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. 2023 Jan 16;76(10):1832–1840. doi: 10.1093/cid/ciad023

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.