Shots:

• The approval was based on the 16wk. interim analysis of P-I/II (MOCHA/ IMPAACT 2017) study to evaluate cabotegravir or rilpivirine in 155 patients aged 12 to ≤18yrs. with HIV-1
• The results showed that the efficacy of Cabenuva in adolescents was derived from adults with support from PK analyses showed similar drug exposure & the safety profile was consistent with the safety profile of cabotegravir + rilpivirine in adults, AEs (61%)
• The expanded indication for Cabenuva provides an option with 6 dosing days/yr. for HIV-1 in virologically suppressed patients on a stable antiretroviral regimen with no history of treatment failure & no known or suspected resistance to cabotegravir or rilpivirine

Ref: Businesswire | Image: ViiV