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Novel HBV Biomarkers-Guided NAs Withdrawal Strategy Promotes HBsAg Clearance in Asian CHB Patients: A Randomized
Rong Fan1, Rui Deng2, Qing Xie3
1State Key Laboratory of Multi-organ Injury Prevention and Treatment, Key Laboratory of Infectious Diseases Research in South China, Ministry of Education, Guangdong Provincial Key Laboratory for Prevention and Control of Major Liver Diseases, Guangdong Provincial Clinical Research Center for Viral Hepatitis, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Background & Aims:
Nucleos(t)ide analogue (NAs) discontinuation promotes hepatitis B surface antigen (HBsAg) clearance among European patients with chronic hepatitis B virus (HBV) infection. The efficacy and safety of a novel HBV biomarker-guided NAs withdrawal strategy among Asian patients was evaluated in this multicenter randomized controlled trial.
Methods:
NAs-experienced patients achieving HBsAg <200 IU/mL and undetectable HBV DNA for ≥12 months with HBV RNA or hepatitis core-related antigen undetectable were randomized 2:1 to stop or continue NAs therapy. Ninety patients were included in final modified intention-to-treat analysis (60 in the NAs-Stop group and 30 in the NAs-Continue group). Cumulative rates of HBsAg loss and relapse were evaluated at week 144.
Results:
Patients enrolled were 45.9 ± 10.2 years of age, with a median 9.4 years (interquartile range, 6.0-13.0 years) of treatment. Baseline characteristics between the two groups were balanced, with a median HBsAg level of 1.7 and 1.8 log10 IU/mL in the NAs-Stop and NAs-Continue groups, respectively (P = .224). Compared with patients in the NAs-Continue group, NAs-stoppers showed an increased 144-week cumulative incidence of HBsAg clearance (25.9% vs 4.2%; P = .013) and more profound HBsAg decline during follow-up (0.90 log10 IU/mL vs 0.46 log10 IU/mL; P = .056). Cumulatively, 38.6% and 20.2% of patients experienced virological and clinical relapse after stopping NAs, with 16 patients retreated and no serious adverse events occurring. Subgroup analysis revealed that hepatitis B e antigen-negative patients with baseline HBsAg level <100 IU/mL had a more favorable response following NAs withdrawal, achieving an HBsAg loss rate of 40.0%.
Conclusions:
Asian patients with long-term HBV suppression benefit from NAs discontinuation guided by novel HBV markers, which provides rationale for finite NAs treatment. ClincialTrials.gov, Number: NCT04519359.
