Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

The University of Alabama at Birmingham

Status

Active, not recruiting

Conditions

Hepatitis Delta Virus

Human Immunodeficiency Virus

Fibrosis, Liver

Cirrhosis, Liver

Alcoholic Hepatitis

Hepatocellular Carcinoma

HBV

Treatments

Drug: Anti-HIV Agents

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT02344680

IRB-3000

K01TW009998 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

303 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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