Abstract
Early declines in serum hepatitis B surface (HBsAg) levels, their optimal cutoffs, and association with therapeutic endpoints in chronic hepatitis B (CHB) patients receiving entecavir treatment remain unclear. We prospectively enrolled 529 patients (195 hepatitis B e antigen [HBeAg]-positive and 334 HBeAg-negative) with a median treatment duration of 49.2 months. Median HBsAg levels declined significantly in both groups at Month 3, but only at Months 6–12 in the HBeAg-negative group. Both groups exhibited a significant HBsAg decline with each successive year of treatment. An HBsAg decline of ≥75% from baseline, assessed at Months 3 and 12 of treatment in the HBeAg-positive and -negative patients, respectively, independently predicted a virological response and HBeAg seroconversion in the HBeAg-positive patients, an HBsAg level of <100 IU/mL in the HBeAg-negative patients, and HBsAg loss in all the patients during treatment. HBsAg levels of <3,000 IU/mL at baseline combined with an HBsAg decline of ≥75% from baseline provided a predictive algorithm for HBsAg loss (positive and negative predictive values: 70% and 100%, respectively) during 5 years of treatment. The proposed cutoffs for defining an HBsAg decline may assist clinicians in early assessments of treatment responses in genotype B-infected or C-infected CHB patients receiving entecavir therapy.
Highlights
Hepatitis B surface antigen (HBsAg) decline is less pronounced during nucleos(t)ide analog (NA) treatment than during peginterferon treatment[6]
To further confirm that a threshold of ≥75% was the optimal cutoff for defining an HBsAg decline during ETV treatment, we evaluated whether various cutoffs (25%, 50%, 75%, 0.5 log[10] IU/mL, and 1.0 log[10] IU/mL) can serve as independent predictors of key therapeutic endpoints such as virological response (VR), hepatitis B e antigen (HBeAg) SC in HBeAg-positive patients, an HBsAg level
Baseline HBsAg levels combined with an HBsAg decline of ≥75% provided a simple algorithm for early prediction of the ultimate achievement of a low HBsAg level during 5 years of ETV treatment
Summary
HBsAg decline is less pronounced during nucleos(t)ide analog (NA) treatment than during peginterferon treatment[6]. Rapid HBsAg decline, defined as ≥0 .5 log[10] IU/mL at Month 6 or ≥1 .0 log[10] IU/mL at Month 12 of telbivudine treatment, and an HBsAg decline of ≥1.0 log[10] IU/mL at Month 6 of tenofovir treatment, are associated with subsequent HBsAg loss in HBeAg-positive patients[7,8]. The early kinetics of HBsAg levels during NA treatment is not well characterized. The optimal cutoffs and time points for defining HBsAg decline during NA treatment are unclear. The present study delineated the kinetics of HBsAg levels; identified the optimal cutoffs and time points for defining HBsAg decline; and investigated the association between early HBsAg decline and key therapeutic endpoints such as virological response (VR), HBeAg SC, and HBsAg loss in a large cohort of genotype B-infected or C-infected CHB patients receiving entecavir (ETV) treatment
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