Resistance to Lamivudine in HBV Egyptian Patients

Ain Shams University

Status: Completed

Conditions: Chronic Hepatitis B Virus Treatment

Study type: Observational

Funder types: Other

Identifiers

NCT01548820

HBV resistance

Details and patient eligibility

About

On treatment parameters for Lamivudine resistance in HBV treated Egyptian patients

Full description

Primarily: To study the correlations between the following parameters in adult Egyptian patients with chronic viral hepatitis B before treatment:

• ALT.
• HBeAg.
• HBV-DNA by quantitative PCR.
• Biopsy (if possible). Secondarily: After receiving lamivudine therapy we will identify the impact of these parameters on viral breakthrough at 1 year of therapy.

Enrollment: 230 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients >18 years old
• Egyptian nationality
• Positive serology for HBsAg for more than 6 months
• Positive HBV viremia (above 2000IU/ml).
• Lamivudine monotherapy

Exclusion criteria

• Anti-HBcIgM seropositivity
• Positive serology for HCV
• Positive serology for HDV
• Patients complicated with HCC

Trial design

230 participants in 1 patient group

Chronic HBV Egyptian patients

Description:

chronic HBV patients receiving Lamivudine therapy in hepatology clinic in the National Hepatology \& Tropical Medicine Research Institute in Egypt.