‘Close follow-up’ needed after nucleos(t)ide analog cessation
medwireNews: An analysis of patients with chronic hepatitis B virus (HBV) infection who relapsed after withdrawal of nucleos(t)ide analog therapy, despite meeting stringent cessation criteria, highlights the importance of monitoring for at least 3 years after stopping treatment.
Of 223 patients who discontinued oral antiviral therapy after meeting cessation criteria outlined in the 2008 Asian Pacific Association for the Study of the Liver guidelines, 87 experienced viral relapse, defined as serum HBV DNA levels higher than 104 copies/mL in two consecutive assessments at least 2 weeks apart, and were included in the current study.
Thirty-eight of the relapsed patients were positive for hepatitis B virus e antigen (HBeAg), whereas the remaining 49 were HBeAg-negative.
Just under half of the patients in each group had an early relapse, defined as viral relapse within 3 months of antiviral cessation, at 44.7% and 44.9% of the HBeAg-positive and HBeAg-negative patients, respectively.
But for HBeAg-positive participants, the large majority (89.5%) of relapses occurred within 4 years of treatment withdrawal, while 91.8% of HBeAg-negative patients relapsed within 3 years.
Therefore, the researchers propose that a minimum of 4 and 3 years of “close follow-up” is necessary for HBeAg-positive and HBeAg-negative patients, respectively, who need to discontinue treatment before achieving hepatitis B surface antigen seroclearance.
Multivariate analysis showed that the only significant predictor of an early relapse was time to undetectable HBV DNA, with a longer interval increasing the likelihood of relapse by 1.3 times (p=0.039). Time to undetectable HBV DNA could distinguish early and late relapsers with an accuracy of 63.5%.
Lei Wang (Second Hospital of Shandong University, Jinan, China) and team, therefore, recommend that “[p]atients with longer times to undetectable HBV DNA should receive more attention in the early stages after cessation.”
They also found that 15.8% of HBeAg-positive individuals and 22.4% of those negative for HBeAg had peak alanine aminotransferase (ALT) levels 10 times the upper limit of normal after relapse.
“Although no cirrhotic patients were included in our study and no cases of hepatic [decompensation] or liver failure were found, the high level of ALT still warrants close monitoring and timely intervention,” the team concludes in Hepatology Research.
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