FDA avumela Vosevi ngoba Hepatitis C

I-US Food and Drug Administration namuhla evunyiwe Vosevi ukwelapha abadala kwesibindi okungamahlalakhona C virus (HCV) genotypes 1-6 ngaphandle isifo sokusha (isifo sesibindi) noma nge isifo sokusha omnene. Vosevi kuyinto umthamo fixed-, inhlanganisela ithebhulethi equkethe imithi emibili ngaphambili kuvunyiwe - sofosbuvir futhi velpatasvir - futhi kungaba khona ikhambi elisha, voxilaprevir. Vosevi iyona yokwelapha yokuqala egunyazelwe ukwenza ezigulini eziye ngaphambilini baphathwe ngqo-esebenza namagciwane izidakamizwa sofosbuvir noma ezinye izidakamizwa ngoba HCV ukuthi zivimbela bathola iprotheni ebizwa ngokuthi NS5A.

"Izidakamizwa Qondisa esebenza namagciwane ukuvimbela igciwane kusuka banda, ngokuvamile ukwelapha HCV. Vosevi ihlinzeka inketho ukwelashwa kwezinye iziguli abangabulawanga iphathwa ngempumelelo nezinye izidakamizwa HCV esikhathini esidlule, "kusho u-Edward Cox, MD, umqondisi we-Ofisi Elwa Namagciwane imikhiqizo FDA Centre for Drug nokuHlola Ucwaningo.

Hepatitis C iyisifo viral okubangela ukuvuvukala kwesibindi engaholela elincane isibindi umsebenzi noma yokwehluleka kwesibindi. Ngokwe-Centers for Disease Control and Prevention, abantu abalinganiselwa ezigidini ezingu-2.7 kuya 3.9 e-United States kufanele HCV ezingamahlalakhona. Ezinye iziguli ezinesifo esingelapheki HCV ukutheleleka eminyakeni eminingi ongase ube jaundice (amehlo aphuzi noma isikhumba) nokuthuthukisa izinkinga ngemva kokuhlinzwa, ezifana ukopha, ekuqongeleleni uketshezi esiswini, izifo, umdlavuza isibindi futhi kubangele ukufa.

Kunezici okungenani eziyisithupha abahlukene HCV genotypes, noma zamagciwane, okuyizinto zofuzo amaqembu ahlukile igciwane. Ukwazi uhlobo igciwane kungasiza wazise izincomo ukwelashwa. Cishe amaphesenti angu-75 abantu baseMelika nge HCV babe genotype 1; amaphesenti 20-25 abe genotypes 2 noma 3; nenani elincane zeziguli itheleleke nge genotypes 4, 5 noma 6.

Ukuphepha kanye kusebenta Vosevi nohlolwe esigabeni 3 izilingo ezimbili emitholampilo ukuthi wabhalisa cishe 750 abadala ngaphandle sibe sesomile noma nge isifo sokusha omnene.

Icala lokuqala kuqhathaniswa amasonto 12 yokwelashwa Vosevi nge-placebo e abadala nge genotype 1 ababeke kuhlulekile ukwelashwa nge izidakamizwa NS5A inhibitor. Iziguli genotypes 2, 3, 4, 5 noma 6 zonke wathola Vosevi.

Icala lesibili kuqhathaniswa kwamasonto angu-12 Vosevi ne izidakamizwa evunyelwe ngaphambilini sofosbuvir futhi velpatasvir e abadala nge genotypes 1, 2 noma 3 owayethe kuhlulekile ukwelashwa nge sofosbuvir kodwa hhayi izidakamizwa NS5A inhibitor.

Imiphumela novivinyo kwabonisa ukuthi amaphesenti angu-96-97 ekubulaleni iziguli ezigulela wathola Vosevi babengenalo igciwane zitholiwe igazi amasonto 12 emva kokuphothula ukwelashwa, okusikisela ukuthi ukutheleleka yeziguli owayelaphekile.

Ukwelashwa izincomo Vosevi zihlukile kuye genotype ezibangelwa amagciwane kanye ngaphambi nomlando ukwelashwa.

Okuvame kakhulu ukusabela ezingezinhle iziguli ukuthatha Vosevi babe ubuhlungu bekhanda, ukukhathala, isifo sohudo kanye nesicanucanu.

Vosevi is contraindicated in iziguli ukuthatha rifampin izidakamizwa.

Ukusha Kwesibindi Kohlobo B igciwane (i-HBV) ukuvuselelwa kubikiwe ngo HCV /-HBV iziguli omdala coinfected ababekwa othola noma sesiqedile ukwelashwa nge HCV antivirals oqondile-esebenza, futhi obani awutholi i-HBV yokwelapha namagciwane. I-HBV iyatholakala ukuvuselelwa iziguli ziphathwe oqondile-wenza nemithi elwa namagciwane kungaholela ezinkingeni isibindi okubucayi noma ekufeni kwezinye iziguli. ukunakekelwa kwezempilo okufanele screen zonke iziguli ubufakazi bokuba wamanje noma ngaphambi kwe-HBV ukutheleleka ngaphambi kokuba baqale ukwelashwa nge Vosevi.

I-FDA anikezwe lolu hlelo  Priority ukubuyekeza  futhi  Breakthrough Ukwelashwa namagama.  
 
The FDA granted approval of Vosevi to Gilead Sciences Inc.

I-FDA, i-ejensi ngaphakathi US Department of Wezempilo Nezinkonzo Zomphakathi wase, evikela impilo yomphakathi by baqinisekisa ukuphepha, ukusebenza, kanye nokuphepha kwabantu wezilwane izidakamizwa, imithi yokugoma kanye neminye imikhiqizo yemvelo ukusetshenziswa womuntu, futhi amadivaysi ezokwelapha. Le nhlangano ibuye unesibopho ukuphepha nokuvikeleka kokudla yesizwe sethu, izimonyo, Izithako zokudla, imikhiqizo zikhipha emisebeni ye-computer, i-elawula ngogwayi.

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isikhathi Iposi: Nov-24-2017
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