Table 3.
Clinical efficacy trials of cabotegravir for the prevention of HIV
| Study (phase) | Trial design | Participant characteristics | Regimens (n for primary endpoint) | Primary endpointaHR (95% CI) | Summary |
| HPTN 083 | Phase 2b/3, randomized, double-blind, double-dummy, multicenter, noninferiority trial | Cisgender MSM and transgender women who have sex with men who were at risk for HIV | Oral TDF–FTC daily (n = 2284)versusOral lead-in: CAB 30 mg daily × 5 weeks followed by LA CAB 600 mg IM Q8W (n = 2282) | Week 153 : 2b[37▪▪]0.34 (018, 0.62)52 Participants acquired HIV: 13 in LA CAB arm (incidence 0.41 per 100 person-years) and 39 in TDF–FTC arm (incidence 1.22 per 100 person-years) | LA CAB was superior to daily oral TDF–FTC in preventing HIV infection among MSM and transgender women |
| HTPN 084 | Phase 3, randomized, double-blind, double-dummy, multicenter, noninferiority trial | Cisgender women between 18 and 45 years at 20 sites in 7 African countries who were at risk for HIV | Oral TDF–FTC daily (n = 1610)versusOral lead-in: CAB 30 mg daily × 5 weeks followed by LA CAB 600 mg IM Q8W (n = 1614) | Interim planned analysis:b[38▪▪]0.11 (0.01, 0.31)40 Participants acquired HIV: 4 in the LA CAB arm (incidence 0.2 per 100 person-years) and 36 in the TDF–FTC arm (incidence 1.86 per 100 person-years) | LA CAB was superior to daily oral TDF–FTC in preventing HIV infection among cisgender women |
CI, confidence interval; HR, hazard ratio; IM, intramuscular; LA CAB, long-acting cabotegravir; Q8W, every 8 weeks; TDF–FTC, tenofovir disoproxil fumarate–emtricitabine.
a
Endpoint was incident HIV infection reported as a HR (95% CI) for LA CAB vs oral TDF-FTC.
b
Trial was stopped early for efficacy on review of results of the first preplanned interim end-point analysis.