Time to HAART Resume after Structured Treatment Interruption is Strongly Associated with HIV DNA Lev - PowerPoint PPT Presentation

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Time to HAART Resume after Structured Treatment Interruption is Strongly Associated with HIV DNA Lev

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Time to HAART Resume after Structured Treatment Interruption is Strongly ... C. Rouzioux3, D. Costagliola2 and The ANRS 116 SALTO study group. 1Georges Pompidou ... – PowerPoint PPT presentation

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Title: Time to HAART Resume after Structured Treatment Interruption is Strongly Associated with HIV DNA Lev


1
Time to HAART Resume after Structured Treatment
Interruption is Strongly Associated with HIV DNA
Level in PBMC at Interruption Results of the
ANRS 116 SALTO trial
  • C. Piketty1, L. Weiss1, S. Bachir-Cherif2, L.
    Assoumou2,
  • M. Burgard3, J-M. Ragnaut4, M. Bentata5, P-M.
    Girard6,
  • C. Rouzioux3, D. Costagliola2 and The ANRS 116
    SALTO study group

1Georges Pompidou hosp and Univ Paris 5, Paris
2INSERM U720 and Univ Pierre et Marie Curie,
Paris 3Necker hosp and Univ Paris 5
4Pellegrin hosp, Bordeaux 5Avicenne hosp,
Bobigny 6Saint-Antoine hosp, Paris, France.
2
Background
  • Patients who started HAART under previous more
    aggressive treatment guidelines may wish to
    discontinue HAART
  • Predictors of outcome in these patients would
    allow clinicians to make recommendations for
    these patients
  • Measurable virologic and immune markers may
    reflect clinical stability after treatment
    interruption (TI)

3
Primary hypothesis
  • A subset of patients who started HAART early
    based on previous guidelines (1996-1997) could
    safely discontinue HAART without significant risk
    of disease progression

4
Objectives
  • The aim of the study was to evaluate the safety
    and efficacy of TI in chronically HIV-infected
    patients who started treatment based on earlier
    guidelines and to assess the predictive factors
    of the duration of TI including HIV DNA level in
    PBMCs at TI

5
Methods
  • A prospective, open-label, multicentre trial of
    TI in patients who have been treated
  • with CD4 cell count gt350 x106/L and plasma
    HIV-RNA (VL)lt50,000 copies/ml,
  • who have CD4 cell count gt450 x106/L and stable VL
    lt5000 copies/ml and,
  • Stable HAART treatment within 6 months prior to
    inclusion and,
  • who experienced no more than one prior treatment
    failure.
  • Criteria to resume HAART were a decrease in CD4
    cell count to lt 300 x106/L or the occurrence of a
    B or C defining event.

6
Baseline demographics
7
Baseline laboratory values
8
HAART history
9
Change in CD4 cell count
10
Change in HIV viral load
11
Change in HIV DNA in PBMC
12
Results Primary End Point
  • To month 12
  • 2 patients CD4 lt 300/mm3
  • 1 severe thrombocytopenia
  • No CDC C events
  • 5 reinitiated HAART for other reasons
  • Month 12 Month 24
  • 7 additional patients CD4 lt 300/mm3
  • 1 additional severe thrombocytopenia
  • 1 CDC C event (cutaneous KS with CD4364/mm3)
  • 7 reinitiated HAART for other reasons
  • From Month 24
  • 11 additional patients CD4 lt 300/mm3 (total 20)
  • No CDC B event (total 2)
  • 1 additional CDC C event (cutaneous KS with
    CD4648/mm3) (total 2)
  • 7 reinitiated HAART for other reasons (total 19)

13
Proportion of patient who did not meet the
criteria to resume HAART
CD4 lt 300 or CDC B or C event
14
Predictors of time to CD4 lt 300 or CDC B or C
event (24/99)
15
Predictors of time to CD4 lt 300 or CDC event by
month 36multivariate analysis
16
Cardiovascular events
  • 232.3 person-years of follow-up
  • 4 cardiovascular events including one death
  • 2 validated
  • 2 validation pending
  • 1.7/100 P-Y
  • No renal or hepatic event

17
Discussion
  • Single treatment interruption resulted in low
    progression rate at 36 months in this selected
    population
  • 31 resume therapy for CD4 lt300 or B/C CDC event
  • Few CDC C clinical events
  • 2 cutaneous KS with CD4 gt 350/mm3
  • 0.9 /100 P-Y
  • Rapid initial CD4 cell loss after stopping HAART
    then gradual loss
  • Predictors of month 36 outcome
  • HIV DNA in PBMCs at entry gt 2.56 log
  • Nadir CD4
  • Prior AIDS events

18
Conclusion
  • In patients who started HAART based on earlier
    guidelines, long term treatment interruption
    resulted in a low absolute risk of AIDS defining
    events or cardiovascular events
  • In addition to CD4 nadir, HIV-DNA level is a
    useful tool to select patients at risk of disease
    progression if they undergo a prolonged treatment
    interruption

19
Acknowledgements
  • ANRS 116 SALTO study group
  • Hôpital Avicenne, Bobigny (M. Bentata) Hôpital
    Européen Georges Pompidou, Paris (M. Kazatchkine,
    L. Weiss, C. Piketty, M. Karaman) Hôpital Saint
    Antoine, Paris (P-M Girard, J-L Meynard )
    Hôpital Pitié Salpétrière, Paris (C. Katlama, R.
    Tubiana, A. Simon) Hôpital Bicêtre (J-F
    Delfraissy, C. Gougard) Hôpital Henri Mondor,
    Creteil (Y. Levy, ) Hôpital Tenon, Paris (G.
    Pialoux) Hôpital Necker, Paris (J-P Viard)
    Hôpital Saint Jacques, Besançon (B. Hoen)
    Hôpital Bichat, Paris (P. Yeni, R. Landman)
    Hôpital Sainte Marguerite, Marseille (JA.
    Gastaut, I. Poizot-Martin) Hôpital Pellegrin,
    Bordeaux (JM Ragnaut) Hôpital Saint Jacques,
    Bordeaux (P. Morlat) Hôpital Brabois, Nancy (T.
    May) CHU de Caen (C. Bazin) CHU Strasbourg (JM.
    Lang) Hôpital Purpan, Toulouse (P. Massip)
    Hôpital de lArchet, Nice (JP. Cassuto) Hôpital
    Edouard Herriot, Lyon Hôpital Bretonneau, Tours
    (P. Choutet)
  • ANRS 116 SALTO Scientific committee
  • C. Piketty, L. Weiss, D. Costagliola, C.
    Rouzioux, M. Burgard, C. Goujard, J-P Viard, Y.
    Levy, G. Pialoux, J-L Meynard, S. Bachir Cherif,
    L. Assoumou, MJ. Commoy
  • ANRS 116 SALTO DSMB
  • JL. Pellegrin, C. Fagard, L. Morand-Joubert, J.
    Gilquin
  • THE PATIENTS ENROLLED IN THE ANRS 116 SALTO STUDY
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