Randomized Comparison of Tenofovir Disoproxil Fumarate vs
Emtricitabine and Tenofovir Disoproxil Fumarate in Patients
With Lamivudine-Resistant Chronic Hepatitis B

J 2014

Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B

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

Základní údaje

Originální název

Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B

Autoři

Vydání

Gastroenterology, Philadelphia, W B Saunders co-Elsevier Inc, 2014, 0016-5085

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30300 3.3 Health sciences

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 16.716

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14110/14:00075497

Organizační jednotka

Lékařská fakulta

Klíčová slova anglicky

HBV DNA; Hepatitis B e Antigen; Renal Function; Viral Suppression

Štítky

EL OK

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 16. 5. 2014 17:16, Ing. Mgr. Věra Pospíšilíková

Anotace

V originále

BACKGROUND & AIMS: Tenofovir disoproxil fumarate (TDF) is active against lamivudine-resistant hepatitis B virus (HBV) infection, but data to support its clinical efficacy in this setting are limited. METHODS: In a prospective, double-blind, 96-week trial, patients were randomly assigned (1:1) to groups given TDF (300 mg, n = 141) or a combination of emtricitabine (FTC, 200 mg; n 139) and TDF (300 mg, FTC/TDF). Patients were hepatitis B e antigen (HBeAg) - positive or HBeAg-negative, with levels of HBV DNA >= 3 log10 IU/mL and lamivudine resistance mutations (HBV polymerase or reverse transcriptase amino acid substitutions rtM204I/V +/- rtL180M by INNO-LiPA Multi-DR v3; Innogenetics, Inc, Alpharetta, GA). The primary end point was proportion with HBV DNA <69 IU/mL (Roche COBAS Taqman assay; Roche Molecular Systems, Inc, Pleasanton, CA). RESULTS: Patient groups were well matched for demographic and disease characteristics, including region (60% from Europe), HBV genotype (45% genotype D), HBeAg status (47% HBeAg-positive), and duration of lamivudine treatment (mean, 3.8 years). At week 96 of treatment, 89.4% of patients in the TDF group and 86.3% in the FTC/TDF group had levels of HBV DNA <69 IU/mL (P = .43). HBeAg loss and seroconversion did not differ between groups; only 1 patient (0.7%) in the FTC/TDF group lost hepatitis B surface antigen. Treatment was well tolerated; confirmed renal events (creatinine increase of >= 0.5 mg/dL [>44 umol/L], creatinine clearance <50 mL/min, or level of PO4 <2 mg/dL [<0.65 mmol/L]) were generally mild and infrequent (<1%). Small reductions (<2%) in mean bone mineral density of hip and spine were detected by dual-energy x-ray absorptiometry in both groups. No TDF resistance developed through 96 weeks of treatment. CONCLUSIONS: TDF alone is safe and effective for treatment of patients with lamivudine-resistant, chronic HBV infection. Clinical Trials.gov No, NCT00737568.

Citovat

FUNG, Scott; Peter KWAN; Milotka FABRI; Andrzej HORBAN; Mijomir PELEMIS; Hie-Won HANN; Selim GUREL; Florin A. CARUNTU; John F. FLAHERTY; Benedetta MASSETTO; Phillip DINH; Amoreena CORSA; G. Mani SUBRAMANIAN; John G. MCHUTCHISON; Petr HUSA a Edward GANE. Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B. Gastroenterology. Philadelphia: W B Saunders co-Elsevier Inc, 2014, roč. 146, č. 4, s. 980-988. ISSN 0016-5085. Dostupné z: https://doi.org/10.1053/j.gastro.2013.12.028.

@article{1182777,
   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 Dinh, Phillip and Corsa, Amoreena and Subramanian, G. Mani and McHutchison, John G. and Husa, Petr and Gane, Edward},
   article_location = {Philadelphia},
   article_number = {4},
   doi = {https://doi.org/10.1053/j.gastro.2013.12.028},
   keywords = {HBV DNA; Hepatitis B e Antigen; Renal Function; Viral Suppression},
   language = {eng},
   issn = {0016-5085},
   journal = {Gastroenterology},
   note = {Ve WoS signalizuje počet stran 10, dle fyzické kopie 9 stran.},
   title = {Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B},
   volume = {146},
   year = {2014}
}

TY  - JOUR
ID  - 1182777
AU  - Fung, Scott - Kwan, Peter - Fabri, Milotka - Horban, Andrzej - Pelemis, Mijomir - Hann, Hie-Won - Gurel, Selim - Caruntu, Florin A. - Flaherty, John F. - Massetto, Benedetta - Dinh, Phillip - Corsa, Amoreena - Subramanian, G. Mani - McHutchison, John G. - Husa, Petr - Gane, Edward
PY  - 2014
TI  - Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B
JF  - Gastroenterology
VL  - 146
IS  - 4
SP  - 980-988
EP  - 980-988
PB  - W B Saunders co-Elsevier Inc
SN  - 00165085
N1  - Ve WoS signalizuje počet stran 10, dle fyzické kopie 9 stran.
KW  - HBV DNA
KW  - Hepatitis B e Antigen
KW  - Renal Function
KW  - Viral Suppression
N2  - BACKGROUND & AIMS: Tenofovir disoproxil fumarate (TDF) is active against lamivudine-resistant hepatitis B virus (HBV) infection, but data to support its clinical efficacy in this setting are limited. METHODS: In a prospective, double-blind, 96-week trial, patients were randomly assigned (1:1) to groups given TDF (300 mg, n = 141) or a combination of emtricitabine (FTC, 200 mg; n 139) and TDF (300 mg, FTC/TDF). Patients were hepatitis B e antigen (HBeAg) - positive or HBeAg-negative, with levels of HBV DNA >= 3 log10 IU/mL and lamivudine resistance mutations (HBV polymerase or reverse transcriptase amino acid substitutions rtM204I/V +/- rtL180M by INNO-LiPA Multi-DR v3; Innogenetics, Inc, Alpharetta, GA). The primary end point was proportion with HBV DNA <69 IU/mL (Roche COBAS Taqman assay; Roche Molecular Systems, Inc, Pleasanton, CA). RESULTS: Patient groups were well matched for demographic and disease characteristics, including region (60% from Europe), HBV genotype (45% genotype D), HBeAg status (47% HBeAg-positive), and duration of lamivudine treatment (mean, 3.8 years). At week 96 of treatment, 89.4% of patients in the TDF group and 86.3% in the FTC/TDF group had levels of HBV DNA <69 IU/mL (P = .43). HBeAg loss and seroconversion did not differ between groups; only 1 patient (0.7%) in the FTC/TDF group lost hepatitis B surface antigen. Treatment was well tolerated; confirmed renal events (creatinine increase of >= 0.5 mg/dL [>44 umol/L], creatinine clearance <50 mL/min, or level of PO4 <2 mg/dL [<0.65 mmol/L]) were generally mild and infrequent (<1%). Small reductions (<2%) in mean bone mineral density of hip and spine were detected by dual-energy x-ray absorptiometry in both groups. No TDF resistance developed through 96 weeks of treatment. CONCLUSIONS: TDF alone is safe and effective for treatment of patients with lamivudine-resistant, chronic HBV infection. Clinical Trials.gov No, NCT00737568.
ER  -

FUNG, Scott; Peter KWAN; Milotka FABRI; Andrzej HORBAN; Mijomir PELEMIS; Hie-Won HANN; Selim GUREL; Florin A. CARUNTU; John F. FLAHERTY; Benedetta MASSETTO; Phillip DINH; Amoreena CORSA; G. Mani SUBRAMANIAN; John G. MCHUTCHISON; Petr HUSA a Edward GANE. Randomized Comparison of Tenofovir Disoproxil Fumarate vs Emtricitabine and Tenofovir Disoproxil Fumarate in Patients With Lamivudine-Resistant Chronic Hepatitis B. \textit{Gastroenterology}. Philadelphia: W B Saunders co-Elsevier Inc, 2014, roč.~146, č.~4, s.~980-988. ISSN~0016-5085. Dostupné z: https://doi.org/10.1053/j.gastro.2013.12.028.

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