Table 2.
Summary of Plasma Human Immunodeficiency Virus Type 1 RNA Outcomes
| Variable | HIV-1 RNA <50 copies/mL, no./No. (% [95% CI]) | HIV-1 RNA <400 copies/mL, no./No. (% [95% CI]) | ||
|---|---|---|---|---|
| TLD + DTG (n = 65) | TLD + Placebo (n = 65) | TLD + DTG (n = 65) | TLD + Placebo (n = 65) | |
| Week 24 | ||||
| mITT analysisa | 55/64 (86 [75–93]) | 53/65 (82 [70–90]) | 63/64 (98 [92–100]) | 59/65 (91 [81–97]) |
| Sensitivity analysisb | 55/64 (86 [75–93]) | 53/61 (87 [76–94]) | 63/64 (98 [92–100]) | 59/61 (97 [89–100]) |
| Week 12 | ||||
| mITT analysisa | 53/64 (83 [71–91]) | 55/65 (85 [74–92]) | 61/64 (95 [87–99]) | 59/65 (91 [81–97]) |
| Sensitivity analysisb | 53/61 (87 [76–94]) | 55/61 (90 [80–96]) | 61/61 (100 [94–100])c | 59/61 (97 [89–100]) |
Abbreviations: CI, confidence interval; DTG, dolutegravir; HIV-1, human immunodeficiency virus type 1; mITT, modified intention-to-treat; TLD, tenofovir-lamivudine-dolutegravir.
mITT analysis excludes those switching study drug for reasons of stopping contraception or desire to become pregnant, becoming pregnant, transfer out for nonclinical reasons, and death from non-HIV and nondrug causes.
Sensitivity analysis excludes those excluded from mITT analysis, as well as loss to follow-up, missing viral load within the window, switching study drug for reasons other than treatment failure, and evidence of poor adherence (tenofovir diphosphate <350 fmol/punch).
One-sided 97.5% CI when 0 or 100% were successful.