Die Toronto Konferenz. K. Arasteh Auguste-Viktoria-Klinikum

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1 Die Toronto Konferenz K. Arasteh Auguste-Viktoria-Klinikum

2 Subjektive Schwerpunkte Medizinische Prävention Monotherapie CD4 guided treatment interuption (CD4-TI)

3 HIV Prävention (Gita Ramjee)

4 Rationale

5 Herausforderungen und Möglichkeiten

6 Was wird wo gemacht?

7 Studien mit Microbiciden

8 Einfachere Anwendung?

9 Es geht den Männern an den Kragen

10 Jetzt schlucken alle

11 Für Menschen die mehr als bis 3 zählen können

12 LPV/r Monotherapie Studien LPV/r Monotherapy MONARK (n=138, LPV/r vs LPV/r+ZDV/3TC) LPV/r Induction/Maintenance M (n=155, LPV/r+ZDV/3TC LPV/r vs EFV+ZDV/3TC) LPV/r Simplification OK-2004 (n=198, LPV/r simplification vs maintain LPV/r + 2 NRTIs regimen)

13 MONARK Study Design and Baseline Characteristics Entry criteria Antiretroviral naïve, HIV-1 RNA <100,000 c/ml, CD4 > 100 cells/mm3 Baseline characteristics: Mean (range) HIV-1 RNA (log10 c/ml): 4.39 ( ; mono) vs 4.34 ( ; Triple) CD4 (cell/µl): 257 ( ; mono) vs 234 ( ; Triple) Primary efficacy analysis Proportion of subjects with HIV-1 RNA < 400 copies/ml at Week 24 AND < 50 copies/ml at Week 48 Delfraissy JF. et al., XVI IAC, Toronto, 2006, #THLB0202

14 MONARK Study Design and Baseline Characteristics Screening LPV/r SGC 400/100 mg BID, n=83 96 weeks LPV/r SGC 400/100 mg + AZT/3TC 300/150 mg) BID, n=53 Wk 24 Wk 48 Delfraissy JF. et al., XVI IAC, Toronto, 2006, #THLB0202

15 Virologic Response HIV-1 RNA < 50 copies/ml (ITT, M=F) % Patients < 50 c/ml (ITT, 95% CI) AZT/3TC/LPVr, ITT, missing = failure LPVr, ITT, missing = failure 75% 71% 0 Sample Size LPV/r Arm Triple Arm Week Delfraissy JF. et al., XVI IAC, Toronto, 2006, #THLB0202

16 Virologic Response HIV-1 RNA < 50 copies/ml (OT) Delfraissy JF. et al., XVI IAC, Toronto, 2006, #THLB0202

17 Resistance Testing Genotypic testing performed: at time of virologic failure (HIV-1 RNA > 500 c/ml after nadir < 400 c/ml, or HIV-1 RNA > 500 c/ml at time of discontinuation after nadir < 400 c/ml) at investigator request for subject safety Subjects qualifying for resistance testing Genotypic results available Subjects w/ PI resistance mutations Subjects w/ AZT resistance mutations Subjects w/ 3TC resistance mutations LPV/r (n=83) 21 (25%) 21 2*/21 0/21 0/21 LPV/r + AZT/3TC (n=53) 3 (6%) 3 0/3 0/3 1/3 * No phenotypic resistance Norton M. et al., XV IHDRW, Sitges, 2006, #74

18 100% 80% 60% MONARK: Summary of Disposition and Virologic Response LPV/r Discontinued On study, HIV RNA > 400 c/ml LPV/r + AZT/3TC 40% 20% 0% Week On study, HIV RNA c/ml On study, HIV RNA < 50 c/ml Week Delfraissy JF. et al., XVI IAC, Toronto, 2006, #THLB0202

19 M03-613: Study Design and Baseline Characteristics Inclusion criteria Antiretroviral naïve, HIV-1 RNA >1000 c/ml, Any CD4 count No resistance to study drugs Baseline characteristics: Mean (range) HIV-1 RNA (log10 c/ml): 5.0 ( ) in LPV arm vs 4.8 ( ) in EFV arm CD4 count (cell/µl): 227 (6-773) in LPV arm vs 250 (3-756) in EFV arm Open label, 2:1 randomization, Primary outcome: HIV-1 viral load < 50 c/ml at week 96 (24 months) Primary analysis: intention-to-treat, prior failure (> 50 c/ml x 2) = failure Cameron DW et al., XVI IAC, Toronto, 2006, #THLB0201 M03-613

20 M03-613: Study Design and Baseline Characteristics Screening LPV/r SGC 400/100 mg BID + ZDV/3TC (n=104) EFV 600 mg QD + ZDV/3TC (n=51) LPV/r 400/100 mg BID LPV/r 400/100 mg BID + ZDV/3TC 96 weeks Cameron DW et al., XVI IAC, Toronto, 2006, #THLB0201

21 100% 80% 60% 40% M03-613: Summary of Disposition and Virologic Response LPV/r Discontinued On study, HIV RNA >500 c/ml On study, HIV RNA c/ml EFV 20% 0% Week On study, HIV RNA <50 c/ml Week Cameron DW et al., XVI IAC, Toronto, 2006, #THLB0201

22 OK04 Study Design and Baseline Characteristics Entry criteria HIV-1 RNA <50 copies/ml for > 6 months, on LPV/r + 2 NRTIs for > 1 month, no virological failure to PI Baseline characteristics Median time <50 copies/ml: Mono 19 (11-31) vs Triple 17 (11-28) Mean CD4 count (range, cell/µl): Mono 474 ( ) vs Triple 473 ( ) Primary study endpoint: Therapeutic failure by Week 48 2 viral loads > 500 c/ml 2 weeks apart OR Change of randomized therapy for reasons different from re-induction OR Treatment discontinuation OR Lost to follow-up Arribas JR. et al., XVI IAC, Toronto, 2006, # THLB0203

23 OK04 Study Design and Baseline Characteristics Screening after 6m <50c/ml LPV/r 400/100 mg BID No NRTIs Mono (n=100) Maintain current regimen 2 NRTIs Triple (n=98) 96 weeks Arribas JR. et al., XVI IAC, Toronto, 2006, # THLB0203

24 100% 80% OK04: Summary of Disposition and Virologic Response OK Triple Discontinued 60% On study, HIV RNA >500 40% On study, HIV RNA % 0% Week Arribas JR. et al., XVI IAC, Toronto, 2006, # THLB0203 On study, HIV RNA < Week

25 CD4+ Cell Count Guided Treatment Interruption (CD4-TI): Rationale HAART hat das große Sterben in den Industrienationen beendet, aber: Behandlungsmüdigkeit Entwicklung von Resistenzen Kardiovaskuläre und metabolische Komplikationen Hohe Kosten CD4+ cell count guided TIs könnten theoretisch Vorteile und Nachteile dieser Therapie ausgleichen

26 CD4+ Cell Count Guided TIs: Studiendesign Parameter Staccato [3] (N = 326) SMART [4] (N = 5472) Arms Randomized 1:2 CT, TI Randomized 1:1 CT, TI CD4+ count at entry (cells/mm³) Inclusion VL (copies/ml) > 350 < 500 > 350 None specified Study design Resume therapy if CD4+ count < 350 Resume therapy if CD4+ count < 250 Endpoints CD4+ count < 350; progression; death; development of resistance; complications HIV disease progression or death *Conducted in developing nations 1. Skiest D, et al. CROI Abstract Danel C, et al. CROI Abstract 105 LB. 3. Ananworanich J, et al. CROI Abstract El-Sadr W, et al. CROI Abstract 106 LB.

27 CD4+ Cell Count Guided TIs: Baseline Data and Outcomes Parameter Staccato [3] (N = 326) SMART [4] (N = 5472) Median time on ARV before study, mos Median age, yrs Median CD4+ count, cells/mm³ at entry (TI arm) Median nadir CD4+ count PYFU in TI arm AIDS or death/100 years TI arm CT arm Endpoint events Progression Death (non-aids) Trial stopped

28 CD4+ Cell Count Guided TIs: Staccato and SMART Staccato [1] 80% on SQV/r-based regimens 2% resistance rate, similar in each arm No difference in resistance profiles between groups Parameter Median CD4+ count, cells/mm³ CD4+ > 350 cells/mm³, % Baseline After HAART retreatment TI Arm Virologic failure, n 9 Resuppressed, % 91 CT Arm Time on HAART, % SMART [2] Treatment experienced cohort Parameter Median time on HAART at baseline, yrs TI Arm Treatment naive, % 4.5 Prior clinical AIDS 24.7 Percent of time on tx below CD4+ thresholds < 200 < 250 < 350 Clinical AIDS or death/100 PY CT Arm Ananworanich J, et al. CROI Abstract El-Sadr W, et al. CROI Abstract 106 LB, Lundgren J. et al Toronto, Abstract

29 Studieneinschluss Smart Studie

30 Primäre Endpunkte

31 Primäre Endpunkte

32 Primäre Endpunkte

33 Primäre Endpunkte

34 Primäre Endpunkte

35 Primäre Endpunkte

36 CD4+ Cell Count Guided TIs: Summary Bei Behandlungsunterbrechungen sollte ab 350 CD4 Zellen/mm 3 mit der HAART wieder begonnen werden Patienten mit Viruskontrolle < 50c/ml sollten besonders engmaschig kontrolliert werden (Allgemeininternistisch, Kardiologisch) Nach Möglichkeit nur in Studien um weitere Erkenntnisse bezüglich der Indikation zu erhalten

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