lyophilized hepatitis-B human immunoglobulin

Recommendations for treatment of viral hepatitis B in 2026 by the Polish Group of Experts for HBV.

Flisiak Robert R, Jaroszewicz Jerzy J, Małkowski Piotr P, Pawłowska Małgorzata M et al.

The Polish Group of Experts (PGE) for hepatitis B virus (HBV), established by the Polish Society of Epidemiologists and Infectious Disease Physicians and the Polish Association for the Study of the Liver, published its first HBV management recommendations in 2007. The current recommendations have been expanded to include the prevention of HBV infection in various populations, the prevention of HBV reactivation, principles for monitoring treatment efficacy and safety, including early detection of hepatocellular carcinoma, and principles for safe treatment discontinuation and interruption. Recommendations for management of acute hepatitis B and co-infections with HDV, HCV, and HIV are also included. Consensus among the ten PGE HBV members was achieved using the Delphi method (5 survey rounds resolving 36 key issues; 2 discussion rounds to clarify doubts).

Molecular Basis and Clinical Significance of the High-risk Phenotype of Hepatitis B Virus Genotype C.

Huang Chenchen C, Liu Zhongjian Z, Zhang Jingyao J, Shen Tao T et al.

Hepatitis B virus (HBV) genotype C is common in East Asia and is associated with poor outcomes, particularly liver cirrhosis and hepatocellular carcinoma (HCC). Clinically, genotype C infection has been associated with persistent viral replication, delayed HBeAg seroconversion, more active hepatic inflammation, and an increased risk of HCC. Current evidence suggests that these features are driven by several key molecular events, including the A1762T/G1764A double mutation in the basal core promoter, the G1896A mutation in the precore region, abnormal hepatitis B virus X protein function, and viral integration. Together, these changes may reshape viral transcription, antigen expression, host immune interactions, and oncogenic signaling, thereby contributing to disease progression and hepatocarcinogenesis. Other factors, such as epigenetic changes, dysregulated DNA damage responses, impaired tumor protein p53 function, and disrupted autophagy, may also be involved, although their exact roles remain unclear. Notably, even after effective viral suppression with potent nucleos(t)ide analogs, patients with genotype C may still have a relatively high residual risk of HCC. This review summarizes the molecular virological features, pathogenic mechanisms, immune dysregulation, and clinical significance of HBV genotype C, and discusses the potential value of genotype information in risk stratification, long-term surveillance, and clinical assessment of chronic hepatitis B.

qHBsAg Trajectories with Peg-IFNα-2b Add-on Therapy in Nucleos(t)ide Analog-experienced HBeAg-positive Chronic Hepatitis B.

Hu Kezhen K, Bi Yanzhen Y, Li Xiaoying X, Liu Xiangzhong X et al.

Comparison of Peg-INF plus TDF versus TDF Monotherapy in Indeterminate-phase Chronic Hepatitis B Patients with High HBsAg levels, HBeAg-negative status, and Normal ALT Levels.

Liu Min M, Xiao An A, Bu Bing B, Zuo Lili L et al.

Chronic hepatitis B patients with baseline hepatitis B surface antigen (HBsAg) <1500 IU/mL are considered as the favorable population for achieving functional cure. This trial aimed to explore a treatment strategy to help the unfavorable population characterized by high HBsAg levels (>3000 IU/mL), hepatitis B e antigen-negative status, and normal alanine transaminase levels in the indeterminate phase (HBeIP), transition to the favorable group. In this investigator-initiated, open-label clinical trial, we randomly assigned participants aged 18 to 60 years with HBeIP characteristics to receive either tenofovir disoproxil fumarate (TDF) monotherapy (monotherapy group) or pegylated interferon alfa-2b (Peg-IFNα-2b) plus TDF (combination group). The primary endpoints were the HBsAg loss rate and the proportion of participants with HBsAg <1,500 IU/mL through week 96. From May 2021 to November 2023, we enrolled 263 participants, with 131 randomly assigned to the combination group and 132 to the monotherapy group. In the primary analysis, none of the 132 participants (0%) in the monotherapy group achieved HBsAg loss, compared with 10 of 131 (7.6%) in the combination group (P = 0.001). Through week 96, 48.9% (64/131) of participants in the combination group achieved HBsAg <1,500 IU/mL, and a reduction in HBsAg level greater than 1 log10 IU/mL between baseline and week 24 was an independent predictor of this endpoint (Odds Ratio = 16.957, 95% Confidence Interval: 3.002-95.797, P = 0.001). In contrast, only two participants (1.5%) in the monotherapy group achieved HBsAg <1,500 IU/mL. Compared with TDF monotherapy, combination therapy with Peg-IFNα-2b and TDF significantly improved both HBsAg <1,500 IU/mL and HBsAg loss rates in HBeIP patients.