Ua hoʻokumu pū ʻia ke ʻano moʻolelo ma ke ʻano he ʻāpana o ka hui pū ʻana me ViiV Healthcare a kūkulu ʻia ma luna o ko Janssen mau makahiki 25 e hana i ka mōʻaukala HIV. ʻO ViiV Healthcare ka mea nona ka mana kūʻai aku no CABENUVA ma US
Ua ʻae ʻia ʻo CABENUVA e ka US FDA i Ianuali 2021 ma ke ʻano he hoʻokahi mahina, hoʻopau piha no ka mālama ʻana i ka maʻi HIV-1 i nā pākeke e hoʻololi i ka regimen antiretroviral i kēia manawa i ka poʻe i hoʻopaʻa ʻia (HIV-1 RNA ma lalo o 50 kope no kēlā me kēia. ml).1 ʻO CABENUVA he ʻelua mau lāʻau injectable ʻokoʻa, ʻo rilpivirine extended-release injectable suspension i loko o kahi hue hoʻokahi, he huahana o Janssen Science Ireland Unlimited Company, a me ViiV Healthcare's cabotegravir extended-release injectable suspension i hoʻokahi hue wai. Ma mua o ka hoʻomaka ʻana i ka mālama ʻana iā CABENUVA, pono e lawelawe ʻia ka dosing waha o ka rilpivirine a me ka cabotegravir no kahi o hoʻokahi mahina e loiloi i ka ʻae ʻana o kēlā me kēia lapaʻau. ʻAe ka US FDA Approval e hoʻopaʻa ʻia ʻo CABENUVA i kēlā me kēia mahina a i ʻole ʻelua mahina.
"ʻO ka ʻae ʻia ʻana o ka lepili i hoʻonui ʻia no CABENUVA - e lawelawe ʻia i kēlā me kēia mahina ʻelua - hōʻailona i kahi hana koʻikoʻi i mua i ka holomua ʻana i ka ʻāina lapaʻau no ka poʻe e noho ana me ka maʻi HIV," wahi a Candice Long, Pelekikena, Infectious Diseases & Vaccines, Janssen Therapeutics, kahi mahele o Janssen. Nā huahana, LP. "Me kēia milestone, loaʻa i nā pākeke e noho ana me ka maʻi HIV kahi koho lapaʻau e hōʻemi hou i ka pinepine o ka lāʻau."
Kaomi no ka Tweet: #BREAKING: Ua ʻae ka @US_FDA i kahi koho dosing hou no ka poʻe e noho ana me #HIV. E aʻo hou aʻe e pili ana i kēia hanana hoihoi i ka ʻāina lapaʻau HIV: http://bit.ly/38rPgFi
"ʻO kahi pahuhopu koʻikoʻi no mākou i ka maʻi HIV e hoʻohaʻahaʻa i ka pono o ka lāʻau lapaʻau i kēlā me kēia lā, hiki ke lilo i mea hoʻomanaʻo mau no ka poʻe e noho nei me ke ʻano," wahi a James Merson, Ph.D., Global Therapeutic Area Head, Infectious Diseases, Janssen Research & Hoʻomohala, LLC. "Me kēia koho lapaʻau hou e hōʻemi ana i ka pinepine dosing CABENUVA i ʻeono manawa i kēlā me kēia makahiki, ke hoʻololi nei mākou i ka maʻi HIV no ka poʻe e noho ana me ka maʻi HIV ma US"
ʻO ka ʻae ʻana o ka US FDA i ka rilpivirine lōʻihi a me ka cabotegravir no ka hoʻohana ʻana i kēlā me kēia mahina ʻelua e pili ana i nā hopena hoʻāʻo ATLAS-2M phase 3b honua, kahi i hōʻike ʻia ʻaʻole i emi iho ka dosing ʻelua mahina ma mua o ka dosing hoʻokahi mahina. Ua hoʻoholo ʻia ka haʻahaʻa haʻahaʻa ma ka hoʻohālikelike ʻana i ka hapa o ka poʻe i komo me ka plasma HIV-2 RNA ≥ 1 c/ml me ka hoʻohana ʻana i ka US FDA Snapshot algorithm i ka Week 50 (Intent-to-Treat Exposed population), i hōʻike ʻia i kēlā me kēia-ʻelua mahina lima. (48/9 [522%]) a me ka lima hoʻokahi mahina (1.7/5 [523%)) i like like (ka ʻokoʻa i hoʻoponopono ʻia: 1.0%, 0.8% ka manawa hilinaʻi [CI]: -95%, 0.6%). Ua ʻike pū ʻia ka haʻawina ʻo ka nui o ka hoʻopau ʻana i ka virologic, kahi hopena koʻikoʻi koʻikoʻi, ua like ia no kēlā me kēia-ʻelua mahina dosing (2.2/492 [522%]) a me hoʻokahi mahina dosing (94.3/489 [523%]) (hoʻololi ʻokoʻa. : 93.5%, 0.8% CI: -95%, 2.1%). ʻO nā hopena ʻino maʻamau (Papa 3.7 a hiki i ka 1) i ʻike ʻia ma ≥4% o nā poʻe i loaʻa i ka rilpivirine lōʻihi a me ka cabotegravir ʻo ia ka hopena o ka wahi injection, pyrexia, luhi, ʻeha ʻeha, ʻeha musculoskeletal, nausea, nā maʻi hiamoe, dizziness, a me ka ʻeha. I loko o ATLAS-2M, ua like ke ʻano a me ka pinepine o nā hopena ʻino i nā poʻe e loaʻa ana i ka rilpivirine lōʻihi a me ka cabotegravir i hoʻokahi mahina a i ʻole ʻelua mahina no 2 mau pule. Ma ka lima o kēlā me kēia mahina ʻelua, haʻahaʻa ka nui o nā hanana ʻino koʻikoʻi (SAEs: 48/27 [522%) a me ka hoʻihoʻi ʻana ma muli o nā hanana ʻino (AEs: 5.2/12 [522%]) a like me nā mea i ʻike ʻia ma ka lima hoʻokahi mahina (SAE: 2.3/19 [523%], hoʻihoʻi ʻia ma muli o AEs 3.6/13 [523%).2.5
"Makemake kēlā me kēia kauka e hiki ke hāʻawi i ka mea maʻi i kahi lapaʻau kūpono no lākou, a he nui nā kumu i komo i kēlā hoʻoholo," wahi a Tony Mills, MD *, Luna Nui o Men's Health Foundation ma Los Angeles, CA. "Me kēia ʻae ʻia, aia kahi koho hoʻohui koʻikoʻi no nā kauka e hoʻoponopono i nā makemake o ka mea maʻi no ka liʻiliʻi pinepine ʻana."
Ua ʻae ʻia hoʻi e ka European Commission, Health Canada, Australia Therapeutic Goods Administration, a me ka Swiss Agency for Therapeutic Products ka mana hoʻokahi mahina o ka rilpivirine a me ka cabotegravir injectable treatment. Ua ʻae ʻia ka mana o kēlā me kēia mahina ʻelua e ka European Commission, Health Canada, a me ka Swiss Agency for Therapeutic Products. Ke hoʻomau nei nā loiloi hoʻoponopono me nā hoʻouna hou i hoʻolālā ʻia i ka makahiki 2022.
He aha e lawe ʻia mai kēia ʻatikala:
- “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,”.
