Četverogodišnja studija učinkovitosti i sigurnosti entekavira u bolesnika s kroničnim hepatitisom B pozitivnih na HBeAg bez prethodne nukleoz(t)idne terapije

Abstract

Entecavir is a guanosine analogue with activity against hepatitis B virus. The aim of this 4-year trial was to evaluate entecavir treatment in nucleos(t)ide-naive HBeAg-positive chronic hepatitis B patients. Forty-nine patients received entecavir and nine of them withdrew from the trial at the end of week 96. The initial mean value of alanine aminotransferase was 79.4}41.5 IU /L, and at the end of the 4-year study period, 90% of patients had alanine aminotransferase values within the normal range. At week 96, 91.7% of patients had HBV DNA <300 copies; at month 48, 90% of patients had HBV DNA <50 IU /mL. HBeAg loss was recorded in 7.1% of patients at week 96 and in 12.5% at month 48. The rate of HBeAg seroconversion was 4.8% at week 96 and 7.5% at month 48. The rate of HBsAg seroconversion was 2.1% at week 96 and 2.5% at month 48. Entecavir as a potent and safe agent leading to continuous viral suppression proved to be safe and well tolerated therapy.Entekavir je analog gvanozina koji djeluje protiv virusa hepatitisa B. Cilj ove četverogodišnje studije bio je procijeniti liječenje entekavirom kod bolesnika s kroničnim hepatitisom B pozitivnih na HBeAg bez prethodne nukleoz(t)idne terapije. Ukupno je 49 bolesnika primalo entekavir, a devetoro ih se povuklo s terapije na kraju 96. tjedna. Početna srednja vrijednost alanin aminotransferaze bila 79,4}41,5 IU /L, dok je nakon 4 godine vrijednost alanin aminotransferaze bila u normalnim granicama kod 90% bolesnika. U 96. tjednu je <300 kopija HBV DNA zabilježeno u 91,7% bolesnika, a u 48. mjesecu je 48,90% bolesnika imalo <50 IJ/mL HBV DNA. Gubitak HBeAg zabilježen je u 7,1% bolesnika u 96. tjednu te u 12,5% bolesnika u 48. mjesecu. Stopa serokonverzije HBeAg iznosila je 4,8% u 96. tjednu i 7,5% u 48. mjesecu. Stopa serokonverzije HBsAg bila je 2,1% u 96. tjednu i 2,5% u 48. mjesecu. Sigurnost terapije bila je dobra. Bolesnici su dobro podnosili entekavir, snažan i siguran lijek koji dovodi do ustaljenog suzbijanja virusa

    Similar works