000064369 001__ 64369
000064369 005__ 20190709135621.0
000064369 0247_ $$2doi$$a10.3748/wjg.v23.i41.7459
000064369 0248_ $$2sideral$$a103574
000064369 037__ $$aART-2017-103574
000064369 041__ $$aeng
000064369 100__ $$aRodríguez, M.
000064369 245__ $$aTenofovir vs lamivudine plus adefovir in chronic hepatitis B: TENOSIMP-B study
000064369 260__ $$c2017
000064369 5060_ $$aAccess copy available to the general public$$fUnrestricted
000064369 5203_ $$aAIM To demonstrate the non-inferiority (15% non-inferiority limit) of monotherapy with tenofovir disoproxil fumarate (TDF) vs the combination of lamivudine (LAM) plus adefovir dipivoxil (ADV) in the maintenance of virologic response in patients with chronic hepatitis B (CHB) and prior failure with LAM. METHODS This study was a Phase IV prospective, randomized, open, controlled study with 2 parallel groups (TDF and LAM+ADV) of adult patients with hepatitis B e antigen (HBeAg)-negative CHB, prior failure with LAM, on treatment with LAM+ADV for at least 6 mo, without prior resistance to ADV and with an undetectable viral load at the start of the study, in 14 Spanish hospitals. The follow-up time for each patient was 48 wk after randomization, with quarterly visits in which the viral load, biochemical and serological parameters, adverse effects, adherence to treatment and consumption of hospital resources were analysed. RESULTS Forty-six patients were evaluated [median age: 55.4 years (30.2-75.2); 84.8% male], including 22 patients with TDF and 24 with LAM+ADV. During study development, hepatitis B virus DNA (HBV-DNA) remained undetectable, all patients remained HBeAg negative, and hepatitis B surface antigen (HBsAg) positive. Alanine aminotransferase (ALT) values at the end of the study were similar in the 2 groups (25.1 ± 7.65, TDF vs 24.22 ± 8.38, LAM+ADV, P = 0.646). No significant changes were observed in creatinine or serum phosphorus values in either group. No significant differences between the 2 groups were noted in the identification of adverse effects (AEs) (53.8%, TDF vs 37.5%, LAM+ADV, P = 0.170), and none of the AEs which occurred were serious. Treatment adherence was 95.5% and 83.3% in the TDF and the LAM+ADV groups, respectively (P = 0.488). The costs associated with hospital resource consumption were significantly lower with the TDF treatment than the LAM+ADV treatment (€4943 ± 1059 vs €5811 ± 1538, respectively, P < 0.001). CONCLUSION TDF monotherapy proved to be safe and not inferior to the LAM+ADV combination therapy in maintaining virologic response in patients with CHB and previous LAM failure. In addition, the use of TDF generated a significant savings in hospital costs.
000064369 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc$$uhttp://creativecommons.org/licenses/by-nc/3.0/es/
000064369 590__ $$a3.3$$b2017
000064369 591__ $$aGASTROENTEROLOGY & HEPATOLOGY$$b35 / 80 = 0.438$$c2017$$dQ2$$eT2
000064369 592__ $$a1.409$$b2017
000064369 593__ $$aMedicine (miscellaneous)$$c2017$$dQ1
000064369 593__ $$aGastroenterology$$c2017$$dQ1
000064369 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000064369 700__ $$aPascasio, J.M.
000064369 700__ $$aFraga, E.
000064369 700__ $$0(orcid)0000-0001-8637-510X$$aFuentes, J.$$uUniversidad de Zaragoza
000064369 700__ $$aPrieto, M.
000064369 700__ $$aSánchez-Antolín, G.
000064369 700__ $$aCalleja, J.L.
000064369 700__ $$aMolina, E.
000064369 700__ $$aGarcía-Buey, M.L.
000064369 700__ $$aBlanco, M.Á.
000064369 700__ $$aSalmerón, J.
000064369 700__ $$aBonet, M.L.
000064369 700__ $$aPons, J.A.
000064369 700__ $$aGonzález, J.M.
000064369 700__ $$aCasado, M.Á.
000064369 700__ $$aJorquera, F.
000064369 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000064369 773__ $$g23, 41 (2017), 7459-7469$$tWORLD JOURNAL OF GASTROENTEROLOGY$$x1007-9327
000064369 8564_ $$s717945$$uhttps://zaguan.unizar.es/record/64369/files/texto_completo.pdf$$yVersión publicada
000064369 8564_ $$s91462$$uhttps://zaguan.unizar.es/record/64369/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000064369 909CO $$ooai:zaguan.unizar.es:64369$$particulos$$pdriver
000064369 951__ $$a2019-07-09-12:28:07
000064369 980__ $$aARTICLE