FDA evunyelwa Vosevi for hepatitis C

I-US Food and Drug Administration namhlanje evunyiweyo Vosevi ukuba ukunyanga abantu abadala kunye kohlobo C virus (abanesifo) genotypes 1-6 ngaphandle kwesibindi (isifo kwesibindi) okanye kwesibindi wobulali. Vosevi yinto esisigxina-ithamo, ukuhlanganiswa tablet equlathe kumachiza ngaphambili ezimbini - sofosbuvir kunye velpatasvir - kwaye ichiza elitsha, voxilaprevir. Vosevi ke unyango lokuqala evunyiweyo kwizigulane eziye ngaphambili ziphathwe sofosbuvir ngqo-ngokwenza antiviral iziyobisi okanye ezinye iziyobisi abanesifo anqanda iproteni ekuthiwa NS5A.

"Iziyobisi omele ngqo-antiviral kuthintela le ntsholongwane ukuba phinda yaye ngokufuthi nokuphilisa abanesifo. Vosevi inika ukhetho unyango ukuba ezinye izigulane zange ngubani baphathwa ngempumelelo kunye namanye amachiza abanesifo ngaphambili, "watsho Edward Cox, MD, umlawuli we-ofisi elwa Products in Centre i-FDA ngo-Drug Evaluation and Research.

Hepatitis C sisifo wentsholongwane ebangela ukudumba kwesibindi enokukhokelela umsebenzi isibindi inciphisa okanye ukusilela isibindi. Ngokutsho kumaZiko for Disease Control and Uthintelo, abantu abaqikelelwa 2.7 ukuya 3.9 yezigidi eUnited States baye abanesifo engapheliyo. Ezinye izigulane abaphethwe usuleleko ezinganyangekiyo abanesifo kwiminyaka emininzi babe senyongo (amehlo bulubhelu okanye kwesikhumba) kunye nokuphuhlisa iingxaki, ezifana ukopha, nokwanda fluid esiswini, izifo, umhlaza wesibindi kunye nokufa.

Kukho genotypes ubuncinane ezintandathu ezahlukahlukeneyo abanesifo, okanye kakhulu, nto leyo zofuzo amaqela athile le ntsholongwane. Ukwazi uhlobo lwe abanentsholongwane kunceda ukwazisa iingcebiso unyango. Malunga nama-75 ekhulwini abantu baseMerika kunye abanesifo babe kweejini 1; 20-25 angu genotypes-2 okanye ezi-3; kwaye inani elincinane lezigulane bosulelwa genotypes 4, 5 okanye 6.

Ukhuseleko kunye nokubaluleka Vosevi yahlaziywa kwiSigaba Amalingo amabini onyango 3 ababhalisa malunga abadala 750 ngaphandle kwesibindi okanye kwesibindi wobulali.

Ulingo lokuqala kuthelekiswa iiveki 12 zonyango Vosevi kunye placebo abadala kunye kweejini 1 abaye ayiphumelelanga ngaphambili unyango kunye ichiza NS5A inhibitor. Izigulane genotypes-2, 3, 4, 5 okanye 6 sonke saphiwa Vosevi.

Ulingo yesibini kuthelekiswa iiveki ezili-12 Vosevi kunye kumachiza ngaphambili sofosbuvir kunye velpatasvir abadala kunye genotypes 1, 2 okanye 3 ababekade ayiphumelelanga unyango kunye sofosbuvir kodwa ichiza NS5A inhibitor.

Iziphumo zombini iimvavanyo wabonisa ukuba 96-97 ekhulwini lezigulane abafumana Vosevi akabanga ntsholongwane ibonakele egazini kwiiveki ezili-12 emva kokugqiba unyango, nto leyo ebonisa ukuba usuleleko izigulane 'wayephilisiwe.

iingcebiso Treatment for Vosevi zahlukile ngokuxhomekeke kweejini wentsholongwane egazini kunye nembali unyango kwangaphambili.

Ukusabela zixhaphakileyo olunzulu izigulane ezithatha Vosevi baba intloko ebuhlungu, ukudinwa, urhudo kunye isicaphucaphu.

Vosevi ke contraindicated xa izigulane ezithatha rifampin iziyobisi.

Hepatitis B virus (HBV) ekuvuseleleni sele zixeliwe abanesifo / HBV kwizigulane coinfected omdala abo bajamelene okanye ubugqibile unyango kunye abanesifo antivirals ngqo-ngokwenza, yaye abazange abafumana HBV unyango antiviral. HBV ekuvuseleleni e abanyangwa ngqo-esebenza amayeza antiviral kungabangela iingxaki kwesibindi okanye ukufa kwezinye izigulane. iingcali zononophelo lwempilo kufuneka umfanekiso zonke izigulane ubungqina losulelo yangoku okanye ngaphambi HBV phambi kokuqala unyango kunye Vosevi.

I-FDA Unikwa le sicelo  Priority Review  and  Therapy nhlanganiso abizwa.  
 
The FDA granted approval of Vosevi to Gilead Sciences Inc.

I-FDA, i-arhente ngaphakathi US Department of Health kunye neeNkonzo zoLuntu, ukhusela impilo karhulumente ukuqinisekisa ngokhuseleko, ukusebenza, kunye nokhuseleko lwabasebenzi lwezilwanyana amachiza, amayeza kunye nezinye iimveliso zebhayoloji ukusetyenziswa ngabantu, kunye nezixhobo zonyango. I-arhente kwakhona unoxanduva lokhuseleko nokuphepha lonikezelo isizwe sethu ukutya, izinto zokuthambisa, izongezo zokutya, iimveliso ukuba zikhupha imitha electronic, kunye nokulawula iimveliso necuba.

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ixesha Post: Nov-24-2017
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