Tenofovir disoproxil fumarate (TDF) vs. emtricitabine (FTC)/TDF in lamivudine resistant hepatitis B: A 5-year randomised study.

Autor: Fung S; Department of Medicine, University of Toronto, Canada. Electronic address: scott.fung@uhn.ca., Kwan P; Department of Medicine, University of British Columbia, Canada., Fabri M; Clinic for Infectious Diseases, Medical University of Novi Sad, Serbia., Horban A; Department of Adult Infectious Diseases, Medical University of Warsaw, Poland., Pelemis M; Clinic for Infectious and Tropical Diseases, Clinical Centre of Serbia, Serbia., Hann HW; Department of Medicine, Thomas Jefferson University, USA., Gurel S; Department of Internal Medicine, Uludag University, Turkey., Caruntu FA; National Institute for Infectious Diseases, 'Prof Dr Matei Bals', Romania., Flaherty JF; Gilead Sciences Inc, Foster City, CA, USA., Massetto B; Gilead Sciences Inc, Foster City, CA, USA., Kim K; Gilead Sciences Inc, Foster City, CA, USA., Kitrinos KM; Gilead Sciences Inc, Foster City, CA, USA., Subramanian GM; Gilead Sciences Inc, Foster City, CA, USA., McHutchison JG; Gilead Sciences Inc, Foster City, CA, USA., Yee LJ; Gilead Sciences Inc, Foster City, CA, USA., Elkhashab M; Toronto Liver Centre, Toronto, Canada., Berg T; Clinic of Gastroenterology and Rheumatology, University Hospital Leipzig, Germany., Sporea I; University of Medicine and Pharmacy, Timisoara, Romania., Yurdaydin C; Department of Gastroenterology, Ankara University, Turkey., Husa P; University Hospital Brno and Faculty of Medicine, Masaryk University Brno, Czech Republic., Jablkowski MS; Department of Infectious and Liver Diseases, Medical University of Lodz, Poland., Gane E; New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.
Jazyk: angličtina
Zdroj: Journal of hepatology [J Hepatol] 2017 Jan; Vol. 66 (1), pp. 11-18. Date of Electronic Publication: 2016 Aug 18.
DOI: 10.1016/j.jhep.2016.08.008
Abstrakt: Background & Aims: Long-term treatment with tenofovir disoproxil fumarate (TDF) alone, or in combination with emtricitabine (FTC) is associated with sustained viral suppression in patients with lamivudine resistant (LAM-R) chronic hepatitis B (CHB).
Methods: LAM-R CHB patients were randomised 1:1 to receive TDF 300mg or FTC 200mg and TDF 300mg once daily in a prospective, double blind, study. The proportion of patients with plasma hepatitis B virus (HBV) DNA<69IU/ml (<400copies/ml) at week 96 (primary efficacy endpoint) was reported previously. Here we present week 240 follow-up data.
Results: Overall, 280 patients were randomised to receive TDF (n=141) or FTC/TDF (n=139), and 85.4% completed 240weeks of treatment. At week 240, 83.0% of patients in the TDF arm, and 82.7% of patients in the FTC/TDF treatment arm had HBV DNA<69IU/ml (p=0.96). Rates of normal alanine aminotransferase (ALT) and normalised ALT were similar between groups (p=0.41 and p=0.97 respectively). Hepatitis B e antigen loss and seroconversion at week 240 were similar between groups, (p=0.41 and p=0.67 respectively). Overall, six patients achieved hepatitis B surface antigen (HBsAg) loss and one patient (FTC/TDF arm) had HBsAg seroconversion by week 240. No TDF resistance was observed up to week 240. Treatment was generally well tolerated, and renal events were mild and infrequent (∼8.6%). The mean change in bone mineral density at week 240 was -0.98% and -2.54% at the spine and hip, respectively.
Conclusions: TDF monotherapy was effective and well tolerated in LAM-R CHB patients for up to 240weeks.
Lay Summary: The goal of oral antiviral treatment for chronic hepatitis B (CHB) is to achieve and maintain undetectable HBV DNA levels. Treatment options with enhanced potency, and low risk of resistance development for patients infected with lamivudine resistant (LAM-R) HBV are required. Tenofovir disoproxil fumarate (TDF) monotherapy was effective and well tolerated without TDF resistance development in CHB patients with LAM-R, for up to 240weeks. Clinical trial number: NCT00737568.
(Copyright © 2016 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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