Table 1. Main characteristic of included studies.
| Study name | Methods | Interventions | Outcomes data extracted | Notes |
|---|---|---|---|---|
| ARIA [12] | Multicenter, RCT, open-label, non-inferiority phase 3b study | DTG+ ABC and 3TC OD or ATV/r + coformulated TDF and FTC, OD | HIV-1 RNA <50 cps/mL at week 48. Adverse events, adverse events requiring discontinuation, overall rate of discontinuation. Virologic failure. Death | ITT analysis according to the FDA snapshot algorithm. |
| FLAMINGO [13. 19] | Multicenter, RCT, open-label, non-inferiority phase 3b study | DTG or DRV/r, with TDF/FTC or ABC/3TC, OD. | HIV-1 RNA <50 cps/mL at week 48 and 96. Adverse events, adverse events requiring discontinuation, overall rate of discontinuation. Virologic failure. Death | ITT analysis according to the FDA snapshot algorithm Data at 96 wks reported in a separate report19 |
| GS 1489 [14, 24] | double-blind, multicenter, RCT non-inferiority trial | BIC + FTC and TAF, or coformulated DTG/ABC/3TC with matching placebo, OD for 144 weeks. | HIV-1 RNA <50 cps/mL at week 48 and 96. Adverse events, adverse events requiring discontinuation, overall rate of discontinuation. Virologic failure. Death | ITT analysis according to the FDA snapshot algorithm |
| GS 1490 [15, 23] | double-blind, multicenter, RCT non-inferiority trial | BIC + FTC and TAF, or DTG+ FTC and TAF, with matching placebo, OD for 144 weeks. | HIV-1 RNA <50 cps/mL at week 48 and 96. Adverse events, adverse events requiring discontinuation, overall rate of discontinuation. Virologic failure. Death | ITT analysis according to the FDA snapshot algorithm |
| SINGLE [16, 22] | Double-blind, RCT, phase 3 trial | DTG + ABC and 3TC or combination therapy with EFV/TDF/FTC | HIV-1 RNA <50 cps/mL at wks 48 and 96/144. Adverse events, adverse events requiring discontinuation, overall rate of discontinuation. Virologic failure. Death | ITT analysis according to the FDA snapshot algorithm. Data at 96 and 144 wks reported in a separate report22 |
| SPRING-1 [17, 20] | RCT, dose ranging, phase 2 study | DTG 10, 25 or 50 mg or 600 mg efavirenz, with either TDF/FTC or ABC/3TC | HIV RNA <50 cps at wks 48 and 96. Adverse events, adverse events requiring discontinuation, overall rate of discontinuation. Virologic failure | ITT analysis using the FDA TLOVR approach. Dose but not drug allocation was masked. Data at 96 wks reported in a separate report.20 |
| SPRING-2 [18, 2] | Double-blind, RCT, phase 3 study | DTG or RTG 400 bid + coformulated TDF/FTC or ABC/3TC | HIV RNA <50 cps at wks 48 and 96. Adverse events, adverse events requiring discontinuation, overall rate of discontinuation. Virologic failure. Death | ITT analysis according to the FDA snapshot algorithm Data at 96 wks reported in a separate report.21 |