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?
• To the individual:– lower plasma viral load set-point?– longer time off HAART?
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
Introduction
• Is temporary HAART during PHI beneficial?• To the individual:
– lower plasma HIV viral load?– longer time off HAART?
Introduction
• Is temporary HAART during PHI beneficial?• To the individual:
– lower plasma HIV viral load?– longer time off HAART?
• Objective of current analysis
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
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
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
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
Correction of KM analysis
Correction of KM analysis
Survival proportions
0 25 50 75 100 1250
50
100 UntreatedTreated
Time
Per
cen
t S
urv
ival
Correction of KM analysis
Results
• 141 Patients identified at Feb 1st 2008• 102 in the analysis
Flow of patients
141 Patients identified
5 Lost
136 Enrolled32 Still on early HAART
2 Protocol violation
47 Untreated 55 Transient HAART
102 In analysis
51 Primo-SHM Trial
51 Primo-SHM Cohort
Baseline and epidemiological data
Untreated early HAART P
N 47 55
Age 38 (36-41) 40 (37-42 0.4
Male 45 (96%) 53 (96%) 0.7
MSM 37 (79%) 46 (84%) 0.5
Caucasian 37 (79%) 52 (95%) 0.2
HIV-1 RNA 5.2 (4.9-5.5) 4.9 (4.6-5.2) 0.1
CD4 cells 516 (446-587) 565 (502-628) 0.3
Wks SC to HAART - 5 (3-7)
Duration of early HAART (wks, range)
- 28 (21-62)
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
Untreated Transient HAART p
CD4 at (re)start
222 (179-266) 254 (190-319) 0.4
Corrected Time off HAART (weeks)250.00200.00150.00100.0050.000.00
On
e M
inu
s C
um
Su
rviv
al1.0
0.8
0.6
0.4
0.2
0.0
Early HAARTUntreated
group
Time to (re)start HAART
Kaplan Meier plot of the time to (re)start HAART, corrected for the duration of early HAART
p = 0.001
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
The time to (re)start HAART in the Cox' proportional hazards modeladjusted for age and baseline CD4 count.
Corrected Time off HAART (weeks)200.00150.00100.0050.000.00
On
e M
inu
s C
um
Su
rviv
al1.0
0.8
0.6
0.4
0.2
0.0
Early HAARTUntreated
group
Time to (re)start HAART
p < 0.001
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
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
AcknowledgementsAMC
• 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
Top Related