tenofovir Alafenamide fit-trattament ta ' kronika Hepatitis B: tad-disinn, żvilupp, u l-post fit-terapija

- Nov 11, 2017 -

Awturi Ogawa E, Furusyo N, Nguyen MH


Wasal Lulju 2017 11


Aċċettati għall-pubblikazzjoni 18 Ottubru 2017


Ippubblikata volum 6 Novembru 2017 2017:11 paġni 3197 — 3204


DTI https://doi.org/10.2147/DDDT.S126742


Kkontrollat għal plagiarism Iva


Reviżjoni minn wieħed-għomja


Reviżuri peer approvat minn Dr Amy Norman


Peer jagħmel kummenti 2


Editur li approvat pubblikazzjoni: Dr Sukesh Voruganti




1Department tal-mediċina interna ġenerali, Sptar ta ' l-Università Kyushu, Fukuoka, il-Ġappun; 2Division ta-Gastroenterology and Hepatology, Dipartiment tal-mediċina, Stanford Università mediku taċ-Ċentru, Palo Alto, CA, USA


Astratt: Tenofovir alafenamide (TAF), a prodrug novella ta tenofovir (TFV), tkun ġiet approvata għat-trattament ta ' l-infezzjoni tal-virus (HBV) kronika epatite B. TAF ġie muri li jkun a inibitur potenti ta ' replikazzjoni HBV fuq id-doża baxxa, b ' konċentrazzjoni għolja intraċellulari u aktar minn 90% tbaxxi l-konċentrazzjoni TFV sistematiku minn fumarat tal-disoproxil ta ' tenofovir (TDF). Fil-provi in-nuqqas ta ' inferiority żewġ saltwarju, double-blind, multinazzjonali, fażi 3, għall-hepatitis B e antiġenu (HBeAg)-pazjenti pożittivi u - negattiv (analiżi primarja: 48 ġimgħat), TAF 25 mg darba kuljum bil-fomm kien mhux inferjuri għal-TDF 300 mg biex jiksbu l-livell tad-DNA HBV<29 iu/ml="" at="" week="" 48.="" no="" amino-acid="" substitutions="" associated="" with="" viral="" breakthrough="" were="" detected="" by="" deep="" sequencing,="" and="" no="" resistance="" to="" taf="" was="" found="" through="" week="" 96.="" in="" addition,="" no="" difference="" in="" the="" frequency="" of="" hbeag="" or="" hepatitis="" b="" surface="" antigen="" loss="" was="" observed.="" however,="" taf="" was="" associated="" with="" a="" significantly="" higher="" alt="" normalization="" rate="" than="" was="" tdf,="" based="" on="" the="" american="" association="" for="" the="" study="" of="" liver="" diseases="" criteria="" (male:="" alt="" ≤30="" u/l="" and="" female:="" alt="" ≤19="" u/l).="" an="" analysis="" of="" renal="" safety="" showed="" that="" patients="" treated="" with="" taf="" had="" a="" significantly="" lower="" decrease="" in="" the="" estimated="" glomerular="" filtration="" rate="" level="" than="" did="" patients="" treated="" with="" tdf.="" similarly,="" the="" declines="" of="" hip="" and="" spine="" bone="" mineral="" density="" were="" significantly="" less="" in="" the="" taf="" group.="" these="" trends="" of="" efficacy="" and="" renal/bone="" safety="" continued="" through="" week="" 96.="" longer="" term="" follow-up="" and="" real-world="" data="" will="" be="" required="" to="" determine="" if="" the="" differences="" in="" viral/biochemical="" response="" and="" renal/bone="" safety="" seen="" with="" taf="" in="" comparison="" with="" tdf="" are="" clinically="">



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