Shots:

• The approval is based on 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

Click here to read full press release/ article | Ref: GSK | Image:  Buisnesswire