Table 2.
Virologic Outcomes at Week 96
| Outcome | Participants, No. (%) | |
|---|---|---|
| DOR/3TC/TDF (n = 364) | EFV/FTC/TDF (n = 364) | |
| Primary analysis (FDA snapshot approach) | ||
| HIV-1 RNA <50 copies/mL | 282 (77.5) | 268 (73.6) |
| HIV-1 RNA ≥50 copies/mLa | 55 (15.1) | 44 (12.1) |
| No virologic data in wk 96 window | 27 (7.4) | 52 (14.3) |
| Discontinued study due to AE or deathb | 12 (3.3) | 30 (8.2) |
| Discontinued study for other reasonsc | 13 (3.6) | 20 (5.5) |
| On study but missing data in window | 2 (0.5) | 2 (0.5) |
| Secondary and exploratory end points | ||
| HIV-1 RNA <50 copies/mL (observed failure) | 282/337 (83.7) | 268/312 (85.9) |
| HIV-1 RNA <40 copies/mL (FDA snapshot) | 277/364 (76.1) | 265/364 (72.8) |
| HIV-1 RNA <200 copies/mL (FDA snapshot) | 292/364 (80.2) | 272/364 (74.7) |
Abbreviations: 3TC, lamivudine; AE, adverse event; DOR, doravirine; EFV, efavirenz; FDA, Food and Drug Administration; FTC, emtricitabine; HIV-1, human immunodeficiency virus type 1; TDF, tenofovir disoproxil fumarate.
aIncluding participants who changed any component of background therapy before week 96, participants who discontinued a study drug before week 96 for lack or loss of efficacy, and participants with HIV-1 RNA levels ≥50 copies/mL in the week 96 window.
bIncluding participants who discontinued because of AEs 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.
cThe other reasons included lost to follow-up, noncompliance with study drug, physician decision, pregnancy, protocol deviation, screen failure, and withdrawal by participant.