FDA expands label approval of Cabenuva + rilpivirine in HIV.

The FDA approval of long-acting cabotegravir and rilpivirine for use every two months is based on the global ATLAS-2M phase IIIb trial results, which demonstrated that every-two-month dosing was non-inferior to once-monthly dosing. Non-inferiority was determined by comparing the proportion of participants with plasma HIV-1 RNA at least 50 c/ml using the FDA Snapshot algorithm at Week 48 (Intent-to-Treat Exposed population), which showed that the every-two-month arm (9/522 [1.7%]) and once-monthly arm (5/523 [1.0%]) were similarly effective (adjusted difference: 0.8%, 95% confidence interval [CI]: -0.6%, 2.2%).

The study also found that rates of virologic suppression, a key secondary endpoint, were similar for every-two-month dosing (492/522 [94.3%]) and once-monthly dosing (489/523 [93.5%]) (adjusted difference: 0.8%, 95% CI: -2.1%, 3.7%). The most common adverse reactions (Grades 1 to 4) observed in greater than 2% of participants receiving long-acting cabotegravir and rilpivirine were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash. In ATLAS-2M, the type and frequency of adverse reactions reported in participants receiving long-acting cabotegravir and rilpivirine once monthly or every two months for 48 weeks were similar.

In the every-two-month arm, rates of serious adverse events (SAEs: 27/522[5.2%]) and withdrawals due to adverse events (AEs: 12/522 [2.3%]) were low and similar to those experienced in the once-monthly arm (SAEs: 19/523 [3.6%], withdrawals due to AEs 13/523 [2.5%]).