Shots:

• The approval is based on the P-IIIb (ATLAS-2M) trial to evaluate the non-inferior antiviral activity & safety of rilpivirine and cabotegravir given as q2mos. vs q4w (OAM, 2ml dose) in 1045 adults patients with HIV-1 for 48wk.
• The results showed that q2mos. was non-inferior to OAM dosing & was similarly effective (9/522 [1.7%]) vs (5/523 [1.0%]) in patients with plasma HIV-1 RNA ≥ 50 c/ml, rates of virologic suppression were similar for q2mos. (492/522 [94.3%]) & OAM (489/523 [93.5%])
• Cabenuva was approved in the US in Jan 2021 as an OAM for HIV-1 & can be used 6 times a year for virologically suppressed adults without prior treatments or resistance to cabotegravir or rilpivirine

Ref: J&J | Image: J&J