Head-to-head evidence
Bictegravir vs Cabotegravir
Same mechanism, same race: design-graded trial evidence for both assets, with the grading rationale shown. Grades describe the quality of the evidence, never the merits of either security.
HIV
Shared mechanism: HIV integrase · full HIV pipeline
Bictegravir · Biktarvy
Marketed by Gilead Sciences
NCT02607956 · Phase 3 · completed
This was a randomized, double-blind, active-controlled Phase 3 trial in 657 treatment-naive HIV-1 adults, powered for non-inferiority with a 12% margin. The primary endpoint was the FDA snapshot proportion with HIV-1 RNA <50 copies/mL at Week 48, a clinical virologic endpoint. The pre-specified non-inferiority comparison was met: B/F/TAF 89.4% vs DTG+F/TAF 92.9%, difference -3.5 (95.002% CI -7.9 to 1.0), with the confidence interval entirely within the 12% margin; the superiority test was not significant.
Next expected readout: December 2026 · NCT06830668 (registry estimate)
Cabotegravir · Vocabria / Cabenuva / Apretude
Marketed by ViiV Healthcare
NCT02720094 · Phase 2/3 · completed
The trial randomized 4,570 participants to cabotegravir or active-controlled TDF/FTC treatment and used quadruple blinding of participants, clinicians, investigators, and outcome assessors. Its hard clinical primary efficacy endpoint—documented incident HIV infection—was met, with 13 versus 39 infections and a hazard ratio of 0.340 (95% CI 0.18–0.62; p=0.0005).
Next expected readout: October 2026 · NCT05660980 (registry estimate)
The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: Bictegravir's landscape · Cabotegravir's landscape