Dynamic Characteristics of Serum Hepatitis B Surface Antigen in Chinese Chronic Hepatitis B Patients Receiving 7 Years of Entecavir Therapy

Abstract

Background:The ultimate goal of hepatitis B treatment is hepatitis B surface antigen (HBsAg) seroclearance. Several factors have been suggested to be associated with the rate of HBsAg reduction in antiviral-naive or lamivudine therapy cohorts. However, there are few studies evaluating the factors during long-term entecavir (ETV) therapy. In the present study, we aimed to evaluate the factors to predict the outcome of ETV therapy for 7 years.Methods:A total of 47 chronic hepatitis B (CHB) patients treated with ETV monotherapy were included in this study. Liver biochemistry, hepatitis B virus (HBV) serological markers, serum HBV DNA, and HBsAg titers were tested at baseline, 3 months, 6 months, and yearly from 1 to 7. The associations between factors and HBsAg reduction were assessed using multivariate tests with repeated measure analysis of variance.Results:At baseline, serum HBsAg levels showed a positive correlation with baseline HBV DNA levels (r = 0.625, P < 0.001). The mean HBsAg titers after ETV treatment were significantly lower than the baseline titers (P ranges from 0.025 to 0.000,000,6). The HBsAg reduction rate during the 1st year was greater compared to after 1 year of treatment (P < 0.05). Multivariate test showed that hepatitis B e antigen (HBeAg) seroclearance and/or HBsAg reduction ≥0.5 log10 IU/ml at 6 months had a high negative predictive value (96.77%) for HBsAg seroclearance (P = 0.002, P = 0.012, respectively).Conclusions:The HBsAg reduction rate during the 1st year was greater than that after 1 year of treatment. Further, HBeAg status and HBsAg levels at month 6 are the optimal factors for the early prediction of HBsAg seroclearance after long-term ETV therapy in CHB patients.

Efficacy of Real-world Entecavir Therapy in Treatment-naïve Chronic Hepatitis B Patients

“…In the study ETV-901, long-term treatment with ETV achieved durable and increasing viral suppression, with undetectable HBV DNA (<300 copies/ml) being achieved in 94% of hepatitis B e antigen (HBeAg) positive patients after over 5 years of therapy and in 95% of HBeAg negative patients after over 3 years of therapy. [ 8 ] Results also suggested that ETV was well tolerated[ 9 ] and the viral resistance rate was very low (1.2%) following up to 6 years of treatment. [ 10 ] Despite its efficacy, about 10–20% of patients treated with ETV showed a partial virological response (PVR).…”

Kinetics of Hepatitis B Surface Antigen Level in Chronic Hepatitis B Patients who Achieved Hepatitis B Surface Antigen Loss during Pegylated Interferon Alpha-2a Treatment

“…In summary, the results of this study demonstrate that patients with lower baseline HBsAg sustained and rapid decline of HBsAg during treatment, and early viral response are more likely to achieve HBsAg clearance[ 34 ] during IFN-based therapy. However, most patients needed extended treatment longer than 48 weeks to achieve HBsAg loss during treatment.…”

Clinical utility of hepatitis B surface antigen kinetics in treatment-naïve chronic hepatitis B patients during long-term entecavir therapy

“…HBsAg levels of < 3000 IU/mL at the baseline combined with HBsAg declines of ≥ 75% from the baseline could predict the eventual loss of HBsAg[ 14 ]. An HBsAg reduction of > 1 log IU/mL could reflect improved immune control[ 12 , 15 ], and a reduction of ≥ 0.5 log IU/mL after 6 mo of treatment had a high negative predictive value for HBsAg seroclearance[ 16 ].…”