Ua Fa'atagaina nei e le US FDA le Togafitiga Muamua ma Na'o le Togafitiga ole HIV Fa'aumi

O le faiga fou na fausia fa'atasi e avea o se vaega o le galulue fa'atasi ma le ViiV Healthcare ma fa'avae i luga o le tautinoga a Janssen mo le 25 tausaga e faia le tala'aga o le HIV. ViiV Healthcare o le pule fa'atauga fa'atau mo CABENUVA i Amerika               

CABENUVA na faʻamaonia e le US FDA ia Ianuari 2021 e avea o se faʻatonuga taʻitasi masina, atoa mo le togafitiga o faʻamaʻi pipisi o le HIV-1 i tagata matutua e sui ai le faʻamaʻi faʻamaʻi o loʻo i ai nei i latou o loʻo taofia faʻamaʻi (HIV-1 RNA e itiiti ifo i le 50 kopi i le tasi). ml).1 CABENUVA o lo'o aofia ai ni vaila'au tu'itu'i se lua, rilpivirine extended-release injectable suspension i se tasi-dose vial, o se oloa a le Janssen Sciences Ireland Unlimited Company, ma le ViiV Healthcare's cabotegravir extended-release injectable suspension i totonu o se fagu fua e tasi. A'o le'i amataina togafitiga ole CABENUVA, ole tu'u gutu ole rilpivirine ma le cabotegravir e tatau ona faia mo le tusa ma le tasi le masina e iloilo ai le gafatia o togafitiga taitasi. Ole US FDA Approval e fa'atagaina le CABENUVA e fa'ainu i masina ta'i lua po'o masina ta'ilua.

"O le faʻalauteleina o igoa faʻamaonia mo CABENUVA-ia faʻatinoina i masina taʻi lua-e faʻailogaina se laasaga taua i luma i le faʻalauteleina o le laufanua togafitiga mo tagata o loʻo maua i le HIV," o le tala lea a Candice Long, Peresetene, Infectious Diseases & Vaccines, Janssen Therapeutics, a Division of Janssen Oloa, LP. "Faatasi ai ma lenei mataʻina, o tagata matutua o loʻo maua i le HIV e iai se togafitiga e faʻaitiitia ai le tele o vailaʻau."

Kiliki i le Tweet: #BREAKING: Ua fa'amaonia e le @US_FDA se filifiliga fou e fai ai tui mo tagata e maua i le #HIV. A'oa'o atili e uiga i lenei mata'ina mata'ina ile va'aiga o togafitiga ole HIV: http://bit.ly/38rPgFi

"O se sini taua mo i matou i le HIV o le faʻaitiitia o le manaʻomia o vailaʻau i aso uma, lea e mafai ona avea o se faʻamanatuga faifai pea mo tagata o loʻo ola i le tulaga," o le tala lea a James Merson, Ph.D., Global Therapeutic Area Head, Infectious Diseases, Janssen Research & Atiina'e, LLC. "Faatasi ai ma lenei filifiliga fou togafitiga e faʻaitiitia ai le faʻaogaina o le CABENUVA i le naʻo le ono taimi i le tausaga, o loʻo matou faʻafouina togafitiga HIV mo tagata o loʻo nonofo i le HIV i le US"

O le faamaoniga a le US FDA o le rilpivirine ma le cabotegravir ua leva ona galue mo le faaaogaina i masina uma e lua, e faavae i luga ole suega ole ATLAS-2M phase 3b i'uga o le lalolagi, lea na faaalia ai e le itiiti ifo le tui ile lua masina nai lo le tui ile tasi masina. -na fa'amauina le maualalo e ala i le fa'atusatusaina o le vaega o tagata auai i le plasma HIV-2 RNA ≥ 1 c/ml e fa'aaoga ai le US FDA Snapshot algorithm i le Vaiaso 50 (Intent-to-Treat Exposed population), lea na fa'aalia ai o le lima ta'ilua masina. (48/9 [522%)] ma le lima masina (1.7/5 [523%)] sa tutusa lelei lava (eseesega fetuutuunai: 1.0%, 0.8% taimi fa'alagolago [CI]: -95%, 0.6%). Na maua foi e le suʻesuʻega o fua faatatau o le taofiofia o le virologic, o se tulaga maualuga lona lua, e tutusa mo faʻamaʻi taʻi lua masina (2.2/492 [522%]) ma le faʻaogaina o le tasi masina (94.3/489 [523%]) (fetuunaʻiga eseesega. : 93.5%, 0.8% CI: -95%, 2.1%). O a'afiaga sili ona taatele (Vaega 3.7 i le 1) na matauina i le ≥4% o tagata auai na mauaina le rilpivirine ma le cabotegravir umi o loʻo faʻaalia i luga o le tui, pyrexia, vaivai, ulu, tiga musculoskeletal, faufau, faʻalavelave moe, niniva, ma mageso. I le ATLAS-2M, o le ituaiga ma le tele o faʻalavelave leaga na lipotia mai i tagata auai na mauaina le rilpivirine ma le cabotegravir umi e tasi i le masina poʻo le lua masina mo le 2 vaiaso e tutusa. I le lima taʻi lua masina, o fua faatatau o faʻalavelave matuia (SAEs: 48/27 [522%)] ma faʻamavae ona o faʻalavelave faʻalavelave (AEs: 5.2/12 [522%)] sa maualalo ma tutusa ma mea na tutupu i totonu. le lima ta'i masina (SAEs: 2.3/19 [523%], fa'aui i tua ona o le AEs 3.6/13 [523%).2.5

"E manaʻo fomaʻi uma e mafai ona tuʻuina atu i se tagata maʻi se togafitiga e saʻo mo i latou, ma e iai le tele o mea e alu i lena filifiliga," o le tala lea a Tony Mills, MD *, Pule Sili o Men's Health Foundation i Los Angeles, CA. "Faatasi ai ma lenei faʻatagaga, o loʻo i ai se filifiliga faʻaopoopo taua mo fomaʻi e faʻafesoʻotaʻi manaʻoga o le maʻi mo le faʻaitiitiina o tui."

O le fa'asologa fa'alemasina o le rilpivirine ma le cabotegravir injectable treatment ua fa'amaonia foi e le Komisi Europa, Health Canada, le Australia Therapeutic Goods Administration, ma le Swiss Agency for Therapeutic Products. Ua fa'amaonia fo'i e le Komisi Europa, Health Canada, ma le Swiss Agency for Therapeutic Products le lomiga ta'ilua masina. Fa'aauau iloiloga fa'atulafono fa'atasi ma fa'amatalaga fa'aopoopo ua fuafuaina ile 2022.