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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. AI266073 Study: Switch PI or NNRTI to TDF/FTC/EFV • Design Randomisation* 2 : 1 Open-label W48 306 HIV+ ≥ 18 years ARV with PI+r + ≥ 2 NRTIs or NNRTI +≥ 2 NRTIs (exclusion of patients on TDF + FTC + EFV) No history of prior virologic failure HIV-1 RNA < 200 c/mL > 3 months Creatinine clearance ≥ 60 mL/min N = 97 N = 203 fdc = fixed drug combination * Randomisation stratified on the use of PI or NNRTI (53% patients on PI, 47% on NNRTI) • Objective • Non inferiority in the proportion of patients with HIV-1 RNA < 200 c/mL at W48 (Intent-to-treat analysis, non completer = failure, TLOVR algorithm) ;lower limit of the 95% CI for the difference = -15%, 80% power DeJesus E, JAIDS 2009;51:163-74 AI266073

  3. AI266073 Study: Switch PI or NNRTI to TDF/FTC/EFV Baseline characteristics and patient disposition DeJesus E, JAIDS 2009;51:163-74 AI266073

  4. % 92 100 89 88 87 87 85 83 82 80 60 40 20 97 203 97 203 45 95 52 108 N= 0 HIV-1 RNA < 200 c/mL HIV-1 RNA < 50 c/mL HIV-1 RNA < 50 c/mL Prior NNRTI Prior PI 95% CI for the difference= -5.9 ; 11.1 95% CI for the difference= -6.7 ; 8.8 95% CI for the difference= -3.1 ; 21.8 95% CI for the difference= -14.8 ; 8.4 AI266073 Study: Switch PI or NNRTI to TDF/FTC/EFV Outcome at Week 48 Virologic response (ITT, NC = F, TLOVR) for the whole population and by prior treatment stratum SBR TDF/FTC/EFV DeJesus E, JAIDS 2009;51:163-74 AI266073

  5. AI266073 Study: Switch PI or NNRTI to TDF/FTC/EFV • Other endpoints • Virologic failure • SBR, N = 1 (1.03%) • TDF/FTC/EFV, N = 3 (1.48%) • No significant changes in CD4 cell counts within or betweentreatment arms • Nervous System and Psychiatric Symptoms • Nervous System Symptoms = SBR: 13% vs TDF/FTC/EFV: 22% • Psychiatric Symptoms = SBR: 8% vs TDF/FTC/EFV: 28% • Study drug discontinuation, N = 5, all in TDF/FTC/EFV group(prior PI stratum) • Renal Adverse events • Discontinuation for increase in creatinine, N = 1, on TDF/FTC/EFV • Grade 1 treatment-emergent creatinine elevations = SBR: 3% vs TDF/FTC/EFV: 2%. No Grade ≥ 2 elevation of creatinine DeJesus E, JAIDS 2009;51:163-74 AI266073

  6. 120 120 100 100 80 80 60 60 40 40 20 20 0 0 0 4 12 24 36 48 0 4 12 24 36 48 Study week Study week AI266073 Study: Switch PI or NNRTI to TDF/FTC/EFV Changes in glomerular filtration rate* (mL/min/1.73 m2) TDF/FTC/EFV 203 200 196 188 182 181 129 127 125 121 120 120 SBR 97 95 95 92 89 87 58 57 57 54 51 50 * Evaluated by the MDRD equation TDF/FTC/EFV SBR DeJesus E, JAIDS 2009;51:163-74 AI266073

  7. AI266073 Study: Switch PI or NNRTI to TDF/FTC/EFV • Fasting lipid changes • Overall, no significant differences were seen between treatment arms for fasting total cholesterol and LDL cholesterol • No change in HDL cholesterol overall or in the prior NNRTI stratum • Significant increase in HDL cholesterol in the TDF/FTC/EFV group vs SBR group for patients in the prior PI regimen • For triglycerides, decrease of levels were significantly higher in the TDF/FTC/EFV group and was greatest in the prior PI stratum • Patients’ questionnaires • Preference of TDF/FTC/EFV over the previous regimen • TDF/FTC/EFV regimen considered easier than SBR (p < 0.001) • Patients in the TDF/FTC/EFV group had more symptoms of dizziness or light-headedness compared with the SBR, at W4 (p = 0.018) • Improvement in diarrhoea and loose bowel movements in the TDF/FTC/EFV group for patients with prior PI-based regimen (p = 0.002) DeJesus E, JAIDS 2009;51:163-74 AI266073

  8. AI266073 Study: Switch PI or NNRTI to TDF/FTC/EFV • Conclusions • Patients with stable ARV treatment and virologically suppressed on NNRTI- or PI-based therapy maintained high rates of virological suppression after simplification to a single-tablet regimen of TDF/FTC/EFV • TDF/FTC/EFV was virologically non inferior to maintenance of prior suppressive ARV regimen • Patients on prior PI-based therapy were more likely to experience transient nervous system and psychiatric symptoms ; for 2% of patients, these adverse eventswere treatment-limiting DeJesus E, JAIDS 2009;51:163-74 AI266073

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