000			02883nam a2200289 4500
001			ESSALUD
005			20260804185551.0
007			ta
008			t pe ||||| |||| 00| 0 spa d
040			_aBMG
041			_aeng
100			_aHou, Jinlin _eAutor _953847
245			_aPhase 3 results of bepirovirsen treatment for chronic hepatitis B virus infection
300			_apáginas: 2395-2406
520			_aBackground: Treatment with bepirovirsen, an antisense oligonucleotide targeting hepatitis B virus (HBV) transcripts, has the potential to result in a functional cure, defined by at least 24 weeks of a sustained HBV DNA level below the lower limit of quantification (LLOQ) and hepatitis B surface antigen (HBsAg) loss after fixed-duration therapy. Methods: In two replicate, double-blind trials (B-Well 1 and B-Well 2), we randomly assigned adults with noncirrhotic chronic HBV infection in a 2:1 ratio to receive subcutaneous bepirovirsen (at a weekly dose of 300 mg) or placebo for 24 weeks. All the patients were receiving stable nucleoside or nucleotide analogue (NA) therapy and had an HBsAg level of more than 100 to 3000 IU per milliliter. Eligible patients discontinued NA therapy at 48 weeks. The primary outcome was a functional cure at week 72. Results: The percentage of patients with a functional cure at week 72 was significantly higher with bepirovirsen than with placebo both in the B-Well 1 trial (in 127 of 650 patients [20%] vs. none of 328 patients) and in the B-Well 2 trial (in 106 of 570 patients [19%] vs. none of 286 patients). In a pooled analysis at 72 weeks, adverse events were reported in 91% of the patients in the bepirovirsen groups and in 73% of those in the placebo groups; serious adverse events were reported in 7% and 4% of the patients, respectively. During the treatment period, adverse events of grade 3 or higher were reported in 16% of the patients who received bepirovirsen and in 3% of those who received placebo; increases in the alanine aminotransferase level were the most common grade 3 adverse events with bepirovirsen (in 6% of the patients). Conclusions: In two phase 3 trials involving patients with chronic HBV infection, a functional cure after the discontinuation of NA therapy was reported in significantly more patients treated with bepirovirsen than in those who received placebo.
650			_aGASTROENTEROLOGÍA _912562
650			_aENFERMEDADES INFECCIOSAS _96776
650			_aENFERMEDAD HEPÁTICA _953848
650			_aINFECCIONES VIRALES _953766
700			_aLim, Seng-Gee _953849
700			_aButi, Maria _953850
700			_aMan-Fung ,Yuen _953851
700			_aGane, Edward _953852
700			_aLampertico, Pietro _953853
773	0		_022717 _922639 _dMassachusetts NEJM Group _oNEJM006 _tThe New England Journal of Medicine _wESSALUD _x0028-4793
942			_cARTICULOS _e2026-07-31 _zSQB
999			_c22757 _d22757