Switching to Dolutegravir/lamivudine or Bictegravir/Emtricitabine/Tenofovir alafenamide. A comparative real-world study

Figures & data

Table 1. Baseline characteristics and previous treatments.

	Dolutegravir/lamivudine (N: 358)	Bictegravir/Emtricitabine/Tenofovir alafenamide (N:332)	p
Age (SD)	47.7 (12.6)	45.1 (11.1)	0.002
Male, N (%)	310 (86.4)	292 (88)	0.593
Place of birth, Spain, N (%)	177 (49.4)	142 (42.8)	0.079
Risk acquisition HIV
MSM, N (%)	229 (64)	213 (64.2)	0.958
IDU, N (%)	39 (10.9)	49 (14.8)	0.128
HTX, N (%)	85 (22.7)	62 (18.7)	0.104
Other, N (%)	5 (1.4)	8 (2.4)	0.328
Time follow-up, median days (IQR)	728 (578–887)	1013 (615–1791)	0.001
Previous ART regimen
TAF, N (%)	86 (24)	133 (40)	0.001
TDF, N (%)	57 (16)	133 (40)	0.001
Other NRTIs, N (%)	215 (60)	66 (20)	0.001
Elvitegravir/c, N (%)	29 (8)	119 (36)	0.001
Dolutegravir, N (%)	150 (42)	36 (11)	0.001
Raltegravir, N (%)	14 (4)	30 (9) %	0.006
Biktegravir, N (%)	7 (2)	0	0.01
Darunavir/c, N (%)	32 (9)	73 (22)	0.001
NNNRTIs, N (%)	79 (22)	116 (35)	0.001
Reason for switch
Simplification, N (%)	287 (80)	117 (35.2)	0.0001
Adverse effect, N (%)	31 (8.6)	80 (24.1)	0.0001
Drug-drug interaction, N (%)	25 (6.9)	51 (15.4)	0.0006
Physician and/or patient decision, N (%)	16 (4.5)	84 (25.3)	0.0001
Baseline comorbidities
Alcohol misuse, N (%)	22 (6.1)	28 (8.4)	0.247
Drug misuse, N (%)	34 (9.5)	40 (12)	0.279
Psychiatric disorder, N (%)	104 (29)	84 (25.3)	0.269
Social issues, N (%)	29 (8.1)	36 (10.8)	0.218
HCV, N (%)	65 (18.1)	75 (22.6)	0.148
HBV, N (%)	0 (0)	20 (6.0)	0.001
Cardiovascular event, N (%)	23 (6.4)	19 (5.7)	0.710
Hypertension, N (%)	56 (15.6)	36 (10.8)	0.064
Dyslipidemia, N (%)	151 (42.1)	123 (37)	0.169
Diabetes mellitus, N (%)	19 (5.3)	14 (4.2)	0.502
Neurologic disorder, N (%)	22 (6.1)	24 (7.2)	0.569

ART: Antiretroviral therapy; TAF: Tenofovir alafenamide; TDF: Tenofovir fumarate; NRTIs: Nucleoside reverse transcriptase inhibitors; NNRTIS: Non-nucleoside reverse transcriptase Inhibitors.

Figure 1. Kaplan–Meier plot of accumulative treatment discontinuation for Dolutegravir/lamivudine (D/L) or Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/T).

Table 2. Discontinuation and virologic outcomes.

	Dolutegravir/lamivudine (N: 358)	Bictegravir/Emtricitabine/Tenofovir alafenamide (N: 332)	p
Total discontinuation, N (%)	31 (8.7)	51 (15.4)	0.007
Reason of discontinuation
Adverse events, N (%)	7 (1.9)^A	7 (2.1)^B	0.887
Loss of follow-up, N (%)	18 (5)	35 (10.5)	0.006
Death; N (%)	4 (1.1)	7 (2.1)	0.299
Drug-drug interactions, N (%)	0 (0)	2 (0.6)	0.141
Virologic and immunologic data
Virological failure^C, N (%)	4 (1.1)	3 (0.9)	0.779
Blips, N (%)	41 (11.5)	39 (11.7)	0.904
Viral load < 50 copies /mL, N (%)	345 (96.4)	319 (96.1)	0.845
Viral load 50–500 copies/mL, N (%)	9 (2.5)	10 (3)	0.689
CD4 cell count difference (IQR) from baseline	14 (−72 + 171)	56.5 (−63 + 196)	0.824
Weight difference from baseline
Median kg (IQR)	N: 145: +1 (−2–+3)	N: 90: +1 (−1–+5)	0.244

A: 3: anxiety and/or insomnia, 1: Subjective lipoatrophy, 1: Cavum cancer, difficult to swallow the pill, 1. abdominal pain, 1: weight gain. B: 1: arthralgia, 4: weight gain, 2: dyslipidemia. C: Viral load > 200 copies/mL in two consecutive measurements.

Data availability statement

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.