Real-World Experience with Dolutegravir-Based Two-Drug Regimens

Table 1

Patient demographics and clinical characteristics.

	Study population, N = 278	Nonsuppressed (≥50 copies/mL), N = 148	Suppressed (<50 copies/mL), N = 116
Age (years), mean (SD)	56 (11.8)	55 (13.2)	57 (9.5)
Male, n (%)	194 (69.8)	82 (55.4)	102 (87.9)
Race, n (%)
Black	137 (49.3)	101 (68.2)	31 (26.7)
White/Caucasian	132 (47.5)	45 (30.4)	78 (67.2)
Other	7 (2.5)	2 (1.4)	5 (4.3)
Data not available	2 (0.7)	0 (0)	2 (1.7)
Hispanic/Latino, n (%)	26 (9.4)	14 (9.5)	11 (9.5)
Most common clinical characteristics (>10%), n (%)
Any comorbidity	138 (49.6)	99 (66.9)	34 (29.3)
Polypharmacy	70 (25.2)	55 (37.2)	13 (11.2)
Mental health issues	68 (24.5)	47 (31.8)	18 (15.5)
Health insurance issues	52 (18.7)	38 (25.7)	11 (9.5)
Low health literacy	49 (17.6)	44 (29.7)	4 (3.4)
Substance abuse	37 (13.3)	32 (21.6)	4 (3.4)
ART regimens prior to DTG 2DR, n (%)
0	6 (2.2)	3 (2.0)	0 (0.0)
1	37 (13.3)	12 (8.1)	24 (20.7)
2	41 (14.7)	19 (12.8)	19 (16.4)
3	51 (18.3)	27 (18.2)	21 (18.1)
4	38 (13.7)	19 (12.8)	17 (14.7)
5	22 (7.9)	18 (12.2)	4 (3.4)
>5	79 (28.4)	50 (33.8)	27 (23.3)
Data not available	4 (1.4)	0 (0.0)	4 (3.4)
Years since initiation of first ART, mean (SD)	13.5 (8.2)	11.2 (7.4)	15.7 (8.4)
ART regimens just prior to DTG 2DR initiation, n (%)
DRV-containing	108 (39.7)	72 (49.7)	34 (29.3)
FTC-containing	101 (37.1)	56 (38.6)	40 (34.5)
TDF-containing	93 (34.2)	56 (38.6)	31 (26.7)
RAL-containing:	79 (29.0)	44 (30.3)	32 (27.6)
DTG-containing	63 (23.2)	19 (13.1)	41 (35.3)
Viral load prior to DTG 2DR initiation, copies/mL, mean (SD)	—	43 389 (108 136.0)	—
CD4+ cell count prior to DTG 2DR initiation, cells/mm^3, mean (SD)	525 (329.8)	410 (299.3)	676 (306.2)

Fourteen patients did not have virologic data and could not be classified as nonsuppressed or suppressed. The suppressed and nonsuppressed virologic categories are determined prior to initiation of the DTG 2DR regimen. Additional patient characteristic data were not known for 11 patients (4.0%). More than 1 characteristic could be selected for each patient case; characteristics selected were based on patient records and/or the opinion of the principal investigator or study site designee completing the eCRF. Use of multiple medications by a patient. Data were available for only N = 125 patients. Data presented for 5 most frequent ARTs (N = 272; nonsuppressed: n = 145, suppressed: n = 116, and data not available: n = 11). Also includes the drug combined with cobicistat or ritonavir. Data for suppressed (<50 copies/mL) patients were not available. Data were not available for 10 patients. 2DR, 2-drug regimen; ART, antiretroviral treatment; DRV, darunavir; DTG, dolutegravir; FTC, emtricitabine; MVC, maraviroc; RAL, raltegravir; RPV, rilpivirine; SD, standard deviation; TDF, tenofovir disoproxil fumarate.