Long Term HBsAg Responses to Peg-Interferon Alpha-2b in HBeAg Negative Chronic Hepatitis B Patients Developing Clinical Relapse after Stopping Long-Term Nucleos(t)ide Analogue Therapy

Karan Kumar; Ankur Jindal; Ekta Gupta; Nirupma Trehanpati; Saggere M Shasthry; Rakhi Maiwall; Vinod Arora; Ankit Bhardwaj; Guresh Kumar; Manoj Kumar; Shiv K Sarin

doi:10.1016/j.jceh.2023.08.008

Long Term HBsAg Responses to Peg-Interferon Alpha-2b in HBeAg Negative Chronic Hepatitis B Patients Developing Clinical Relapse after Stopping Long-Term Nucleos(t)ide Analogue Therapy

J Clin Exp Hepatol. 2024 Jan-Feb;14(1):101272. doi: 10.1016/j.jceh.2023.08.008. Epub 2023 Aug 23.

Authors

Affiliations

¹ Department of Hepatology and Liver Transplantation, Institute of Liver and Biliary Sciences, New Delhi, India.
² Department of Virology, Institute of Liver and Biliary Sciences, New Delhi, India.
³ Department of Molecular and Cellular Medicine, Institute of Liver and Biliary Sciences, New Delhi, India.
⁴ Department of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India.
⁵ Department of Biostatistics, Institute of Liver and Biliary Sciences, New Delhi, India.

PMID: 38076362
PMCID: PMC10709173 (available on 2025-01-01)
DOI: 10.1016/j.jceh.2023.08.008

Abstract

Background and aims: A high proportion of hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) patients develop clinical relapse after stopping long-term nucleotide analogues (NAs). The aim of this study was to assess the efficacy of pegylated interferon (PEG-IFN) alpha 2b in inducing hepatitis B surface antigen (HBsAg) loss in such patients.

Methods: NAs were stopped in 118 HBeAg-negative CHB patients fulfilling the Asian Pacific Association for the Study of Liver (APASL) 2015 criteria for stopping NAs; they had received NAs for a median interquartile range (IQR) of 60 (48-84) months.

Results: Overall, 82 of 118 (69.5%) patients developed clinical relapse after stopping NAs; 44 within 12 months (and treated with PEG-IFN alpha 2b 1.5 mcg/kg weekly subcutaneous injections for 48 weeks); and 38 after 12 months [and treated with tenofovir alafenamide fumarate (TAF) 25 mg daily] of follow-up. The decision to treat with either PEG-IFN or TAF was not a time-bound decision but was due to logistical problems.During the median IQR follow-up of 48 (43.5-52.5) months after the start of PEG-IFN, 14 of 44 (31.8%) patients developed clinical relapse after stopping PEG-IFN and were started on TAF. At the last follow-up visit, HBsAg was found to be negative in 7/44 (15.9%) of patients receiving PEG-IFN.Among 38 patients treated with TAF for clinical relapse, during the median IQR follow-up of 18 (12-30) months after start of TAF, no patient became HBsAg negative.36 patients did not develop clinical relapse during the follow-up, and after a median IQR follow-up of 60 (60-60) months after stopping NAs, HBsAg negative was found in 1/36 (2.8%) of patient at the last follow-up.

Conclusions: Among patients with HBeAg-negative chronic hepatitis B who developed clinical relapse after stopping long-term NAs therapy and were subsequently treated with PEG-IFN alpha 2b, 15.9% achieved HBsAg loss on long-term follow-up.

Keywords: HBeAg negative chronic hepatitis B; pegylated interferon alpha; relapse.