IJanssen Pharmaceutical Companies of Johnson & Johnson namhlanje ibhengeze ukuba iUS Food and Drug Administration (FDA) ivume uhlaziyo lweleyibhile yeCABENUVA (cabotegravir kunye nerilpivirine), enika abaqeqeshi bezempilo kunye nabantu abaphila nentsholongwane ye-HIV-1 e-US. ukhetho lokuqalisa olu unyango olutofwayo kube kanye ngenyanga okanye kwiinyanga ezimbini ngaphandle kwesidingo senqanaba lokukhokela ngomlomo (ipilisi zemihla ngemihla ze-cabotegravir kunye ne-rilpivirine, ezithathwa inyanga enye phambi kokuqaliswa kwenaliti ye-cabotegravir kunye ne-rilpivirine). Idatha yeklinikhi ibonise irejimeni ibonisa ukhuseleko olufanayo kunye neprofayili esebenzayo zombini kunye nangaphandle kwexesha lokukhokela ngomlomo. I-CABENUVA yaphuhliswa ngokubambisana njengenxalenye yentsebenziswano ne-ViiV Healthcare kwaye yakhela phezu kokuzinikela kuka-Janssen amashumi eminyaka ekulweni ne-HIV.
“Sinerekhodi eqinisekisiweyo yokuzisa amayeza olutsha kubantu abaphila ne-HIV, kwaye ukuzinikela kwethu ekungeniseni inkqubela phambili yenzululwazi akukhange kushukume,” utshilo uJames Merson, Ph.D., iNtloko yeGlobal Therapeutic Area, Izifo ezosulelayo, uPhando lukaJanssen. & Nophuhliso, LLC. "Ngalo mgama wandisiweyo weleyibhile, uJanssen ubonelela ngendlela eyongezelelweyo eyenza lula imeko yonyango kubantu abaphila ne-HIV e-US abamiselwe unyango lwe-CABENUVA."
I-CABENUVA yeyokuqala kunye nokuphela kwenkqubo yonyango ye-HIV ethatha ixesha elide kwaye ivunyiwe e-US njengonyango lwe-HIV kanye ngenyanga okanye iinyanga ezimbini ze-HIV-1 kubantu abadala abaxinzelelwe nge-virologically (HIV-1 RNA <50 iikopi / mL) kwirejimeni ezinzileyo ye-antiretroviral engenambali yokusilela kunyango kwaye akukho kwaziwayo okanye okukrokrelekayo ukuxhathisa nokuba yi-cabotegravir okanye i-rilpivirine. Iqulethe i-ViiV Healthcare's cabotegravir yokukhululwa okuxhonyiweyo okutofwayo okwedosi enye kunye ne-rilpivirine ukukhutshwa okwandisiweyo okutofwayo kwibhotile yedosi enye, imveliso ye-Janssen Sciences Ireland Unlimited Company, enye yeeNkampani ze-Janssen Pharmaceutical Companies of Johnson & Johnson.
"E-Janssen, siyazingca ngokuqhubeka nokuqhubela phambili ukhetho oluxhasa izigulane kunye nokunceda ababoneleli bezempilo ekufumaneni izicwangciso zonyango lomntu ngamnye ezijongene neemfuno ezizodwa kunye neemeko zabantu abaphila ne-HIV," kusho uCandice Long, uMongameli, iZifo ezosulelayo kunye neZitofu, i-Janssen Therapeutics. , iCandelo leeMveliso zeJanssen, LP. "Ukubonelela ngeepotifoliyo ezahlukeneyo zonyango lwe-HIV kubalulekile ukunceda ukuhlangabezana nezi mfuno zonyango ezahlukeneyo, kwaye sikholelwa ukuba i-CABENUVA lukhetho olunentsingiselo kwizigulana kunye nababoneleli esibasebenzelayo."
Le mvume ye-FDA yase-US isekelwe kwi-FLAIR (i-First Long-Acting Injectable Regimen) kwiveki ye-124 iziphumo, ezibonise ukuba kukho iziphumo ezifanayo malunga nokugcinwa kwe-virologic suppression, ukhuseleko, ukunyamezela kunye ne-pharmacokinetics kubantu abaqala i-cabotegravir kunye ne-rilpivirine injection kunye okanye ngaphandle komlomo. ukukhokelela ngaphakathi.
INTO ONOKUYITHATHA KWELI NQAKU:
- It contains ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies of Johnson &.
- as a once-monthly or every-two-month treatment for HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
- the option to start this once-monthly or every-two-month injectable treatment without the need for the oral lead-in phase (daily cabotegravir and rilpivirine tablets, taken for one month prior to initiation of cabotegravir and rilpivirine injections).
