Table 1.

Randomized trials of dolutegravir in treatment-naïve HIV-1-positive patients

Trial	Antiretrovirals	Backbone	Outcomesa	Serious adverse events	Protocol-defined virologic failureb	Mutations due to INSTI
SPRING-143	DTG 10 mg (n=53) DTG 25 mg (n=51) DTG 50 mg (n=51) EFV (n=50)	TDF–FTC (67%) ABC–3TC (33%)	DTG 10 mg 91% DTG 25 mg 88% DTG 50 mg 90% EFV 82%	DTG 10 mg 6% DTG 25 mg 2% DTG 50 mg 8% EFV 5%	DTG 10 mg 4% DTG 25 mg 4% DTG 50 mg 0% EFV 2%	DTG 10 mg NRTI: M184V DTG 25 mg, DTG 50 mg, EFV None
SPRING-245	DTG (n=411) RAL (n=411)	TDF–FTC (59%) ABC–3TC (41%)	DTG 88% RAL 85%	DTG 0.7% RAL 1%	DTG 5% RAL 7%	DTG None RAL INSTI: T97A, E138D, V151I NRTI: A62V, K65R, K70E, and M184V NRTI: M184I NRTI: A62V NRTI: M184V
SINGLE26	DTG–ABC–3TC (n=414) EFV–TDF–FTC (n=419)	Not applicable	DTG–ABC–3TC 88% EFV–TDF–FTC 81%	DTG–ABC–3TC <1% EFV–TDF–FTC 2%	DTG–ABC–3TC 4% EFV–TDF–FTC 4%	DTG–ABC–3TC None
FLAMINGO47	DTG (n=242) DRV/R (n=242)	TDF–FTC (67%) ABC–3TC (33%)	DTG 90% DRV/R 83%	DTG 11% DRV/R 5%	DTG 1% DRV/R 1%	No INSTI, PI, NRTI mutations

Notes:

^aPercentage of cohort achieving HIV RNA <50 copies/mL at 48 weeks.

^bVirologic failure defined in SINGLE and SPRING-2 as two HIV RNA levels >50 copies/mL on or after 24 weeks; in FLAMINGO as two HIV RNA levels >200 copies/mL on or after 24 weeks; in SPRING-1 as one HIV RNA level >400 copies/mL on or after 24 weeks or decrease less than 1.0 log₁₀ copies/mL by week 4.

Abbreviations: DTG, dolutegravir; EFV, efavirenz; RAL, raltegravir; TDF, tenofovir; ABC, abacavir; 3TC, lamivudine; FTC, emtricitabine; DRV/R, darunavir/ritonavir; INSTI, integrase strand transfer inhibitor; NRTI, nucleoside and nucleotide reverse-transcriptase inhibitors; PI, protease inhibitor.