Table 2.
Virologic Outcomes at Week 48
| DOR/3TC/TDF (N = 364) | EFV/FTC/TDF (N = 364) | |||
|---|---|---|---|---|
| Primary Analysis (FDA Snapshot Approach) | n | (%) | n | (%) |
| HIV-1 RNA <50 copies/mL | 307 | (84.3) | 294 | (80.8) |
| HIV-1 RNA ≥50 copies/mLa | 39 | (10.7) | 37 | (10.2) |
| No virologic data in week 48 window | 18 | (4.9) | 33 | (9.1) |
| Discontinued study due to AE or deathb | 9 | (2.5) | 24 | (6.6) |
| Discontinued study for other reasonsc | 9 | (2.5) | 8 | (2.2) |
| On study but missing data in window | 0 | (0.0) | 1 | (0.3) |
| Secondary and exploratory endpoints | n/N | (%) | n/N | (%) |
| HIV-1 RNA <50 copies/mL (observed failure) | 307/346 | (88.7) | 294/331 | (88.8) |
| HIV-1 RNA <40 copies/mL (FDA snapshot) | 305/364 | (83.8) | 290/364 | (79.7) |
| HIV-1 RNA <200 copies/mL (FDA snapshot) | 313/364 | (86.0) | 301/364 | (82.7) |
Abbreviations: AE, adverse event; DOR/3TC/TDF, doravirine at 100 mg, lamivudine at 300 mg, and tenofovir disoproxil fumarate at 300 mg; EFV/FTC/TDF, efavirenz at 600 mg, emtricitabine at 200 mg, and tenofovir disoproxil fumarate at 300 mg; HIV, human immunodeficiency virus; FDA, Food and Drug Administration.
aIncludes participants who changed any component of background therapy before week 48, participants who discontinued study drug before week 48 for lack or loss of efficacy, and participants with HIV-1 RNA of ≥50 copies/mL in the week 48 window (relative day 295–378).
bIncludes participants who discontinued because of adverse event (AE) or death at any time point from day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
cOther reasons include: lost to follow-up, non-compliance with study drug, physician decision, pregnancy, protocol deviation, screen failure, withdrawal by participant.