Does the rapid initiation of antiretroviral therapy at HIV diagnosis impact virological response in a real-life setting? A single-centre experience in Northern Italy

Figures & data

Table 1. Patients’ baseline characteristics.

Characteristics	Outpatients (n = 206)	Inpatients (n = 114)	Total (n = 320)	p-value
Age, years, median (IQR)	39.3 (30.4–50.6)	46.3 (37.5–52.1)	41.8 (32.0–51.5)	0.002
Gender, n (%):				0.042
Male	149 (72.3)	94 (82.5)	243 (75.9)
Female	57 (27.7)	20 (17.5)	77(24.1)
Geographical origin, n (%)				0.392
Italy	137 (66.5)	78 (68.4)	215 (67.2)
Foreign
Africa	29 (14.1)	19 (16.7)	48 (15.0)
East Europe	14 (6.8)	11 (9.6)	25 (7.8)
South/Central America	13 (6.3)	3 (2.6)	16 (5.0)
Asia	10 (4.9)	2 (1.8)	12 (3.8)
North America	2 (1.0)	0 (0.0)	2 (0.6)
Western Europe	1 (0.5)	1 (0.9)	2 (0.6)
Risk factor for HIV acquisition, n (%)				0.090
Heterosexual	119 (57.8)	82 (71.9)	201 (62.8)
MSM/bisex	80 (38.8)	27 (23.6)	107 (33.4)
IVDU	7 (3.4)	4 (3.5)	11 (3.4)
Unknown	0	1 (0.9)	1 (0.3)
HCV co-infection, n (%)	10 (4.9)	6 (5.3)	16 (5.0)	0.913
HBV co-infection, n (%)	11 (5.3)	4 (3.5)	15 (4.7)	0.623
Baseline CD4+ T cell count, cells/uL				<0.001
mean (SD)	391.0 (247.6)	250.3 (270.6)	341.5 (264.2)
median (IQR)	387.0 (199.0–556.0)	157.0 (30.0–369.0)	323.0 (103.5–520.5)
Baseline CD4+ T cell count, %				<0.001
mean (SD)	20.4 (10.8)	16.4 (19.1)	19.0 (14.3)
median (IQR)	20.9 (12.2–27.6)	12.7 (5.6–22.5)	18.4 (8.6–26.5)
Baseline HIV RNA viral load, n (%)				<0.001
< 100000 copies/ml	143 (70.4)	49 (43.8)	192 (61.0)
> 100000 copies/ml	60 (29.6)	63 (56.2)	123 (44.3)
AEHI, n (%)	28 (13.6)	9 (7.9)	37 (11.6)	0.127
AIDS, n (%)	19 (9.2)	63 (55.3)	82 (25.6)	<0.001
Median time from HIV diagnosis to first referral, days (IQR)	19.0 (12.0–32.0)	10.5 (5.0–17.0)	15.0 (8.0–28.0)	<0.001

MSM: men who have sex with other men; IVDU: intravenous drug user; AEHI: acute or early HIV infection.

Table 2. Characteristics of ART timing initiation and prescription.

Patients starting ART	Outpatients (n = 197)	Inpatients (n = 114)	Total (n = 311)	p-value
Median time from the first visit to ART start, days (IQR)	34.0 (9.0–44.0)	4.0 (0.2–17.8)	24.0 (2.5–41.0)	<0.001
Timing of ART start, n (%):	46 (23.4)	71 (62.3)	117	< 0.001
rapid start	40 (20.3)	24 (21.1)	(37.6)
intermediate start  late start	111 (56.3)	19 (16.7)	64 (20.6) 130 (41.8)
ART regimen chosen, n (%):
PI:				0.050
ATV/booster	13 (6.6)	1 (0.9)	14 (4.5)
DRV/booster	18 (9.1)	14 (12.3)	32 (10.3)
NNRTI (RPV)	24 (12.1)	4 (3.5)	28 (9.0)	0.010
NRTI:				0.269
FTC/TAF	66 (33.3)	50 (43.9)	116 (37.2)
FTC/TDF	65 (32.8)	28 (24.6)	93 (29.8)
ABC/3TC	64 (32.3)	35 (30.7)	99 (31.7)
3TC	2 (1.0)	0 (0.0)	2 (0.6)
INSTI:				0.004
DTG	119 (60.4)	88 (77.2)	207 (66.6)
ELV/cobicistat	18 (9.1)	3 (2.6)	21 (6.8)
RAL	8 (4.1)	7 (6.1)	15 (4.8)

Table 3. Median time to viral suppression and rates of retention in care during follow-up.

	Total (n = 320)
Median time to HIV RNA < 50 copies/ml, days (IQR)	84 (35.0–161.0)
Status at the sixth month of follow-up, n (%)
LTFU	15 (4.7)
Followed up	302 (94.4)
Transferred	3 (0.9)
Deceased	0
Status at the twelfth month of follow-up, n (%)
LTFU	30 (9.4)
Followed up	280 (87.5)
Transferred	5 (1.6)
Deceased	5 (1.6)

LTFU: lost to follow-up.

Figure 1. Time from ART starts to virological response (HIV RNA < 50 copies/ml) according to different timings of initiation (rapid, intermediate and late).

Table 4. Rates of viral suppression according to the ART initiation.

Months	Rapid start (%)	Intermediate start (%)	Late start (%)
1	20.7	19.8	18.2
3	69.4	67.6	64.1
6	95.0	94.2	92.5
12	99.6	99.5	99.2

Table 5. Multivariable Cox Proportional Hazard model for Predictors of viral suppression.

	HIV RNA < 50 copies/ml
Predictors	Hazard ratios	95% CI	p
Time (weeks) to start	0.96	0.93–0.99	0.016
Sex M vs F	1.01	0.73–1.38	0.966
Age	1.00	0.98–1.01	0.414
Inpatients vs Outpatients	0.86	0.65–1.15	0.320
PI vs INSTI-based regimen	0.52	0.36–0.77	0.001
NNRTI vs INSTI-based regimen	0.63	0.41–0.97	0.036
Log (HIV RNA at T0)	0.85	0.80–0.90	<0.001
Log (CD4 at T0)	1.18	1.04–1.34	0.008

M: male; F: female.