TY - JOUR
T1 - Incidence of Hepatic Decompensation After Nucleos(t)ide Analog Withdrawal
T2 - Results From a Large, International, Multiethnic Cohort of Patients With Chronic Hepatitis B (RETRACT-B Study)
AU - Hirode, Grishma
AU - Hansen, Bettina E.
AU - RETRACT-B study group
AU - Chen, Chien Hung
AU - Su, Tung Hung
AU - Wong, Grace
AU - Seto, Wai Kay
AU - Van Hees, Stijn
AU - Papatheodoridi, Margarita
AU - Brakenhoff, Sylvia M.
AU - Lens, Sabela
AU - Choi, Hannah S.J.
AU - Chien, Rong Nan
AU - Feld, Jordan J.
AU - Forns, Xavier
AU - Sonneveld, Milan J.
AU - Papatheodoridis, George V.
AU - Vanwolleghem, Thomas
AU - Yuen, Man Fung
AU - Chan, Henry L.Y.
AU - Kao, Jia Horng
AU - Hsu, Yao Chun
AU - Cornberg, Markus
AU - Jeng, Wen Juei
AU - Janssen, Harry L.A.
N1 - Publisher Copyright:
© 2023 Wolters Kluwer Health. All rights reserved.
PY - 2023/9
Y1 - 2023/9
N2 - INTRODUCTION: Despite improvements in the management of chronic hepatitis B (CHB), risk of cirrhosis and hepatocellular carcinoma remains. While hepatitis B surface antigen loss is the optimal end point, safe discontinuation of nucleos(t)ide analog (NA) therapy is controversial because of the possibility of severe or fatal reactivation flares.METHODS: This is a multicenter cohort study of virally suppressed, end-of-therapy (EOT) hepatitis B e antigen (HBeAg)-negative CHB patients who stopped NA therapy (n = 1,557). Survival analysis techniques were used to analyze off-therapy rates of hepatic decompensation and differences by patient characteristics. We also examined a subgroup of noncirrhotic patients with consolidation therapy of ≥12 months before cessation (n = 1,289). Hepatic decompensation was considered related to therapy cessation if diagnosed off therapy or within 6 months of starting retreatment. RESULTS: Among the total cohort (11.8% diagnosed with cirrhosis, 84.2% start-of-therapy HBeAg-negative), 20 developed hepatic decompensation after NA cessation; 10 events were among the subgroup. The cumulative incidence of hepatic decompensation at 60 months off therapy among the total cohort and subgroup was 1.8% and 1.1%, respectively. The hepatic decompensation rate was higher among patients with cirrhosis (hazard ratio [HR] 5.08, P < 0.001) and start-of-therapy HBeAg-positive patients (HR 5.23, P < 0.001). This association between start-of-therapy HBeAg status and hepatic decompensation remained significant even among the subgroup (HR 10.5, P < 0.001). DISCUSSION: Patients with cirrhosis and start-of-therapy HBeAg-positive patients should be carefully assessed before stopping NAs to prevent hepatic decompensation. Frequent monitoring of viral and host kinetics after cessation is crucial to determine patient outcome.
AB - INTRODUCTION: Despite improvements in the management of chronic hepatitis B (CHB), risk of cirrhosis and hepatocellular carcinoma remains. While hepatitis B surface antigen loss is the optimal end point, safe discontinuation of nucleos(t)ide analog (NA) therapy is controversial because of the possibility of severe or fatal reactivation flares.METHODS: This is a multicenter cohort study of virally suppressed, end-of-therapy (EOT) hepatitis B e antigen (HBeAg)-negative CHB patients who stopped NA therapy (n = 1,557). Survival analysis techniques were used to analyze off-therapy rates of hepatic decompensation and differences by patient characteristics. We also examined a subgroup of noncirrhotic patients with consolidation therapy of ≥12 months before cessation (n = 1,289). Hepatic decompensation was considered related to therapy cessation if diagnosed off therapy or within 6 months of starting retreatment. RESULTS: Among the total cohort (11.8% diagnosed with cirrhosis, 84.2% start-of-therapy HBeAg-negative), 20 developed hepatic decompensation after NA cessation; 10 events were among the subgroup. The cumulative incidence of hepatic decompensation at 60 months off therapy among the total cohort and subgroup was 1.8% and 1.1%, respectively. The hepatic decompensation rate was higher among patients with cirrhosis (hazard ratio [HR] 5.08, P < 0.001) and start-of-therapy HBeAg-positive patients (HR 5.23, P < 0.001). This association between start-of-therapy HBeAg status and hepatic decompensation remained significant even among the subgroup (HR 10.5, P < 0.001). DISCUSSION: Patients with cirrhosis and start-of-therapy HBeAg-positive patients should be carefully assessed before stopping NAs to prevent hepatic decompensation. Frequent monitoring of viral and host kinetics after cessation is crucial to determine patient outcome.
UR - http://www.scopus.com/inward/record.url?scp=85163189711&partnerID=8YFLogxK
U2 - 10.14309/ajg.0000000000002203
DO - 10.14309/ajg.0000000000002203
M3 - Article
C2 - 36719174
AN - SCOPUS:85163189711
SN - 0002-9270
VL - 118
SP - 1601
EP - 1608
JO - The American journal of gastroenterology
JF - The American journal of gastroenterology
IS - 9
ER -
