FDA ansixiyay Vosevi waayo, Hepatitis C

Maamulka Cuntada iyo Dawooyinka Mareykanka ayaa maanta ansixiyay Vosevi in ​​lagu daweeyo dadka waaweyn fayraska cagaarshow chronic C (HCV) noocyo kala 1-6 oo aan cirrhosis (cudurka beerka) ama cirrhosis fudud. Vosevi waa a-dose go'an, kiniinka isku dhafan oo ka kooban laba daroogada hore u ansixiyay - sofosbuvir iyo velpatasvir - iyo daroogada cusub, voxilaprevir. Vosevi waa daawaynta ugu horeysay loo ogolaaday bukaanka kuwaas oo hore loola dhaqmo si sofosbuvir toos-simaha fayruska daroogada ama daroogo kale, waayo, HCV in la xakameeyo protein ah oo lagu magacaabo NS5A.

"Daawooyinka fayruska Direct-simaha hortago fayraska tarmo oo inta badan ku bogsiiyaan HCV. Vosevi bixisaa xulashada daaweynta bukaannada qaar ka mid ah kuwaas oo aan si guul ah lagu daaweeyaa daawooyin kale HCV ee la soo dhaafay, "ayuu yiri Edward Cox, MD, oo ah agaasimaha Xafiiska Antimicrobial Products ee xarunta FDA ee Qiimeynta Drug iyo Cilmi-baarista.

Hepatitis C waa cudur fayras keeno oo keena caabuq ku dhaca beerka oo keeni kara beerka goolkuduwe ama beerka. Sida laga soo xigtay Xarumaha Xakamaynta iyo Kahortagga Cudurrada, lagu qiyaasay 2.7 si 3.9 milyan oo qof oo ah in Mareykanka ayaa HCV chronic. Qaar ka mid ah bukaannada qaba cudurka HCV chronic sannado badan ayaa laga yaabaa in cagaarshow (indhaha ama jidhka oo huruud) iyo dhibaatooyinka, sida dhiig, dheecaan caloosha, cudurada, kansarka beerka, iyo dhimasho.

Waxaa jira ugu yaraan lix noocyo kala duwan HCV, ama nooc, oo hiddo jira kooxo kala duwan ee fayraska. Ogaanshaha nooca fayraska ayaa kaa caawin kara wargeliyaan talooyinka iyo tilmaamaha daweeynta. Qiyaastii 75 boqolkiiba Maraykanka oo qaba HCV genotype 1, 20-25 boqolkiiba leedahay noocyo 2 ama 3; iyo tiro yar oo ah dadka bukaanka ah waxa ku dhaca noocyo 4, 5 ama 6.

Badbaadada iyo waxtarka of Vosevi waxaa qiimeeyo laba Phase 3 tijaabo in ku dhowaad 750 ka diiwaangashan dadka waaweyn oo aan cirrhosis ama cirrhosis fudud.

maxkamad ayaa marka hore marka la barbar dhigo 12 wiig ee daaweynta Vosevi la jaallaha ah ee dadka waaweyn ee genotype 1 kaasoo markii hore ku guuldareystay in lagu daaweeyo daroogada inhibitor NS5A ah. Bukaanka qaba noocyo 2, 3, 4, 5 ama 6 dhan helay Vosevi.

tijaabo labaad marka loo eego 12 toddobaad ee Vosevi la daroogada hore u ansixiyay sofosbuvir iyo velpatasvir in dadka waaweyn ee noocyo 1, 2 ama 3 kii hore ku guuldareysatay daaweynta la sofosbuvir laakiin ma daroogada inhibitor NS5A ah.

Natiijada labada tijaabooyin muujisay in 96-97 boqolkiiba bukaannada helay Vosevi lahaa virus ma ogaan karo in dhiigga 12 toddobaad kadib markaad dhamaysato daaweyn, ku talinaya in cudurka bukaanka la bogsiiyey.

talooyinka Daaweynta Vosevi way kala duwan yihiin waxay ku xiran tahay genotype viral iyo taariikhda daaweynta ka hor.

The dhibaato ugu badan ee bukaanka qaadanaya Vosevi ahaayeen madax-xanuun, daal, shuban iyo lallabo.

Vosevi waa u bukaanka qaadanaya daawada rifampin.

Fayraska cagaarshow B (HBV) reactivation ayaa la sheegay in HCV / HBV bukaanada qaangaarka coinfected kuwaas oo lagu dhammeeyey ama daaweynta HCV antivirals toos-simaha, iyo kuwaas oo aan helin HBV therapy fayruska. reactivation HBV in bukaanka loola dhaqmo si toos ah-simaha daawooyinka fayruska ka keeni kartaa dhibaatooyin beerka halis ah ama dhimasho ee bukaanada qaar ka mid ah. shaqaalaha daryeelka caafimaadka waa in u baaraan dhammaan bukaan caddayn ah ee infakshanka HBV hadda ama ka hor inta aadan bilaabin daawaynta Vosevi.

FDA waxay siiyey this codsiga  Review Mudnaanta  iyo  Therapy Breakthrough tilmaamood.  
 
The FDA granted approval of Vosevi to Gilead Sciences Inc.

FDA waxay, hay'ad gudahood US Department of Caafimaadka iyo Adeegga Aadamaha, ka ilaaliya caafimaadka dadweynaha loo hubiyo ammaanka, waxtarka, iyo ammaanka oo ka mid ah daroogada aadanaha iyo xoolaha, tallaalada iyo alaabooyinka kale ee noolaha loo isticmaalo aadanaha, iyo qalabka caafimaadka. Hay'adda ayaa sidoo kale mas'uul ka yahay ammaanka iyo nabadgalyada ee sahayda qarankeena cuntada, isku qurxiyo, supplements cuntada, alaabta siin off shucaaca elektarooniga ah, iyo sharci u sameysan tubaako.

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waqti Post: Nov-24-2017
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