1. Switch to ATV- or ATV/r-containing regimen Switch to ATV/r-containing regimen  ATAZIP Switch to ATV ± r-containing regimen  SWAN Study  SLOAT Study Switch to ATV-containing regimen  ARIES Study  INDUMA Study  ASSURE Study

2.  Design  Endpoints –Primary: 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 events Continue 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 allowed Ghosn J, Antiviral Therapy 2010;15:993-1002 INDUMA INDUMA Study: Switch ATV/r to ATV Randomisation* 1 : 1 Open-label HIV+ ARV-naïve HIV-1 RNA ≥ 5000 c/mL CD4 ≥ 50/mm 3 N = 87 N = 85 W48 ATV/r 300/100 mg qd + 2 NRTIs** Induction phase 26 to 30 weeks Maintenance phase N = 252

3. ATV/r N = 85 ATV N = 87 Median age, years35 Female28%25% History of Class C AIDS events2%0 Hepatitis B or C co-infection24%19% Median HIV-1 RNA at baseline of induction phase, log 10 c/mL 4.864.85 Median CD4 cell count at baseline of induction phase, /mm 3 265255 NRTIs use at baseline : ABC + 3TC / ZDV + 3TC53% / 31%51% / 33% Discontinuation before W48, n (%)13 (15.3%)9 (10.3%) For adverse event41 For virologic failure00 Baseline characteristics and patient disposition Ghosn J, Antiviral Therapy 2010;15:993-1002 INDUMA INDUMA Study: Switch ATV/r to ATV

4. Outcome at week 48 of the maintenance phase NC=F: Non completer equals Failure HIV RNA < 50 c/mLOther endpoints  Virological 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 groups  Serious adverse events –ATV/r: 3 (4%) –ATV: 4 (5%) Ghosn J, Antiviral Therapy 2010;15:993-1002 INDUMA INDUMA Study: Switch ATV/r to ATV 75 89 78 88 ITT, NC = FObserved data ATV/r ATV % 0 20 40 60 80 100 95% CI for the difference = - 9.8 ; 15.5 95% CI for the difference = -11.8 ; 8.7

5. ATV/rATV Fasting lipids Mean value at end of induction Mean % change at W48 of maintenance Mean value at end of induction Mean % change at W48 of maintenance Total cholesterol*188 + 4.3+ 1.4192 + 5.1- 4.7 HDL cholesterol*51 + 1.6+ 0.853 + 1.8+ 3.7 LDL cholesterol*109 + 3.7- 2.1109 + 4.3- 0.7 Non HDL cholesterol*137 + 4.4+ 1.1140 + 5.1- 7.4 Triglycerides*138 + 8.9+ 9.8**164 + 18.0- 27** Adverse events of all grades or with a frequency ≥ 5% reported in maintenance phase Hyperbilirubinemia28%16% Jaundice4%0 ALT increase6%5% AST increase1%6% Nausea5% Diarrhoea8%6% Abdominal pain4%6% * mg/dL, last observation carried forward ; ** p < 0.0001 Ghosn J, Antiviral Therapy 2010;15:993-1002 INDUMA INDUMA Study: Switch ATV/r to ATV Lipid changes and adverse events during maintenance phase

6.  Conclusions –After 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 weeks –Switching to ATV might represent a feasible treatment option in patients with virologic suppression on ATV/r Ghosn J, Antiviral Therapy 2010;15:993-1002 INDUMA INDUMA Study: Switch ATV/r to ATV