European Journal of Medical Research - Deutsche AIDS ...

June 27, 2007 EUROPEAN JOURNAL OF MEDICAL RESEARCH
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inhibitors (NRTIs) and FPV 700 mg/RTV 100 mg BID. The
second group consists of 12 pts taking NRTIs and FPV 1400
mg/RTV 100 mg QD. Exclusion criteria were the use of didanosine
(ddI) or stavudine (d4T) as part of an NRTI backbone,
as well as the use of drugs to treat dyslipidemia (statins
and fibrates). The viral load, CD4 count, and lipid values
were compared at baseline, weeks 4, 8 and 24.
In our patients, the once daily FPV boosted with 100 mg
RTV demonstrated comparable virological and immunological
efficacy to twice daily boosted FPV, and showed good tolerability
in both arms as well. Compared to the FPV BID administration,
the QD regimen showed a tendency towards a
smaller increase in cholesterol and triglyceride levels. Further
evaluation of the QD dosing of FPV is warranted to confirm
the influence on lipid levels.
D.22 (Poster)
Didanosine in a large and unselected German
patient population: Efficacy, safety and clinical
outcome
Fenske S. 1 , Postel N. 2 , Stoehr A. 3 , Lauenroth-Mai E. 4 ,
Eckert M. 5 , Reeb I. 2 , Schewe K. 6
1 ICH Grindel, Hamburg, Germany, 2 Bristol-Myers Squibb
GmbH&Co.KGaA, Medizinische Abteilung, München,
Germany, 3 ifi-Institut für interdisziplinäre Medizin, Hamburg,
Germany, 4 Privatpraxis, Berlin, Germany, 5 SIMW GmbH,
Wegberg, Germany, 6 Infektionsmedizinisches Centrum
Hamburg, Hamburg, Germany
Background: Didanosine (ddI) is a potent antiretroviral agent
which has been investigated in numerous cohort and clinical
studies. However to date there are no data on the use of ddI in
a large and unselected patient group in Germany.
Objectives: To assess clinical outcome, efficacy and safety of
ddI in antiretroviral treatment (ART)-naïve and –experienced
HIV+ patients in clinical practise. To assess the prevalence of
M184V mutation at study entry.
Methods: Single-arm, non-interventional, multicenter, prospective
cohort study in 121 HIV specialised outpatient departments
throughout Germany. Patients eligible for analysis
were treated with ddI-containing ART in 2003-04. Clinical
and laboratory status, CD4 cells and viral load (VL) were assessed
at baseline (BL) and months 3 and 6. Intention-totreat-analysis
(missing=ignored). Query management for implausible
reports.
Results: 342 patients (79% male, 15% female) with a mean
age of 40 yrs [range 21-68] were eligible for analysis. 232 pts
(68%) were ART experienced; 69% had current or previous
symptoms of HIV infection and/or AIDS. Median duration of
treatment was 184 days. M184V mutation was present at
baseline in 86% of 74 pts in whom genotypic data were available.
DdI was most frequently combined with tenofovir
(60%). Median CD4 cell count increased from BL (296/l,
range 4-1302) to 379 (+83) and 424 (+128) at months 3 and 6,
respectively. Median VL decreased from BL (7,740 cp/ml,
range