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Switch studies in virologically suppressed patients

Switch studies in virologically suppressed patients. Switch to TDF/FTC/EFV AI266-073 Switch to FTC + ddI + EFV ALIZE Switch to ATV/r-containing regimen ATAZIP Switch to ATV ± r-containing regimen SWAN SLOAT Switch to ATV-containing regimen ARIES INDUMA Switch to ATV/r monotherapy

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Switch studies in virologically suppressed patients

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  1. Switch studies in virologically suppressed patients Switch to TDF/FTC/EFV AI266-073 Switch to FTC + ddI + EFV ALIZE Switch to ATV/r-containing regimen ATAZIP Switch to ATV±r-containing regimen SWAN SLOAT Switch to ATV-containing regimen ARIES INDUMA Switch to ATV/r monotherapy ATARITMO Swedish Study ACTG A5201 OREY Synopsis • Switch to LPV/r monotherapy • Pilot LPV/r • M03-613 • American Study • KalMo • OK • OK04 • KALESOLO • MOST • HIV-NAT 077 • Switch to DRV/r monotherapy • MONOI • MONET • Switch to RAL-containing regimen • Canadian Study • CHEER • Montreal Study • EASIER • SWITCHMRK • SPIRAL

  2. M03-613 Study: Switch to LPV/r monotherapy • Design Randomisation 2 : 1 Open-label W96 * N = 104 HIV+, ARV-naïve HIV-1 RNA > 1000 c/mL Any CD4 cell count No documented resistance N = 51 * Patients with HIV-1 RNA < 50 c/mL on 3 consecutive measures between W24 and W48 discontinued ZDV/3TC and remained on LPV/r monotherapy • Endpoints • Primary: proportion of patients with HIV-1 RNA < 50 c/mL at W96 (ITT-exposed, previous-failure = failure analysis) ; 80% power to detect a difference of 25% in response rate • Secondary: lipoatrophy (> 20% loss in limb fat) at W96 ; 70% power to detect a 20% difference in the mean change in limb fat percentage Cameron DW, JID 2008;198:234-40 M03-613

  3. M03-613 Study: Switch to LPV/r monotherapy Baseline characteristics and patient disposition • 79% of patients were male • 65% were white • Mean age was 38 years • Mean baseline HIV-1 RNA was 4.9 log10 c/mL • Patients in the LPV/r group had a higher mean baseline HIV-1 RNA and a higher mean age • 112 patients (57% in the LPV/r group and 69% in the EFV group) completed their assigned treatment regimen out to week 96 • In the LPV/r group, after a median of 24 weeks, 92 patients (88%) simplified to LPV/r monotherapy Cameron DW, JID 2008;198:234-40 M03-613

  4. LPV/r mono EFV M03-613 Study: Switch to LPV/r monotherapy Outcome at week 96 ITT-E Non completion= failure analysis* % HIV-1 RNA < 50 c/mL HIV-1 RNA < 50 c/mL 100 80 63 61 60 60 48 40 20 0 95% CI for the difference = - 29% ; 4% 95% CI for the difference = - 19% ; 13% * Confirmed virologic failure before W96 and reintensified therapy with NRTIs were ignored * major PI mutations in all 4 cases Cameron DW, JID 2008;198:234-40 M03-613

  5. Discontinued LPV/r or EFV HIV-1 RNA > 500 copies/mL HIV-1 RNA 50-500 copies/mL HIV-1 RNA < 50 copies/mL M03-613 Study: Switch to LPV/r monotherapy HIV-1 RNA level and discontinuation status, by visit, through 96 weeks % % LPV/r EFV 100 100 80 80 60 60 40 40 20 20 0 0 0 16 32 48 64 80 96 0 16 32 48 64 80 96 Weeks Weeks Cameron DW, JID 2008;198:234-40 M03-613

  6. M03-613 Study: Switch to LPV/r monotherapy Median percent change from baseline in limb fat and trunk fat Scatter plot of percent change from baseline to W96 in limb fat vs trunk fat 30 100 Lipohypertrophy 20 * 75 10 50 * p < 0.001 0 25 % change in limb fat at week 96 LPV/r (N = 74) EFV (N = 32) * LPV/r limb fat -10 0 EFV limb fat -20 -25 Lipoatrophy (p < 0.001) LPV/r trunk fat EFV trunk fat Weeks -30 -50 0 24 48 72 96 -40 0 40 80 120 % change in trunk fat at week 96 Cameron DW, JID 2008;198:234-40 M03-613

  7. M03-613 Study: Switch to LPV/r monotherapy Adverse events • Most common (frequency > 5%) moderate or severe adverse events related to treatment • LPV/r monotherapy group • Diarhoea: 15% • Nausea: 14% • EFV group • Asthenia: 12% • Dizziness: 12% • Insomnia: 12% • Rash: 10% • Depression: 6% • Most frequent grade 3 or 4 laboratory abnormalities • LPV/r monotherapy group • Total cholesterol > 7.8 mmol/L: 12% ; Triglycerides > 8.5 mmol/L: 7% • Amylase > 2 ULN: 6% • EFV group • Amylase > 5 ULN: 10% • ALAT > 5 ULN: 6% Cameron DW, JID 2008;198:234-40 M03-613

  8. M03-613 Study: Switch to LPV/r monotherapy • Conclusions • LPV/r monotherapy was less effective than EFV + ZDV/3TC in maintaining virologic suppression: time to confirmed virologic rebound was shorter with LPV/r monotherapy • Lipoatrophy was significantly lower in the LPV/r monotherapy group Cameron DW, JID 2008;198:234-40 M03-613

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