The first complete long-acting antiretroviral therapy (ART) regimen, cabotegravir + rilpivirine long-acting injectable, was approved in the US for the treatment of HIV-1 in individuals on a stable antiretroviral regimen with a viral load < 50 copies/mL who had no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine. Real-world evidence is sparse and limited to small study populations or lacking clinical outcomes.

A total of 321 people with HIV initiated cabotegravir + rilpivirine long-acting injections and received ≥ 1 continuation injection between 21 January 2021 and 15 March 2022 during routine clinical care in the US.

A total of 1152 continuation cabotegravir + rilpivirine long-acting injections were administered over 13 months; 90% were administered within 7 days before or after the target date, as per the label. Only a history of AIDS-defining events was associated with an increased risk of delayed injections.

Among 237 individuals with a viral load < 50 copies/mL at initiation and ≥ 1 available follow-up viral load, 95% were undetectable (viral load < 50 copies/mL), 99% were virologically suppressed (viral load < 200 copies/mL) at their last viral load measurement, and 96% had sustained virologic suppression with all measured viral loads < 200 copies/mL.

These results suggest that CAB + RPV LA injectable can be administered effectively during routine clinical care.