Observational cohort of adults with acute and chronic hepatitis B infection in Zambia, with and without HIV coinfection. Participants join the study at the time of diagnosis and before or at the time when they are starting antiviral treatments and then they are followed up over multiple years to assess changes to their liver and evolution of HBV (and HIV if applicable) infection. All treatments for HBV and HIV are standard per local Ministry of Health guidelines.
Study Type
OBSERVATIONAL
Enrollment
390
Kanyama Level 1 Hospital
Lusaka, Zambia
RECRUITINGMatero Level 1 Hospital
Lusaka, Zambia
RECRUITINGUniversity Teaching Hospital
Lusaka, Zambia
RECRUITINGChange in Intrahepatic Immune Cell Subset Frequencies
Percentage of immune cell subsets (CD4+ T cells, CD8+ T cells, B cells, NK cells, Macrophages, and Neutrophils) among total liver immune cells as measured by single-cell RNA sequencing. Comparisons will be made between acute and chronic HBV infection, with and without HIV coinfection, and before and after nucleoside analog antiviral therapy.
Time frame: Baseline and 1 year
Number of Differentially Expressed Hepatic Genes Associated with HBsAg Reduction/Loss
Count of genes showing differential expression (fold change ≥2.0, adjusted p-value \<0.05) by single-cell RNA sequencing in liver biopsies from participants achieving HBsAg loss compared to those without HBsAg loss. Gene expression will be analyzed at baseline (predictive analysis), longitudinally (trajectory analysis), and at end of follow-up. Analysis will include comparison across acute vs. chronic HBV infection and with vs. without HIV coinfection.
Time frame: Baseline and 1 year
HBV viral suppression
Reduction of HBV DNA in blood to below detectable levels
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HIV viral suppression
HIV RNA suppression in blood below the level of assay detection
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, and 5 years
HBsAg seroclearance
Loss of hepatitis B surface antigen in blood samples
Time frame: Through study completion, an average of 5 years
HBeAg seroconversion
HBeAg-negativity in blood
Time frame: Through study completion, an average of 5 years
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