Long-Acting Cabotegravir plus Rilpivirine: A Viable Option for Management of HIV Infection?

摘要

Encouraging safety and virologic efficacy results support administration every 8 weeks of intramuscular coformulated cabotegravir plus rilpivirine. The efficacy of monthly injectable long-acting cabotegravir plus rilpivirine (LA CAB+RPV) for HIV infection was recently demonstrated in the ATLAS (N Engl J Med 2020; 382:1112) and FLAIR (N Engl J Med 2020; 382:1124) studies. Based on LATTE-2 study data (Lancet 2017 Jul 24; [e-pub]), investigators conducted an industry-funded study of LA CAB+RPV every 4 weeks versus every 8 weeks for maintaining viral suppression in persons with HIV (PWH). Participants comprised PWH who had achieved viral suppression on an oral standard-of-care antiretroviral therapy (ART) regimen or who were continuing enrollees in the ATLAS study (one third had completed 52 weeks); all were receiving therapy and virally suppressed for ≥6 months with no history of virologic failure and no known integrase strand transfer inhibitor or nonnucleoside reverse transcriptase inhibitor mutations (except K103N). They were assigned 1:1 to receive intramuscular injections of LA CAB+RPV every 8 weeks (CAB [600 mg] plus RPV [900 mg]) or every 4 weeks (CAB [400 mg] plus RPV [600 mg]). The primary efficacy end-point was the proportion of participants with HIV-1 viral load (VL) ≥50 copies/ml at week 48. Of 1149 participants screened, 1045 were randomized (522 [8-week group], 523 [4-week group]; median age, 42; 27% female at birth; 73% white; 20% BMI ≥30 kg/m~2). Participants who had not previously received CAB+RPV took oral lead-in CAB (30 mg) plus RPV (25 mg) for 4 weeks before intramuscular injections.