studies

HEPATOLOGY, VOLUME 62, NUMBER 1 (SUPPL) AASLD ABSTRACTS 1183A
2002
Final Results of Peginterferon Alfa-2b Add-on
during Long-term Nucleos(t)ide Analogue Therapy in
HBeAg-positive Patients – a Multicenter Randomized
Controlled Trial (PEGON Study)
Heng Chi 1 , Qing Xie 2 , Ning-Ping Zhang 3 , Xun Qi 4 , Chen Liang 4 ,
Simin Guo 2 , Qing Guo 2 , Pauline Arends 1 , Jiyao Wang 3 , Elke Verhey
1 , Robert J. de Knegt 1 , Bettina E. Hansen 1 , Harry L. Janssen 1,5 ;
1 Gastroenterology and Hepatology, Erasmus MC University Medical
Center Rotterdam, Rotterdam, Netherlands; 2 Department of
Infectious Diseases, Ruijin Hospital, Jiaotong University, Shanghai,
China; 3 Department of Gastroenterology and Hepatology, Zhongshan
hospital, Fudan University, Shanghai, China; 4 Department of
Hepatitis Disease, Shanghai Public Health Clinical Center, Fudan
University, Shanghai, China; 5 Toronto Centre for Liver Disease,
Toronto General & Western Hospital, University of Toronto, Shanghai,
ON, Canada
BACKGROUND: Nucleos(t)ide analogues (NA) are potent
inhibitors of viral replication in chronic hepatitis B (CHB)
patients. However, sustained off-treatment response is infrequently
achieved indicating the necessity of long-term therapy.
Peginterferon (PEG-IFN) add-on in HBeAg-positive patients on
long-term NA may facilitate serological responses and finite
therapy. METHODS: In this investigator-initiated randomized
trial conducted in Europe and China, 82 HBeAg-positive
patients were treated for at least 12 months with entecavir
(ETV) or tenofovir (TDF) with suppressed HBV DNA and HBeAg
positivity at randomization. Patients were randomized to 48
weeks of PEG-IFN alfa-2b add-on, or continued NA monotherapy.
Response (HBeAg seroconversion with HBV DNA