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

J 2017

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

FUNG, Scott; Peter KWAN; Milotka FABRI; Andrzej HORBAN; Mijomir PELEMIS et. al.

Základní údaje

Originální název

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

Autoři

Vydání

Journal of Hepatology, Amsterdam, Elsevier Science BV, 2017, 0168-8278

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30219 Gastroenterology and hepatology

Stát vydavatele

Nizozemské království

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 15.040

Kód RIV

RIV/00216224:14110/17:00095992

Organizační jednotka

Lékařská fakulta

DOI

https://doi.org/10.1016/j.jhep.2016.08.008

UT WoS

000390642900003

EID Scopus

2-s2.0-85000692609

Klíčová slova anglicky

Bone mineral density; Emtricitabine; Lamivudine resistant; Renal function; Tenofovir disoproxil fumarate; Viral suppression

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 20. 3. 2018 15:44, Soňa Böhmová

Anotace

V originále

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 300 mg or FTC 200 mg and TDF 300 mg once daily in a prospective, double blind, study. The proportion of patients with plasma hepatitis B virus (HBV) DNA <69 IU/m1 (<400 copies/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 240 weeks 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 <69 IU/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 (similar to 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 240 weeks. 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 240 weeks.

Citovat

FUNG, Scott; Peter KWAN; Milotka FABRI; Andrzej HORBAN; Mijomir PELEMIS; Hie-Won HANN; Selim GUREL; Florin A. CARUNTU; John F. FLAHERTY; Benedetta MASSETTO; Kyungpil KIM; Kathryn M. KITRINOS; G. Mani SUBRAMANIAN; John G. MCHUTCHISON; Leland J. YEE; Magdy ELKHASHAB; Thomas BERG; Ioan SPOREA; Cihan YURDAYDIN; Petr HUSA; Maciej S. JABLKOWSKI a Edward GANE. Tenofovir disoproxil fumarate (TDF) vs. emtricitabine (FTC)/TDF in lamivudine resistant hepatitis B: A 5-year randomised study. Journal of Hepatology. Amsterdam: Elsevier Science BV, 2017, roč. 66, č. 1, s. 11-18. ISSN 0168-8278. Dostupné z: https://doi.org/10.1016/j.jhep.2016.08.008.

@article{1366478,
   author = {Fung, Scott and Kwan, Peter and Fabri, Milotka and Horban, Andrzej and Pelemis, Mijomir and Hann, HieandWon and Gurel, Selim and Caruntu, Florin A. and Flaherty, John F. and Massetto, Benedetta and Kim, Kyungpil and Kitrinos, Kathryn M. and Subramanian, G. Mani and McHutchison, John G. and Yee, Leland J. and Elkhashab, Magdy and Berg, Thomas and Sporea, Ioan and Yurdaydin, Cihan and Husa, Petr and Jablkowski, Maciej S. and Gane, Edward},
   article_location = {Amsterdam},
   article_number = {1},
   doi = {https://doi.org/10.1016/j.jhep.2016.08.008},
   keywords = {Bone mineral density; Emtricitabine; Lamivudine resistant; Renal function; Tenofovir disoproxil fumarate; Viral suppression},
   language = {eng},
   issn = {0168-8278},
   journal = {Journal of Hepatology},
   title = {Tenofovir disoproxil fumarate (TDF) vs. emtricitabine (FTC)/TDF in lamivudine resistant hepatitis B: A 5-year randomised study},
   volume = {66},
   year = {2017}
}

TY  - JOUR
ID  - 1366478
AU  - Fung, Scott - Kwan, Peter - Fabri, Milotka - Horban, Andrzej - Pelemis, Mijomir - Hann, Hie-Won - Gurel, Selim - Caruntu, Florin A. - Flaherty, John F. - Massetto, Benedetta - Kim, Kyungpil - Kitrinos, Kathryn M. - Subramanian, G. Mani - McHutchison, John G. - Yee, Leland J. - Elkhashab, Magdy - Berg, Thomas - Sporea, Ioan - Yurdaydin, Cihan - Husa, Petr - Jablkowski, Maciej S. - Gane, Edward
PY  - 2017
TI  - Tenofovir disoproxil fumarate (TDF) vs. emtricitabine (FTC)/TDF in lamivudine resistant hepatitis B: A 5-year randomised study
JF  - Journal of Hepatology
VL  - 66
IS  - 1
SP  - 11-18
EP  - 11-18
PB  - Elsevier Science BV
SN  - 01688278
KW  - Bone mineral density
KW  - Emtricitabine
KW  - Lamivudine resistant
KW  - Renal function
KW  - Tenofovir disoproxil fumarate
KW  - Viral suppression
N2  - 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 300 mg or FTC 200 mg and TDF 300 mg once daily in a prospective, double blind, study. The proportion of patients with plasma hepatitis B virus (HBV) DNA <69 IU/m1 (<400 copies/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 240 weeks 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 <69 IU/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 (similar to 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 240 weeks. 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 240 weeks.
ER  -

FUNG, Scott; Peter KWAN; Milotka FABRI; Andrzej HORBAN; Mijomir PELEMIS; Hie-Won HANN; Selim GUREL; Florin A. CARUNTU; John F. FLAHERTY; Benedetta MASSETTO; Kyungpil KIM; Kathryn M. KITRINOS; G. Mani SUBRAMANIAN; John G. MCHUTCHISON; Leland J. YEE; Magdy ELKHASHAB; Thomas BERG; Ioan SPOREA; Cihan YURDAYDIN; Petr HUSA; Maciej S. JABLKOWSKI a Edward GANE. Tenofovir disoproxil fumarate (TDF) vs. emtricitabine (FTC)/TDF in lamivudine resistant hepatitis B: A 5-year randomised study. \textit{Journal of Hepatology}. Amsterdam: Elsevier Science BV, 2017, roč.~66, č.~1, s.~11-18. ISSN~0168-8278. Dostupné z: https://doi.org/10.1016/j.jhep.2016.08.008.

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