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01-02-2011 | Clinical and Epidemiological Study

Impact of earlier HAART initiation on the immune status and clinical course of treated patients on the basis of cohort data of the German Competence Network for HIV/AIDS

Authors: A. Plettenberg, N. H. Brockmeyer, B. Haastert, C. Michalik, S. Dupke, K. Schewe, M. Rausch, M. Hower, A. Ulmer, E. Wolf, T. Lorenzen, G. Arendt, K. Jansen, the Competence Network for HIV/AIDS

Published in: Infection | Issue 1/2011

Abstract

Purpose

Hitherto, studies on highly active antiretroviral therapy (HAART) initiation have shown partly inconsistent results. Our study investigated the clinical course and course of immune status after HAART initiation at CD4-cell-count/μl of treated patients between 250 and 349 (group 1), compared to 350–449 (group 2), on the basis of the cohort of the Competence Network for HIV/AIDS (KompNet cohort).

Methods

Patients had to be HAART-naïve. Medication had to start at the earliest in 1996, being at least triple combination therapy. The primary endpoints of death, first AIDS-defining illness and first drop of CD4-cell-count/μl below 200 were evaluated as censored event times between the initiation of HAART (t ₀) and the date of the first event/date of last observation. Probabilities of event-free intervals since t ₀ were calculated by Kaplan–Meier estimation, compared by logrank tests. The results were adjusted for confounders using Cox regression. Additionally, incidences were estimated.

Results

A total of 822 patients met the inclusion criteria (group 1: 526, group 2: 296), covering 4,133 patient years (py) overall. In group 1, 0.64 death cases/100 py were found, with the corresponding vale being 0.17 in group 2. In group 1, 1.38 AIDS-defining events/100 py occurred, whereas it was 0.78 in group 2. In group 1, 2.64 events of first drop of CD4-cell-count/μl below 200 occurred per 100 py, compared to 0.77 in group 2. Kaplan–Meier estimations showed borderline significant differences regarding death (p = 0.063), no differences regarding first AIDS-defining illness (p = 0.148) and distinct differences regarding the first drop of CD4-cell-count/μl below 200 (p = 0.0004).

Conclusions

The results gave a strong hint for a therapy initiation at higher CD4-cell-count/μl regarding the outcome of death in treated patients. A distinct benefit was shown regarding the first decline of CD4-cell-count/μl below 200.

Central clinical and therapy related data of patients regarding the time before enrolment into the cohort are documented retrospectively [3]. Due to the high proportion of data documented retrospectively before 2005, the calendar year of the start of HAART (<2005 vs. ≥2005) was considered as a confounder to adjust for potential influences of different modes of data documentation (retrospective vs. prospective).

The percentage of quarters with a documented CD4-cell-count/μl measurement is lower for the subpopulation with an observation time ≥3 years than in all patients. For the analysis shown in Table 3, a fixed datum reference of 12 quarters was used as a basis for the analyses due to the observation period of at least 3 years. Because not every patient had a CD4-cell-count/μl measurement just in the 12 quarter, the named percentage is lower.

It was not reasonable to calculate the incidences of death for this subpopulation due to the inclusion criteria of this group (observation period at least 3 years) and due to seven cases of death within the first 3 years.

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Title: Impact of earlier HAART initiation on the immune status and clinical course of treated patients on the basis of cohort data of the German Competence Network for HIV/AIDS
Authors: A. Plettenberg
N. H. Brockmeyer
B. Haastert
C. Michalik
S. Dupke
K. Schewe
M. Rausch
M. Hower
A. Ulmer
E. Wolf
T. Lorenzen
G. Arendt
K. Jansen
the Competence Network for HIV/AIDS
Publication date: 01-02-2011
Publisher: Springer-Verlag
Published in: Infection / Issue 1/2011
Print ISSN: 0300-8126
Electronic ISSN: 1439-0973
DOI: https://doi.org/10.1007/s15010-010-0070-8

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