European Journal of Medical Research - Deutsche AIDS ...

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June 27, 2007 EUROPEAN JOURNAL OF MEDICAL RESEARCH 105 D.65 (Poster) Pharmacokinetic assessment of LPV/r (Kaletra ® ) in children younger than 24 months reveals extremely low plasma concentrations Königs C. 1 , Dunsch D. 1 , Scheuplein M. 1 , Kurowski C. 2 , Linde R. 1 , Kreuz W. 1 , von Hentig N. 3 1 JW Goethe University, Department for Pediatrics, Hemostasis and Immundeficiency Treatment and Research Unit, Frankfurt, Germany, 2 HIV Lab, Berlin, Germany, 3 JW Goethe University, Department for Pharmacology, Frankfurt, Germany Antiretroviral drugs offer a range of therapies for HIV-1-infected individuals. Treating HIV-positive children remains challenging. Only a few drugs are available in adequate formulations. Pediatric guidelines and dosage recommendations are partly based on data from adult trials. Very limited data is available on children younger than 2 yrs, who need to start antiretroviral therapy (ART). Eight children 1.000.000 cps/ml at baseline. 5/8 children reached VL of
106 EUROPEAN JOURNAL OF MEDICAL RESEARCH June 27, 2007 Kaever, V. (2005) Quantification of antiretroviral drugs in dried blood spot samples by means of liquid chromatography/tandem mass spectrometry. Rapid Commun. Mass Spectrom. 19, 2995– 3001 D.68 (Vortrag) Antiretroviral therapy of patients infected with drug-resistant HIV-strains: Analysis of the composition of the first-line regimen in patients with a documented date of HIV-infection in Germany Poggensee G. 1 , Kücherer C. 2 , Werning J. 1 , Bartmeyer B. 1 , Fleischhauer C. 1 , Braun P. 3 , Cordes C. 4 , Jessen H. 4 , Klausen G. 4 , Schewe K. 5 , Stoll M. 6 , vanLunzen J. 7 , Hamouda O. 8 1 Robert Koch-Institute, Department of Infectious Disease and Epidemiology, Berlin, Germany, 2 Robert Koch-Institute, HIV- Variability and Molecular Epidemiology, Berlin, Germany, 3 private practitioner, Aachen, Germany, 4 private practitioner, Berlin, Germany, 5 private practitioner, Hamburg, Germany, 6 Hannover Medical School, Internal Medicine, Hannover, Germany, 7 University Clinic Hamburg Eppendorf, Hamburg, Germany, 8 Robert Koch-Institute, Department of Infectious Disease and Epidemiology and the German Seroconverter Study Group, Berlin, Germany Objectives: Studies of the first-line regimen in patients with transmitted drug resistance are limited. Aim of this study was to investigate the influence of genotypic resistance test results on the choice of first-line treatment in patients with a documented date of HIV-infection with transmitted drug-resistance. Methods: Genotypic resistance testing was performed in all drug-naïve patients of the HIV-seroconverter cohort. Data acquisition took place between 1998 and 2005. Start of antiretroviral therapy and drug composition of firstline treatment were assessed. Proportions were given with interquartile ranges. Mantel-Haenzels X2test and Fisher’s exact test were used. Viral loads and CD4 counts were compared by the Kruskall-Wallis test. p-values were two sided and p-values of < 0.05 were considered significant. Results: Of 922 tested patients drug resistant HIV was identified in 130 patients. Susceptible strains were found in 792 individuals. Any NRTI resistant HIV was found in 25 individuals (25/35). NRTI resistance alone was detected in 21 patients (21/35). Combinations of NRTI with PI and/or NNRTI resistance were found in 4 patients (4/25). PI or NNRTI resistance alone was assessed in 5 (5/35) and 4 (4/35) patients, respectively. The remaining 5 patients showed different combinations of multi-drug resistance. Antiretroviral therapy was prescribed for 35 patients (35/130) with predicted drug resistant HIV. Treatment regimen of 25 patients (25/35) included at least one inactive drug. One inactive drug was included in the regimen of 17 individuals. The regimen of 5 patients comprised 2 inactive drugs. In 3 patients no active drug was included in the first-line regimen. The majority of mutations conferred AZT-resistance (11/35). Since 2002 72% of first-line treatments included AZT (p=0.011). Since 2003 no PI or NNRTI were included in first-line treatments of patients with predicted PI/NNRTI resistance. AZT was not included in the regimen of three patients who were infected with highly AZT-resistant HIV. CD4-cell counts and viral load did not differ between individuals treated with or without compromised drugs. Conclusions: More recently a trend to omit compromised PI and NNRTI drugs appeared. Supported by BMG, BMBF/Competence Network HIV/AIDS D.69 (Poster) Ritonavir-boosted fosamprenavir dramatically increased tacrolimus drug concentrations in an HIV/HCV-infected patient with liver transplantation Schulbin H. 1 , Masuhr A. 1 , Stocker H. 1 , Müller M. 1 , Broelsch C. 2 , Beckebaum S. 2 , Cicinnati V. 2 , Arasteh K. 1 1 Vivantes Auguste-Viktoria Klinikum, Berlin, Germany, 2 Universitätsklinikum Essen, Essen, Germany Introduction: Drug drug interactions with ritonavir-boosted protease inhibitors (PI) are increasingly troublesome, as HIVinfected patients require treatment for other conditions than HIV. Methods: We describe the case of an HIV/HCV co-infected patient who initiated the immunosuppressant tacrolimus following liver transplantation. Results: The 36 year old male with HIV/HCV-coinfection underwent liver transplantation in December 2005 for chronic liver failure. Along with his stable antiretroviral therapy consisting of fosamprenavir/ritonavir 700/100 mg, twice daily and coformulated tenofovir/emtricitabine he was started on tacrolimus 5 mg, twice daily. 5 Days after the start of this treatment the serum tacrolimus concentration was 65,4 ng/mL, which is more than six times the desired value of 10 ng/ml. Only after the dosage was reduced to 0,25 mg q 3 days stable drug trough concentrations within the required concentration range could be achieved. Serum amprenavir concentrations were also monitored but were within the normal range as compared to historical controls. Conclusions: Enhanced tacrolimus exposure in patients receiving coformulated lopinavir ritonavir has been described before. However, no prospective controlled pharmacokinetic studies have been performed. This is the first report on an interaction between ritonavir-boosted fosamprenavir and tacrolimus. As the numbers of HIV-infected patients with solid organ transplantation will rise clinicians must be increasingly aware of potential drug interactions with PI and immunosuppressants such as tacrolimus. D.70 (Poster) Low dose Prednisolone helps to delay HAART initiation Ulmer A. 1 , Müller M. 1 , Stützer H. 2 , Frietsch B. 1 1 Praxis Ulmer Frietsch Müller, Stuttgart, Germany, 2 University of Cologne, IMSIE - Institute of Medical Statistics, Köln, Germany Objective: HAART is the best and almost the only established treatment option for HIV infected individuals. But it is expensive and complicated, leading to limited access in developing countries with dramatic consequences, connected with side effects and potential resistances. An important issue is to find additional or alternative therapeutic options and to increase the independence of HAART. The study groups of Andrieu and ourselves have already published a CD4-stabilizing effect of Prednisolone. The number of patients and the time of
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