Table 1.
Clinical Efficacy Trials of Long-Acting (LA) Injectable Antiretroviral Therapy (ART) for Treatment and Prevention of HIV
| Study | Trial Design | Study Population | Treatment Arms | Response Rate | Summary |
|---|---|---|---|---|---|
| ATLAS [3, 4] | Phase 3, randomized, multicenter, open-label, noninferiority switch trial | Adults with HIV on ART with suppressed HIV RNA (N = 616) | Continue daily regimen (2 NRTI + [PI, NNRTI or INSTI]) vs CAB 30 mg daily + RPV 25 mg daily × 4 w oral lead-in followed by CAB-LA 600 mg IM × 1 + RPV-LA 900 mg IM × 1 at week 4 followed by CAB-LA 400 mg IM + LA RPV 600 mg IM Q4W beginning at week 8 | HIV-1 RNA level <50 copies/mL: Week 48: 92% in LA arm vs 95% in oral arm Week 96: 100% in LA arm and 97% in switch arm |
CAB/RPV-LA IM Q4W noninferior to standard oral ART |
| FLAIR [5, 6] | Phase 3, randomized, multicenter, open-label, noninferiority trial | ART-naive adults with HIV (N = 629) |
Oral induction (all participants): DTG/ABC/3TC daily × 20 w Maintenance regimen: Continue daily oral regimen vs Oral lead-in CAB 30 mg daily + RPV 25 mg daily × 4 w followed by CAB-LA 600 mg IM × 1 + RPV-LA 900 mg IM × 1 at week 4 followed by CAB-LA 400 mg IM + RPV-LA 600 mg IM Q4W beginning at week 8 |
HIV-1 RNA level <50 copies/mL: Week 48: 94% in LA arm vs 93% in oral arm Week 96: 87% in LA arm vs 89% in oral arm |
CAB/RPV-LA IM Q4W noninferior to standard oral ART |
| ATLAS-2M [7, 8] | Phase 3b, randomized, multicenter, open-label, noninferiority switch trial | Adults with HIV on ART with suppressed HIV RNA (N = 1045) | CAB-LA 400 mg IM + RPV-LA 600 mg IM Q4W vs CAB-LA 600 mg IM + RPV-LA 900 mg IM Q8W | HIV-1 RNA level <50 copies/mL: Week 48: 94% in Q8W arm vs 93% in Q4W arm Week 96: 91% in Q8W arm vs 90% in Q4W arm |
CAB/RPV-LA IM Q8W noninferior to Q4W regimen |
| HPTN 083 [9] | Phase 2b/3, randomized, multicenter, double-blind, double-dummy, noninferiority trial | Cisgender MSM and transgender women who have sex with men at risk for HIV (N = 4570) | Oral TDF/FTC daily vs CAB 30 mg daily × 5 w oral-lead in followed by CAB-LA 600 mg IM Q8W | Incident HIV infections: Week 153: 13 in the CAB-LA arm (0.41 per 100 person-years) vs 39 in TDF/FTC arm (1.22 per 100 person-years) |
CAB-LA IM Q8W superior to daily oral TDF/FTC for HIV prevention among MSM and transgender women |
| HPTN 084 [10] | Phase 3, randomized, multicenter, double-blind, double-dummy, noninferiority trial | Cisgender women aged 18–45 y at risk for HIV (N = 4570) | Oral TDF/FTC daily vs Oral lead-in: CAB 30 mg daily × 5 w oral lead-in followed by CAB-LA 600 mg IM Q8W | Incident HIV infections: Interim planned analysis: 4 in the CAB-LA arm (0.2 per 100 person-years) v 36 in the TDF/FTC arm (1.86 per 100 person-years) |
CAB-LA IM Q8W superior to daily oral TDF/FTC for HIV prevention among cisgender women |
Abbreviations: ART, antiretroviral therapy; CAB-LA, long-acting cabotegravir; HIV, human immunodeficiency virus; IM, intramuscular; Q4W, every 4 weeks; Q8W, every 8 weeks; RPV-LA, long-acting rilpivirine; TDF/FTC, tenofovir disoproxil fumarate–emtricitabine.