Untreated patients with chronic hepatitis B in the immune-tolerant phase had higher risks for hepatocellular carcinoma, death or need for liver transplantation compared with patients in the immune-active phase treated with nucleos(t)ide analogues, according to recently published data.
“Antiviral treatment is generally not recommended for these patients by most practice guidelines because of the notion that the histological activity is dormant, and the risk of disease progression is low in the [immune-tolerant] phase,” Gi-Ae Kim, MD, from the University of Ulsan College of Medicine, Republic of Korea, and colleagues wrote. “Our results suggest that many unnecessary deaths could be prevented by earlier antiviral intervention in the IT phases before the appearance of clinically active liver disease.”
The study comprised 413 untreated patients with HBV in the immune-tolerant (IT) phase and 1,497 patients with HBV in the immune-active (IA) phase who received nucleos(t)ide analogues (NUC) treatment and had been advised to continue treatment regardless of HBV e-antigen seroconversion.
During a median follow-up of 6.3 years, 78 patients developed HCC and 52 died or received liver transplantation. Compared with the IA group, patients in the IT group had significantly higher rates of HCC incidence (1.05% vs. 0.51%; P = .001) and death or need for transplantation (0.76% vs. 0.32%; P = .001).
Multivariate analyses confirmed that the IT group had a significantly higher risk for HCC (HR = 2.54; 95% CI, 1.54-4.18) and death or need for transplantation (HR = 3.38; 95% CI, 1.85-6.16) compared with the IA group.
The higher risk for HCC among IT patients remained similarly significant after inverse probability of treatment weighting analysis, propensity score-matched analysis and competing risks analysis.
In a subanalysis of 1,554 patients with HCV in either the IT phase or a mildly active phase, older age (HR = 1.07; 95% CI, 1.05-1.09), male sex (HR = 2.3; 95% CI, 1.5-3.52), lower HBV DNA levels (HR = 0.62; 95% CI, 0.53-0.73) and lower platelet counts (HR = 0.99; 95% CI, 0.99-0.99) correlated independently with a significantly higher risk for clinical events.
“Further studies taking new emerging biomarkers for HBV infection into account would be warranted to further stratify the patients for the risk of clinical events,” the researchers wrote. “Randomized controlled trials evaluating the long-term clinical outcomes of the IT-phase patients with or without antiviral treatment may be worthwhile.” – by Talitha Bennett
Disclosure: Kim reports no relevant financial disclosures. Please see the full study for the other authors’ relevant financial disclosures.