FDA rinobvumira Vosevi nokuda Hepatitis C

The US Food uye Drug Administration nhasi vanotenderwa Vosevi kubata vakuru vane chirwere hepatitis C utachiona (HCV) genotypes 1-6 pasina cirrhosis (chiropa chirwere) kana nyoro cirrhosis. Vosevi munhu wakaiswa-dose, mubatanidzwa Hwendefa rine mbiri kare vanotenderwa zvinodhaka - sofosbuvir uye velpatasvir - uye mushonga mutsva, voxilaprevir. Vosevi ndiye kurapwa wokutanga mvumo varwere vanenge kare kubatwa zvakananga-kuita antiviral zvinodhaka sofosbuvir kana zvimwe zvinodhaka kuti HCV kuti inogona kuderedza imwe puroteni inonzi NS5A.

"Zvinodhaka Direct-achiita antiviral kudzivisa hutachiwana kubva vachiwedzera uye kazhinji nekuporesa HCV. Vosevi inopa kurapwa chingaitwa nevamwe varwere vasina vakabudirira kurapwa nedzimwe HCV zvinodhaka kare, "akadaro Edward Cox, MD, mutungamiriri Office inorwisa utachiona Products muna FDA kuti Centre Drug Yekuongorora uye Research.

Hepatitis C chinhu nemavhairasi chirwere chinokonzera kuzvimba chiropa kuti kungaita kuti Nemhaka chiropa kushanda kana chiropa kukundikana. Maererano Centers for Disease Control and Prevention, zvinofungidzirwa kuti vanhu 2.7 kusvika mamiriyoni 3.9 muUnited States vane chirwere HCV. Vamwe varwere vanotambura nekuora HCV chirwere kwemakore akawanda vangava jaundice (Meso yellowish kana ganda) uye kukudziridza matambudziko akadai ropa, mvura kuunganidza mudumbu, utachiona, kenza chiropa uye rufu.

Pane zvinenge nhanhatu akasiyana HCV genotypes, kana utachiona, idzo majini mapoka vakasiyana kweutachiwana. Kuziva tisawirirane kweutachiwana kunogona kubatsira zivisa kurapwa audzwa. Inenge 75 muzana yevanhu vokuAmerica vane HCV vane genotype 1; 20-25 muzana vane genotypes 2 kana 3; uye vashoma varwere vari utachiwana genotypes 4, 5 kana 6.

The kuchengeteka uye efficacy pamusoro Vosevi akanga dzinoongororwa kuyaruka 3 miedzo miviri navanachiremba kuti akanyoresa inenge vakuru 750 pasina cirrhosis kana nyoro cirrhosis.

kutongwa yokutanga yakaenzanisa kwevhiki 12 Vosevi kurapwa pamwe kurapa kunonyaradza pfungwa nedzevakuru pamwe genotype 1 aimbovenga vakakundikana kurapwa ane NS5A inhibitor zvinodhaka. Varwere genotypes 2, 3, 4, 5 kana 6 zvose akagamuchira Vosevi.

kudare kechipiri yakaenzanisa kwevhiki 12 Vosevi pamwe zvinodhaka kare mvumo sofosbuvir uye velpatasvir mune vakuru vane genotypes 1, 2 kana 3 uyo ndamboramba vakakundikana kurapwa pamwe sofosbuvir asi kwete NS5A inhibitor zvinodhaka.

Results miedzo vose zvakaratidza kuti 96-97 muzana varwere vakagamuchira Vosevi haana utachiwana dzakaonekwa muropa masvondo 12 pashure pokupedza kurapwa, zvichireva kuti chirwere varwere 'akanga aporeswa.

Treatment kurumbidza nokuti Vosevi akasiyana zvichienderana nemavhairasi genotype uye asati kurapwa nhoroondo.

Rakajairika nenjodzi Varwere vachitora Vosevi vaiva nemusoro, kurukutika, manyoka uye svoto.

Vosevi ari contraindicated Varwere kutora zvinodhaka rifampin.

Hepatitis B utachiona (HBV) reactivation kwave inotaurwa HCV / HBV coinfected mukuru varwere vakanga kuwana kana apedza kurapwa pamwe HCV zvakananga-kuita antivirals, uye vakanga vasina kugamuchira HBV antiviral kurapa. HBV reactivation pavarwere kubatwa zvakananga-kuita mishonga antiviral kunogona kuguma zvakakomba chiropa matambudziko kana rufu vamwe varwere. Dzoutano nenyanzvi vanofanira dzokuongorora varwere vose kuti uchapupu kuitika kana risati HBV chirwere asati atanga kurapwa pamwe Vosevi.

The FDA akapa ichi kushanda  Pokutanga Review  uye  budiriro Therapy mazita.  
 
The FDA granted approval of Vosevi to Gilead Sciences Inc.

The FDA, chishandiso mukati US Department of Health uye Human Services, anodzivirira vanhu utano nokuvimbisa vakachengeteka, kubudirira, uye kuchengeteka kwevanhu uye wemhuka zvinodhaka, yokudzivirira nezvimwe utachiona zvinogadzirwa kuti kushandiswa kwevanhu, uye zvokurapa namano. Inoshandiswa zvakare ndiye anokonzera ngozi uye rudzi vedu zvokudya, zvizoro, Mishonga zvokuwedzera, zvinogadzirwa kuti ape kure zvemagetsi nemwaranzi, uye nokuda yokudzora mufodya.

Tumira shoko renyu kwatiri:

muvhunzo NOW
  • * CAPTCHA: Tapota kusarudza Tree


Post nguva: Nov-24-2017
WhatsApp Online Chat !