Head-to-head evidence
Bictegravir vs Raltegravir
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)
Raltegravir · Isentress
Marketed by Merck & Co.
NCT00293254 · Phase 3 · completed
This was a randomized, double-blind, placebo-controlled trial with 351 patients, using HIV-1 RNA suppression - a regulator-accepted, disease-defining measure - as the primary endpoint. The raltegravir arm showed clearly higher suppression rates than placebo at both Week 16 and Week 48, with confidence intervals that do not overlap, indicating a statistically robust and clinically meaningful benefit.
Next expected readout: January 2028 · NCT02140255 (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 · Raltegravir's landscape