Basic Science Programme / Effect of ART on chronic hepatitis B virus infection (substudy of DART trial)

Lead Research Organisation: MRC/UVRI Uganda Research Unit on AIDS

Abstract

Infection with the hepatitis B virus (HBV) occurs frequently in Africa. The infection is acquired early in childhood, and later through contaminated blood transfusions, but also through sexual contact with an infected individual. The infection causes liver inflammation. It may heal spontaneously, but many patients become chronically infected. Patients with chronic HBV infection may develop chronic liver disease and liver carcinoma, and remain infectious for others. It is possible that HBV occurs more often among individuals also infected with the human immunodeficiency virus (HIV) that cause AIDS.||Antiretroviral (ARV) drugs that can treat HIV infection also have a suppressive effect on HBV. However it is not known how effective these drugs are in suppressing HBV over time, and to what extent HBV will develop resistance to ARVs. The study will make use of the opportunity of a long lasting HIV trial (the MRC funded international DART Trial in which thousand of patients are treated with ARVs) to study the effects of ARVs on HBV in those patients who are infected with both HIV and HBV.

Technical Summary

The project aims to determine the prevalence of co-infection with Hepatitis B Virus (HBV) in the DART Trial cohort, and the effects of antiretroviral drugs (tenofovir and lamivudine) on HBV after 1 and 5 years of therapy. The DART Trial is a multicentre trial to compare the effectiveness and safety of different strategies of ART monitoring.||Using archived blood samples from participants in the DART trial, the project will initially determine the HBV status of all patients at the time of enrollment to the DART study. HBV viral load will be measured at baseline and sequentially in all patients identified as HBsAg-positive, with further testing for HBe markers in HBsAg-reactive samples. HBV viral load will be measured on samples from follow-up visits collected at 4, 12, 24, 48 weeks after enrolment and every 48 weeks thereafter until last attendance, or until collection of the last sample before treatment switch. The work is funded by Gilead with co-funding from the MRC.

Publications

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Description Hepatitis B studies 
Organisation University College London
Department MRC Centre for Medical Molecular Virology
Country United Kingdom 
Sector Public 
PI Contribution Protocol development Running of viral load tests
Collaborator Contribution Reagents Staff costs Publications
Impact Training Reagents Abstracts Staff costs
Start Year 2008
 
Description Research in Hepatitis B 
Organisation University College London
Department MRC Centre for Medical Molecular Virology
Country United Kingdom 
Sector Public 
PI Contribution Our laboratory performed viral loads and some genotyping
Collaborator Contribution Training Capacity in Hepatitis research
Impact Training Increased capacity to conduct research in hepatitis
Start Year 2008