Alcoholic Hepatitis, Cirrhosis, Liver, Fibrosis, Liver, HBV, Hepatitis Delta Virus, Hepatocellular Carcinoma, Human Immunodeficiency Virus
Conditions
Brief summary
A cohort of adults with HIV-HBV co-infection will be created in Lusaka, Zambia, to describe the short and long-term (up to 10 years of follow-up) HBV and liver outcomes, including the effectiveness of current therapies, and to identify the risk factors for major endpoints of interest, including HCC and HBV functional cure. This cohort will also create a pool of potential participants for in-depth mechanistic studies and clinical trials of novel HBV cure drugs.
Detailed description
Among people with HIV in Africa, liver disease is a neglected area of investigation but is anticipated to become increasingly common as patients live longer due to antiretroviral therapy. In Lusaka, Zambia, we previously (NCT02060162, clinicaltrials.gov) described that HIV-HBV co-infection was the most important liver risk factor. However, in that study, only very short-term outcomes could be assessed. Building on these preliminary results and addressing the need to study HIV-HBV during a longer duration of follow-up, the current protocol will focus exclusively on people with HIV-HBV in Zambia. Zambia is an ideal site for this research as it has \ 12% HIV prevalence and 6% HBsAg-positivity among adults nationwide. In fact, \ 70% of people with HIV-HBV globally reside in Africa. In the proposed study, we will obtain consent from people with HIV-HBV to participate in an observational cohort study with up to 10 years of follow-up. Standard of care antiviral therapies will be received by participants. More in-depth analysis of liver and HBV viral and serological outcomes will occur. Screening for liver cancer will also occur. This study will provide useful clinical and epidemiological information to health policymakers in Zambia and beyond. It will also provide a platform for the training of health workers in Zambia in HBV clinical management.
Interventions
DRUGAnti-HIV Agents
Sponsors
University of Alabama at Birmingham
Fogarty International Center of the National Institute of Health
National Institutes of Health (NIH)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Living with HIV infection * Living with active HBV infection, defined as any single positive HBsAg assay * Naïve to antiretroviral therapy or currently participating in HIV/HBV co-infection in IeDEA-SA
Exclusion criteria
* Unable or unwilling to provide informed consent * Planning to relocate out of Lusaka district
Countries
Zambia
Contacts
PRINCIPAL_INVESTIGATORMichael J Vinikoor, MD
University of Alabama at Birmingham
Outcome results
None listed