European Journal of Medical Research - Deutsche AIDS ...

80 EUROPEAN JOURNAL OF MEDICAL RESEARCH
June 27, 2007
D.4 (Poster)
What experts anticipate: Predictability of
virological response in the RADATA cohort
Plettenberg A. 1 , van Lunzen J. 2 , Rockstroh J. 3 ,
Knechten H. 4 , Mauss S. 5 , Salzberger B. 6 , Stoll M. 7 ,
Stoehr A. 1 , Hoffmann C. 1 , Lorenzen T. 1 , for the
Radata-studygroup
1 ifi-Institut für interdisziplinäre Medizin, Hamburg, Germany,
2 Universitätsklinikum Hamburg-Eppendorf,
Ambulanzzentrum Infektiologie, Hamburg, Germany,
3 Universitätsklinikum Bonn, Medizinische Klinik und
Poliklinik I, Bonn, Germany, 4 HIV-Schwerpunktpraxis,
Aachen, Germany, 5 HIV-Schwerpunktpraxis, Düsseldorf,
Germany, 6 Universitätsklinikum Regensburg, Klinik I für
Innere Medizin, Regensburg, Germany, 7 Medizinische
Hochschule Hannover, Abteilung Klinische Immunologie,
Hannover, Germany
Objective: Recent studies suggested that virological response
in HIV-infected patients is better when expert advice for new
antiretroviral therapy (ART) is available. However, data on
predictability of virological outcome after expert-guided
switch of ART is limited.
Methods: RADATA is an internet-based system which provides
external expert advice for ART-switch. After external
experts had given advice on ART switch which based on pretreatment,
resistance analysis, drug monitoring, compliance
questionnaire and demographic parameters, experts were requested
to provide their opinion on virological outcome of the
patients after three and twelve months. Prognoses were
grouped into “good virological outcome” (at least a viral load
decline > 1 log copies/ml) and “poor virological outcome”
(viral load decline < 1 log copies/ml). Prognoses were correlated
with virological outcome which was grouped in the
same way. For analysis, only cases in which the treating
physicians followed expert advice where selected.
Results: Of 187 expert prognoses for 64 patients, 67 for 37
patients were eligible for further analysis. Compared to actual
outcome, virological outcome (good or poor) was predicted
correctly in 40 (60 %) of the cases. A good virological outcome
was predicted in 38 cases (57 %). Of these, 31/38 prognoses
(82 %) were correct. In 29 cases (43 %) experts assumed
poor virological outcome. Of these, only 9/29 prognoses
(31 %) were accurately predicted. Comparing these two
groups p-value is 0.04 in Chi-Square-Test. Of note, 19 patients
achieved a viral load of < 50 copies/ml although the external
experts anticipated either an unchanged viral load or a
decline < 1 log copies/ml.
Conclusions: In this cohort of pretreated patients, preliminary
data suggest that virological outcome is predicted accurately
in most cases. However, there remains a considerable number
of cases in which the virological response is underestimated
by external experts.
D.5 (Poster)
The rainbow cohort: Saquinavir/r is effective and
well tolerated in antiretroviral therapy (ART)-
naïve patients initiating treatment with saquinavir
500mg film-coated tablets - 24 week interim results
from Germany
Knechten H. 1 , Carganico A. 2 , Glaessel F. 3 , Jaeger H. 4 ,
Knecht G. 5 , Koeppe S. 2 , Lutz T. 5 , Mayr C. 2 , Mosthaf F. 6 ,
Schewe K. 7 , Schuler C. 2 , Stephan C. 8 , Wolf E. 4 ,
Steinmueller J. 9 , Waesle B. 9 , Tappe A. 9 , Wellmann E. 9
1 Praxen Zentrum Blondelstrasse (PZB), Aachen, Germany,
2 HIV treating physician, Berlin, Germany, 3 HIV treating physician,
Munich, Germany, 4 HIV Research and Clinical Care
Center, Munich, Germany, 5 HIV treating physician, Frankfurt
a.M., Germany, 6 HIV treating physician, Karlsruhe, Germany,
7 HIV treating physician, Hamburg, Germany, 8 Klinikum der
Johann-Wolfgang-Goethe Universität, Frankfurt a.M.,
Germany, 9 Roche Pharma AG, Grenzach-Wyhlen, Germany
Objective: The aim of the Rainbow Cohort – an international
observational study - is to assess the efficacy and tolerability
of initiating treatment with, or switching treatment to the new
saquinavir (SQV) Invirase® 500 mg film-coated tablet (FCT)
formulation. We present an interim 24-week subgroup analysis
of antiretroviral therapy (ART)-naïve patients in Germany
participating in the Rainbow Cohort.
Methods: Multicenter, prospective, open label, observational
study. Efficacy assessments include changes in viral load
(VL) and CD4 count, tolerability assessments include changes
in liver enzymes and lipid levels from baseline.
Results: 24-week interim analysis of n=142 ART-naïve patients
from the German cohort. Baseline characteristics: 85%
male, median age 39 years, median time since first diagnosis
1 year (IQR 0 - 4), median baseline viral load (VL) 111,204
HIV RNA copies/mL (IQR 19,000 – 306,000), median CD4
count 198 cells/mm3 (IQR 107 - 204). In week 24 the proportion
of patients achieving a VL < 400 copies/mL was 92.7%
in the as treated (AT)- and 85.2% in the intent-to-treat (non
completers=failures) [ITT (NC=F)] population. 73.4 % (AT)
and 67.4% [ITT (NC=F)] of patients respectively, had undetectable
VL < 50 copies/mL in week 24. Median increase in
CD4 cell count was + 147 cells/mm3 (IQR 70 - 237). Median
changes in triglycerides, total cholesterol, ALT, AST and g-
GT were +12 mg/dL (IQR -39 - 85), +26 mg/dL (8 - 46), -6
U/L (-21 - 3), -3 U/L (-13 - 1), -2 U/L (-25 - 5), respectively.
There were no clinical grade 3 and 4 adverse events. SQV
treatment was stopped in 7.7 % of the patients (1 patient due
to virological failure, 3 pts due to side effects, 3 pts were lost
to follow up, 4 pts due to other reasons).
Conclusions: These data confirm that SQV/r is effective and
well tolerated in ART-naïve patients in the real-life clinical
setting. The results of this observational cohort of treatment
with the new 500 mg tablet formulation of SQV are consistent
with high efficacy and tolerability results seen in controlled
studies with SQV/r.