Suchergebnisse

The life‐long antiretroviral treatment of HIV‐1 infection requires effective and well tolerated medications complemented by high rates of adherence in order to achieve viral suppression, immunologic reconstitution and to prevent the development of resistance. Single‐tablet regimens (STRs), combining a full antiretroviral regimen in one tablet taken once daily, have been designed to achieve high adherence and better long‐term outcomes. "STRike" is the first cohort study, describing the use of various STRs in routine clinical practice in Germany. In this observational cohort study 800 participants will be included in 4 treatment arms, treated with the STRs of TDF/FTC/EFV (a retrospective and prospective arm), TDF/FTC/RPV or TDF/FTC/COBI/EVG after regulatory approval. Patients are followed for at least two years, and reasons for choice of medications and treatment satisfaction will be collected, in addition to safety, demographic, effectiveness data. To date 344 patients on TDF/FTC/EFV and 123 patients on TDF/FTC/RPV are being followed. In general, the spectrum of patients in the study reflects the German HIV‐1 infected population with regards to gender (88%/89% male), age (median 40/38 years of age) and mode of infection (71%/63% MSM). However, patients starting TDF/FTC/RPV are less progressed in their disease according to their CDC stage compared with patients on TDF/FTC/EFV (74.5% stage "A" vs. 53.2%). Patients starting TDF/FTC/RPV show less comorbidities (54% vs. 82%) with a spectrum different from patients on TDF/FTC/EFV. Pre‐existing neuropsychiatric comorbidities are relatively more common (10% more) among patients starting TDF/FTC/RPV than TDF/FTC/EFV. The decision to use an STR is mostly driven by patient preference to start with a more convenient ART regimen (56%) or to simplify their current ART regimen (75%). STRs aim to make treatment of HIV more convenient, more efficacious and more durable and by that allowing for earlier initiation of treatment. Different STRs may meet the requirements of distinct patient populations. TDF/FTC/RPV in this early review of our data, is utilized by younger patients with fewer overall comorbidities, but is selected more frequently for patients with pre‐existing neuropsychiatric comorbidities presumably to avoid the known neuropsychiatric complications of TDF/FTC/EFV. TDF/FTC/RPV appears to fit into the concept of early HIV treatment initiation as recommended by national and international guidelines.image

Purpose of the studyIn Germany, older age is described as a risk factor for late presentation of HIV disease (defined as<200 CD4/μL or AIDS at diagnosis). We describe treatment outcomes with respect to age distribution at the time of antiretroviral therapy (ART) initiation in the multicentre, observational, ongoing STAR and STELLA cohorts, which included patients (pts) initiated on LPV/r‐based ART.MethodsThis analysis included ART‐naïve HIV+ pts with a minimum of 48 weeks follow‐up. Time to virologic response (defined as HIV1‐RNA <50 c/mL) and time to CD4 cell increase of at least 100/μL were calculated using Kaplan‐Meier analyses. Virologic response rates at week 48 were evaluated using 2 approaches: i) defining discontinuations for virologic or immunologic failure, side effects, noncompliance, or death as failures (ITT) and ii) as‐treated (AT) analysis excluding discontinuations for reasons other than virologic failure.Summary of results1011 ART‐naïve pts were included (85% men; median age 43 years [y]). Baseline (BL) characteristics and treatment response rates are shown in Table 1. The overall prevalence of advanced immunodeficiency with<200 CD4/μL at ART initiation was 48%:*Comparison across groups64% in pts aged >60 y and 31%–49% in the younger age groups (see Table 1). Across age groups, 43%–60% of pts had pretreatment HIV1‐RNA levels>100,000 c/mL. Median times to virologic response (Figure 1) and response rates at week 48 did not differ across age groups in either analysis, nor did immunologic outcomes. Median times to+100/μL CD4 increase were between 11.1 and 15.3 weeks. CD4 increase at week 48 was lower in pts >60 y compared to patients of younger age categories (165/μL vs 211/μL; P=ns). However, these differences between age groups did not reach statistical significance, even when stratified by baseline CD4 count<vs=200/μL. Over the first 48 weeks of therapy, clinical and laboratory adverse events (AEs) of grade 3 or 4 were spontaneously reported in 9.6% of pts in the=60 y group and 4.5% of pts in the >60 y group (P=0.194). In addition, 11.3 % of pts =60 and 14.9% of pts >60 y discontinued therapy prior to week 48 due to treatment related AEs (P=0.427).













Age, y
≤30
>30–40
>40–50
>50–60
>60
P value
Statistical tests*




N
68
321
411
144
67




Male, %
69
80
89
89
88
P<0.001
χ2


Median time since diagnosis, y (IQR)
0.79 (0.21–2.98)
0.67 (0.09–3.23)
0.32 (0.06–3.24)
0.35 (0.06–2.27)
0.10 (0.05–0.69)
P=0.015
Kruskal‐Wallis


BL HIV1‐RNA>100,000 c/mL, %
43
49
56
60
48
P=0.038
χ2


BL median CD4 count, cells/μL
256
208
203
212
121
P=0.001*
Kruskal‐Wallis


BL CD4 count<200/μL, %
31
47
49
48
64




BL CD4 count200–350/μL, %
47
36
33
31
31




BL CD4 count>350/μL, %
22
17
18
21
5




Median CD4 count at wk 48, 1/μL
446
416
412
392
361
P=0.033*
Kruskal‐Wallis


Median time to+100/μL CD4 increase, wk
11.1
12.1
12.1
12.9
15.3
P=0.754
log‐rank


Median change in CD4 at wk 48, 1/μL
234
214
214
180
165
P=0.113*
Kruskal‐Wallis


Median time to HIV1‐RNA<50 c/mL, wk
25.1
25.6
25.9
25.1
35.0
P=0.496
log‐rank


Wk 48 HIV1‐RNA<50 c/mL, % ITT
63.2
69.8
69.6
68.1
61.2
P=0.556
χ2


Wk 48 HIV1‐RNA<50 c/mL, % AT
75.4
82.1
80.1
77.8
78.9
P=0.755
χ2




ConclusionsIn the STAR/STELLA cohorts, pts aged >60 y had high rates of late presentation, with two‐thirds of patients with CD4 cell counts<200/μL. Nevertheless, older pts did not differ significantly from younger pts regarding immunologic and virologic response after initiation of LPV/r‐based therapy. image