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Baseline evaluation in CSF and neuropsycho-logical testing in patients starting Monotherapy
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Reported by Jules Levin
IAC Mexico City Aug 3-8, 2008-08-17
F. Zenger 1, S. Daneel 1, M. Flepp 4, Ch Fux 3 A. Cusini 2, M. Opravil 2, B. Hirschel 5, P. Vernazza 1 and the Swiss HIV Cohort study (SHCS)
1 Cantonal Hospital St.Gallen, 2 University Hospital ZŸrich, 3 University Hospital Bern, 4 Center of infectious disease Switzerland, 5 University Hospital Geneva
INTRODUCTION
Previous Monotherapy studies with protease inhibitors (PI) have shown to successfully suppress plasma viral load for up to 54 month
Concerns remain regarding long- term effects, especially with respect to viral suppression in central nervous system (CNS)
No prognostic markers for Monotherapy failure do exists for patients considering Monotherapy
Patients on continous HAART (cont- HAART) and LPV/r Monotherapy (LPV/r Mono) were compaired with a special emphasis on failure rates in CNS and genital compartment
ABSTRACT
Background:Previous mono therapy with protease inhibitors (PI) have shown to successfully suppress plasma viral load for up to 54 months. Still, concern remains regarding long-term effects, especially with respect to viral suppression in genital and central nervous system (CNS). In addition, no prognostic markers for compartment failure do exist for patients considering PI mono therapy.
In this study, patients on continuous HAART (cont-HAART) and LPV/r mono therapy (LPV/r-mono) were compared, with a special emphasis on failure rates in CNS and genital compartment.
Method: Patients were randomized to either cont-HAART or LPV/r-mono for 48 weeks. At baseline genital secretion, cerebral spinal fluid (CSF) and a neuropsychological (NP) test battery was performed in all patients. Primary endpoint was treatment failure in compartment (CSF, genital).
Results: Current study duration is 5.3 +/- 2.3 month, with 45 patients (men: n=31 (69%); women: n=14) having been randomised (LPV/r-mono n=22; cont-HAART n=23). Median therapy duration in patients is 4.2 years (0.7-15.7 years), with an average age of 44.2 +/- 10.1 years. At baseline all patients had undetectable plasma viral load, with a CD4 of 530 +/- 227 cl/ml (CD4% 29.2 +/- 9.2). Mean CD4 nadir was 179 +/- 126 (CD4% 14.3 +/- 9.0). One patient had a CSF viral load of 82cp/ml (kept on cont-HAART). In NP tests, mean time for Colour trail1&2 completion was 54 +/- 26.2 sec., 103 +/- 46.0 sec, respectively. Average digits entered during 90 sec. (EWIA Digit) were 52 +/- 15.7. Grooved pegboard showed borderline significance between dominant and non-dominant hand (p-value=0.048), with 76 +/- 18.9 sec. and 84 +/- 19.6 sec., respectively. Treatment groups did not differ at baseline, and no significant correlations were found between NP variables and patient characteristics (age, CD4, CD4 nadir).
Conclusion: At baseline, virologically suppressed patients were also undetectable in CSF and had normal NP-tests. Week 48 will show how the 2 treatment arms evolve.
METHODS
At baseline cerebral fluid (CSF) and neurological (NP) test battery (Fig) was performed in all patients
In Color Trail 1, the participant is instructed to draw a line between the numbered circles one after the other, following the number sequence
In Color Trail 2, participant must maintain the sequence of numbers and alternate between pink and yellow
In EWIA Digit Symbol test participants need to assign correct symbols (90 seconds time) to a digit
In the Grooved Pegboard ripped sticks have to be placed in grooved holes
RESULTS
At baseline, all 55 patients (80% men) had undetectable plasma viral load and a CD4 count of 502 ±214 cl/ml (CD4% 29.1 ±9.1). Mean CD4 nadir was 167 ±120 (CD4% 14 ±9.0). Only one patient had a CSF viral load of 82 cp/ml (kept on cont-HAART).
Mean therapy duration in these patients was 5.8 years (1.9-13.6 years). The average age was 45.3 ±9.6 years. Treatment groups didn't differ at baseline, and no significant correlation was found between NP variables and patient characteristics (age, CD4, CD4 nadir). Test results were compared with historical controls (see table and references)
AUTHOR CONCLUSIONS
With the exception of one patient, viral load in CSF was suppressed and patients showed normal NP-test results compaired to other HIV cohorts
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