Risk of Hepatocellular Carcinoma in HCV Cirrhotic Patients Treated With Direct Acting Antiviral Drugs.
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Occurrence and risk factors for HCC post DAAs
研究概览
简要总结
Direct acting antivirals (DAAs) are a novel and completely oral hepatitis C therapy . DAAs are used in most patients being treated for hepatitis C, including those with decompensated cirrhosis. This type of treatment has now completely replaced interferon-based therapy .Therapy of chronic hepatitis C with direct-acting antivirals (DAAs) is able to induce a sustained virological response (SVR) in over 85% of patients, even if liver cirrhosis is present. Cirrhotic patients should be closely monitored after treatment.HCC is thought to develop over time as the liver is exposed to inflammation and develops fibrosis. Thus, if DAAs can eliminate inflammation mediated by HCV, the risk of HCC should decrease. However, several centers have observed that this actually may not be the case. Tumor genesis occurs through a multistep, multifactorial process. Eliminating HCV-induced inflammation may not be enough to decrease risk of HCC.DAAs have provided an effective, well tolerated treatment for hepatitis C in patents with cirrhosis . However, several studies have shown unexpectedly high rates of recurrence of HCC in the early post DAAs treatment time period.
- Evalution of occurrence and risk factors for hepatocellular carcinoma (HCC) in patients with HCV-related liver cirrhosis after direct acting antiviral drugs (DAAs) therapy.
- To asses diagnostic value of novel markers in patients who developed hepatocellular carcinoma (HCC) after (DAAs)
详细描述
HCV is a worldwide infection, it is estimated that about at about 3.0% (170-200 million people) of the world's population are infected. HCV is associated with an increased disease burden due to liver cirrhosis and considerable mortality . More than 350,000 people dying each year from hepatitis C-related liver disease. Adding to the problem of HCV infection is the presence of occult HCV infection.
Egypt has the highest prevalence worldwide, it is estimated to be 14.7% among a representative sample of Egyptian population, aged 15-59 year . Egypt is among countries responsible for 80.0% of global infections. Further, prevalence is higher among hospitalized patients and special clinical populations.
Hepatitis C virus (HCV) has great genetic variability, with 6 major genotypes (GTs); GT-1 to 6. In Egypt, HCV is almost exclusive GT-4 distribution. HCV has significant differences in their global distribution and prevalence.
Worldwide, Hepatocellular carcinoma (HCC) is the fifth most common cancer in men and the seventh in women. Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death worldwide and one of the leading causes of death among patients with cirrhosis. In Egypt, HCC is the second most common cancer in men and the sixth most common cancer in women.
Direct acting antivirals (DAAs) are a novel and completely oral hepatitis C therapy . DAAs are used in most patients being treated for hepatitis C, including those with decompensated cirrhosis. This type of treatment has now completely replaced interferon-based therapy .Therapy of chronic hepatitis C with direct-acting antivirals (DAAs) is able to induce a sustained virological response (SVR) in over 85% of patients, even if liver cirrhosis is present. Cirrhotic patients should be closely monitored after treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HCV-related liver cirrhosis (eligible for treatment) who developed (HCC) after DAAs therapy within one year follow up.
- •Age and sex matched group of patients with HCV- related liver cirrhosis who didn't develop HCC after DAAs therapy within one year follow up(as control group)
- •Patients with chronic HCV related liver cirrhosis complicated by hepatocellular carcinoma not eligible for treatment.(discovered during enrollment in HCV treatment program)
排除标准
- •Patients who refuse to participate in the study.
- •Patients with hepatitis B virus, any other causes of cirrhosis.(Alcohol consumpation, Biliary, Cardiac.....etc)
- •Patients with cancers other than HCC or metastatic liver cancer.
- •Patients who developed HCC on transplanted liver.
- •Patients who previously treated for HCC.
- •Patients who receive any immunosuppression drugs.
结局指标
主要结局
Occurrence and risk factors for HCC post DAAs
时间窗: One year
Perecentage of occurrence of hepatocellular carcinoma (HCC) in patients with HCV-related liver cirrhosis after direct acting antiviral drugs (DAAs) therapy.
次要结局
- Diagnostic value of miRNA in patients who developed HCC post DAAs(One Year)
研究者
Alshaimaa Mohammed Rafat Ali
Principal investigator at Tropical medicine and Gastroenterology Department
Assiut University