Effectiveness and safety of a single‐tablet regimen of emtricitabine/efavirenz/tenofovir in HIV‐1‐infected patients in infectious diseases department
In: Journal of the International AIDS Society, Band 15, Heft S4, S. 1-1
ISSN: 1758-2652
ObjectiveEvaluate the effectiveness and safety of simplification of tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV) in selected treatment‐experienced HIV‐1‐infected patients who have been virologically suppressed for>3 months on their current regimen.MethodsWe selected patients who started the simplified regimen between December 1st 2008 and March 31st 2012. Exclusion criteria: prior therapeutic failure, presence of resistance mutations to any component of TDF/FTC/EFV and patients previously observed in other centers. Efficacy and safety assessments were performed at baseline, 4 weeks after switch and then every 12–24 weeks. Statistical analysis was performed with SPSS version 20.0.Results384 patients were evaluated; 302 (79%) male; mean age 47 (SD=10) years; median CD4 cells count was 504 cells/mm3 (367–710). Baseline median glomerular filtration rate (eGFR; Cockcroft‐Gault equation) was 100 mL/min (86–116) and median ALT was 33 U/L (21–47). Median total cholesterol (TC) was 205 mg/dL (176‐236), high‐density lipoproteins (HDL) 45 mg/dL (38–54); low‐density lipoproteins (LDL) 130 mg/dL (108–151); triglycerides (TG) 125 mg/dL (84–176). Prior NNRTI‐based regimen in 327 (85%) patients (TDF/FTC and EFV in 76%); protease inhibitor in 52 (14%) and integrase inhibitor in 5 (1%). Discontinuation of treatment occurred in 49 patients (13%) after a mean time of 1.1 years (SD=1.1) of follow‐up: nervous system symptoms (n=11), decreased eGFR (n=5), virological failure (n=5), pregnancy (n=5), gastrointestinal symptoms (n=3), rash (n=1), other reasons (n=2); 12 patients dropped out the treatment and 5 died. Occurrence of blips (transient increase in VL ≤200 copies/mL) was documented in 98 (26%) patients; in 70, VL decreased to <20 copies/mL after the blips and in 28 VL is not yet available. 317 patients (83%) achieved≥48 weeks of follow‐up after simplification. Compared with baseline, significantly higher levels of CD4 cells count, HDL and eGFR were found and lower levels of TC, LDL and TG.
CD4
AST
ALT
TC
HDL
LDL
TG
eGFR
Baseline
Median
501
27
32
203
46
130
123
100
Percentiles 25
358
22
22
174
39
108
84
85
Percentiles 75
712
36
45
236
54
151
179
113
Follow‐up
Median
541
28
32
196
49
123
115
111
Percentiles 25
397
22
22
174
41
101
80
96
Percentiles 75
734
36
46
223
57
141
155
133
p‐value
<0.001
0.395
0.513
<0.001
<0.001
<0.001
<0.001
<0.001
ConclusionSimplification to TDF/FTC/EFV was shown to be an efficient and safe option in virologically suppressed patients and without a previous virological failure.