Real World Experience of Chronic Hepatitis C Treatment in Israeli Patients With Advanced Liver Fibrosis With Fixed Dose Combination (FDC) Grazoprevir (100 mg)/Elbasvir (50mg) (Zepatier) ± Ribavirin: A Retrospective Multicenter Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Percentage of participants with sustained virological response at week 12 (SVR12) [ Time Frame (for each patient): 12 weeks after the last dose of treatment ]
研究概览
简要总结
Primary objective:
- To estimate the effectiveness of treatment with FDC of Zepatier with or without ribavirin in Israeli patients with CHC and advanced fibrosis in real life setting.
Secondary objective:
- To estimate the safety and tolerability of treatment with FDC of Zepatier with or without ribavirin in real life setting in Israeli patients with CHC and advanced disease.
Hypotheses:
Effectiveness and tolerability of treatment with FDC of Zepatier with or without ribavirin in Israeli patients with CHC and advanced fibrosis will be similar to that demonstrated in phase 3 clinical trials.
详细描述
The following data will be collected:
Demographics information: age, gender, race, country of birth (COB). Data on liver and virological characteristics: Hepatitis C virus(HCV) genotype, fibrosis stage (F0-4), technology of fibrosis assessment (fibroscan, fibrotest, elastography, biopsy), , cirrhosis (y/n), presence of portal hypertension: esophageal varices, ascites, hepatic encephalopathy, history of decompensation, liver transplantation (y/n).
Previous anti-viral treatment: PR- Peg-Riba (relapse, partial/null responder, unknown response), direct anti-viral agents (DDAs): Protease Inhibitors (PI) (Bocepravir,Telepravir, Simepravir), Sofosbuvir (SOF), NS5A (Ledipasvir, Daclatasvir), NS5B.
Co-morbidities: BMI, Diabetes Mellitus, HIV-co infection, HBV-co infection, alcohol abuse, CKD (Chronic kidney disease)/renal failure, cardiovascular disease, inherited blood disorders, pre/post-transplant (liver/kidney) Concomitant medication (drug-drug interactions): antiacids (Proton pump inhibitors,H2-blockers), statins,beta-blockers, oral contraceptives, anti hypertensive, Anti retrovirals for HIV, etc.
Base line and end-of treatment parameters: White blood cells(WBC), Hemoglobin (HB), Platelates (PLT), Alanine transferase (ALT), Aspartate transaminase (AST), Alpha phetoprotein (ALP), Gamma glutamyl transferase (GGT), albumin, bilirubin, Protrombin time (PT)/INR, LDL-C, IL28 (if available), Model for end stage liver disease (MELD) score, Child pugh (CPT) score/class, viral load and virological response: HCV ribonucleic acid (RNA) at week 4 and 8 (if available), and sustained virological response (SVR) 12 and SVR24.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that treated with Zepatier after SVR results
排除标准
- 未提供
结局指标
主要结局
Percentage of participants with sustained virological response at week 12 (SVR12) [ Time Frame (for each patient): 12 weeks after the last dose of treatment ]
时间窗: 12 weeks after the last dose of treatment
SVR12 is defined as hepatitis c virus ribonucleic acid (HCV RNA) levels less than the lower limit of quantification 12 weeks after the last dose of treatment
次要结局
- Safety of Elbasvir/Grazoprevir treatment against HCV infection in real-life conditions is reflected as the number of patients with clinical and biological adverse events occurring during the treatment .(24 weeks)
研究者
Eli Zuckerman
Prof. Eli Zuckerman
Carmel Medical Center