A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 275
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.
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
- •Age ≥ 18 years with HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection
- •HCV RNA > 10,000 IU/mL at screening
- •HCV treatment history:
- •Treatment-naive for HCV genotypes 1, 2, 3, or 4, or
- •Treatment-experienced for HCV genotypes 2 or 3
- •HIV antiretroviral (ARV) criteria:
- •On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for > 8 weeks prior to screening, or
- •ARV untreated for ≥ 8 weeks prior to screening, with a CD4 T-cell count > 500 cells/mm^3
- •Presence or absence of cirrhosis; a liver biopsy may be required
- •Healthy according to medical history and physical examination with the exception of HCV and HIV diagnosis
- •Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
排除标准
- •HCV genotype 1 or 4 with previous HCV treatment
- •Poor control with HIV ARV regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing
- •A new AIDS-defining condition diagnosed within 30 days prior to screening
- •Prior use of any other inhibitor of the HCV NS5B polymerase
- •History of any other clinically significant chronic liver disease
- •Evidence of or history of decompensated liver disease
- •Chronic hepatitis B virus (HBV) infection
- •Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- •Chronic use of immunosuppressive agents or immunomodulatory agents
- •Clinically relevant drug or alcohol abuse within 12 months of screening
- •History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study or not be in the best interest of the participant in the opinion of the investigator
研究组 & 干预措施
Genotype 2 treatment-naive
Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks.
干预措施: Sofosbuvir (Drug)
Genotype 2 treatment-naive
Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks.
干预措施: RBV (Drug)
Genotype 2/3 treatment-experienced
Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.
干预措施: Sofosbuvir (Drug)
Genotype 2/3 treatment-experienced
Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.
干预措施: RBV (Drug)
Genotype 1/3/4 treatment-naive
Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks.
干预措施: Sofosbuvir (Drug)
Genotype 1/3/4 treatment-naive
Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir 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) at 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) 12 weeks following the last dose of study drug.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
时间窗: Up to 24 weeks
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
次要结局
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- HCV RNA Change From Baseline at Week 1(Baseline; Week 1)
- HCV RNA Change From Baseline at Week 2(Baseline; Week 2)
- HCV RNA Change From Baseline at Week 4(Baseline; Week 4)
- HCV RNA Change From Baseline at Week 6(Baseline; Week 6)
- HCV RNA Change From Baseline at Week 8(Baseline; Week 8)
- Percentage of Participants Experiencing Virologic Failure(Baseline up to Posttreatment Week 24)