of follow-up.
干预措施: EBR/GZR (50 mg/100 mg) FDC (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sustained Virologic Response 12 Weeks After End of Treatment (SVR12)
时间窗: 12 weeks after completing study treatment (Arm 1: Week 20 / Arm 2: Week 24)
The percentage of participants to achieve SVR12 was determined for each arm (SVR12 was defined as HCV ribonucleic acid \[RNA\] \< lower limit of quantification \[LLOQ\] at 12 weeks after the end of all study therapy). Plasma HCV RNA was measured using the COBAS™ AmpliPrep/COBAS™ TaqMan HCV Test, v2.0®, which has a LLOQ of 15 IU/mL.
Number of Participants With ≥ 1 Adverse Events (AEs)
时间窗: Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Number of Participants Who Discontinued From Study Treatment Due to an AE
时间窗: Up to Study Week 12
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
次要结局
- Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)(24 weeks after completing study treatment (Arm 1: Week 32 / Arm 2: Week 36))
- Prevalence of Baseline NS5A RASs to EBR or GZR(Day 1)
- Prevalence of Baseline NS3 Resistance-Associated Substitutions (RASs) to EBR or GZR(Day 1)