Download
switch studies in virologically suppressed patients n.
Skip this Video
Loading SlideShow in 5 Seconds..
Switch studies in virologically suppressed patients PowerPoint Presentation
Download Presentation
Switch studies in virologically suppressed patients

Switch studies in virologically suppressed patients

124 Views Download Presentation
Download Presentation

Switch studies in virologically suppressed patients

- - - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript

  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