Patients with chronic hepatitis B virus (HBV) who discontinued treatment with entecavir or tenofovir disoproxil fumarate (TDF) experienced different relapse patterns but similar rates of hepatitis B surface antigen loss and retreatment, according to study findings published in Clinical Gastroenterology and Hepatology.
Researchers retrospectively analyzed patterns of relapse in 1402 virally suppressed patients with chronic HBV, who discontinued treatment using entecavir (n=981) or TDF (n=421). Patients were included from 13 centers throughout Asia, North America, and Europe between 2001 and 2020.
After a median follow-up of 18 months, loss of hepatitis B surface antigens (HBsAg), virological relapse, and clinical relapse occurred in 96 (6.8%), 1097 (78%), and 598 (43%) patients with chronic HBV, respectively. Of the 1402 patients, 667 (48%) received retreatment. There were no observed differences in rate of retreatment between the entecavir and TDF groups (P =.14).
Patients who discontinued TDF demonstrated a higher rate of HBsAg loss (P =.03) than those who discontinued entecavir; however, following weighted analysis, the rate of HBsAg loss was no longer significantly different between the 2 groups (P =.61).
Patients who discontinued TDF experienced earlier virological relapses (P <.01) accompanied by elevated alanine transaminase (ALT) liver enzyme levels and higher rates of clinical relapse (P <.01). Patients who experienced clinical relapse after discontinuing TDF also had higher peak ALT levels compared with patients who discontinued entecavir.
“Findings from our combined multi-ethnic cohort demonstrate that TDF and [entecavir] have differential relapse patterns,” the study authors wrote. “Despite the high rates of relapse occurring earlier after TDF withdrawal, HBsAg loss and retreatment rates in the two groups were comparable, suggesting that clinical outcomes following treatment discontinuation are similar between the two groups.”
Study limitations include the retrospective design, unknown HBV viral genotypes, and lack of adequate longitudinal data making it difficult to compare viral marker kinetics between the treatment groups.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Choi HSJ, Hirode G, Chen CH, et al. Differential relapse patterns after discontinuation of entecavir vs tenofovir disoproxil fumarate in chronic hepatitis B. Clin Gastroenterol Hepatol. Published online July 18, 2022. doi:10.1016/j.cgh.2022.07.005