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. Author manuscript; available in PMC: 2022 Apr 3.
Published in final edited form as: Lancet. 2021 Apr 3;397(10281):1276–1292. doi: 10.1016/S0140-6736(21)00314-7

Table 2.

HIV-1 RNA suppression to <200 copies/mL at delivery visit in women in the DTG groups vs. the EFV group, among all women and by entry HIV-1 RNA result

DTG groups n/N
(%)		 EFV group
n/N (%)		 Difference in
proportions		 P-value
All women
 Intention-to treat, <200 cp/mL 395/405 (97·5%) 182/200 (91·0%) 6·5% (2·0%, 10·7%) 0·005*
 Per-protocol, <200 cp/mL 389/399 (97·5%) 171/187 (91·4%) 6·0% (1·6%, 10·3%) 0·008*
 FDA snapshot, <200 cp/mL 389/432 (90·0%) 171/211 (81·0%) 9·0% (3·0%, 15·0%) 0·003
 Intention-to-treat, <50 cp/mL 387/407 (95·1%) 160/201 (79·6%) 15·5% (9·5%, 21·4%) <0·001
 Per-protocol, <50 cp/mL 381/401 (95·0%) 151/188 (80·3%) 14·7% (8·6%, 20·8%) <0·001
Stratified by entry HIV-1 RNA (to <200 cp/mL, intention-to-treat)
 Women with entry HIV-1 RNA ≥200 copies/mL 275/285 (96·5%) 130/148 (87·8%) 8·7% (3·0%, 14·3%) 0·003
 Women with entry HIV-1 RNA <200 copies/mL 119/119 (100·0%) 50/50 (100·0%)
*

P-value has been corrected for interim analyses.

Intention-to-treat (ITT) comparisons were based on the randomized group. Per-protocol analyses excluded viral loads from participants who switched, added, stopped, or did not start any of the ARVs in the randomized regimen before the delivery viral load was sampled.