US FDA Ivomereza Panopa Chithandizo Choyambirira komanso Chotenga Nthawi Yaitali Kachilombo ka HIV

A GWIRITSANI KwaulereKutulutsidwa 4 | eTurboNews | | eTN
Avatar ya Linda Hohnholz
Written by Linda Hohnholz

Janssen Pharmaceutical Companies of Johnson & Johnson lero yalengeza kuti US Food and Drug Administration (FDA) yavomereza chizindikiro chowonjezera cha CABENUVA (rilpivirine ndi cabotegravir) kuti chiziperekedwa miyezi iwiri iliyonse pochiza HIV-1 mwa akuluakulu omwe ali ndi kachilombo ka HIV. -1 RNA zosakwana 50 makope pa mililita [c/ml]) pa ndondomeko yokhazikika, popanda mbiri ya kulephera kwa mankhwala, komanso popanda zodziwika kapena kukayikira kukana rilpivirine kapena cabotegravir.

Regimen yatsopanoyi idapangidwa limodzi ngati gawo limodzi la mgwirizano ndi ViiV Healthcare ndipo imakhazikika pa kudzipereka kwa Janssen kwa zaka 25 kupanga mbiri ya HIV. ViiV Healthcare ndi omwe ali ndi chilolezo chotsatsa ku CABENUVA ku US               

CABENUVA idavomerezedwa ndi US FDA mu Januware 2021 ngati njira imodzi pamwezi, yokwanira yochizira matenda a HIV-1 mwa akulu kuti alowe m'malo mwamankhwala omwe alipo omwe ali ndi kachilombo ka HIV (HIV-1 RNA zosakwana makope 50 pa). ml).1 CABENUVA imapangidwa ndi mitundu iwiri yobaya jekeseni, rilpivirine kuyimitsidwa kwanthawi yayitali mu botolo la mlingo umodzi, zopangidwa ndi Janssen Sciences Ireland Unlimited Company, ndi ViiV Healthcare's cabotegravir jekeseni yotulutsidwa mu vial ya mlingo umodzi. Asanayambe chithandizo cha CABENUVA, mlingo wa pakamwa wa rilpivirine ndi cabotegravir uyenera kuperekedwa kwa pafupifupi mwezi umodzi kuti awone kulekerera kwa chithandizo chilichonse. Kuvomerezeka kwa FDA kwa US kumapangitsa kuti CABENUVA imwe mwezi uliwonse kapena miyezi iwiri iliyonse.

"Kuvomerezedwa kowonjezera kwa CABENUVA -kuperekedwa miyezi iwiri iliyonse - ndi gawo lofunikira patsogolo pakupititsa patsogolo chithandizo cha anthu omwe ali ndi kachilombo ka HIV," atero a Candice Long, Purezidenti, Matenda Opatsirana & Vaccines, Janssen Therapeutics, Division of Janssen. Products, LP. "Ndi chochitika ichi, akuluakulu omwe ali ndi kachilombo ka HIV ali ndi njira yochizira yomwe imachepetsanso kuchuluka kwa mankhwala."

Dinani kuti Tweet: #BREAKING: A @US_FDA yavomereza njira yatsopano yoperekera kwa anthu omwe ali ndi #HIV. Dziwani zambiri zachitukuko chosangalatsachi pazamankhwala a HIV: http://bit.ly/38rPgFi

"Cholinga chofunikira kwa ife mu HIV ndi kuchepetsa kufunikira kwa mankhwala a tsiku ndi tsiku, omwe angakhale chikumbutso chokhazikika kwa anthu omwe ali ndi vutoli," adatero James Merson, Ph.D., Global Therapeutic Area Head, Matenda opatsirana, Janssen Research. & Development, LLC. "Ndi njira yatsopanoyi yochizira yomwe imachepetsa kuchuluka kwa mlingo wa CABENUVA kufika kasanu ndi kamodzi pachaka, tikusintha chithandizo cha HIV kwa anthu omwe ali ndi kachilombo ka HIV ku US"

Chivomerezo cha US FDA cha rilpivirine ndi cabotegravir ogwiritsidwa ntchito kwa nthawi yayitali miyezi iwiri iliyonse chimachokera ku zotsatira za kuyesa kwapadziko lonse kwa ATLAS-2M phase 3b, zomwe zimasonyeza kuti mlingo wa miyezi iwiri iliyonse unali wocheperapo poyerekeza ndi dosing kamodzi pamwezi.2 Non -kutsika kunatsimikiziridwa poyerekezera chiwerengero cha anthu omwe ali ndi plasma HIV-1 RNA ≥ 50 c/ml pogwiritsa ntchito US FDA Snapshot algorithm pa Week 48 (Intent-To-Treat Exposed population), zomwe zinasonyeza kuti mkono wa miyezi iwiri iliyonse. (9/522 [1.7%]) ndi mkono kamodzi pamwezi (5/523 [1.0%]) zinali zogwira ntchito mofananamo (kusiyana kosinthika: 0.8%, 95% nthawi yodalirika [CI]: -0.6%, 2.2%). Kafukufukuyu adapezanso kuti kuchuluka kwa kuponderezedwa kwa virologic, gawo lofunikira lachiwiri, linali lofanana ndi dosing ya miyezi iwiri iliyonse (492/522 [94.3%]) ndi dosing kamodzi pamwezi (489/523 [93.5%]) (kusiyana kosintha). : 0.8%, 95% CI: -2.1%, 3.7%). Zotsatira zoyipa kwambiri (Makalasi 1 mpaka 4) omwe adawonedwa mu ≥2% ya omwe adalandira rilpivirine ndi cabotegravir omwe amakhala nthawi yayitali anali machitidwe a jekeseni, pyrexia, kutopa, kupweteka mutu, kupweteka kwa minofu ndi mafupa, nseru, kusokonezeka kwa kugona, chizungulire, ndi zidzolo. Mu ATLAS-2M, mtundu ndi kuchuluka kwa zoyipa zomwe zimanenedwa mwa omwe adalandira rilpivirine ndi cabotegravir kamodzi pamwezi kapena miyezi iwiri iliyonse kwa milungu 48 zinali zofanana. M'miyezi iwiri iliyonse, ziwopsezo zazovuta zoyipa (SAEs: 27/522 [5.2%]) ndi zotuluka chifukwa cha zovuta (AEs: 12/522 [2.3%]) zinali zotsika komanso zofanana ndi zomwe zidachitika mkono kamodzi pamwezi (SAEs: 19/523 [3.6%], kuchotsa chifukwa cha AEs 13/523 [2.5%]).2

"Sing'anga aliyense amafuna kuti azitha kupereka chithandizo choyenera kwa wodwala, ndipo pali zifukwa zingapo zomwe zimatengera chisankho chimenecho," adatero Tony Mills, MD *, CEO wa Men's Health Foundation ku Los Angeles. CA. "Ndi chivomerezochi, pali njira ina yofunika yomwe madokotala angachite kuti athetsere zomwe wodwala amakonda pakumwa mankhwala pafupipafupi."

Chithandizo cha jakisoni cha rilpivirine ndi cabotegravir kamodzi pamwezi chavomerezedwanso ndi European Commission, Health Canada, Australia Therapeutic Goods Administration, ndi Swiss Agency for Therapeutic Products. Mtundu wa miyezi iwiri iliyonse wavomerezedwanso ndi European Commission, Health Canada, ndi Swiss Agency for Therapeutic Products. Ndemanga zowongolera zikupitilira ndi zina zowonjezera zomwe zakonzedwa mu 2022.

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Linda Hohnholz

Mkonzi wamkulu kwa eTurboNews zochokera ku eTN HQ.

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