US FDA e Amohela Hona Joale Kalafo ea Pele le ea Nako e Telele ea HIV

Lenaneo le letjha le ile la ntlafatswa ka kopanelo e le karolo ya tshebedisano-mmoho le ViiV Healthcare mme le thea hodima boitlamo ba Janssen ba dilemo tse 25 ba ho etsa nalane ya HIV. ViiV Healthcare ke mofani oa tumello ea ho bapatsa bakeng sa CABENUVA naheng ea Amerika               

CABENUVA e amohetsoe ke US FDA ka Pherekhong 2021 joalo ka mokhoa o felletseng oa khoeli le khoeli bakeng sa kalafo ea tšoaetso ea HIV-1 ho batho ba baholo ho nkela sebaka sa hajoale sa antiretroviral ho ba hatelletsoeng ke vaerase (HIV-1 RNA e ka tlase ho likopi tse 50 ml).1 CABENUVA e na le meriana e mmedi e arohaneng e nang le ente, rilpivirine e fanyehwang nako e telele ka hara vial ya lethal dose e le nngwe, e leng sehlahiswa sa Janssen Sciences Ireland Unlimited Company, le ViiV Healthcare's cabotegravir e ntshitsweng ka nako e telele e nang le ente ka vial ya lethal dose e le nngwe. Pele o qala kalafo ea CABENUVA, tekanyetso ea molomo ea rilpivirine le cabotegravir e lokela ho tsamaisoa nako e ka etsang khoeli e le 'ngoe ho lekola mamello ea kalafo ka 'ngoe. Tumello ea US FDA e lumella CABENUVA ho nooa khoeli le khoeli kapa likhoeli tse ling le tse ling tse peli.

"Kamohelo e atolositsoeng ea label bakeng sa CABENUVA-e lokelang ho tsamaisoa likhoeling tse ling le tse ling tse peli-e tšoaea mohato oa bohlokoa ho nts'etsapele boemo ba kalafo bakeng sa batho ba phelang le HIV," ho boletse Candice Long, Mopresidente, Mafu a tšoaetsanoang le Liente, Janssen Therapeutics, Karolo ea Janssen. Lihlahisoa, LP. "Ka ketsahalo ena ea bohlokoahali, batho ba baholo ba phelang le HIV ba na le khetho ea kalafo e fokotsang khafetsa ea litlhare."

Click to Tweet: #BREAKING: @US_FDA e tjhaelletse monwana kgetho e ntjha bakeng sa batho ba phelang le #HIV. Ithute haholoanyane ka ketsahalo ena e monate ea kalafo ea HIV: http://bit.ly/38rPgFi

"Sepheo sa bohlokoa ho rona HIV ke ho fokotsa tlhokahalo ea meriana ea letsatsi le letsatsi, e ka sebetsang e le khopotso ea kamehla ho batho ba phelang le boemo bona," ho boletse James Merson, Ph.D., Global Therapeutic Area Head, Infectious Diseases, Janssen Research. & Development, LLC. "Ka khetho ena e ncha ea kalafo e fokotsang khafetsa ea litekanyetso tsa CABENUVA ho makhetlo a ts'eletseng feela ka selemo, re fetola kalafo ea HIV ho batho ba phelang le HIV US"

Tumello ea US FDA ea rilpivirine le cabotegravir tse sebetsang nako e telele hore li sebelisoe likhoeling tse ling le tse ling tse peli li ipapisitse le liphetho tsa liteko tsa lefats'e tsa ATLAS-2M phase 3b, tse bonts'itseng hore dosing ea likhoeli tse ling le tse ling tse peli e ne e se tlase ho feta hanngoe ka khoeli.2 Non -inferiority e ile ea khethoa ka ho bapisa karolo ea barupeluoa ba nang le plasma HIV-1 RNA ≥ 50 c/ml ba sebelisa US FDA Snapshot algorithm ka Beke ea 48 (Baahi ba Boikemisetso ba ho Tšoara ba pepesehetseng), e bontšitseng hore letsoho le leng le le leng la likhoeli tse peli. (9/522 [1.7%]) le letsoho la khoeli le khoeli (5/523 [1.0%]) ka tsela e tšoanang (phapang e fetotsoeng: 0.8%, 95% nako ea tšepo [CI]: -0.6%, 2.2%). Phuputso e boetse e fumane hore litekanyetso tsa khatello ea virologic, ntlha ea bohlokoa ea bobeli, e ne e tšoana le ea khoeli e 'ngoe le e' ngoe ea likhoeli tse peli (492 / 522 [94.3%]) le dosing hang ka khoeli (489 / 523 [93.5%]) (phapang e fetotsoeng : 0.8%, 95% CI: -2.1%, 3.7%). Litlamorao tse mpe tse atileng haholo (Lithuto tsa 1 ho isa ho 4) tse hlokometsoeng ho ≥2% ea barupeluoa ba fumanang rilpivirine le cabotegravir ea nako e telele e ne e le karabelo ea sebaka sa ente, pyrexia, mokhathala, hlooho, bohloko ba mesifa, ho nyekeloa ke pelo, mathata a ho robala, ho tsekela le lekhopho. Ho ATLAS-2M, mofuta le makhetlo a litlamorao tse mpe tse tlalehiloeng ho barupeluoa ba fumanang rilpivirine le cabotegravir ea nako e telele hang ka khoeli kapa likhoeli tse ling le tse ling tse peli bakeng sa libeke tse 48 li ne li tšoana. Ka letsoho la khoeli e 'ngoe le e' ngoe ea likhoeli tse peli, litekanyetso tsa liketsahalo tse mpe tse tebileng (SAEs: 27 / 522 [5.2%]) le ho tlosoa ka lebaka la liketsahalo tse mpe (AEs: 12 / 522 [2.3%]) li ne li le tlaase 'me li tšoana le tse nang le phihlelo letsoho la hang ka khoeli (SAEs: 19/523 [3.6%], ho tlosoa ka lebaka la AEs 13/523 [2.5%]).2

"Ngaka e 'ngoe le e' ngoe e batla ho khona ho fa mokuli phekolo e nepahetseng bakeng sa bona, 'me ho na le lintlha tse' maloa tse kenang qeto eo," ho boletse Tony Mills, MD *, CEO oa Men's Health Foundation, Los Angeles. CA. "Ka tumello ena, ho na le khetho e 'ngoe ea bohlokoa bakeng sa lingaka ho sebetsana le likhetho tsa mokuli bakeng sa ho noa khafetsa khafetsa."

Mofuta o mong oa khoeli le khoeli oa phekolo ea ente ea rilpivirine le cabotegravir e boetse e amohetsoe ke European Commission, Health Canada, Australia Therapeutic Goods Administration, le Swiss Agency for Therapeutic Products. Phetolelo ea likhoeli tse ling le tse ling tse peli e boetse e amohetsoe ke Khomishene ea Europe, Health Canada, le Swiss Agency for Therapeutic Products. Litlhahlobo tsa taolo li ntse li tsoela pele ka litlatsetso tse ling tse reriloeng ho pholletsa le 2022.