Head-to-head evidence
Bictegravir vs Dolutegravir
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)
Dolutegravir · Tivicay / Triumeq / Dovato / Juluca (component)
Marketed by ViiV Healthcare
NCT01263015 · Phase 3 · completed
This was a randomized, quadruple-blind, active-controlled phase 3 trial in 833 participants comparing dolutegravir plus abacavir/lamivudine to Atripla. The primary endpoint of virologic suppression (<50 copies/mL) at week 48 was a hard clinical measure, and the comparison was statistically significant in favor of dolutegravir (88% vs 81%, p=0.003), with the confidence interval excluding zero. The trial was adequately powered and the primary outcome was met, supporting a strong evidence grade.
Next expected readout: November 2026 · NCT04892654 (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 · Dolutegravir's landscape