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J Hepatol. 2017 Nov;67(5):918-924. doi: 10.1016/j.jhep.2017.07.012. Epub 2017 Jul 21.

Long-term response after stopping tenofovir disoproxil fumarate in non-cirrhotic HBeAg-negative patients - FINITE study.

Author information

1
Section of Hepatology, Clinic for Gastroenterology and Rheumatology, University Clinic Leipzig, Leipzig, Germany. Electronic address: thomas.berg@medizin.uni-leipzig.de.
2
Gastroentrologische Gemeinschaftspraxis, Leverkusen, Germany.
3
Zentrum für HIV und Hepatogastroenterologie, Düsseldorf, Germany.
4
Charite Universitätsmedizin, Berlin, Germany.
5
Leberzentrum Checkpoint, Berlin, Germany.
6
Klinikum Lüneburg, Lüneburg, Germany.
7
Dept. Gastroenterology, GRN-Klinik Weinheim, Weinheim, Germany.
8
Klinikum der J.W. Goethe-Universität Frankfurt am Main, Germany.
9
Klinikum der Ludwig-Maximilians München University, München, Germany.
10
Gastroenterologische Gemeinschaftspraxis, Herne, Germany.
11
Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
12
Hannover Medical School, Hannover; German Center for Infection Research (DZIF), partner site Hannover-Braunschweig, Germany.
13
Gilead Sciences Europe Ltd., Uxbridge, United Kingdom.
14
Gilead Sciences Inc., Foster City, USA.
15
Gilead Sciences, Martinsried, Germany.
16
IFI Institute for Interdisciplinary Medicine at the Asklepios Klinik St. George, University of Hamburg, Hamburg, Germany.

Abstract

BACKGROUND & AIMS:

There is currently no virological cure for chronic hepatitis B but successful nucleos(t)ide analogue (NA) therapy can suppress hepatitis B virus (HBV) DNA replication and, in some cases, result in HBsAg loss. Stopping NA therapy often leads to viral relapse and therefore life-long therapy is usually required. This study investigated the potential to discontinue tenofovir disoproxil fumarate (TDF) therapy in HBeAg-negative patients.

METHODS:

Non-cirrhotic HBeAg-negative patients who had received TDF for ≥4years, with suppressed HBV DNA for ≥3.5years, were randomly assigned to either stop (n=21) or continue (n=21) TDF monotherapy. Standard laboratory tests including HBV DNA viral load, HBsAg and alanine aminotransferase (ALT) measurements, and adverse event reporting were carried out during treatment and post-treatment follow-up for 144weeks.

RESULTS:

Of the patients who stopped TDF therapy, 62% (n=13) remained off-therapy to Week 144. Median HBsAg change in this group was -0.59log10IU/ml (range -4.49 to 0.02log10IU/ml) vs. 0.21log10IU/ml in patients who continued TDF therapy. Four patients (19%) achieved HBsAg loss. Patients stopping therapy had initial fluctuations in viral load and ALT; however, at Week 144, 43% (n=9) had either achieved HBsAg loss or had HBV DNA <2,000IU/ml. There were no unexpected safety issues identified with stopping TDF therapy.

CONCLUSIONS:

This controlled study demonstrated the potential for HBsAg loss and/or sustained virological response in non-cirrhotic HBeAg-negative patients stopping long-term TDF therapy. Lay summary: Nucleos(t)ide analogue (NA) is usually a life-long therapy for HBV patients. This randomised controlled study investigated the discontinuation of tenofovir disoproxil fumarate (TDF) therapy in HBeAg-negative patients. Of the patients who stopped TDF therapy, 62% remained off-therapy to Week 144, of which 43% of patients had achieved either HBsAg loss or HBV DNA <2,000IU/ml. This offers a potential for long-term HBV-suppressed patients without cirrhosis to stop NA therapy under strict surveillance. Clinical trial number: NCT01320943.

KEYWORDS:

Finite therapy; HBeAg-negative; HBsAg loss; Tenofovir disoproxil fumarate

PMID:
28736139
DOI:
10.1016/j.jhep.2017.07.012
[Indexed for MEDLINE]

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