Ua hoʻolaha ka Janssen Pharmaceutical Companies o Johnson & Johnson i kēia lā ua ʻae ka US Food and Drug Administration (FDA) i kahi hōʻailona hōʻailona no CABENUVA (cabotegravir a me rilpivirine), hāʻawi i nā limahana mālama olakino a me nā poʻe e noho ana me ka maʻi immunodeficiency kanaka (HIV-1) ma US ʻO ka koho e hoʻomaka i kēia lāʻau injectable hoʻokahi mahina a i ʻole ʻelua mahina me ka ʻole o ka pono o ke alakaʻi waha (nā papa cabotegravir a me rilpivirine i kēlā me kēia lā, lawe ʻia no hoʻokahi mahina ma mua o ka hoʻomaka ʻana o ka cabotegravir a me rilpivirine injections). Hōʻike ka ʻikepili lapaʻau i ka hōʻike ʻana o ka regimen i kahi ʻano palekana like ʻole a me ka ʻole o ka wā alakaʻi waha. Ua hoʻokumu pū ʻia ʻo CABENUVA ma ke ʻano o ka hui pū ʻana me ViiV Healthcare a kūkulu ʻia ma luna o ko Janssen kūpaʻa lōʻihi i ka hakakā ʻana i ka maʻi HIV.
"Loaʻa iā mākou kahi moʻolelo i hōʻoia ʻia no ka lawe ʻana i nā lāʻau lapaʻau hou i ka poʻe e noho ana me ka maʻi HIV, a ʻo kā mākou kūpaʻa i ka hoʻokomo ʻana i nā holomua ʻepekema hou ʻaʻole i hoʻoluliluli ʻia," wahi a James Merson, Ph.D., Global Therapeutic Area Head, Infectious Diseases, Janssen Research & Hoʻomohala, LLC. "Me kēia hōʻailona hōʻailona i hoʻonui ʻia, hāʻawi ʻo Janssen i kahi ala hou e hoʻomaʻamaʻa i ka ʻāina lapaʻau no ka poʻe e noho ana me ka maʻi HIV ma US i kuhikuhi ʻia i ka CABENUVA therapy."
ʻO CABENUVA ka mua a hoʻokahi wale nō ka hoʻopaʻa ʻana i ka maʻi HIV lōʻihi a ua ʻae ʻia i ka US ma ke ʻano he lapaʻau hoʻokahi mahina a i ʻole ʻelua mahina no ka maʻi HIV-1 i nā poʻe mākua i hoʻopaʻa ʻia me ka virologically (HIV-1 RNA <50 kope/mL) ma kahi hoʻoponopono antiretroviral paʻa me ka mōʻaukala ʻole o ka hāʻule ʻana o ka mālama ʻana a me ka ʻike ʻole ʻia a i ʻole ka manaʻo kūʻē i ka cabotegravir a i ʻole rilpivirine. Loaʻa iā ViiV Healthcare's cabotegravir extended-release injectable suspension i loko o ka pahu hoʻokahi-dose a me ka rilpivirine extended-release injectable suspension i loko o ka pahu hoʻokahi-dose, he huahana o Janssen Sciences Ireland Unlimited Company, kekahi o ka Janssen Pharmaceutical Company o Johnson & Johnson.
"Ma Janssen, haʻaheo mākou e hoʻomau i ka holomua ʻana i nā koho e kākoʻo ana i nā mea maʻi a kōkua i nā mea mālama olakino i ka ʻimi ʻana i nā hoʻolālā lapaʻau pilikino e hoʻoponopono i nā pono pilikino a me nā kūlana no ka poʻe e noho ana me ka maʻi HIV," wahi a Candice Long, Pelekikena, Infectious Diseases & Vaccines, Janssen Therapeutics , He Mahele o Janssen Products, LP. "He mea koʻikoʻi ka hāʻawi ʻana i kahi kōpili o nā lāʻau lapaʻau HIV e kōkua i ka hoʻokō ʻana i kēia mau pono lapaʻau like ʻole, a ke manaʻoʻiʻo nei mākou he koho kūpono ʻo CABENUVA no nā maʻi a me nā mea lawelawe a mākou e lawelawe nei."
Hoʻokumu ʻia kēia ʻae ʻana o US FDA ma ka hopena FLAIR (First Long-Acting Injectable Regimen) Week 124, i hōʻike ʻia aia nā hopena like e pili ana i ka mālama ʻana i ka virologic suppression, palekana, tolerability a me pharmacokinetics i ka poʻe e hoʻomaka ana i ka cabotegravir a me ka rilpivirine injection me ka waha a i ʻole. alakai-i.
He aha e lawe ʻia mai kēia ʻatikala:
- 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).
