Treatment response to LPV/r‐based HAART in HIV‐infected patients aged >60 years ‐ data from the STAR/STELLA cohorts
Authors: Koegl C , Baumgarten A , Bieniek B , Holm S , Hower M , Jaeger H , Koeppe S , Lutz T , Mueller M , Schmidt W , Trein A , van Wyk J , Koenig B , Stellbrink H 
Published: November 2012

Purpose of the study

In 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.

Methods

This 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 results

1011 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 groups

64% 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

Conclusions

In 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.

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