Date: 11-Mar-2020

GSK's ViiV touts 2-month HIV data as sister injection Cabenuva awaits FDA redemption

After the FDA rejected its once-monthly HIV injection Cabenuva in December, GlaxoSmithKline’s keeping the talk going about its long-acting options. Now, it has rolled out detailed data showing a bimonthly sister version works as well. A combo injection of GSK subsidiary ViiV Healthcare’s cabotegravir and Johnson & Johnson’s rilpivirine—sold in pill form as Edurant—given every two months was “similarly effective” at suppressing existing HIV patients’ viral load as its once-monthly regimen Cabenuva in a phase 3 study, ViiV said Monday. Nine of the 522 patients (1.7%) on the two-month arm and five of 523 (1.0%) who got the one-month injection had plasma HIV at or above 50 copies per milliliter at week 48, according to data revealed at the Conference on Retroviruses and Opportunistic Infections. With an adjusted difference of 0.8% between the two groups, the outcome is “well within the 4% noninferiority margin,” Kimberly Smith, ViiV’s head of R&D, explained to FiercePharma in an interview.