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Journal Articles Hepatology international Year : 2016

Entecavir plus tenofovir combination therapy for chronic hepatitis B in patients with previous nucleos(t)ide treatment failure

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Jolanta Bia\l Kowska-Warzecha
  • Function : Author
Mircea Mihai Diculescu
  • Function : Author
Adrian Eugen Goldis
  • Function : Author
Renate Heyne
  • Function : Author
Tomasz Mach
  • Function : Author
Jörg Petersen
  • Function : Author
Krzysztof Simon
  • Function : Author
Soumaya Bendahmane
  • Function : Author
Isabelle Klauck
  • Function : Author
Wojciech Wasiak
  • Function : Author
Harry L. A. Janssen
  • Function : Author

Abstract

BACKGROUND AND AIMS: In patients with chronic hepatitis B (CHB) who have failed on other nucleos(t)ide analogs (NUCs), the combination of entecavir (ETV) plus tenofovir disoproxil fumarate (TDF), two potent agents with non-overlapping resistance profiles, may provide a single rescue regimen. METHODS: In this single-arm, open-label study, 92 CHB patients with a primary non-response, partial response, or virologic breakthrough on their current NUC were switched to ETV (1 mg) plus TDF (300 mg) and treated for 96 weeks. RESULTS: At baseline, 62 % of patients were HBeAg(+) and mean HBV DNA was 4.4 log10IU/mL. Patients had received \\textgreater/=1 line of prior NUC therapy, with the latest regimen consisting of monotherapy with ETV (53 %), lamivudine (LVD 22 %), TDF (12 %), adefovir (ADV 4 %), or telbivudine (2 %), or combinations of these agents (7 %); 58 % had evidence of single- or multidrug resistance mutations (LVD 52 %, ETV 26 %; ADV 7 %). Response rates for HBV DNA \\textless50 IU/mL were 76 % (70/92) at week 48 (primary endpoint), and 85 % (78/92) at week 96, including 80 % (16/20) in prior LVD failures, 100 % (4/4) in ADV failures, 82 % (9/11) in TDF failures, and 88 % (42/48) in ETV failures. No treatment-emergent resistance to ETV or ADV was observed. ETV/TDF was well tolerated, with no significant renal or additive toxicities observed. CONCLUSIONS: In NUC-experienced patients who have failed prior NUC therapy, ETV/TDF was well tolerated and effective, achieving virologic suppression through 96 weeks in the majority (85 %), irrespective of prior NUC exposure, without occurrence of treatment-emergent resistance to either agent
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Dates and versions

hal-01796203 , version 1 (19-05-2018)

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Fabien Zoulim, Jolanta Bia\l Kowska-Warzecha, Mircea Mihai Diculescu, Adrian Eugen Goldis, Renate Heyne, et al.. Entecavir plus tenofovir combination therapy for chronic hepatitis B in patients with previous nucleos(t)ide treatment failure. Hepatology international, 2016, 10 (5), pp.779-788. ⟨10.1007/s12072-016-9737-2⟩. ⟨hal-01796203⟩
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