Rukobia Fostemsavir from ViiV Healthcare gots the USFDA approval for HIV in Patients with Limited Treatment Options
Rukobia (Fostemsavir) from ViiV Healthcare gots the USFDA approval for HIV in Patients with Limited Treatment Options
Rukobia (Fostemsavir) got the approval based on the P-III BRIGHTE study assessing Rukobia (600mg, ER) + OBT in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort
In the randomized cohort, 60% adults achieved undetectable HIV viral load and clinically meaningful improvements to CD4 + T-cell count @ 96wks., HIV-1 RNA <40 copies / mL @ 24 & 96wks. (53% & 60%); changes in CD4 + cell count (90 & 205 cells / mm3) respectively
In the nonrandomized cohort, 37% achieved HIV-1 RNA <40 copies / mL @ 24 & 96wks .; HIV-1 RNA <200 copies / mL (42% & 39%); mean changes in CD4 + cell count (41 & 119 cells / mm3) respectively. Fostemsavir is a first-in-class HIV-1 attachment inhibitor, currently under EMA's review with additional submissions to regulatory authorities anticipated in 2020 & 2021
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