Comparative Study of the Effect of Entecavir Versus Tenofovir on the Presence of HBV DNA in the Peripheral Blood Mononuclear Cells in Chronic Hepatitis B Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Compare the Effect of Entecavir versus Tenofovir on the Presence of HBV DNA in the Peripheral Blood Mononuclear Cells in Chronic Hepatitis B Patients
研究概览
简要总结
Liver disease associated with persistent hepatitis B virus (HBV) infection remains an important public health problem with significant morbidity and mortality. In spite of the existence of an effective vaccine, worldwide approximately 260 million people are chronic HBV surface antigen (HBsAg) carriers and current treatment with interferon and/or nucleoside analogues (NA) is not able to achieve a complete cure.
The key obstacle to HBV eradication is the persistence of HBV DNA in the nuclei of infected hepatocytes, either integrated into the host genome or as a covalently closed circular DNA (cccDNA) episomal form.
While HBV integration is rare and its clinical implications still require investigation, cccDNA plays an essential role in the long-term persistence of HBV infection and can often be detected even following NA therapy and HBsAg seroconversion.
Since quantification of cccDNA in infected hepatocytes requires invasive liver biopsy, more accessible tissues, such as serum or peripheral blood mononuclear cells (PBMCs) have been investigated in different patient populations.
详细描述
Some reports have shown that cccDNA in serum is a marker of off-treatment virological relapse, whereas others have not found cccDNA in the serum of chronic hepatitis B patients.
Some investigators speculate that PBMCs support HBV replication only partially, with linear and circular relaxed HBV DNA but not cccDNA formed in these cells, while others have detected cccDNA in PBMCs and/or plasma in a variable proportion of patients with chronic and occult HBV infection.
Although hepatocytes are recognized as the main target of HBV infection, HBV and other members of the hepadnaviral family, such as woodchuck hepatitis virus (WHV), have significant lymphotropic properties.
Hepadnaviral infection of lymphoid cells is an important mechanism by whitch virus escapes immune recognition and lymphoid reservoirs, particularly those harbouring drug-resistant HBV, may be the key to develop antiviral resistance.
Positive detection rate of HBV-DNA in neutrophils of chronic hepatitis B patients was 30.95%, After treatment of adefovir, the positive rate of HBV-DNA in neutrophils of chronic hepatitis B patients was 9.52% acting as asource of extrahepatic occult infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic HBV
- •Receiving anti-HB viral therapy (Entecavir or Tenofovir)
- •Compliant on treatment
- •Sustained virological response for at least 2 years
排除标准
- •Patients co-infected with hepatitis C virus
- •Less than 18 years old patients
- •Cirrhotic patients
- •Non compliant patients
结局指标
主要结局
Compare the Effect of Entecavir versus Tenofovir on the Presence of HBV DNA in the Peripheral Blood Mononuclear Cells in Chronic Hepatitis B Patients
时间窗: 1 week
Measurment of HBV-DNA level in Peripheral Blood Mononuclear cells
次要结局
未报告次要终点
研究者
MAOmar
Principle investigator
Assiut University