DARING-B: Discontinuation of Effective Entecavir or Tenofovir Disoproxil Fumarate Long-Term Therapy before HBsAg Loss in Non-Cirrhotic HBeAg-Negative Chronic Hepatitis B

作者：George Papatheodoridis, Eirini I. Rigopoulou, Μargarita Papatheodoridi, Kalliopi Zachou, Vassilios Xourafas, Nikolaos Gatselis, Emilia Hadziyannis, John Vlachogiannakos, Spilios Manolakopoulos, George Ν. Dalekos · 发表于：Antiviral Therapy · 年份：2017 · DOI：10.3851/imp3256 · 被引用次数：97 · 研究领域：Hepatitis B Virus Studies、Hepatitis Viruses Studies and Epidemiology、Pediatric Hepatobiliary Diseases and Treatments

BACKGROUND: The remission rates after stopping antivirals in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) vary among studies, while reliable predictors of relapse have not been identified. This prospective study assessed rates and predictors of relapse and retreatment in 57 non-cirrhotic hepatitis B surface antigen (HBsAg)-positive patients with HBeAg-negative CHB who discontinued effective ≥4-year entecavir or tenofovir disoproxil fumarate (TDF) therapy. METHODS: A total of 57 patients discontinued therapy after median virological remission of 5.3 years and remained under close follow-up. They were retreated with entecavir/TDF if they fulfilled predetermined criteria. RESULTS: During median follow-up of 18 months, no patient died, developed jaundice or liver decompensation. The cumulative relapse rates varied according to HBV DNA and alanine aminotransferase cutoffs; for HBV DNA >2,000 IU/ml, they were 56%, 70% and 72% at 3, 12 and 18 months after stopping entecavir/TDF. The cumulative probability of retreatment was 18% and 26% at 3 and 12 months being significantly affected only by pretreatment fibrosis severity (adjusted relative hazard: 3.43; P=0.015). Cumulative rates of HBsAg loss were 5%, 16% and 25% at 6, 12 and 18 months being higher in patients with lower HBsAg levels at treatment discontinuation. CONCLUSIONS: Our prospective study shows that effective ≥4-year entecavir/TDF therapy can be safely discontinued in non-cirrhotic HBeAg-negative CHB pa...