HCC Clinical Trial
Official title:
Risk of Hepatocellular Carcinoma in HCV Cirrhotic Patients Treated With Direct Acting Antiviral Drugs.
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.
1. Evalution of occurrence and risk factors for hepatocellular carcinoma (HCC) in patients
with HCV-related liver cirrhosis after direct acting antiviral drugs (DAAs) therapy.
2. To asses diagnostic value of novel markers in patients who developed hepatocellular
carcinoma (HCC) after (DAAs)
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.
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.
MicroRNAs (miRNAs) are a set of small, single-stranded, non-coding RNA molecules (21-30
nucleotides) that negatively regulate gene expression at the posttranscriptional level by
translational inhibition or degradation of target mRNA, depending on the degree of
complementary base pairing. Aberrant expression of miRNA is common in various human
malignancies and modulates cancer-associated genomic regions or fragile sites. As for the
relationship between miRNA and HCC several studies have demonstrated that the aberrant
expression of specific miRNA can be detected in HCC cells and tissues. However, little is
known about the mechanisms of miRNA-related cell proliferation and development.ref
Aim of work:
1. Evalution of occurrence and risk factors for hepatocellular carcinoma (HCC) in patients
with HCV-related liver cirrhosis after direct acting antiviral drugs (DAAs) therapy.
2. To asses diagnostic value of novel markers in patients who developed hepatocellular
carcinoma (HCC) after direct acting antiviral drugs -DAAs -therapy.
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