FDA ta amince da Vosevi for Hepatitis C - China Unibest Industrial
A Amurka Food and Drug Administration yau amince Vosevi mu bi manya da kullum hepatitis C virus (HCV) genotypes 1-6 ba tare da cirrhosis (hanta cuta) ko da m cirrhosis. Vosevi ne tsayayyen-kashi, hade kwamfutar hannu dauke da biyu a baya amince kwayoyi - sofosbuvir da velpatasvir - da kuma wani sabon maganin, voxilaprevir. Vosevi ne na farko da magani amince ga marasa lafiya wanda aka a baya a bi da kai tsaye-aiki antiviral miyagun ƙwayoyi sofosbuvir ko wasu kwayoyi don HCV cewa hana mai gina jiki kira NS5A.
"Direct-aiki antiviral kwayoyi hana cutar daga halitta kuma sau da yawa warkar HCV. Vosevi samar da wani magani zaɓi don wasu marasa lafiya da suke da aka ba nasarar bi da tare da sauran HCV kwayoyi a baya, "ya ce Edward Cox, MD, darektan ofishin Antimicrobial Products a FDA ta Center for Drug Evaluation da kuma Research.
Hepatitis C ne mai kwayar cutar da cewa yana sa kumburi da hanta da cewa zai iya kai wa ga rage hanta aiki ko hanta gazawar. Bisa ga Cibiyar Kula da Cututtuka da kuma Rigakafin, an kiyasta 2.7 zuwa 3.9 mutane miliyan a Amurka da na kullum HCV. Wasu marasa lafiya da suke wahala daga matsananciyar HCV kamuwa shekaru masu yawa na iya samun jaundice (yellowish idanu ko fata) da kuma ci gaba da rikitarwa, kamar jini, m jari a ciki, cututtuka, hanta ciwon daji da kuma mutuwa.
Akwai a kalla shida jinsin HCV genotypes, ko damuwa, waxanda suke da genetically jinsin kungiyoyin da cutar. Sanin iri da cutar zai iya taimaka sanar da magani shawarwari. Aƙalla kashi 75 na jama'ar {asar Amirka tare da HCV da genotype 1; 20-25 bisa dari da genotypes 2 ko 3; da kuma karamin yawan marasa lafiya da ke kamuwa da genotypes 4, 5 ko 6.
A aminci da kuma inganci na Vosevi aka kimanta a cikin biyu Phase 3 gwajinsu da sa suna kamar 750 manya ba tare da cirrhosis ko da m cirrhosis.
A farko fitina idan aka kwatanta da 12 makonni na Vosevi magani da placebo a manya da genotype 1 wanda ya rigaya ya gaza lura da wani NS5A hanawa miyagun ƙwayoyi. Marasa lafiya da genotypes 2, 3, 4, 5, ko 6 duk samu Vosevi.
Na biyu fitina idan aka kwatanta da 12 makonni na Vosevi da baya amince kwayoyi sofosbuvir da velpatasvir a manya da genotypes 1, 2 ko 3 da suka yi a baya gaza lura da sofosbuvir amma ba wani NS5A hanawa miyagun ƙwayoyi.
Sakamako na biyu gwaji nuna cewa 96-97 bisa dari na marasa lafiya da suke samu Vosevi da babu cutar gano a cikin jini 12 makonni bayan kammala magani, bayar da shawara cewa marasa lafiya 'kamuwa da cuta da aka warke.
Jiyya shawarwari ga Vosevi ne daban-daban dangane da kwayar genotype kuma kafin magani tarihi.
Mafi na kowa m halayen a marasa lafiya shan Vosevi sun ciwon kai, gajiya, zawo da tashin zuciya.
Vosevi ne contraindicated a marasa lafiya shan miyagun ƙwayoyi rifampin.
Hepatitis B cutar (HBV) reactivation da aka ruwaito a cikin HCV / HBV coinfected adult marasa lafiya da suke aka jurewa ko ya kammala magani da HCV kai tsaye-aiki antivirals, da kuma wanda aka ba ta karbar HBV antiviral far. HBV reactivation a marasa lafiya bi da tare da kai tsaye-aiki antiviral magunguna iya haifar da tsanani hanta matsaloli ko mutuwa a wasu marasa lafiya. Kiwon lafiya kwararru kamata duduba duk marasa lafiya domin shaida na halin yanzu ko kafin HBV kamuwa da cuta kafin fara jiyya da Vosevi.
A FDA garantin wannan aikace-aikace Fifiko Review da kuma nasara Far zane-zane da.
A FDA, wata hukumar a cikin US Department of Health da kuma Human Services, kare da kiwon lafiyar jama'a, ta hanyar tabbatar da kare lafiya, da tasiri, da kuma jami'an tsaro na 'yan Adam da kuma dabbobi da kwayoyi, alluran da sauran nazarin halittu kayayyakin ga mutum amfani, da kuma na'urorin kiwon lafiya. A dillancin kuma shi ne alhakin da aminci da kuma tsaro na mu al'umma ta abinci, kayan shafawa, abin da ake ci kari, kayayyakin da cewa ba kashe lantarki radiation, kuma domin gudãnar taba kayayyakin.
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Post lokaci: Nov-24-2017