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

S. Fung, P. Kwan, M. Fabri, A. Horban, M. Pelemis, HW. Hann, S. Gurel, FA. Caruntu, JF. Flaherty, B. Massetto, K. Kim, KM. Kitrinos, GM. Subramanian, JG. McHutchison, LJ. Yee, M. Elkhashab, T. Berg, I. Sporea, C. Yurdaydin, P. Husa, MS....

. 2017 ; 66 (1) : 11-18. [pub] 20160818

Jazyk angličtina Země Nizozemsko

Typ dokumentu časopisecké články, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc18011052

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.

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$a Kwan, Peter $u Department of Medicine, University of British Columbia, Canada.
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$a Horban, Andrzej $u Department of Adult Infectious Diseases, Medical University of Warsaw, Poland.
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$a Pelemis, Mijomir $u Clinic for Infectious and Tropical Diseases, Clinical Centre of Serbia, Serbia.
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$a Hann, Hie-Won $u Department of Medicine, Thomas Jefferson University, USA.
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$a Kitrinos, Kathryn M $u Gilead Sciences Inc, Foster City, CA, USA.
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