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

FUNG, Scott (124 Kanada), Peter KWAN (124 Kanada), Milotka FABRI (688 Srbsko), Andrzej HORBAN (616 Polsko), Mijomir PELEMIS (688 Srbsko), Hie-Won HANN (840 Spojené státy), Selim GUREL (792 Turecko), Florin A. CARUNTU (642 Rumunsko), John F. FLAHERTY (840 Spojené státy), Benedetta MASSETTO (840 Spojené státy), Kyungpil KIM (840 Spojené státy), Kathryn M. KITRINOS (840 Spojené státy), G. Mani SUBRAMANIAN (840 Spojené státy), John G. MCHUTCHISON (840 Spojené státy), Leland J. YEE (840 Spojené státy), Magdy ELKHASHAB (124 Kanada), Thomas BERG (276 Německo), Ioan SPOREA (642 Rumunsko), Cihan YURDAYDIN (792 Turecko), Petr HUSA (203 Česká republika, garant, domácí), Maciej S. JABLKOWSKI (616 Polsko) a Edward GANE (554 Nový Zéland)

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

UT WoS

000390642900003

Klíčová slova anglicky

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

Štítky

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.