FDA anakwere Vosevi maka Ịba ọcha n'anya C

The US Food na ọgwụ ọjọọ nchịkwa taa mma Vosevi na-emeso ndị okenye na-adịghị ala ala ịba ọcha n'anya C virus (HCV) genotypes 1-6 enweghị imeju (ọrịa imeju) ma ọ bụ na nke dị nwayọọ imeju. Vosevi bụ a ofu-dose, Nchikota mbadamba nwere abụọ mbụ mma ọgwụ ọjọọ - sofosbuvir na velpatasvir - na a ọgwụ ọhụrụ, voxilaprevir. Vosevi bụ nke mbụ ọgwụgwọ mma n'ihi ọrịa ndị e mbụ emeso ya na kpọmkwem-eme antiviral ọgwụ sofosbuvir ma ọ bụ ọgwụ ọjọọ ndị ọzọ maka HCV na inhibit a protein na-akpọ NS5A.

"Direct-eme antiviral ọgwụ gbochie virus si amụba ma na-agwọ HCV. Vosevi enye a ọgwụgwọ nhọrọ maka ụfọdụ ọrịa na-adịghị ọma-emeso ya na ndị ọzọ HCV ọgwụ ọjọọ na n'oge gara aga, "kwuru Edward Cox, MD, director nke Office nke antimicrobial Products na FDA si Center maka Drug Evaluation and Research.

Ịba ọcha n'anya C bụ a malitere ịrịa ọrịa nke na-akpata mbufụt nke imeju na ike eme ka e belata imeju ọrụ ma ọ bụ mmebi imeju. Dị ka Ụlọ Ọrụ nke Nchịkwa na Mgbochi Ọrịa, ihe e mere atụmatụ 2,7 na 3.9 nde mmadụ na United States nwere adịghị ala ala HCV. Ụfọdụ ọrịa ndị na-ata ahụhụ site na-adịghị ala ala HCV ọrịa ruo ọtụtụ afọ nwere ike jaundice (acha anya ma ọ bụ na akpụkpọ) na ịzụlite nsogbu, dị ka ọbara ọgbụgba, ọmụmụ ìgwè ke afo, na-efe efe, imeju cancer na ọnwụ.

E nwere ma ọ dịkarịa ala isii iche HCV genotypes, ma ọ bụ pụta, nke bụ genetically iche iche iche nke virus. Ịmara nke nje nke virus nwere ike inyere agwa ọgwụgwọ kwe nkwa. Odika 75 percent nke ndị America na HCV nwere genotype 1; 20-25 percent nwere genotypes 2 ma ọ bụ 3; na a obere ọnụ ọgụgụ ndị ọrịa na-ebute nje genotypes 4, 5 ma ọ bụ 6.

The nchekwa na nrụpụta ọrụ nke Vosevi e inyocha na abụọ adọ 3 adakarị ọnwụnwa ndị na-debara aha dị 750 ndị okenye enweghị imeju ma ọ bụ na nke dị nwayọọ imeju.

The mbụ ikpe tụnyere 12 izu nke Vosevi ọgwụgwọ na placebo na ndị okenye na genotype 1 onye mbụ dara ọgwụgwọ na ihe NS5A inhibitor ọgwụ. Ọrịa na genotypes 2, 3, 4, 5 ma ọ bụ 6 niile natara Vosevi.

The abụọ ikpe tụnyere 12 izu nke Vosevi na mbụ mma ọgwụ ọjọọ sofosbuvir na velpatasvir na ndị okenye na genotypes 1, 2 ma ọ bụ 3 onye nwere na mbụ na-emezughị ọgwụgwọ na sofosbuvir ma ọ bụghị ihe NS5A inhibitor ọgwụ.

Results nke ma ọnwụnwa gosiri na 96-97 percent nke ọrịa ndị na-natara Vosevi enweghị virus ahụrụ n'ime ọbara 12 izu gụchara ọgwụgwọ, na-ekwu na ọrịa ọrịa a gwọrọ ọrịa.

Ọgwụgwọ nwere ikwu maka Vosevi dị iche dabere na malitere ịrịa genotype na tupu ọgwụgwọ ihe mere eme.

The kasị oghom Jeremaya mere na ọrịa na-ewere Vosevi ndị isi ọwụwa, ike ọgwụgwụ, afọ ọsịsa na ọgbụgbọ.

Vosevi na-contraindicated na ọrịa na-ewere ọgwụ rifampin.

Ịba ọcha n'anya B virus (HBV) reactivation a kọrọ na HCV / HBV coinfected okenye ọrịa ndị na-enwe ụdị ihe ahụ ma ọ bụ dechara ọgwụgwọ na HCV kpọmkwem-eme antivirals, na ndị na-anaghị enweta HBV antiviral ọgwụ. HBV reactivation na ọrịa emeso ya na kpọmkwem-eme antiviral ọgwụ pụrụ ịkpata oké njọ imeju nsogbu ma ọ bụ ọnwụ na ụfọdụ ọrịa. Health na-elekọta ndị ọkachamara ga-enyocha ihe niile ọrịa na-egosi ugbu a ma ọ bụ tupu HBV ọrịa tupu ịmalite ọgwụgwọ na Vosevi.

The FDA nyere a ngwa  Ibu ụzọ Review  na  itunanya Agwọ e.  
 
The FDA granted approval of Vosevi to Gilead Sciences Inc.

The FDA, ihe gị n'ụlọnga n'ime US Department of Health and Human Services, na-echebe ndị ahụ ike ọha site n'imesi nchekwa, irè, na nche nke ụmụ mmadụ na ọgwụgwọ ọrịa anụmanụ ọgwụ ọjọọ, ọgwụ mgbochi ndị ọzọ ndu ngwaahịa nke ụmụ mmadụ na-eji, na ọgwụ na ngwaọrụ. The gị n'ụlọnga na-bụ maka nchekwa na nche nke na anyị na mba nri, ihe ntecha, dietary Mmeju, na ngwaahịa na-enye electronic radieshon, na maka inye iwu na-emepụta sịga na ngwaahịa.

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Post oge: Nov-24-2017
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