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R. Steingrover, S. Jurriaans, J. Lange, J.M. Prins on behalf of the Primo-SHM study group

Transient HAART During PHI Prolongs the Total Time Off HAART in Patients Presenting with PHI: Data from the Dutch Primo-SHM Cohort. R. Steingrover, S. Jurriaans, J. Lange, J.M. Prins on behalf of the Primo-SHM study group. Introduction. Is temporary HAART during PHI beneficial?

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R. Steingrover, S. Jurriaans, J. Lange, J.M. Prins on behalf of the Primo-SHM study group

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  1. Transient HAART During PHI Prolongs the Total Time Off HAART in Patients Presenting with PHI: Data from the Dutch Primo-SHM Cohort R. Steingrover, S. Jurriaans, J. Lange, J.M. Prins on behalf of the Primo-SHM study group

  2. Introduction • Is temporary HAART during PHI beneficial? • To the individual: • lower plasma viral load set-point? • longer time off HAART?

  3. Lower viral set-point: RCT Steingrover et al, Temporary ART During PHI Lowers the Viral Set-point: the Prospective Randomized Trial Primo-SHM CROI 2008, poster 698b

  4. Introduction • Is temporary HAART during PHI beneficial? • To the individual: • lower plasma HIV viral load? • longer time off HAART?

  5. Introduction • Is temporary HAART during PHI beneficial? • To the individual: • lower plasma HIV viral load? • longer time off HAART? • Objective of current analysis

  6. Methods • Patients with PHI • Negative/indeterminate WB • Detectable plasma HIV-1 RNA • or • Negative screening < 180 days • Participating in Prospective Primo-SHM Trial or Cohort

  7. Methods • Primo-SHM Trial: randomization • No treatment • 24 weeks early HAART • 60 weeks early HAART • Primo-SHM Cohort: physician/patient choice: • No treatment • early HAART

  8. Methods • Objectives, to analyze: • the effect of transient HAART during PHI: the total time off antiretroviral therapy • factors associated with a longer total time off HAART

  9. Methods Endpoint: restart of HAART • Two times CD4 < 350 • Symptomatic HIV-1 disease • CDC-B or C Statistical analysis: • Corrected KM • Corrected Cox’ proportional hazards analysis

  10. Correction of KM analysis

  11. Correction of KM analysis

  12. Correction of KM analysis

  13. Results • 141 Patients identified at Feb 1st 2008 • 102 in the analysis

  14. Flow of patients

  15. Baseline and epidemiological data

  16. Results (cont’d) • 47 untreated • 23 started HAART for low CD4 count, 2 for symptomatic HIV-1 disease • 55 early HAART + interruption • 10 restarted HAART, all for low CD4 counts

  17. Kaplan Meier plot of the time to (re)start HAART, corrected for the duration of early HAART p = 0.001

  18. Results corrected KM • Total time off HAART: • 126 (95%CI: 104-150) weeks for untreated patients • 181 (161-201) weeks for treated patients • p=0.001

  19. p < 0.001 The time to (re)start HAART in the Cox' proportional hazards model adjusted for age and baseline CD4 count.

  20. Conclusion • Transient, early HAART during PHI prolongs the total time that patients can remain off HAART • Other independent predictors: • Age • CD4 count at baseline • Note: pVL at baseline is not an independent predictor

  21. Discussion • What is the effect of details of early treatment: • timing • duration • Is treatment of PHI worth the effort? • Confirmed by randomized trials? • Primo-SHM • SPARTAC

  22. AMC Dpt Internal Medicine - Jan Prins Marlous Grijsen Joep Lange Nicollette Hulshof, Marian Nievaard, Bonnie Slegtenhorst Harold Doevelaar Dpt Experimental Immunology - Hanneke Schuitemaker Dpt Medical Microbiology Suzanne Jurriaans, Nicole Back Dpt Experimental Virology Georgios Pollakis UMC Utrecht Dpt Immunology - Frank Miedema HIV monitoring foundation Frank de Wolf - Rosalind Beard Participating sites Maastricht UMC EMC, Rotterdam HAGA, Den Haag KGH, Haarlem Leiden UMC MC Leeuwarden MST, Enschede OLVG, Amsterdam St. Elizabeth, Tilburg UMC Nijmegen All study participants Acknowledgements

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