Abstract:
OBJECTIVE To evaluate the value of HBV pregenomic RNA (pgRNA) and soluble programmed death ligand 1 (sPD-L1) in diagnosing the status of very low-level viremia (VLLV) in patients with chronic hepatitis B (CHB).
METHODS The clinical data of 315 CHB patients, who received nucleos(t)ide analogues (NAs) at the outpatient clinic of the department of infectious diseases in Zibo First Hospital between Oct. 2024 and Jan. 2026, were retrospectively analyzed. Patients were divided into a sustained virological response (SVR) group (n=189) and a VLLV group (n=126) based on their high-sensitivity HBV DNA test results within the past year. The levels of pgRNA and sPD-L1 were measured in both groups, and the risk factors for VLLV status in CHB patients were analyzed. Subsequently, an exploratory subgroup analysis stratified by HBeAg status was performed. Receiver operating characteristic (ROC) curves were adopted to evaluate the diagnostic value of pgRNA and sPD-L1 for VLLV in CHB patients.
RESULTS Among CHB patients, those in the SVR group had significantly higher age and FIB-4 levels than those in the VLLV group (P<0.05). The ALT, HBeAg positivity rate, and the log10-transformed levels of HBsAg (lg HBsAg), pgRNA (lg pgRNA) and sPD-L1 (lgsPD-L1) were lower in the SVR group than in the VLLV group (P<0.05). Multivariable adjustment revealed that age (OR=0.967), HBeAg positivity (OR=2.361) and lg pgRNA (OR=1.469) were identified as risk factors for VLLV status in CHB patients (P<0.05). The area under the ROC curve for the combined model of lg pgRNA and lgsPD-L1 in diagnosing VLLV status in CHB patients was 0.831, which was significantly higher than that of either marker alone (P<0.05). Additionally, lg pgRNA (OR=1.623) was identified as a risk factor for VLLV status in HBeAg-negative CHB patients (P<0.001).
CONCLUSIONS Age, HBeAg positivity and pgRNA are risk factors for VLLV status in CHB patients. The combination of pgRNA and sPD-L1 screening exhibits a high negative predictive value for VLLV status in CHB patients, and pgRNA is a risk factor for VLLV status in HBeAg-negative CHB patients.