Entecavir treatment for chronic hepatitis B: Adaptation is... : Hepatology (original) (raw)

Viral Hepatitis

Entecavir treatment for chronic hepatitis B: Adaptation is not needed for the majority of naïve patients with a partial virological response

Zoutendijk, Roeland1; Reijnders, Jurriën G. P.1; Brown, Ashley2; Zoulim, Fabien3; Mutimer, David4; Deterding, Katja5; Petersen, Jörg6; Peter Hofmann, Wolf7; Buti, Maria8; Santantonio, Teresa9; van Bömmel, Florian10; Pradat, Pierre3; Oo, Ye4; Luetgehetmann, Marc11; Berg, Thomas10; Hansen, Bettina E.1; Wedemeyer, Heiner5; Janssen, Harry L. A.1 for the VIRGIL Surveillance Study Group

1_Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center Rotterdam, Rotterdam, the Netherlands_

2_Department of Hepatology and Gastroenterology, Imperial College London, London, United Kingdom_

3_Department of Hepatology, Hotel Dieu Hospital Lyon, Lyon, France_

4_Department of Hepatology and Gastroenterology, Queen Elizabeth Hospital, Birmingham, United Kingdom_

5_Department of Gastroenterology, Hepatology, and Endocrinology, Medical School Hannover, Hannover, Germany_

6_Liver Unit, IFI Institute, Asklepios Klinik St. Georg, Hamburg, Germany_

7_Medizinische Klinik 1, Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt am Main, Germany_

8_Department of Hepatology, Hospital Vall de Hebron, Barcelona, Spain_

9_Clinic of Infectious Diseases, University of Foggia, Foggia, Italy_

10_Klinik und Poliklinik für Gastroenterologie und Rheumatologie, Leipzig, Germany_

11_Department for Internal Medicine, University Medical Center, Hamburg-Eppendorf, Germany_

Address reprint requests to: Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Center Rotterdam, 's Gravendijkwal 230, room Ha 204, 3015 CE Rotterdam, Netherlands. E-mail:[email protected]

Abstract

Entecavir (ETV) is a potent inhibitor of viral replication in nucleos(t)ide analogue (NA)-naïve chronic hepatitis B (CHB) patients. The aim of this study was to investigate the long term efficacy and safety of ETV in NA-naïve CHB patients, particularly in those with detectable hepatitis B virus (HBV) DNA after 48 weeks, in whom treatment adaptation is suggested by current guidelines. In a multicenter cohort study, we investigated 333 CHB patients treated with entecavir monotherapy. The NA-naïve population consisted of 243 patients, whereas 90 were NA-experienced. Virological response (VR) (HBV DNA <80 IU/mL) was achieved in 48%, 76%, and 90% of hepatitis B e antigen (HBeAg)-positive and in 89%, 98%, and 99% of HBeAg-negative NA-naïve patients at weeks 48, 96, and 144, respectively. Thirty-six of 175 (21%) NA-naïve patients with at least 48 weeks of follow-up had a detectable load at week 48 (partial virological response [PVR]). Twenty-nine (81%) patients with PVR reached VR during prolonged ETV monotherapy, and none of them developed ETV-resistance. Among 22 patients with HBV DNA <1,000 IU/mL at week 48, VR was achieved in 21 (95%) patients, compared with eight of 14 (57%) patients with HBV DNA ≥1,000 IU/mL. Continuous HBV DNA decline was observed in most patients without VR during follow-up, and in three patients adherence was suboptimal according to the treating physician. ETV was safe and did not affect renal function or cause lactic acidosis. Conclusion: ETV monotherapy can be continued in NA-naïve patients with detectable HBV DNA at week 48, particularly in those with a low viral load because long-term ETV leads to a virological response in the vast majority of patients. (Hepatology 2011;)