Chronic Hepatitis B Virus Infection in Zambia

Hepatocellular Carcinoma Clinical Trial

— HUTCH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03158818
• Other study ID #: F151224005
• Status: Active, not recruiting
• Start date: August 23, 2016
• Est. completion date: August 2024

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 326
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholic Hepatitis
• Cirrhosis, Liver
• Fibrosis, Liver
• HBV
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis D
• Hepatitis, Alcoholic
• Hepatitis, Delta
• Hepatocellular Carcinoma
• Herpesviridae Infections
• Liver Cirrhosis
• Virus Diseases

Intervention

Other:
• Standard of care
Routine standard of care per Ministry of Health protocol, including blood draws and examinations.

Locations

Country	Name	City	State
Zambia	Tropical Gastroenterology and Nutrition Group	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Centre for Infectious Disease Research in Zambia, Tropical Gastroenterology and Nutrition Group

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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,
Secondary	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