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J Hepatol. 2014 Apr;60(4):715-22. doi: 10.1016/j.jhep.2013.11.024. Epub 2013 Dec 1.

Long-term efficacy and safety of emtricitabine plus tenofovir DF vs. tenofovir DF monotherapy in adefovir-experienced chronic hepatitis B patients.

Author information

1
Sektion Hepatologie, Klinik und Poliklinik für Gastroenterologie und Rheumatologie, Universitätsklinikum Leipzig, Leipzig, Germany. Electronic address: thomas.berg@medizin.uni-leipzig.de.
2
INSERM U1052 and Hospices Civils de Lyon, Lyon, France.
3
Private practice, Berlin, Germany.
4
Private practice, San Jose, CA, USA.
5
Service d'Hepatologie and INSERM CRB3, University of Paris, Hopital Beaujon, Pavillon Abrami, Paris, France.
6
Private practice, Flushing, NY, USA.
7
Gilead Sciences, Inc., Foster City, CA, USA.
8
Department of Gastroenterology, Hepatology and Endocrinology, Medical School of Hannover, Hannover, Germany.

Abstract

BACKGROUND & AIMS:

Suboptimal virologic response to nucleos(t)ide analogs may represent a significant risk factor for resistance development in patients with chronic hepatitis B virus infection; treatment options have not been well studied. We evaluated long-term efficacy and safety of tenofovir alone and in combination with emtricitabine in a prospective, placebo-controlled trial in patients who remained viremic on adefovir therapy.

METHODS:

Hepatitis B e antigen-positive and -negative patients with hepatitis B virus DNA ⩾ 1000 copies/ml despite up to 96 weeks of adefovir were randomized to double-blind tenofovir or emtricitabine/tenofovir for 168 weeks. Patients with hepatitis B virus DNA ⩾ 400 copies/ml (⩾ 69IU/ml) at or after week 24 could switch to open-label emtricitabine/tenofovir.

RESULTS:

Overall, 90/105 (86%) patients (46/53 tenofovir and 44/52 emtricitabine/tenofovir) completed the 168-week study period, including 74/105 (70%) patients (35/53 tenofovir and 39/52 emtricitabine/tenofovir) who completed the study on their initial randomized treatment. Long-term viral suppression (hepatitis B virus DNA <400 copies/ml) was maintained at week 168 in 84% and 82% of patients receiving either emtricitabine/tenofovir combination or tenofovir monotherapy, respectively (non-completer equal to failure analysis). Baseline viral load as well as the presence of lamivudine and/or adefovir resistance-associated mutations at baseline had no impact on long-term treatment response. No resistance to tenofovir was observed through 168 weeks. Both treatments had a favorable safety profile.

CONCLUSIONS:

Tenofovir monotherapy is as effective as emtricitabine/tenofovir combination therapy in maintaining long-term viral suppression in patients with a suboptimal response to adefovir, and is well tolerated in this population.

KEYWORDS:

Adefovir; Combination treatment; Emtricitabine; Hepatitis B; Monotherapy; Mutations; Resistance; Tenofovir

PMID:
24295873
DOI:
10.1016/j.jhep.2013.11.024
[Indexed for MEDLINE]

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