A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 546
- 试验地点
- 48
- 主要终点
- Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
研究概览
简要总结
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.
详细描述
Randomization was stratified by geographic region (China, South Korea, Singapore), genotype (GT1, GT2, combined GT3 - 6), and HCV/HIV co-infection status (co-infected, not co-infected). In China, eligible participants were randomized to Arm A or Arm B (defined below) in the following ratios: 2:1 for GT1, 2:1 for GT2, and 2:1 for combined GT3-6. In South Korea and Singapore, eligible participants were randomized to Arm A or Arm B in the following ratios: 2:1 for GT1 and 2:1 for GT2.
All Primary and Secondary Outcome Measures were pre-specified to be analyzed only in Arm A.
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
- •Must be of Asian descent
- •Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5 or 6 infection.
- •Positive anti-HCV antibody (Ab) and HCV ribonucleic acid (RNA) viral load ≥ 1000 IU/ mL at Screening Visit.
- •Chronic HCV infection defined as one of the following:
- •Positive for anti-HCV Ab or HCV RNA at least 6 months before Screening; or
- •A liver biopsy consistent with chronic HCV infection
- •HCV treatment-naïve to any approved or investigational HCV treatment or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon[pegIFN] with or without ribavirin, OR sofosbuvir with RBV with or without IFN. Previous treatment must have been completed ≥ 8 weeks prior to screening.
- •Participant must be documented as non-cirrhotic.
- •Participants enrolled with human immunodeficiency virus (HIV)-1 and HCV co-infection must also meet the following criteria:
- •Positive test result for human immunodeficiency virus antibody (HIV Ab) at Screening
- •Naïve to treatment with any antiretroviral therapy (ART) with a cluster of differentiation (CD)4+ count greater than or equal to 500 cells/mm³ (or CD4+ percent ≥ 29%)
- •On a stable, qualifying HIV-1 ART regimen with CD4+ count ≥ 200 cells/mm³ (or CD4+ % ≥ 14%) at Screening and plasma HIV-1 RNA below lower limit of quantification (LLOQ) by an approved plasma HIV-1 RNA quantitative assay at Screening and at least once during the 12 months prior to Screening.
排除标准
- •Positive test result for Hepatitis B surface antigen (HbsAg) or positive test result for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) if HBsAg is negative.
- •Any cause of liver disease other than chronic HCV-infection.
- •HCV genotype performed during screening indicating co-infection with more than one HCV genotype
- •Clinically significant abnormalities, other than HCV infection or HCV/HIV co-infection
- •Chronic human immunodeficiency virus, type 2 (HIV-2) infection
- •Additional Exclusion Criteria for participants with HCV/HIV Co-Infection:
- •For participants on stable ART, taking anti-retroviral agent(s) other than those permitted
- •Treatment for an acquired immunodeficiency syndrome (AIDS)-associated opportunistic infection within 12 months of Screening or prophylaxis for an AIDS-associated opportunistic infection within 6 months of screening
- •Diagnosis of any clinical AIDS-defining event within 12 months prior to Screening.
研究组 & 干预措施
Glecaprevir/Pibrentasvir
Participants received oral glecaprevir/pibrentasvir (300 mg/120 mg) once daily with food for 8 or 16 weeks during the double-blind (DB) treatment period.
Participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
干预措施: Glecaprevir/Pibrentasvir (Drug)
Placebo / Glecaprevir/Pibrentasvir
Participants received placebo to glecaprevir/pibrentasvir for 8 or 16 weeks during the DB treatment period followed by glecaprevir/pibrentasvir (300 mg/120 mg) once daily for 8 or 16 weeks during the open-label (OL) treatment period.
In each period participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
干预措施: Placebo (Drug)
Placebo / Glecaprevir/Pibrentasvir
Participants received placebo to glecaprevir/pibrentasvir for 8 or 16 weeks during the DB treatment period followed by glecaprevir/pibrentasvir (300 mg/120 mg) once daily for 8 or 16 weeks during the open-label (OL) treatment period.
In each period participants received treatment for 8 weeks with the exception of treatment-experienced, genotype 3-infected participants who received treatment for 16 weeks.
干预措施: Glecaprevir/Pibrentasvir (Drug)
结局指标
主要结局
Percentage of HCV GT1 - GT6-Infected Participants in Arm A Who Achieved Sustained Virologic Response 12 Weeks Post Treatment (SVR12)
时间窗: 12 weeks after the last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
Sustained virologic response 12 weeks post-treatment (SVR12) was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (LLOQ; less than 15 IU/mL) 12 weeks after the last dose of study drug.
Percentage of HCV GT1-Infected Participants in Arm A Who Achieved SVR12
时间窗: 12 weeks after last actual dose of study drug, Week 20 or Week 28 depending on the treatment regimen
SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last dose of study drug.
Percentage of HCV GT2-Infected Participants in Arm A Who Achieved SVR12
时间窗: 12 weeks after the last dose of study drug, Week 20 or Week 28 depending on the treatment regimen.
SVR12 was defined as plasma HCV RNA level less than 15 IU/mL 12 weeks after the last actual dose of study drug.
次要结局
- Percentage of Participants in Arm A With On-treatment Virologic Failure(8 or 16 weeks depending on the treatment regimen)
- Percentage of Participants in Arm A With Post-treatment Relapse(From the end of treatment (Weeks 8 or 16) through 12 weeks after the last dose of study drug (Weeks 20 or 28 depending on the treatment regimen).)
- Percentage of HCV/HIV Co-infected Participants in Arm A Who Achieved SVR12(12 weeks after the last actual dose of study drug, Week 20 or 28 depending on the treatment regimen)