FDA amavomereza Vosevi kwa chiwindi C

The US zakudya ndi mankhwala Administration lero ovomerezeka Vosevi kuchitira akulu ndi aakulu chiwindi C HIV (matendawa) genotypes 1-6 popanda matenda enaake (chiwindi matenda) kapena ndi matenda enaake wofatsa. Vosevi ndi kuliika mankhwala, kuphatikiza piritsi munali mankhwala kale anthu awiri anavomereza - sofosbuvir ndi velpatasvir - ndi mankhwala atsopano, voxilaprevir. Vosevi ndi chithandizo choyamba wovomerezeka kwa odwala amene kale ankachitira ndi mwachindunji wotenga mavairasi oyambitsa sofosbuvir mankhwala kapena mankhwala ena matendawa kuti ziletsa mapuloteni otchedwa NS5A.

"Direct wotenga mankhwala mavairasi oyambitsa kupewa HIV kuchokera kuchulukana ndi zambiri kuchiza matendawa. Vosevi amapereka njira chithandizo kwa odwala ena amene sanali bwino ankachitira ndi mankhwala ena matendawa m'mbuyomu, "anatero Edward Cox, MD, mkulu wa Office za antimicrobial Zamgululi mu Center ya FDA kwa Mankhwala Bwino ndi Research.

Chiwindi C ndi matenda tizilombo zimene zimachititsa kutupa chiwindi zimene zingachititse kuti kuchepa kwa chiwindi ntchito kapena kulephera chiwindi. Malinga ndi Malo matenda, pafupifupi 2,7 miliyoni 3,9 anthu mu United States ndi matendawa aakulu. Odwala ena amene amadwala matenda aakulu matendawa kwa zaka zambiri mwina matenda a chikasu ndiyo (maso chikasu kapena khungu) ndi kukhala mavuto, monga magazi, kudzikundikira madzimadzi m'mimba, matenda, khansa chiwindi ndi imfa.

Pali osachepera asanu osiyana matendawa genotypes, kapena tizilombo, amene ali osiyana magulu osiyana a HIV. Kudziwa mavuto a HIV angathandize kudziŵitsa ayamikira chithandizo. Pafupifupi 75 peresenti ya ku America ndi matendawa ndi genotype 1; peresenti 20-25 ndi genotypes 2 kapena 3; ndi ochepa odwala matenda genotypes 4, 5 kapena 6.

Chitetezo ndi efficacy wa Vosevi anali ayesedwa mu awiri fezi 3 mayesero matenda amene analembetsa pafupifupi 750 akuluakulu popanda matenda enaake kapena ndi matenda enaake wofatsa.

Kanali koyamba poyerekeza masabata 12 a Vosevi mankhwala ndi placebo akuluakulu ndi genotype 1 amene poyamba analephera chithandizo ndi NS5A woletsa mankhwala. Odwala genotypes 2, 3, 4, 5 kapena 6 onse analandira Vosevi.

Mayesedwe chachiwiri poyerekeza masabata 12 a Vosevi ndi mankhwala kale ovomerezeka sofosbuvir ndi velpatasvir akuluakulu ndi genotypes 1, 2 kapena 3 amene kale analephera mankhwala ndi sofosbuvir koma osati NS5A woletsa mankhwala.

Zotsatira za mayesero onse anasonyeza kuti anthu 96-97 cha odwala amene Vosevi analibe kachilombo wapezeka mwazi masabata 12 akamaliza mankhwala, kusonyeza kuti matenda odwala anachiritsidwa.

ayamikira mankhwala Vosevi zosiyana malingana genotype tizilombo ndi mbiri isanafike mankhwala.

Ambiri zosiyanasiyana chokhwima odwala kutenga Vosevi anali mutu, kutopa, m'mimba ndiponso nseru.

Vosevi ali contraindicated odwala kumwa mankhwala rifampicin.

Chiwindi B HIV (HBV) reactivation ali zalembedwa mu matendawa / HBV coinfected wamkulu odwala amene akukumana kapena atamaliza mankhwala ndi matendawa antivirals mwachindunji wotenga, ndi amene samalandira HBV mavairasi oyambitsa mankhwala. HBV reactivation odwala mankhwala mwachindunji wotenga mankhwala mavairasi oyambitsa ungabweretse mavuto aakulu chiwindi kapena imfa odwala ena. akatswiri zaumoyo ayenera pounika odwala onse umboni wa matenda panopa kapena koyamba HBV musanayambe mankhwala ndi Vosevi.

The FDA mwapatsidwa ntchito imeneyi  Patsogolo Review  ndi  yojambula Therapy mayina.  
 
The FDA granted approval of Vosevi to Gilead Sciences Inc.

The FDA, Bungweli mu dipatimenti ya umoyo, kuteteza chavuta ndi kutsimikizila chitetezo, mogwira mtima, ndipo chitetezo cha mankhwala anthu ndi Chowona Zanyama, katemera ndi mankhwala ena kwachilengedwenso ntchito anthu, ndi zipangizo zachipatala. bungwe nayenso ali ndi udindo chifukwa chitetezo ndi chitetezo cha kotunga mtundu wathu chakudya, mafuta odzola zowonjezera zakudya, mankhwala kutulutsa cheza zamagetsi, ndi malamulo fodya.

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Post nthawi: Nov-24-2017
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