Hepatitis B surface antigen quantification at hepatitis B e antigen seroconversion predicts virological relapse after the cessation of entecavir treatment in hepatitis B e antigen-positive patients

Abstract

Objectives: To assess off-treatment virological relapse rates and to determine the role of hepatitis B surface antigen (HBsAg) quantification in predicting virological relapse after stopping entecavir (ETV) treatment in patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB). Methods: One hundred and twelve CHB patients for whom ETV was stopped in accordance with the Asian Pacific Association for the Study of the Liver guidelines stopping rules were enrolled. Patient HBsAg and HBV DNA levels were monitored every 4-12 weeks during ETV treatment and after ETV cessation. Post-treatment virological relapse was defined as a serum HBV DNA level of >10 000 copies/ml after stopping ETV treatment. Results: The virological relapse rate at 52 weeks after stopping ETV was 48.2%. The post-treatment virological relapse rate was significantly higher in patients aged >50 years than in those aged <50 years (p < 0.001), and the virological relapse rate was significantly lower in patients with an HBsAg level <2.0 log 10 IU /ml than in those with a level !2.0 log 10 IU /ml at ETV cessation (p = 0.005). An HBsAg level of 2.5 log 10 IU/ml at HBeAg seroconversion was the optimal cut-off value for predicting post-treatment virological relapse (p < 0.001). In those aged <50 years and with HBsAg 2.5 log 10 IU/ml at HBeAg seroconversion, the relapse rate was only 5%. In patients with HBsAg 2.5 log 10 IU/ml at HBeAg seroconversion, 52.4% achieved HBsAg levels 2.0 log 10 IU/ml at ETV cessation, while in those with HBsAg >2.5 log 10 IU/ml at HBeAg seroconversion, only 4.4% achieved this criterion. Conclusions: HBsAg levels can help guide the timing of cessation of ETV treatment. HBsAg levels of 2.5 log 10 IU/ml at HBeAg seroconversion may be a useful marker to predict virological relapse after the cessation of ETV treatment in HBeAg-positive CHB patients.

The Role of Hepatitis B Surface Antigen in Nucleos(t)ide Analogues Cessation Among Asian Patients With Chronic Hepatitis B: A Systematic Review

“…The cessation criteria were described in all studies. Ten studies discontinued NAs according to the APASL stopping criterion . One study discontinued NAs according to the recommendation from the National Health Plan of Taiwan, China; the clinical physician’s opinion; and sufficient discussion between physicians and patients .…”

“…Off‐treatment events including virological relapse, clinical relapse, and HBsAg loss were analyzed. The definition of virological relapse varied across studies: reappearance of HBV DNA to >1,000 IU/mL from an undetectable level during the off‐treatment period and reappearance of HBV DNA to >2,000 IU/mL from an undetectable level during the off‐treatment period . The definition of clinical relapse was the reappearance of HBV DNA to >2,000 IU/mL from an undetectable level and an increase of ALT levels to >2× the upper limit of normal (ULN).…”

Response-Guided Therapy Based on the Combination of Quantitative HBsAg and HBV DNA Kinetics in Chronic Hepatitis B Patients

“…Thus, patients aged <50 years who achieved an HBsAg level <2.5 log 10 IU/mL at HBeAg seroconversion had the lowest rate of relapse, 5% respectively [34]. In HBeAg-positive CHB patients treated with ETV, a serum HBsAg level below 2.5 log 10 IU/mL at HBeAg seroconversion could be a useful predictor of post-treatment virological relapse [34].…”

“…In a recent Asian study, it has been showed that post-treatment virological relapse rate was significantly higher in patients over 50 years old and in patients with an HBsAg level >2 log 10 IU/mL at the ETV cessation [34]. In the same study, an HBsAg level of 2.5 log 10 IU/mL at HBeAg seroconversion has been established as an optimal cutoff for prediction of post-treatment virological relapse [34]. Thus, patients aged <50 years who achieved an HBsAg level <2.5 log 10 IU/mL at HBeAg seroconversion had the lowest rate of relapse, 5% respectively [34].…”

“…In the same study, an HBsAg level of 2.5 log 10 IU/mL at HBeAg seroconversion has been established as an optimal cutoff for prediction of post-treatment virological relapse [34]. Thus, patients aged <50 years who achieved an HBsAg level <2.5 log 10 IU/mL at HBeAg seroconversion had the lowest rate of relapse, 5% respectively [34]. In HBeAg-positive CHB patients treated with ETV, a serum HBsAg level below 2.5 log 10 IU/mL at HBeAg seroconversion could be a useful predictor of post-treatment virological relapse [34].…”