Percentage of patients with HIV-1 RNA <50 copies/mL in the MOTIVATE studies through 48 weeks

1. Efficacy of maraviroc (MVC) administered once-daily or twice-daily with boosted protease inhibitors to treatment-experienced patients S Taylor,1 J Arribas,2 C-F Perno,3 R Burnside,4 L McFadyen,5D Hardy,6 H-J Stellbrink,7 DA Cooper,8 J-M Molina,9E van der Ryst,5 J Heera,4 H Valdez10 1Birmingham Heartlands Hospital, Birmingham, UK; 2Hospital La Paz, Madrid, Spain; 3University of Rome, Tor Vergata, Italy; 4Pfizer Inc., Groton, CT, USA; 5Pfizer Global Research and Development, Sandwich, Kent, UK; 6Cedars-Sinai Medical Center/Geffen School of Medicine-UCLA, Los Angeles, CA, USA; 7ICH Study Center, Hamburg, Germany; 8University of New South Wales and St Vincent’s Hospital, Sydney, Australia; 9Assistance Publique-Hopitaux de Paris, Paris, France; 10Pfizer Inc., New York, NY, USA

2. MVC QD + OBT (N=414) MVC BID + OBT (N=426) Placebo + OBT (N=209) Percentage of patients with HIV-1 RNA <50 copies/mL in the MOTIVATE studies through 48 weeks 100 90 80 Option to switch to open-label MVC BID 70 60 50 Patients (%) 45.5%* 43.2%* 40 30 20 16.7% 10 *P <0.0001 vs placebo 0 0 4 8 12 16 20 24 28 32 36 40 44 48 Time (weeks) In this analysis, non-completers and missing data were categorized as failures OBT, optimized background therapy Hardy et al, Abstract 792 , CROI, 2008.

3. MOTIVATE: Effect of boosted PIs on MVC Cavg Phase 2b/3 MVC 150 mg QD vs Phase 2a 300 mg BID monotherapy1 800 600 MVC Cavg (ng/mL) 400 200 0 FPV/r ATV/r IDV/r LPV/r SQV/r QD 78 72 QD 56 109 QD 6 134 QD 107 149 QD 35 174 n = Median = Horizontal line = median Phase 2a 300 mg BID in asymptomatic HIV-1 infected subjects as target exposure (133 ng/mL) DRV/r boosts MVC exposures comparable to LPV/r and ATV/r in formal drug interaction studies in healthy volunteers2 1Weatherly et al, Poster 17a, IWCPHIV, 2008. 2Kakuda et al, Antimicrob Agents Chemother, 2011; 55(5) 2290-6.

4. Rationale for once-daily MVC with a boosted PI in treatment-experienced patients • MVC monotherapy data show comparable antiviral responses with both 300 mg QD and BID1 • MVC 150 mg QD with boosted PIs achieved similar or greater concentrations compared to 300 mg BID without inhibitors/inducers2 • MVC when dosed QD with select boosted PIs may offer treating physicians and patients the option of simplified dosing of MVC 1. Fätkenheuer et al, Nat Med, 2005. 2. Weatherley et al, Poster 17a, IWCPHIV, 2008.

5. Objective • To determine in a post-hoc analysis, whether the efficacy of QD MVC in combination with select boosted PIs (excluding TPV/r and FPV/r) is comparable to MVC BID at week 48

6. Analysis population MOTIVATE patients n=1049 CCR5+ patients by enhanced sensitivity Trofile assay (ESTA) n=841 Remainder patients n=244( TPV/r , unboosted or no PI) FPV/r patients n=149 Boosted PI patients n=448 MVC QD n=187 MVC BID n=176 Placebo n=85 MVC QD n=50 MVC BID n=56 Placebo n=43 MVC QD n=98 MVC BID n=96 Placebo n=50 Boosted PI patients: patients whose baseline regimen included ATV/r, IDV/r, LPV/r, or SQV/r

7. Baseline characteristics BID, twice daily; bPI, boosted PI; ESTA, enhanced sensitivity Trofile assay; MVC, maraviroc; QD, once daily

8. In a post-hoc analysis, a comparable percentage of patients treated with MVC QD or BID with a boosted PI achieved VL <50 copies/mL at Week 48 MVC 150 mg QD 100 MVC 150 mg BID Placebo 80 Difference (97.5% CI) QD vs PBO 27.8% (16.2, 39.4) BID vs PBO 30.6% (18.5, 42.7) 60 47.7 Patients with HIV-1 RNA <50 copies/mLat Week 48 (%) 45.5 40 16.5 20 0 n/N= 85/187 84/176 14/85 BID, twice daily; CI, confidence interval; MVC, maraviroc; PBO, placebo; QD, once daily; VL, viral blood

9. Patient subgroup analyses: Screening VL < or ≥ 100,000 copies/mL MVC 150 mg QD 100 MVC 150 mg BID Placebo 80 61.0 60.4 60 Patients with HIV-1 RNA <50 copies/mLat Week 48 (%) 38.5 39.0 40 23.8 20 14.3 0 <100,000 copies/mL ≥100,000 copies/mL Baseline HIV-1 RNA n/N= 64/105 58/96 10/42 30/78 30/77 6/42 BID, twice daily; MVC, maraviroc; PBO, placebo; QD, once daily; VL, viral blood

10. Patient subgroup analyses: Baseline CD4 cell count < or ≥ 50 cells/mm3 MVC 150 mg QD 100 MVC 150 mg BID Placebo 80 57.8 56.8 60 Patients with HIV-1 RNA <50 copies/mLat Week 48 (%) 40 22.2 18.5 17.2 20 5.0 0 <50 cells/mm3 ≥50 cells/mm3 Baseline CD4 count n/N= 5/29 5/27 1/20 89/154 83/146 14/63 BID, twice daily; MVC, maraviroc; PBO, placebo; QD, once daily

11. Patient subgroup analyses: Number of active drugs in background regimen at baseline (wOBTss < or ≥ 1) MVC 150 mg QD 100 MVC 150 mg BID Placebo 80 59.7 58.1 60 Patients with HIV-1 RNA <50 copies/mLat Week 48 (%) 35.9 35.7 40 26.3 20 3.7 0 <1 ≥1 wOBTss n/N= 23/64 20/56 1/27 71/119 68/117 15/57 BID, twice daily; MVC, maraviroc; PBO, placebo; QD, once daily; wOBTss, weighed optimized background therapy susceptibility score

12. Patient subgroup analyses: First-time use of a selected boosted PI MVC 150 mg QD 100 MVC 150 mg BID Placebo 80 69.0 59.4 59.0 58.1 57.1 56.3 60 Patients with HIV-1 RNA <50 copies/mLat Week 48 (%) 40 22.2 20.5 16.7 20 0 All boosted PIfirst use Atazanavir/rfirst use Lopinavir/rfirst use n/N= 49/83 40/71 8/39 19/32 16/28 4/18 20/29 18/31 2/12 BID, twice daily; MVC, maraviroc; PBO, placebo; QD, once daily

13. Patient subgroup analyses: Use of a selected boosted PI to which virus is susceptible MVC 150 mg QD 100 MVC 150 mg BID Placebo 80 65.0 63.3 58.3 59.0 56.5 60 55.3 Patients with HIV-1 RNA <50 copies/mLat Week 48 (%) 40 33.3 31.0 23.1 20 0 All boosted PI susceptible Atazanavirsusceptible Lopinavirsusceptible n/N= 36/61 35/62 9/29 14/24 13/20 3/13 19/30 21/38 5/15 BID, twice daily; MVC, maraviroc; PBO, placebo; QD, once daily

14. Conclusions • Comparable efficacy was demonstrated in subjects treated with MVC 150 mg QD or BID compared to placebo in combination with a boosted PI (except TPV/r and FPV/r) • Efficacy was maintained with MVC QD or BID with a boosted PI compared to placebo in patients: • with high screening VL or low baseline CD4+ cells • receiving >1 other fully active drug (wOBTss >1) • receiving selected boosted PI for the first time or with documented viral susceptibility to the selected boosted PI • MVC administered QD in combination with select boosted PIs may be a potential option for treatment-experienced patients seeking a simplified treatment regimen

15. Acknowledgments • Thank you to all study participants and investigators who participated in the MOTIVATE 1 and MOTIVATE 2 studies. • Editorial support was provided by Dr Clemence Hindley at Complete Medical Communications and funded by ViiV Healthcare

16. Back ups

17. Maraviroc 150 mg QD + Darunavir/r 800/100 mg QD • Ongoing study evaluating intensive PK in HIV-infected patients receiving MVC 150 mg QD + DRV/r 800/100 mg QD Taylor et al, CROI, 2011

18. In a post-hoc analysis a comparable percentage of patients on MVC QD or BID with a boosted PI achieved a VL <50 copies/mL at Week 48 MVC 150 mg QD 100 MVC 150 mg BID Placebo 80 Difference (97.5% CI) QD vs PBO 27.8% (16.2, 39.4) BID vs PBO 30.6% (18.5, 42.7) Difference (95% CI) QD vs BID -2.4% (-12.5, 7.7) 60 47.7 Patients with HIV-1 RNA <50 copies/mLat Week 48 (%) 45.5 40 16.5 20 0 n/N= 85/187 84/176 14/85 BID, twice daily; CI, confidence interval; MVC, maraviroc; PBO, placebo; QD, once daily; VL, viral blood