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Entecavir plus tenofovir combination as rescue therapy in
pre-treated chronic hepatitis B patients: An international
multicenter cohort study
Jorg Petersen1,⇑, Vlad Ratziu2, Maria Buti3, Harry L.A. Janssen4, Ashley Brown5, Pietro Lampertico6,
Jan Schollmeyer7, Fabien Zoulim8, Heiner Wedemeyer9, Martina Sterneck10, Thomas Berg11,
Christoph Sarrazin12, Marc Lutgehetmann7,13,, Peter Buggisch1,
1 Liver Unit, IFI Institute for Interdisciplinary Medicine, Asklepios Klinik St. Georg Hamburg, Germany;
2 Service d Hepato-Gastroenterologie,
Universite Pierre et Marie Curie, Paris, France;
3 Liver Unit, Hospital Vall de Hebron and Ciber-ehd del Instituto Carlos III, Barcelona, Spain;
4 Gastroenterology and Hepatology, University Medical Center, Rotterdam, The Netherlands; 5 Department of Medicine, Imperial College London,
London, UK;
6 st Division of Gastroenterology, Fondazione IRCCS CáGranda Ospedale Maggiore Policlinico, Universita degli studi di Milano, Italy;
7 Department of Internal Medicine, University Hospital Eppendorf, Hamburg, Germany; 8 Hepatology Department, Hospices Civils de, Lyon,
France;
9 Department of Gastroenterology and Hepatology, Hanover Medical School, Hanover, Germany;
10 Department of Hepatobiliary Surgery
and Transplantation, University Hospital Eppendorf, Hamburg, Germany;
11 Department of Gastroenterology and Hepatology, University Leipzig,
Leipzig, Germany;
12 Department of Medicine, University of Frankfurt, Frankfurt, Germany;
13 Department of Microbiology, University Hospital
Eppendorf, Hamburg, Germany
Background & Aims: Long-term viral suppression is a major goal
to prevent disease progression in patients with HBV. Aim of this
study was to investigate the efficacy and safety of entecavir plus
tenofovir combination in 57 CHB partial responders or multidrug
resistant patients.
Methods: Investigator-initiated open-label cohort study. Quantitative
HBV-DNA measurement and resistance testing (line-probeassays
and direct-sequencing) at baseline and every 3 months.
Results: Fifty seven patients (37 HBeAg+), median age 45 years,
previously treated with a median of three lines of antiviral therapy
(range 1–6), 24/57 with advanced liver disease, were included.
Median ALT at baseline was 1.0 ULN (range 0.3–22) and HBVDNA
1.5 104 IU/ml (range 500–1 1011 IU/ml). Median treatment
duration of combination therapy was 21 months. HBV-DNA
level dropped 3 logs (median, range 0–8 log; p <0.0001), 51/57
patients became HBV-DNA undetectable, median after 6 months
(95% CI, 4.6–7). The probability for HBV DNA suppression was
not reduced in patients with adefovir or entecavir resistance or
in patients with advanced liver disease. Viral suppression led to
decline in ALT (median 0.7 ULN; range 0.2–2.4; p = 0.001). Five
patients lost HBeAg (after 15, 18, 20, 21, and 27 months, respectively),
one patient showed HBs-seroconversion. Patients with
advanced disease did not show clinical decompensation, two
patients with cirrhosis and undetectable HBV DNA developed
HCCs. No death, newly induced renal impairment or lactic acidosis
were reported.
Conclusions: Rescue therapy with entecavir and tenofovir in CHB
patients harboring viral resistance patterns or showing only partial
antiviral responses to preceding therapies was efficient, safe,
and well tolerated in patients with and without advanced liver
disease (249).
2011 European Association for the Study of the Liver. Published
by Elsevier B.V. All rights reserved.
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发表于 2013-5-16 20:52