Search
DEEN
more info

Contact:
Phone:+49 0761 1514 440Fax:+49 0761 1514 460Email:info[at]falkfoundation.org

    Liver and Bile

    Gastroenterology. 2022;162(3):757–71.e4

    Hirode G, Choi HSJ, Chen CH, Su TH, Seto WK, Van Hees S, Papatheodoridi M, Lens S, Wong G, Brakenhoff SM, Chien RN, Feld J, Sonneveld MJ, Chan HLY, Forns X, Papatheodoridis GV, Vanwolleghem T, Yuen MF, Hsu YC, Kao JH, Cornberg M, Hansen BE, Jeng WJ, Janssen HLA; RETRACT-B Study Group

    Off-therapy response after nucleos(t)ide analogue withdrawal in patients with chronic hepatitis B: An international, multicenter, multiethnic cohort (RETRACT-B Study)


    Background and aims: Functional cure, defined based on hepatitis B surface antigen (HBsAg) loss, is rare during nucleos(t)ide analogue (NA) therapy and guidelines on finite NA therapy have not been well established. The aim of this study was to analyze off-therapy outcomes after NA cessation in a large, international, multicenter, multiethnic cohort of patients with chronic hepatitis B (CHB).
    Methods: This cohort study included patients with virally suppressed CHB who were hepatitis B e antigen (HBeAg)-negative and stopped NA therapy. Primary outcome was HBsAg loss after NA cessation, and secondary outcomes included virological, biochemical, and clinical relapse, alanine aminotransferase flare, retreatment, and liver-related events after NA cessation.
    Results: Among 1552 patients with CHB, cumulative probability of HBsAg loss was 3.2% at 12 months and 13.0% at 48 months of follow-up. HBsAg loss was higher among Whites (vs. Asians: subdistribution hazard ratio [HR] = 6.8; 95% confidence interval [CI]: 2.7–16.8; p < 0.001) and among patients with HBsAg levels < 100 IU/ml at end of therapy (vs. ≥ 100 IU/ml: subdistribution HR = 22.5; 95% CI: 13.1–38.7; p < 0.001). At 48 months of follow-up, Whites with HBsAg levels < 1000 IU/ml and Asians with HBsAg levels < 100 IU/ml at end of therapy had a high predicted probability of HBsAg loss (> 30%). Incidence rate of hepatic decompensation and hepatocellular carcinoma was 0.48 per 1000 person-years and 0.29 per 1000 person-years, respectively. Death occurred in 7/19 decompensated patients and 2/14 patients with hepatocellular carcinoma.

    Conclusions: The best candidates for nucleos(t)ide analogue withdrawal are virally suppressed, hepatitis B e antigen-negative, non-cirrhotic patients with chronic hepatitis B with low hepatitis B surface antigen levels, particularly Whites with < 1000 IU/ml and Asians with < 100 IU/ml. However, strict surveillance is recommended to prevent deterioration.

    Prof. Dr. H.L.A. Janssen, Toronto Centre for Liver Disease, University Health Network – Toronto General Hospital, Toronto, ON, Canada,
    E-Mail: harry.janssen@uhn.ca

    DOI: DOI: 10.1053/j.gastro.2021.11.002

    Back to overview

    this could be of interest:

    Liver and Bile

    Updated efficacy and safety data from IMbrave150: Atezolizumab plus bevacizumab versus sorafenib for unresectable hepatocellular carcinoma

    J Hepatol. 2022;76(4):862–73

    Cheng AL, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Lim HY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Ma N, Nicholas A, Wang Y, Li L, Zhu AX, Finn RS

    Go to article

    Liver and Bile

    Probability of HBsAg loss after nucleo(s)tide analogue withdrawal depends on HBV genotype and viral antigen levels

    J Hepatol. 2022;76(5):1042–50

    Sonneveld MJ, Chiu SM, Park JY, Brakenhoff SM, Kaewdech A, Seto WK, Tanaka Y, Carey I, Papatheodoridi M, van Bömmel F, Berg T, Zoulim F, Ahn SH, Dalekos GN, Erler NS, Höner Zu Siederdissen C, Wedemeyer H, Cornberg M, Yuen MF, Agarwal K, Boonstra A, Buti M, Piratvisuth T, Papatheodoridis G, Chen CH, Maasoumy B; CREATE study group

    Go to article
    More articles on the topic