Effect Of Interferon-Free Direct Acting Antiviral Agents For Treatment Of Hepatitis C Virus Patients On The Normal Kidney
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- Effect of the direct acting antiviral agents used for HCV treatment on the function of the normal kidney by measurement of serum creatinine.
研究概览
简要总结
The aim of the study is to determine the effect of different direct acting antiviral drugs used for treatment of chronic HCV infected patients on normal kidney.
详细描述
Hepatitis C virus (HCV) infection is a major health problem. The World Health Organization (WHO) estimated that at least 150-170 million people, approximately 3% of the world's population, are chronically infected. These patients are known to be at risk of developing liver complications, i.e., cirrhosis and liver cancer, with an estimated liver-related mortality of 350,000 people/year. However, the risks of morbidity and mortality are underestimated because they do not take into account the extra-hepatic consequences of HCV infection. Numerous extra-hepatic manifestations (HCV-EHMs) have been reported. In some large cohort studies, up to 74% of patients experienced HCV-EHMs of different severity, from perceived to disabling conditions.
Treatment of HCV infection has a long history. It began with interferon (IFN) mono-therapy, with less than 20% sustained virological response (SVR). Milestones include the addition of ribavirin (RBV) to the treatment protocol and providing pegylated-IFN (PegIFN) as an alternative treatment.
Treatment with PegIFN/RBV was the standard of care for about 10 years. The success rate of treatment with this regimen is very dependent on patient characteristics, including age, body mass index, ethnicity, and genetic factors.
Viral factors, especially HCV genotype, also affect the response to HCV treatment, and there are always additional factors that should be taken into account in each treatment approach, including treatment success rate, duration, cost, and side effects.
In light of these concerns, attempts have continued to introduce better therapeutic regimens.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both male and female patients with age above 18 years presented with chronic HCV infection (diagnosed by HCV RNA positive) with normal kidney functions, i.e.:
- •Normal S.creatinine
- •Normal urine analysis (without proteinuria, haematuria or abnormal casts).
- •Normal renal sonography.
- •and candidate for direct acting antiviral drugs.
排除标准
- •Any chronic HCV patient with known renal disease.
- •Patients with abnormal kidney functions, i.e.:
- •Abnormal S.creatinine.
- •Abnormal urine analysis (with proteinuria, haematuria or abnormal casts).
- •Abnormal renal US
- •Any other known renal disease (lupus nephritis, diabetic nephropathy).
- •Severe co-morbidity as severe heart failure or malignancy.
- •Other liver disease (autoimmune hepatitis, HBV, Wilson, ......).
- •Decompansated liver disease (ascites, hepatic encephalopathy, ...).
研究组 & 干预措施
first drug group
Sofosbuvir 400 MG Oral Tablet
干预措施: Sofosbuvir 400 MG Oral Tablet, (Drug)
second drug group
Ombitasvir/paritaprevir/ritonavir
干预措施: Ombitasvir/paritaprevir/ritonavir (Drug)
结局指标
主要结局
Effect of the direct acting antiviral agents used for HCV treatment on the function of the normal kidney by measurement of serum creatinine.
时间窗: one year
assessment of the renal toxicity of direct acting antivirals used for HCV treatment by measurement of the serum creatinine to detect any deviation beyond the normal values.
次要结局
未报告次要终点
研究者
Hazem shoman
principle investigator
Assiut University