ViiV Healthcare: Cabenuva superior to daily oral therapy in adolescents at AIDS 2026
- LATA Week‑96 in 476 adolescents: CAB+RPV LA every‑8‑weeks had confirmed viral rebound in 0.9% vs 6.4% for daily oral DTG/TDF/3TC.
- OPERA real‑world cohort ~6,800 adults: viral load <50 copies/mL in 89% on CAB+RPV LA vs 83% on BIC/FTC/TAF; confirmed virologic failure 1% vs 2%.
- CLARITY (n=63) single‑dose comparison: 70% rated CAB LA injection experience as very/totally acceptable vs 37% for lenacapavir; fewer, shorter, less bothersome ISRs with CAB.
- EXTEND 4M baseline: 229 participants across 27 US sites; 45% assigned female at birth, 32% Black, 37% Hispanic/Latine, 28% prior oral PrEP; tests every‑4‑month cabotegravir formulation.
Key trial outcomes
Week‑96 results from the LATA trial in 476 virologically suppressed adolescents (12–19 years) across Kenya, South Africa, Uganda and Zimbabwe showed CAB+RPV LA dosed every two months was superior to daily oral DTG/TDF/3TC, with confirmed viral rebound in 0.9% (2/235) versus 6.4% (15/241). Ninety‑four percent reported injections were much easier than daily pills.
New OPERA real‑world data in nearly 6,800 adults found CAB+RPV LA maintained virologic suppression comparable to daily BIC/FTC/TAF: 89% versus 83% with median follow‑up of 15 and 22 months respectively; confirmed virologic failure was low (1% vs 2%).
Injection experience and PrEP preference
CLARITY phase I follow‑up after a single dose found CAB LA produced less visible, shorter‑lasting and less bothersome injection‑site reactions than lenacapavir, with 70% rating CAB LA as very/totally acceptable vs 37% for LEN and fewer persistent nodules (20% vs 90%). CAPTIVATE showed 97% of prior oral PrEP users preferred CAB LA; providers reported positive experiences administering it.
PrEPFACTS real‑world analysis (n=2,913) reported very high adherence to CAB LA for PrEP (median PDC 1.00), 89% covered ≥90% of the period, and most continuation injections given within recommended timeframes.
Pipeline: EXTEND 4M
Baseline data from the phase IIb EXTEND 4M registrational study (n=229 across 27 US sites) show diverse enrolment (45% assigned female at birth; 32% Black; 37% Hispanic/Latine; 28% prior oral PrEP). The study will assess pharmacokinetics, safety and tolerability of an intramuscular cabotegravir formulation dosed every four months to reduce clinic visit frequency; data are expected at a future medical congress.
Source: GSK
