Chronic Hepatitis B Virus Infection in Zambia

Study Overview
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Brief Summary
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Chronic hepatitis B virus infection is a common condition in Zambia. Among Zambian blood donors, up to 8% are chronically infected with HBV. Despite the burden, awareness of HBV is low in Zambia and the Ministry of Health is in early stages of development of guidelines for HBV screening, treatment, and prevention. The purpose of this clinical cohort study is to characterize the clinical features of chronic HBV infection at UTH and describe treatment and care outcomes. The investigators will enroll 500 adults and follow the cohort for up to 5 years to assess short and long-term viral, serologic, and liver outcomes such as cirrhosis and liver cancer.

Detailed Description
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Viral hepatitis is the #7 cause of death worldwide, yet it has been neglected when compared to other infectious diseases such as HIV/AIDS, tuberculosis, and malaria. Chronic viral hepatitis is caused by hepatitis C virus and hepatitis B virus and these infections are most common in low and middle-income countries, notably Asia and sub-Saharan Africa. In Zambia there are limited data, but from an HIV cohort, the investigators of this study described 10-12% prevalence of chronic HBV. To raise awareness of viral hepatitis in Zambia and to generate local data to guide policymakers, the investigators will recruit 500 adults with chronic HBV infection and follow the cohort in an observational cohort study. In the study patients would be managed according to standards of care and no experimental or investigational drugs would be used. The investigators will carefully describe patient clinical characteristics and among those who receive drug treatment, the investigators will describe the effectiveness of that treatment in reducing liver disease.

Official Title
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Chronic Hepatitis B Virus Infection in Zambia: a Prospective Clinical Cohort Study

Conditions
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HBV, Fibrosis, Liver, Cirrhosis, Liver, Alcoholic Hepatitis, Hepatocellular Carcinoma, Hepatitis, Delta

Intervention / Treatment
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* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older HBV-infected, defined as any single positive HBsAg assay Exclusion Criteria: Unable or unwilling to provide informed consent HIV-positive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HBV mono-infected (Standard of Care)<br>500 patients in Zambia | Other: Standard of care<br>* Routine standard of care per Ministry of Health protocol, including blood draws and examinations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the percentage of patients with HBV viral suppression (Effectiveness of antiviral therapy in HBV-infected patients) | The percentage of patients with HBV viral suppression. | Baseline and after 1 year of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of chronic HBV-infected patients with an indication for antiviral treatment. | Using WHO HBV guidelines, the investigators will determine the proportion of chronic HBV infected patients in the cohort requiring antiviral treatment. | baseline, after 1 year of treatment, after 2 years of treatment | 
| HBV viral control among patients on antiviral treatment | The percentage of patients with viral control defined as undetectable HBV viral load after 1 and 2 years of treatment. | baseline, after 1 year of treatment, after 2 years of treatment | 
| Serologic, virologic, and hepatic features of chronic HBV infection in Zambia | HBV patients' demographic characteristics at baseline and clinical characteristics at baseline and at 60 months, including alcohol use disorders diagnosed with AUDIT-C, HBV genotypes, HBV viral loads, prevalence of advanced liver disease (based on non-invasive tests), phase of HBV infection (immune tolerant, HBeAg-positive chronic hepatitis, HBeAg-negative chronic hepatitis, and immune control) - based on international guidance. | 0 to month 60 | 
| Proportion with significant liver fibrosis | Measure of liver fibrosis using AST-to-platelet ration index (APRI), Fibrosis 4 (FIB-4) and transient elastography. | 0, 12, 24, 36, 48, and 60 months, | 
| Incidence and prevalence of hepatocellular carcinoma (HCC) | The number of new HCC cases (among those without evidence of HCC at baseline) divided by the time in the cohort study. | baseline and after month 60 |