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http://www.sciencedirect.com/science/article/pii/S0168827811007884
Research Article
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 1st 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
- Received 30 June 2011. Revised 16 August 2011. Accepted 5 September 2011. Available online 26 October 2011.
Background & AimsLong-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. MethodsInvestigator-initiated open-label cohort study. Quantitative HBV-DNA measurement and resistance testing (line-probe-assays and direct-sequencing) at baseline and every 3 months. ResultsFifty 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 HBV-DNA 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. ConclusionsRescue 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).
Abbreviations- IFN, interferon;
- CHB, chronic hepatitis B;
- HBV, hepatitis B virus;
- LAM, lamivudine;
- TDF, tenofovir disoproxil fumarate;
- ADV, adefovir didivoxil;
- LdT, telbivudine;
- ALT, alanine aminotransferase;
- HBeAg, hepatitis B e antigen;
- HBsAg, hepatitis B surface antigen;
- MDR, multidrug resistance
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发表于 2012-2-17 17:08
