A Phase 3, Open-label Study to Investigate the Efficacy and Safety of GS-7977 Plus Ribavirin in Chronic Genotype 1, 2 and 3 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
- 224
- 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 study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) plus ribavirin (RBV) in adults with chronic genotypes 1, 2, and 3 HCV infection who are coinfected with HIV-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Willing and able to provide written informed consent
- •Male or female, age ≥ 18 years with chronic HCV and HIV-1 infection
- •HCV RNA > 1 x 10^4 IU/mL at screening
- •Infection with HCV genotype 1, 2 or 3 as determined at screening
- •HIV-1 infection confirmed with positive ELISA or Western blot at screening
- •Medical records must be sufficient to be categorized on interferon (IFN) eligibility or prior treatment history with PEG/RBV.
- •Confirmation of chronic HCV infection
- •Ability to determine presence/absence of cirrhosis.
- •HIV antiretroviral therapy (ARV) criteria of one of the following:
- •ARV untreated with a CD4 T-cell count > 500 cells/mm^3
- •On a stable, protocol-approved, ARV for > 8 weeks prior to screening with a CD4 T-cell count > 200 cells/mm^3 and a documented undetectable plasma HIV-1 RNA level for ≥ 8 weeks preceding the screening visit
- •Approved HIV antiretroviral medications based on drug interaction studies
- •Not been treated with any investigational drug or device within 30 days of the screening visit
- •Females if confirmed that she is not pregnant or nursing of non-childbearing potential or of childbearing potential but has a negative serum pregnancy test at screening and agrees to use protocol approved method of birth control from screening through 6 months after the last dose of RBV
- •Males who agree to consistently and correctly use a condom while their female partner agrees to use protocol approved method of birth control from screening through 7 months after the last dose of RBV
- •Must be of generally good health as determined by the investigator.
- •Liver imaging within 6 months of baseline/Day 1 is required in cirrhotic patients only, to exclude hepatocellular carcinoma (HCC)
排除标准
- •Non-genotype 1/2/3 or mixed genotype at screening
- •Genotype 1 with prior treatment for HCV
- •Poor control with ARV regimen
- •Prior exposure to a direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
- •Chronic liver disease of a non-HCV etiology (eg, hemochromatosis, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
- •A new AIDS-defining condition diagnosed within 30 days prior to screening
- •Active, serious infection (other than HIV or HCV) requiring parenteral antibiotics, antivirals or antifungals within 30 days prior to baseline
- •Infection with hepatitis B virus (HBV)
- •Contraindication to RBV therapy
- •Chronic use of systemically administered immunosuppressive agents (eg, prednisone equivalent > 10 mg/day)
- •History of solid organ transplantation or malignancy diagnosed or treated within 5 years
- •Current or prior history of clinical hepatic decompensation or other significant gastrointestinal disorder
研究组 & 干预措施
SOF+RBV 12 Weeks (GT 2/3, TN)
Treatment-naive (TN) participants coinfected with HIV-1 and genotype (GT) 2 or genotype 3 HCV infection will receive SOF+RBV for 12 weeks.
干预措施: SOF (Drug)
SOF+RBV 12 Weeks (GT 2/3, TN)
Treatment-naive (TN) participants coinfected with HIV-1 and genotype (GT) 2 or genotype 3 HCV infection will receive SOF+RBV for 12 weeks.
干预措施: RBV (Drug)
SOF+RBV 24 Weeks (GT 2/3, TE)
Treatment-experienced (TE) participants coinfected with HIV-1 and genotype 2 or genotype 3 HCV infection will receive SOF+RBV for 24 weeks.
干预措施: SOF (Drug)
SOF+RBV 24 Weeks (GT 2/3, TE)
Treatment-experienced (TE) participants coinfected with HIV-1 and genotype 2 or genotype 3 HCV infection will receive SOF+RBV for 24 weeks.
干预措施: RBV (Drug)
SOF+RBV 24 Weeks (GT 1, TN)
Treatment-naive (TN) participants coinfected with HIV-1 and genotype 1 HCV infection will receive SOF+RBV for 24 weeks.
干预措施: SOF (Drug)
SOF+RBV 24 Weeks (GT 1, TN)
Treatment-naive (TN) participants coinfected with HIV-1 and genotype 1 HCV infection will receive SOF+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) at 12 weeks after stopping study treatment.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
时间窗: Up to 24 weeks
The percentage of participants 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)
- Change From Baseline in HCV RNA at Week 1(Baseline; Week 1)
- Change From Baseline in HCV RNA at Week 2(Baseline; Week 2)
- Change From Baseline in HCV RNA at Week 4(Baseline; Week 4)
- Change From Baseline in HCV RNA at Week 6(Baseline; Week 6)
- Change From Baseline in HCV RNA at Week 8(Baseline; Week 8)
- Percentage of Participants Experiencing On-treatment Virologic Failure(Up to 24 weeks)
- Percentage of Participants Experiencing Viral Relapse(Up to Posttreatment Week 24)