Hepatitis Clinical Trial
Official title:
The Curative Effect and Security of Entecavir Combined Thymosin or Resveratrol on HBeAg Positive Chronic Hepatitis B Patients - a Multi-center, Random, Control, Open Clinical Trial
The purpose of this study is to use entecavir combined with other drug such as resveratrol and thymosin to treat patients with hepatitis B, which may provide a novel therapy target hepatitis B.
Hepatitis B virus (HBV) infections continue to be a major public health problem worldwide.
More than 400 million people worldwide are currently infected with hepatitis B virus.
Approximately 20% of HBV patients will develop chronic hepatitis, and are at significant risk
of developing cirrhosis or liver hepatocarcinoma. HBV is the prototype of hepadnaviridae, a
family of small enveloped hepatotropic DNA viruses that can infect the liver of human.
In recent years, researches on antiviral treatment of chronic hepatitis B has made remarkable
progress, interferon and nucleoside analogues which are the synthetic reverse transcriptase
inhibitors can attenuate liver inflammation and fibrosis. However, HBsAg and HBeAg
seroconversion ratio is merely 7% and 21%, respectively. To completely clear HBsAg is very
difficult, the main reason is that HBV cccDNA (a covalently closed circular form of the viral
genome through DNA repair of the relaxed circular replicative HBV DNA inside the nuclei of
hepatocytes in the HBV life cycle), the template for viral and pregenomic messenger RNA
cannot be eliminated, lead to the continuous replication of the virus. Apart from that, none
of these therapies are completely safe and effective. Although direct antiviral therapy could
efficiently control chronic active hepatitis B, drug resistance or renal toxicity could
develop progressively several months after the initiation of therapy. It is thus still
urgently required to identify effective anti-HBV agents.
Pegylated IFN-α (pegIFN-α) is effective in achieving sustained virologic response, defined as
HBeAg seroconversion and/or hepatitis B virus (HBV) DNA levels below 20,000 copies/mL at 6
months after completion of the therapy, in only 30% of hepatitis e antigen (HBeAg)-positive
and 40% of HBeAg-negative cases. However, the pegIFN-α therapy does promote HBsAg clearance
or seroconversion in a small, but significant fraction of treated patients. Hence, we should
develop feasible antiviral therapeutics target cccDNA in liver cells to cure chronic
hepatitis B.
Resveratrol, a grape polyphenol, is representative of a group of diet-derived putative cancer
chemopreventive agents encompassing, among others, curcumin, tea polyphenols and apigenin,
which have attracted a lot of interest in the cancer chemoprevention community. It has shown
considerable promise as a therapeutic agent in the treatment of liver ailments. Recent study
found that SITR1 activators can inhibit cccDNA, and resceratrol is a member of SIRT1
activator family. Apart from that, several studies have highlighted the hepatoprotective
properties of resveratrol. Resveratrol has been shown to prevent hepatic damage because of
free radicals and inflammatory cytokines, induce antioxidant enzymes and elevate glutathione
content. Resveratrol has also been shown to modulate varied signal transduction pathways
implicated in liver diseases. For instance, resveratrol can inhibit Th17 proliferation and
function, and many researches found that increasing Th17 in patients with hepatitis B.
Importantly, in vitro, we found that resveratrol can significantly reduce both HBsAg and
HBeAg in a dose-depend manner.
Nowadays, increasing studies focus on natural materials in the application of the treatment,
and there are many health care products used resveratrol as main ingredient. Report on trial
of resveratrol in healthy volunteers after daily doses of up to 5g per day administered for
29 days suggests that it is safe, as borne out by the lack of serious adverse reactions
detected by clinical, biochemical or hematological analyses during the study and study
follow-up. Besides, in our country, the traditional Chinese medicine also used giant knotweed
(main ingredients is resveratrol) to treat viral hepatitis and autoimmune hepatitis.
Therefore, We aim to use entecavir combined with other drug such as resveratrol and
peg-interferon to treat patients with hepatitis B, which may provide a novel therapy target
hepatitis B.
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