STOP-NUC: A multicentre randomized controlled trial evaluating the rate of sustained remission and the safety when stopping nucleos(t)ide analogue treatment in non-cirrhotic HBeAg-negative chronic Hepatitis B patients with long-term virologic response

Coordinating investigator: Prof. Dr. Florian van Bömmel Sektion Hepatologie, Klinik und Poliklinik für Gastroenterologie und Rheumatologie Universitätsklinikum Leipzig
Sponsor: Universität Leipzig Ritterstr. 26, 04109 Leipzig
Registration: EudraCT: 2013-004882-15 DRKS: DRKS00006240

Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg -negative hepatitis B, as functional cure (loss of HBsAg) is rarely achieved. Discontinuation of NUC treatment may lead to functional cure; however, to date, the evidence for this has been based on small or non-randomized clinical trials. The STOP-NUC trial was designed with the aim of increasing the HBsAg loss rate using a NUC treatment interruption approach.

In this multicenter, randomized controlled trial, 166 HBeAg-negative chronic hepatitis B patients on continuous long-term NUC treatment, with HBV DNA < 172 IU/mL (1,000 copies/mL) for at least 4 years, were randomized to either stop (Arm A) or continue NUC treatment (Arm B) for a 96-week observation period. In total, 158 patients were available for final analysis, 79 per arm. The primary endpoint was sustained HBsAg loss up to week 96.