Effect of Entecavir Versus Tenofovir on HBV DNA Level in Peripheral Blood Mononuclear Cells

NCT05168293 | Unknown

• 1 other identifier: CSEEVTPHDPBMCCHBP
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• Compare the Effect of Entecavir versus Tenofovir on the Presence of HBV DNA in the Peripheral Blood Mononuclear Cells in Chronic Hepatitis B Patients

  Measurment of HBV-DNA level in Peripheral Blood Mononuclear cells

  1 week

Study Arms (2)

Entecavir group

Other: Detection of HBV-DNA in Peripheral Blood Mononuclear cells

Tenofovir group

Other: Detection of HBV-DNA in Peripheral Blood Mononuclear cells

Interventions

Detection of HBV-DNA in Peripheral Blood Mononuclear cells OTHER

Detection of HBV-DNA level in Peripheral Blood mononuclear cells

Entecavir group; Tenofovir group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with chronic HBV receiving entecavir or tenofovir with sustained virological response for at least 2 years.

You may qualify if:

• Patients with chronic HBV
• Receiving anti-HB viral therapy (Entecavir or Tenofovir)
• Compliant on treatment
• Sustained virological response for at least 2 years

You may not qualify if:

• Patients co-infected with hepatitis C virus
• Less than 18 years old patients
• Cirrhotic patients
• Non compliant patients

Sponsors & Collaborators

• Assiut University: lead

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITH DNA

Detection of HBV-DNA level in Peripheral Blood Mononuclear cells

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed Abdelhady Mohamed Omar, Assistent lecturer

CONTACT

00201000954364; midotropicalmedicine@gmail.com

Mohamed Zakaria Ali Abu-Rahma, Assistent professor

CONTACT

00201013443702; mzaburahma@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: December 23, 2021
• Study Start: February 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: May 1, 2023
• Last Updated: December 23, 2021

Record last verified: 2021-12