Irejimeni inoveli yaphuhliswa ngokubambisana njengenxalenye yentsebenziswano ne-ViiV Healthcare kwaye yakhela phezu kokuzinikela kuka-Janssen iminyaka engama-25 ekwenzeni imbali ye-HIV. I-ViiV Healthcare inegunya lokuthengisa i-CABENUVA e-US
I-CABENUVA yamkelwa yi-US FDA ngoJanuwari 2021 njengerejimeni kanye ngenyanga, irejimeni epheleleyo yonyango losulelo lwe-HIV-1 kubantu abadala ukuze kuthathelwe indawo irejimeni yangoku ye-antiretroviral kwabo bacinezelekileyo ngokwentsholongwane (HIV-1 RNA ngaphantsi kweekopi ezingama-50 ml).1 I-CABENUVA iqulathe amayeza amabini awohlukeneyo atofwayo, i-rilpivirine ukukhutshwa okwandisiweyo okutofwayo kwibhotile enedosi enye, imveliso ye-Janssen Sciences Ireland Unlimited Company, kunye ne-ViiV Healthcare's cabotegravir ukukhutshwa okwandisiweyo okutofwayo kwibhotile yedosi enye. Phambi kokuba kuqaliswe unyango lwe-CABENUVA, idosi yomlomo ye-rilpivirine kunye ne-cabotegravir kufuneka isetyenziswe malunga nenyanga enye ukuhlola ukunyamezeleka kunyango ngalunye. Imvume ye-FDA yase-US ivumela i-CABENUVA ukuba ithathelwe ithamo ngenyanga okanye emva kweenyanga ezimbini.
"Imvume yeleyibhile eyandisiweyo yeCABENUVA-iya kulawulwa rhoqo emva kweenyanga ezimbini-ibonisa inyathelo elibalulekileyo ekuqhubeleni phambili indawo yonyango kubantu abaphila ne-HIV," utshilo uCandice Long, uMongameli, iZifo ezosulelayo kunye noVaccines, iJanssen Therapeutics, iCandelo laseJanssen. Iimveliso, LP. "Ngalo mda ubalulekileyo, abantu abadala abaphila ne-HIV banokhetho lonyango olunciphisa ngakumbi ukuxhaphaka kwamayeza."
Cofa kuTweet: #BREAKING: I-@US_FDA iphumeze indlela entsha yokudosa kubantu abaphila ne#HIV. Funda ngakumbi ngalo mda unika umdla kunyango lwe-HIV: http://bit.ly/38rPgFi
"Injongo ebalulekileyo kuthi kwi-HIV kukunciphisa imfuno yonyango lwemihla ngemihla, enokuthi isebenze njengesikhumbuzo rhoqo kubantu abaphila nemeko," watsho uJames Merson, Ph.D., iNtloko ye-Global Therapeutic Area, izifo ezithathelwanayo, uPhando lukaJanssen. & Nophuhliso, LLC. "Ngolu khetho lutsha lonyango olunciphisa ukuphindaphinda kwe-CABENUVA yedosi ukuya kumaxesha amathandathu ngonyaka, siguqula unyango lwe-HIV kubantu abaphila ne-HIV e-US"
Imvume ye-FDA ye-US ye-rilpivirine esebenza ixesha elide kunye ne-cabotegravir ukuba isetyenziswe rhoqo emva kweenyanga ezimbini isekelwe kwiziphumo zolingo lwehlabathi jikelele ze-ATLAS-2M isigaba 3b, ezibonise ukuba idosi yeenyanga ezimbini ibingekho ngaphantsi kwedosi yakanye ngenyanga. -ubuphantsi buchongwe ngokuthelekisa umlinganiselo wabathathi-nxaxheba abane-plasma HIV-2 RNA ≥ 1 c/ml usebenzisa i-US FDA Snapshot algorithm kwiVeki ye-50 (iNjongo-yokuPhatha abantu abaveziweyo), ebonisa ukuba ingalo nganye yeenyanga ezimbini (48/9 [522%]) kunye nengalo yenyanga kanye (1.7/5 [523%]) yayisebenza ngokufanayo (umohluko olungisiweyo: 1.0%, 0.8% ukuzithemba kwexesha [CI]: -95%, 0.6%). Uphononongo luphinde lwafumanisa ukuba amazinga oxinzelelo lwe-virologic, isiphelo sesibini esiphambili, ayefana ne-dosing yeenyanga ezimbini (2.2 / 492 [522%]) kunye ne-dosing kanye ngenyanga (94.3 / 489 [523%)) (umahluko olungisiweyo : 93.5%, 0.8% CI: -95%, 2.1%). Ezona mpendulo zixhaphakileyo (amaBanga 3.7 ukuya ku-1) eziqatshelwe kwi-≥4% yabathathi-nxaxheba abafumana i-rilpivirine yexesha elide kunye ne-cabotegravir yayiyi-injection site reactions, i-pyrexia, ukukhathala, intloko, intlungu ye-musculoskeletal, isicaphucaphu, ukuphazamiseka kokulala, isiyezi, kunye ne-rash. Kwi-ATLAS-2M, uhlobo kunye nokuphindaphindwa kweempembelelo ezimbi ezixelwe kubathathi-nxaxheba abafumana i-rilpivirine esebenza ixesha elide kunye ne-cabotegravir kanye ngenyanga okanye kwiinyanga ezimbini kwiiveki ezingama-2 ziyafana. Kwingalo yeenyanga ezimbini, amazinga eemeko ezimbi kakhulu (SAEs: 48 / 27 [522%]) kunye nokuhoxiswa ngenxa yeziganeko ezimbi (AEs: 5.2 / 12 [522%]) ziphantsi kwaye zifana nalabo abanamava ingalo yenyanga enye (SAEs: 2.3/19 [523%], ukuhoxiswa ngenxa ye-AEs 3.6/13 [523%]) .2.5
"Wonke ugqirha ufuna ukukwazi ukunika isigulane ngonyango olufanelekileyo kubo, kwaye kukho izinto ezininzi eziya kweso sigqibo," kusho uTony Mills, MD *, i-CEO ye-Men's Health Foundation eLos Angeles. CA. "Ngale mvume, kukho enye into ebalulekileyo eyongeziweyo koogqirha ukulungisa izinto ezikhethwa sisigulana zokuthatha idosi rhoqo."
Inguqulelo kanye ngenyanga yonyango olutofwayo lwe-rilpivirine kunye ne-cabotegravir luvunyiwe yiKhomishini yaseYurophu, i-Health Canada, i-Australia Therapeutic Goods Administration, kunye ne-Swiss Agency for Therapeutic Products. Uguqulelo lweenyanga ezimbini zonke luye lwavunywa yiKhomishini yaseYurophu, i-Health Canada, kunye ne-Swiss Agency for Therapeutic Products. Uphononongo lolawulo luyaqhubeka kunye neziphakamiso ezongezelelweyo ezicwangcisiweyo kulo lonke u-2022.
INTO ONOKUYITHATHA KWELI NQAKU:
- “Every clinician wants to be able to provide a patient with a treatment that is right for them, and there are a number of factors that go into that decision,”.
- FDA in January 2021 as a once-monthly, complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml).
- “An important goal for us in HIV is alleviating the need for daily medication, which can serve as a constant reminder for people living with the condition,”.
