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June 27, 2007 EUROPEAN JOURNAL OF MEDICAL RESEARCH 107 observation are meanwhile sufficient for an evaluation on the potential delay of the first HAART start. Methods: All therapy naïve HIV-patients who came to us in the 4 years from 1999-2002 and remained HAART-naïve at least 6 months, either with or without 5mg Prednisolone daily, were included. 46 took Prednisolone, 45 did not. 20 of the latter started to take Prednisolone later. Thus 25 remained as the evaluable control group. Times to start of HAART or death were analyzed using Kaplan-Meier estimates and compared by the logrank test. Results: Mean CD4-baseline-counts were similar in the Prednisolone and the control group (554/�l resp. 564/�l, p=0.83). 5 patients were lost in the Prednisolone group, 6 in the control group, during follow-up. One patient of the control group died of a heroin overdose. The cumulated rate of patients surviving 3 years without HAART was 62% in the Prednisolone group compared to 29% in the control group (logrank, p=0.032). >50% of the Prednisolone group were on HAART after 3.5 years, of the control group after 1.5 years. Estimated overall median observation time was about 4.9 years (reverse Kaplan- Meier). Conclusion: The results are very preliminary, based on a monocentric observation of cohorts from clinical routine practice. There were no standardized HAART-initiation criteria and no ordinary methodical minimization of possible bias. The number of evaluated patients is small, especially in the control group. Otherwise, there is a sound difference. Time to HAART initiation is more than doubled, a result corresponding to the better time dependent CD4-profile of the Prednisolone-treated patients. It seems probable that Prednisolone is appropriate to extend the time prior to the start of HAART. D.71 (Poster) Pharmakokinetik der Lopinavir/r- Meltrexformulierung im Vergleich zur Lopinavir/r-Weichkapsel Leyh M. 1 , Winzer R. 1 , Heinz W. 1 , Guhl C. 1 , Klinker H. 1 , Langmann P. 2 1 Medizinische Klinik und Poliklinik II der Universität Würzburg, Schwerpunkt Infekiologie, Würzburg, Germany, 2 Praxis für Gastroenterologie und Infektiologie, Karlstadt, Germany Hintergrund: Der Protease-Inhibitor Lopinavir (LPV) erreicht in der Kombination mit Ritonavir (r) sichere therapeutische Plasmaspiegel (PS). Die ursprüngliche Formulierung von LPV/r war eine Weich-Gelatine-Kapsel (SGC) in einer Dosierung von 2x3 a 133/33mg zu den Mahlzeiten. Seit Juni 2006 ist die LPV/r Fixkombination als Tabl. zugelassen und ersetzt die SGC. Die Dosierung der mittels Melt-Extrusion Technik hergestellten Tabl. beträgt 2x2 a 200/50mg. Fragestellung: Da sich LPV/r-SGC und –Tabl. sowohl in Darreichungsform als auch im Einnahmemodus und der empfohlenen Lagerung unterscheiden, wurde prospektiv untersucht, ob sich Unterschiede in der Pharmakokinetik bezüglich der beiden Formulierungen zeigen. Methodik: Bei 14 konsekutiven Patienten unter LPV/r –Therapie wurden vor und nach der Therapieumstellung von SGC auf die Tabl. insgesamt 123 LPV-PS zu den Zeitpunkten 0h, 3h, 6h und 9h (±15min) nach Einnahme mittels HPLC bestimmt. Zusätzlich dazu wurde eine retrospektive Untersuchung der 3h- und 0h- LPV-PS von insgesamt 366 Plasmasproben (174 Patienten) vorgenommen. Hiervon waren unter SGC 115 Talspiegel von 87 Patienten (Zeitpunkt 0h) und 190 PS von 87 Patienten zum Zeitpunkt 3h nach Einnahme. Unter LPV/r-Tabletten-Therapie waren 33 PS von 25 Patienten zum Zeitpunkt 0h, und 28 PS von 27 Patienten zum Zeitpunkt 3h. Die Datenanalyse erfolge mittels Mann-Whitney Test. Ergebnisse: Die prospektiven Untersuchung (SCG./.Tabl.) von 14 Patienten ergab zu allen 4 Zeitpunkten keinen signifikanten Unterschied der LPV-PS-Mediane (0h: 4754 ng/ml./.4878ng/ml, p=0,99; 3h: 9180ng/ml./.8428ng/ml, p = 0,89; 6h: 7556 ng/ml./.6425ng/ml, p = 0,91; 9h: 5624 ng/ml./.5603ng/ml, p = 0,82). In der retrospektiven Untersuchung (SCG./.Tabl.) von 174 Patienten ergaben sich keine Unterschiede bezüglich der LPV-PS-Mediane zum Zeitpunkt 0h (5087ng/ml./.4998ng/ml, p = 0,73), jedoch fanden sich signifikant höhere LPV-PS zum Zeitpunkt 3h (7842 ng/ml./.10264 ng/ml, p=0,0002). Diskussion: Trotz Reduktion der „Pillenlast“ sowie verändertem Einnahmemodus und Lagerungsbedingungen können mit der neuen LPV/r-Formulierung gleichwertige, während der 3h-Spitzenspiegel sogar höhere Plasmaspiegel erreicht werden im Vergleich zur etablierten LPV/r-SGC. D.72 (Poster) Amprenavir (APV) and Atazanavir (ATV) pharmacokinetics: Therapeutic drug monitoring (TDM) of double-PI therapy (APV/ATV/r) in clinical practice Winzer R. 1 , Heinz W. 1 , Guhl C. 1 , Schirmer D. 1 , Leyh M. 1 , Klinker H. 1 , Langmann P. 2 1 Medizinische Klinik und Poliklinik II der Universität Würzburg, Schwerpunkt Infekiologie, Würzburg, Germany, 2 Praxis für Gastroenterologie und Infektiologie, Karlstadt, Germany Objective: The pharmacological interaction of the combination of amprenavir (APV) with Atazanavir (ATV) may be helpful to achieve positive effects on drug levels because of the inhibitory effect of APV on the CYP-System. The aim of the present study was to analyse the drug levels of a APV/ATV/r double-PI regiment during clinical practice. Methods: APV and ATV drug levels of 39 patients (m/f: 30/9) on FAPV (fosamprenavir)/ATV/r ± optimised backbone were determined with a HPLC-based method at their regular outpatient visits over a total period of 40 months. Results: Under a recommended dosis (FAPV: 1400 mg/d, ATV: 300 mg/d, RTV: 200 mg/d), 364 samples of 39 patients could be determined. 32 samples were excluded because of incomplete data. APV trough levels were 4.211±3.510 ng/ml. APV peak levels (5.840±2.410 ng/ml) were reached between 3-6 h. 6 drug levels were under the lower recommended level for Cthrough (400 ng/ml). ATV trough levels were 1.423±1.049 ng/ml. ATV peak levels (2.068±1.271 ng/ml) were also reached between 3-6 h. 16 ATV drug levels were below the lower recommended level for Cthrough (150 ng/ml). Mean treatment-time was 8,2 ± 8,6 months. Conclusion: During the combination of ATV and APV, the drug levels of ATV and APV reached are stable over a longterm treatment period. Despite of the variance of APV/ATV trough levels, the attended high levels in the salvage situation will be reached in most patients. This treatment should be controlled by therapeutic drug monitoring.
108 EUROPEAN JOURNAL OF MEDICAL RESEARCH June 27, 2007 D.73 (Poster) Are there differences in first line treatment between acute and documented seroconverters? Analysis of the composition of first line regimens in patients of the German HIV Seroconverter Study starting between 1987 and 2006 Bartmeyer B. 1 , Kücherer C. 2 , Fleischhauer C. 1 , Poggensee G. 1 , Kollan C. 1 , Hamouda O. 1 , For the German HIV-1 Seroconverter Study Group 1 Robert Koch-Institute, Department of Infectious Disease Epidemiology, Berlin, Germany, 2 Robert Koch-Institute, HIV- Variability and Molecular Epidemiology, Berlin, Germany Objective: The aim of this observational study is to describe differences in onset and composition of first line treatments in HIV infected patients with a documented date of infection. Recommendations when to start therapy are often derived from cohort studies and not from randomized clinical trials. Methods: Individuals with a first positive and last negative and first positive HIV antibody test within a maximum three year interval were defined as documented seroconverters. Individuals with an acute seroconversion confirmed by laboratory criteria were defined as acute HIV seroconverters. Patients included had a calculated date of infection between and including 1985-2006. Differences in the time of first line therapy onset were assessed using the Kruskal-Wallis test. Logistic regression was used to analyze differences in components of first line regimens between documented and acute seroconverters. Results: Of 1555 patients in the German seroconverter cohort, recruited until December 2006, 544 have started antiretroviral therapy (ART). For 364 the first line regimen was clearly indicated. Of those 228 were documented and 136 were acute seroconverters. Our sample was composed of 335 males (92%) and 29 females. The majority were men who have sex with men (MSM; 300/364). Whereas the most prevalent female risk group were heterosexuals (21/29). The year of therapy onset ranged between 1987 and 2006. The overall median time between calculated date of infection and onset of first line regimen were 147.5 days. First line therapy in the acute group started significantly (p
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