Background And Aim: Few studies have reported hepatitis B surface antigen (HBsAg) kinetics after nucleos(t)ide analog (NA) discontinuation in patients with noncirrhotic chronic hepatitis B (CHB). The study specifically investigated long-term HBsAg kinetics after NA discontinuation.
Methods: Between January 2014 to January 2024, this study prospectively enrolled 106 outpatients with noncirrhotic CHB who met the discontinuation criteria after NA consolidation treatment. Demographic, clinical, and laboratory data were collected and analyzed after NA discontinuation.
Results: Ninety-six patients who finished 5 years of follow-up were included. HBsAg remained undetectable in 29 patients with end of treatment (EOT) HBsAg negativity. Among 67 patients with EOT HBsAg positivity, HBsAg seroclearance occurred in 12 (17.9%) patients with an estimated annual incidence of HBsAg seroclearance of 3.6%. Patients with EOT HBsAg levels of ≤1000 IU/mL had a higher HBsAg seroclearance rate than those with EOT HBsAg levels of >1000 IU/mL (33.3% . 5.4%). The proportion of patients with HBsAg ≤1000 IU/mL increased during follow-up. Logistic regression analysis indicated that the EOT HBsAg level was an independent factor for HBsAg seroclearance and an HBsAg level decline exceeding 1 log10 IU/mL. The optimal EOT HBsAg cutoff for both HBsAg seroclearance and an HBsAg level decline exceeding 1 log10 IU/mL was 359 IU/mL.
Conclusions: Patients with EOT HBsAg negativity experienced no relapse and maintained HBsAg seroclearance during 5 years of follow-up after NA discontinuation. A higher HBsAg seroclearance rate can be obtained in patients with EOT HBsAg levels of ≤1000 IU/mL during 5 years of follow-up after NA discontinuation. Close monitoring and proper NA retreatment are recommended to guarantee the safety of NA discontinuation.
Clinical Trial Number: Clinicaltrials.gov number NCT02883647.
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http://dx.doi.org/10.1016/j.livres.2024.07.001 | DOI Listing |
J Gastroenterol Hepatol
March 2025
Division of Gastroenterology, Department of Medicine, King Chulalongkorn Memorial Hospital and Thai Red Cross Society, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Aim: To identify factors influencing HBsAg seroclearance rates after stopping nucleos(t)ide analogue (NA) therapy in patients with chronic hepatitis B (CHB).
Methods: We conducted a comprehensive literature search in databases from inception to July 2024. Subgroup analyses and meta-regression were performed to determine factors associated with HBsAg seroclearance, including ethnicity, HBV genotype, NA therapy duration, end-of-treatment (EOT) qHBsAg levels, HBeAg status, cirrhosis status, and follow-up duration.
Hepatol Commun
March 2025
Department of Clinical Microbiology & Immunology, Janssen Pharmaceutica NV, a Johnson & Johnson Company, Clinical Microbiology & Immunology Beerse, Belgium.
Background: In the nucleos(t)ide analog (NA)-control arm of the REEF-2 study (NCT04129554), virologic relapse (confirmed increase in HBV DNA >2000 IU/mL) and biochemical flare (ALT increases ≥3× upper limit of normal) were frequently observed after stopping NA treatment. We characterized the posttreatment virologic relapses and biochemical flares and assessed their association with end-of-treatment (EOT) HBV serum markers.
Methods: In REEF-2, a randomized-controlled study, virologically suppressed HBeAg-negative patients stopped treatment at week 48, followed by 48 weeks of follow-up.
Unlabelled: Background & Aims: This study investigated the off-therapy relapse in hepatitis B e antigen (HBeAg)-negative non-cirrhotic patients who discontinued tenofovir alafenamide (TAF) or entecavir (ETV).
Methods: Non-cirrhotic HBeAg-negative patients who discontinued TAF or ETV were enrolled. The propensity score -matching method at a ratio of 1:1 and Cox proportional hazard model were performed to analyze factors associated with virological relapse and clinical relapse.
Liver Res
September 2024
Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
Background And Aim: Few studies have reported hepatitis B surface antigen (HBsAg) kinetics after nucleos(t)ide analog (NA) discontinuation in patients with noncirrhotic chronic hepatitis B (CHB). The study specifically investigated long-term HBsAg kinetics after NA discontinuation.
Methods: Between January 2014 to January 2024, this study prospectively enrolled 106 outpatients with noncirrhotic CHB who met the discontinuation criteria after NA consolidation treatment.
Aliment Pharmacol Ther
February 2025
Department of Gastroenterology and Hepatology, Erasmus University Medical Centre, Rotterdam, The Netherlands.
Background: Severe flares (ALT ≥ 10×ULN) are a well-recognised adverse outcome after nucleos(t)ide analogue (NA) cessation and may lead to liver failure. Thus, identification of patients at risk for these flares is of major importance.
Methods: Data were used from two prospective studies on NA cessation conducted in the Netherlands and Canada.
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