Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment
研究概览
简要总结
The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.
详细描述
This is an open-label single arm study that will evaluate the antiviral efficacy, safety and tolerability of ledipasvir/sofosbuvir fixed dose combination administered for 12 weeks in HCV treatment-naive and treatment-experienced participants with chronic genotype 1 or 4 HCV infection. Approximately 240 participants will be enrolled and treated with sofosbuvir (SOF) 400 mg/LDV 90 mg fixed dose combination (FDC) one tablet once daily for 12 weeks in the SHARED 1 study. Sixty additional participants will be enrolled in the SHARED 2 sub-cohort with laboratory monitoring blinded to study clinicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •patients that are willing and able to provide written informed consent
- •age ≥ 18 years
- •HCV RNA ≥ 103 IU/mL
- •HCV genotype 1 or 4
- •screening ultrasound excluding hepatocellular carcinoma (HCC)
- •acceptable laboratory values (hemoglobin ≥8.0 g/dL, platelet count ≥40,000/mm3; AST, ALT, and alkaline phosphatase ≤10 × ULN; creatinine clearance ≥30 mL/min)
- •general good health
- •ability to comply with study procedures
- •HIV-infected patients must have completed at least 6 months of any approved HIV antiretroviral therapy (ART) per Rwanda National Guidelines 2013, have been taking for at least 2 weeks prior to screening ART compatible with SOF/LDV (efavirenz, rilpivirine, raltegravir, dolutegravir, emtricitabine, lamivudine, zidovudine, tenofovir), have screening HIV RNA < 200 copies/mL, and have screening CD4 T-cell count of ≥100 cells/µL
排除标准
- •current or history of clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
- •active tuberculosis
- •other clinically-significant illness (except HCV and/or HIV) or any other major medical disorder
- •active Hepatitis B infection
- •difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- •any IFN-containing regimen within 8 weeks prior to screening or any prior exposure to HCV-specific direct-acting antiviral agent (other than a NS3/4A protease inhibitor and SOF), current pregnancy or breastfeeding, and active drug or alcohol use or dependence
研究组 & 干预措施
Harvoni
sofosbuvir/ledipasvir once daily for 12 weeks
干预措施: sofosbuvir/ledipasvir (Drug)
结局指标
主要结局
Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment
时间窗: After study completion (24 weeks)
To determine the hepatitis C virus (HCV) antiviral efficacy of sofosbuvir/ledipasvir (SOF/LDV) fixed-dose combination (FDC) as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12) in Rwanda.
Proportion of participants with sustained viral response as defined by an HCV RNA below the limit of quantification 12 weeks after discontinuation of study treatment, with limited lab monitoring
时间窗: After study completion (24 weeks)
To determine the HCV antiviral efficacy of SOF/LDV FDC, as measured by the proportion of participants with sustained viral response 12 weeks after discontinuation of study treatment (SVR12), with limited lab monitoring in Rwanda.
Proportion of participants with a new grade 3 or 4 adverse event or premature study drug discontinuation due to an adverse event.
时间窗: After study completion (24 weeks)
To evaluate the safety and tolerability of SOF/LDV FDC in Rwanda
次要结局
- SVR12, stratified by genotypic subtype(After study completion (24 weeks))
- A set of minimum required monitoring tests(After study completion (24 weeks))
- Distribution of HCV genotypes subtypes among participants(After study completion (24 weeks))
- Proportion of participants with HCV RNA below the level of quantitation (BLQ) while on treatment(After study completion (24 weeks))
- Basic demographic and clinical characteristics of patients referred for HCV treatment(After study completion (24 weeks))
- Adherence to SOF/LDV measured by pill count(After 12 weeks medication therapy)
- Proportion of participants with virologic failure(After study completion (24 weeks))
- Proportion of HIV co-infected participants that maintain HIV-1 RNA< 200 copies/mL while on HCV treatment(After 12 weeks of medication therapy)
- Proportion of participants reporting increased quality of life after SVR12 using the Medical Outcomes Study HIV Health Survey(After study completion (24 weeks))