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Gilead radījis alternatīvu pašā Stribildam (Quad)
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09.11.2014


Farmācijas kompānija Gilead Sciences Inc. iesniegusi ASV Pārtikas un zāļu administrācijai (FDA) pieteikumu reģistrēt perorālo kombinēto antiretrovīrusu preparātu HIV infekcijas ārstēšanai pieaugušajiem pacientiem. Tabletē ietilpst 4 kompānijas Gilead Sciences izstrādātās ārstnieciskās vielas:  150 mg elvitegravīra, 200 mg emtricitabīna, 150 mg kobicistāta (pielietojams līdzīgi ritonavīram) un 10 mg tenofovīra alafenamīda. Tenofovīra alafenamīds (jeb TAF) ir aktivāks savā iedarbībā uz vīrusiem, salīdzinot ar labi zināmu tenofovīra dizoproksīlu (jeb TDF) un pielietojams 10 reizes mazākās devās.
Ne tik sen pardošanas atļauju ASV un Eiropas Savienībā iegūva Gilead praparats Stribild (jeb Quad). Šai tabletē ietilpst 150 mg elvitegravīra, 200 mg emtricitabīna, 150 mg kobicistāta un 245 mg tenofovīra dizoproksila.
Abas šīs tabletes jālieto tikai vienreiz dienā.
Latvijā Stribild pagaidām nav pieejams pacientiem.
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(Avots: http://www.dddmag.com/news/2014/11/gilead-submits-application-new-hiv-pill-fda )  
Gilead Submits Application for New HIV Pill to FDA
Gilead Sciences Inc. announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg (E/C/F/TAF) for the treatment of HIV-1 infection in adults. The data submitted in the NDA support the use of the regimen among adult and adolescent treatment-naïve HIV individuals, virologically suppressed patients who switch regimens and those with renal impairment. If approved, E/C/F/TAF would be Gilead’s first single tablet regimen to contain TAF.
TAF is an investigational, novel prodrug of tenofovir, the active agent in Gilead’s Viread (tenofovir disoproxil fumarate). TAF is a more targeted form of tenofovir than Viread that has demonstrated high antiviral efficacy at a dose that is 10 times lower, as well as an improved renal and bone safety profile.
“This TAF-based regimen has the potential to provide a range of HIV patients with a highly effective and well-tolerated new treatment option with a favorable safety profile,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “Gilead remains focused on advancing next-generation therapies that have the potential to improve HIV treatment over the long-term and TAF will be the cornerstone of future Gilead single tablet regimens.”
The NDA for E/C/F/TAF is supported by 48-week data from two pivotal Phase 3 studies in which the regimen met its primary objective of non-inferiority compared to Gilead’s Stribild among treatment-naïve patients. In the studies, E/C/F/TAF demonstrated improved renal and bone safety compared to Stribild. The NDA is also supported by data from additional Phase 3 studies evaluating the TAF-based regimen among virologically suppressed patients who switched to E/C/F/TAF and among patients with renal impairment. In addition, the filing is supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components and the co-formulated single tablet regimen.
Gilead plans to submit a regulatory application for E/C/F/TAF in the European Union by the end of 2014.
TAF and TAF-based regimens are investigational products and have not been determined safe or efficacious.
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Gilead Submits New Drug Application to U.S. Food and Drug Administration for Tenofovir Alafenamide (TAF)-Based Single Tablet Regimen for HIV – High Rates of Viral Suppression and Improved Renal and Bone Safety Demonstrated in Phase 3 Studies – – First of Several TAF-Based Single Tablet Regimens Being Evaluated by Gilead - (See more at: http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1986740#sthash.SGHazNh9.dpuf )
FOSTER CITY, Calif.--(BUSINESS WIRE)--Nov. 6, 2014-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide (TAF) 10 mg (E/C/F/TAF) for the treatment of HIV-1 infection in adults. The data submitted in the NDA support the use of the regimen among adult and adolescent treatment-naïve HIV individuals, virologically suppressed patients who switch regimens and those with renal impairment. If approved, E/C/F/TAF would be Gilead’s first single tablet regimen to contain TAF.
TAF is an investigational, novel prodrug of tenofovir, the active agent in Gilead’s Viread® (tenofovir disoproxil fumarate). TAF is a more targeted form of tenofovir than Viread that has demonstrated high antiviral efficacy at a dose that is 10 times lower, as well as an improved renal and bone safety profile. 
“This TAF-based regimen has the potential to provide a range of HIV patients with a highly effective and well-tolerated new treatment option with a favorable safety profile,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “Gilead remains focused on advancing next-generation therapies that have the potential to improve HIV treatment over the long-term and TAF will be the cornerstone of future Gilead single tablet regimens.” 
The NDA for E/C/F/TAF is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the regimen met its primary objective of non-inferiority compared to Gilead’s Stribild®(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among treatment-naïve patients. In the studies, E/C/F/TAF demonstrated improved renal and bone safety compared to Stribild. The NDA is also supported by data from additional Phase 3 studies evaluating the TAF-based regimen among virologically suppressed patients who switched to E/C/F/TAF and among patients with renal impairment. In addition, the filing is supported by Chemistry, Manufacturing and Controls (CMC) information on the individual components and the co-formulated single tablet regimen. 
Gilead plans to submit a regulatory application for E/C/F/TAF in the European Union by the end of 2014.
TAF and TAF-based regimens are investigational products and have not been determined safe or efficacious. 

   


 
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