1061
LONG-TERM EFFECTS ON HBSAG CLEARANCE, RELAPSED, AND SAFETY OF TENOFOVIR AND ENTECAVIR CESSATION IN NON-CIRRHOTIC HBEAG NEGATIVE CHRONIC HEPATITIS B PATIENTS
Date
May 21, 2024
Background: Recent studies found that nucleos(t)ide analogues (NA) stopping will lead to more rapid HBsAg clearance and safety. However, few studies reported the long-term outcomes after the discontinuation. This study aims to evaluate HBsAg loss, virological relapse (VR), clinical relapse (CR), and safety after cessation of tenofovir (TDF) or entecavir (ETV).
Methods: A total of 98 non-cirrhotic HBeAg negative chronic hepatitis B patients (CHB), treated with either TDF or ETV for at least three years and virally suppressed were enrolled into TDF discontinued (TDF-D, n=39), ETV discontinued (ETV-D, n=27) groups compared continued group (continue, n=32). All patients were followed for at least one year and up to 4 years after NA discontinuation.
Results: of 98 patients, the mean age was 60, and 66% were male. Patients’ characteristics are shown in Table 1. The median follow-up time was 146 weeks; seven patients (10.6%) achieved HBsAg clearance after NA discontinuation. They all had end-of-treatment (EOT) HBsAg levels <100 IU/ml. Cumulative incidences of VR at weeks 48, 96, and 144 were 66.9%, 71.6%, and 83% in TDF-D and 40.7%,55.8% and 55.8% in ETV-D, respectively(P=0.002). Cumulative incidences of CR at weeks 48, 96, and 144 were 38.6%, 45.7%, 49.8% in TDF-D and 22.2%, 26.5%, and 26.5% in ETV-D, respectively(P=0.022). The continued group had no HBsAg loss, VR, or CR. (Fig1A, B, C) The cumulative rate of HBsAg loss, VR, and CR in patients with EOT-HBsAg<100 IU/ml and >100 IU/ml were shown in Fig1(D, E, F). EOT-HBsAg level was a significant predictor for HBsAg clearance (HR=0.21, 95% CI 0.05-0.89, P=0.028). Six patients in TDF-D had severe ALT flares, two required admission, and one death.
Conclusion: NA cessation led to achieving HBsAg clearance more than NA continuation usually in the first year; however, it increased the risk of VR and CR, especially in the TDF group and patients with high EOT-HBsAg levels. Some resulted in early and more severe CR, which led to hepatic decompensation and death.
Methods: A total of 98 non-cirrhotic HBeAg negative chronic hepatitis B patients (CHB), treated with either TDF or ETV for at least three years and virally suppressed were enrolled into TDF discontinued (TDF-D, n=39), ETV discontinued (ETV-D, n=27) groups compared continued group (continue, n=32). All patients were followed for at least one year and up to 4 years after NA discontinuation.
Results: of 98 patients, the mean age was 60, and 66% were male. Patients’ characteristics are shown in Table 1. The median follow-up time was 146 weeks; seven patients (10.6%) achieved HBsAg clearance after NA discontinuation. They all had end-of-treatment (EOT) HBsAg levels <100 IU/ml. Cumulative incidences of VR at weeks 48, 96, and 144 were 66.9%, 71.6%, and 83% in TDF-D and 40.7%,55.8% and 55.8% in ETV-D, respectively(P=0.002). Cumulative incidences of CR at weeks 48, 96, and 144 were 38.6%, 45.7%, 49.8% in TDF-D and 22.2%, 26.5%, and 26.5% in ETV-D, respectively(P=0.022). The continued group had no HBsAg loss, VR, or CR. (Fig1A, B, C) The cumulative rate of HBsAg loss, VR, and CR in patients with EOT-HBsAg<100 IU/ml and >100 IU/ml were shown in Fig1(D, E, F). EOT-HBsAg level was a significant predictor for HBsAg clearance (HR=0.21, 95% CI 0.05-0.89, P=0.028). Six patients in TDF-D had severe ALT flares, two required admission, and one death.
Conclusion: NA cessation led to achieving HBsAg clearance more than NA continuation usually in the first year; however, it increased the risk of VR and CR, especially in the TDF group and patients with high EOT-HBsAg levels. Some resulted in early and more severe CR, which led to hepatic decompensation and death.
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