Impact of treatment adherence on efficacy of dolutegravir plus lamivudine and dolutegravir plus tenofovir disoproxil fumarate/emtricitabine: pooled analysis of the GEMINI-1 and GEMINI-2 clinical studies

Figures & data

Table 1. Baseline characteristics by adherence category in GEMINI-1 and GEMINI-2 (ITT-E population).

Characteristic	Dolutegravir + lamivudine (N = 716)	Dolutegravir + tenofovir disoproxil fumarate/ emtricitabine (N = 717)
Adherence category, n (%)^a
<90%	35 (5)	34 (5)
≥90%	679 (95)	677 (94)
Baseline HIV-1 RNA by adherence category, median (range), log10 copies/mL
<90%	4.39 (2.82–5.75)	4.35 (3.07–5.88)
≥90%	4.43 (1.59–6.27)	4.48 (2.11–6.37)
Baseline CD4+ cell count by adherence category, median (range), cells/mm^3
<90%	407.0 (41–1399)	415.0 (19–929)
≥90%	427.0 (19–1364)	440.0 (19–1497)

2DR, 2-drug regimen; 3DR, 3-drug regimen; ITT-E, intention-to-treat − exposed.

a Adherence categories only include participants with derived study drug adherence data (data unavailable for 2 and 6 participants in the 2DR and 3DR treatment groups, respectively).

Figure 1. (A) Proportion of participants with HIV-1 RNA <50 copies/mL at Week 48 using the FDA Snapshot algorithm and last on-treatment viral load by adherence category, (B) unadjusted treatment differences (95% CI) between groups, and (C) Snapshot outcomes by adherence category. AE, adverse event; ART, antiretroviral therapy; 2DR, dolutegravir + lamivudine; 3DR, dolutegravir + tenofovir disoproxil fumarate/emtricitabine; FDA, US Food and Drug Administration.

Data availability statement

Anonymized individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com.