Switch to ATVr containing regimen ATAZIP Switch to ATV rcontaining regimen SWAN Study SLOAT Study Switch to ATV containing regimen ARIES Study INDUMA Study ASSURE ID: 1037036
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1. Switch to ATV- or ATV/r-containing regimenSwitch to ATV/r-containing regimenATAZIPSwitch to ATV ± r-containing regimenSWAN StudySLOAT StudySwitch to ATV-containing regimenARIES StudyINDUMA StudyASSURE Study
2. DesignEndpointsPrimary: non inferiority in the proportion of patients with HIV-1 RNA < 50 c/mL at W48 of the maintenance phase (non completer = failure, intent-to-treat analysis), lower limit of the 95% CI for the difference = - 15%, 80% power) Secondary: treatment failure, CD4, fasting lipids, adverse eventsContinue ATV/r + 2 NRTIs**Switch to ATV 400 mg qd + continue 2 NRTIs*** Randomisation if 2 consecutives HIV-1 RNA < 50 c/mL between W16 and W28** TDF not allowedGhosn J, Antiviral Therapy 2010;15:993-1002INDUMAINDUMA Study: Switch ATV/r to ATVRandomisation*1 : 1Open-labelHIV+ARV-naïveHIV-1 RNA ≥ 5000 c/mLCD4 ≥ 50/mm3N = 87N = 85W48ATV/r 300/100 mg qd+ 2 NRTIs**Induction phase26 to 30 weeksMaintenance phaseN = 252
3. ATV/rN = 85ATVN = 87Median age, years3535Female28%25%History of Class C AIDS events2%0Hepatitis B or C co-infection24%19%Median HIV-1 RNA at baseline of induction phase, log10c/mL4.864.85Median CD4 cell count at baseline of induction phase, /mm3265255NRTIs use at baseline : ABC + 3TC / ZDV + 3TC53% / 31%51% / 33%Discontinuation before W48, n (%)13 (15.3%)9 (10.3%)For adverse event41For virologic failure00Baseline characteristics and patient dispositionGhosn J, Antiviral Therapy 2010;15:993-1002INDUMAINDUMA Study: Switch ATV/r to ATV
4. Outcome at week 48 of the maintenance phaseNC=F: Non completer equals FailureHIV RNA < 50 c/mLOther endpointsVirological rebound(HIV-1 RNA ≥ 50 c/mL)ATV/r: 7%ATV: 13%Time to treatment failure or to virological rebound not significantly different between the 2 groupsSerious adverse eventsATV/r: 3 (4%)ATV: 4 (5%)Ghosn J, Antiviral Therapy 2010;15:993-1002INDUMAINDUMA Study: Switch ATV/r to ATV75897888ITT, NC = FObserved dataATV/rATV%02040608010095% CI for the difference= - 9.8 ; 15.595% CI for the difference= -11.8 ; 8.7
5. ATV/rATVFasting lipidsMean value at end of inductionMean % change at W48 of maintenanceMean value at end of inductionMean % change at W48 of maintenanceTotal cholesterol*188 + 4.3+ 1.4192 + 5.1- 4.7HDL cholesterol*51 + 1.6+ 0.853 + 1.8+ 3.7LDL cholesterol*109 + 3.7- 2.1109 + 4.3- 0.7Non HDL cholesterol*137 + 4.4+ 1.1140 + 5.1- 7.4Triglycerides*138 + 8.9+ 9.8**164 + 18.0- 27**Adverse events of all grades or with a frequency ≥ 5% reported in maintenance phaseHyperbilirubinemia28%16%Jaundice4%0ALT increase6%5%AST increase1%6%Nausea5%5%Diarrhoea8%6%Abdominal pain4%6%* mg/dL, last observation carried forward ; ** p < 0.0001Ghosn J, Antiviral Therapy 2010;15:993-1002INDUMAINDUMA Study: Switch ATV/r to ATVLipid changes and adverse events during maintenance phase
6. ConclusionsAfter induction with ritonavir-boosted ATV, switching to unboosted ATV shows non-inferior efficacy and a more favourable safety profile than a triple combination regimen based on boosted ATV for up to 48 weeksSwitching to ATV might represent a feasible treatment optionin patients with virologic suppression on ATV/rGhosn J, Antiviral Therapy 2010;15:993-1002INDUMAINDUMA Study: Switch ATV/r to ATV