HCV Cure and Kidney Health: A Prospective, Observational Cohort Study of HCV Genotype 1 and 4 Infected Adults With and Without HIV Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Glomerular filtration rate and injury
研究概览
简要总结
The purpose of this study is to learn how 12 weeks of HCV treatment with elbasvir and grazoprevir (brand name Zepatier) impacts your kidney function.
详细描述
Prospective data collection of 25 Genotype 1 or 4 HCV-infected women from the San Francisco Women's Interagency HIV Study (WIHS) site and 25 Genotype 1 or 4 HCV-infected men from the San Francisco VA Medical Center who are initiated on Zepatier for 12 weeks (Total n=50). For women and men with HCV genotype 1a infection, only those without baseline NS5A resistance mutations will be included. Blood/urine samples will be collected before initiation of treatment, 4 weeks after treatment initiation, 12 weeks after treatment initiation (end of treatment), 24 weeks after treatment initiation to determine Sustained Virological Response (SVR), and at 48 weeks after treatment initiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Active Genotype 1 or 4 HCV infection (If with Genotype 1a infection, only those without baseline NS5A resistance mutation will be included; Genotype 4 HCV infection is uncommon in both study populations). Subjects with HIV coinfection are included. We will not exclude patients who have severe Chronic Kidney Disease, are on dialysis, or have undergone kidney transplant.
排除标准
- •HCV genotype 2, 3, 5, or 6 infection
- •Previous virologic failure to regimens containing an NS5A inhibitor
- •Decompensated liver disease (Child-Pugh Class B or C)
- •Albumin below 3g/dL
- •Platelet count below 75,000
- •Any condition that the investigator considers a contraindication to study participation including limited life expectancy
- •Pregnant or breastfeeding woman
- •Hepatitis B virus (HBV) surface antigen positive (Note: Patients positive for the HBV core antibody will not be excluded, but will have HBV DNA levels checked and will be monitored while on Direct Acting Antivirals (DAA) therapy and medically managed as considered appropriate)
- •Documented ongoing nonadherence to prescribed medications or medical treatment, failure to complete HCV disease evaluation appointments and procedures or unable to commit to scheduled followup/monitoring for the duration of treatment
- •Poor venous access not allowing screening laboratory collection
- •Known hypersensitivity to elbasvir/grazoprevir
- •Co-administration with drugs that are 1) strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin); 2) OATP1B1/3 inhibitors (e.g., cyclosporine, darunavir, atazanavir, tipranavir, lopinavir or saquinavir) or 3) efavirenz
结局指标
主要结局
Glomerular filtration rate and injury
时间窗: 1 year
measured by Cystatin C
glomerular filtration rate and injury
时间窗: 1 year
measured by albuminuria
Tubule dysfunction
时间窗: 1 year
measured by beta2-microglobulin
Tubule injury
时间窗: 1 year
measured by Interleukin-18
tubule injury
时间窗: 1 year
measured by Trefoil factor-3 (TFF-3)
次要结局
- HCV clearance(1 year)
- liver fibrosis(1 year)
研究者
Phyllis Tien
Professor of Medicine and Clinical Pharmacy and Staff Physician
San Francisco Veterans Affairs Medical Center