GRACE: Study Design and Baseline Characteristics

1. Safety, Tolerability and Efficacy of Darunavir/ritonavir in Treatment-Experienced Women With HIV Infection: 24-Week Interim Analysis of GRACE (Gender, Race, And Clinical Experience) Judith Currier, MD, MSc1; Kathleen Squires, MD2; Dawn Averitt Bridge3; Robert Ryan, MS4; Joseph Mrus, MD, MSc5; Alan Tennenberg, MD, MPH5; Ron Falcon, MD5; on behalf of the GRACE Study Group 1University of California, Los Angeles, School of Medicine, Los Angeles, CA, USA; 2Jefferson Medical College of Thomas Jefferson University, Philadelphia, PA, USA; 3The Well Project, Inc., Atlanta, GA, USA; 4Tibotec, Inc., Yardley, PA, USA; 5Tibotec Therapeutics, Bridgewater, NJ, USA

2. GRACE: Study Design and Baseline Characteristics • 17% of women had no active ARVs in their background regimenb • Approximately 60% of women had been treated with ≥2 PIs previously bBased on phenotypic sensitivity; etravirine activity was not included (phenotypic cutoffs were not available) 4-Week follow-up 48 Weeks Pre-planned 24-week interim analysis 429 treatment-experienced patients enrolled Darunavir/ritonavir 600/100mg bid + investigator-selected background regimena aNRTIs and NNRTIs (including etravirine). Enfuvirtide, tipranavir, integrase inhibitors and CCR5 antagonists were not allowed

3. GRACE 24-week Interim Analysis: Efficacy and Safety 66% Women 100 65% All patients 90 TLOVR-non-VF 80 70 60 Patients with HIV-1 RNA <50 copies/mL, % (95% CI) 51% 50 51% 40 ITT-TLOVR 30 20 10 BAS 4 8 12 16 24 Time, weeks Safety and Tolerability in Women Virologic response (VL <50 copies/mL) • Most common grade 2-4 adverse events at least possibly related to study drug: • Nausea (6.1%) • Diarrhea (5.6%) • Rash (2.8%) • Weight gain (2.8%) • Serious AEs were reported in 16.7% (n=30) of women • Most common was pneumonia, reported in 4.4% (n=8) of women • No major issues with Grade 2-4 laboratory abnormalities were noted • At Week 24, mean increase in CD4 cell count in women was 86 cells/mm3 (ITT-NC=F) • At Week 24, discontinuation rate for women was 24.4% • Discontinuations were generally unrelated to VF (0.6%) or AEs (7.8%) ITT, intention-to-treat; TLOVR, time to loss of virologic response algorithm; TLOVR-non-VF, algorithm excluded patients who discontinued for reasons other than virologic failure; NC=F, non-completer=failure

4. GRACE 24-week Interim Analysis: Conclusions • GRACE is the largest treatment trial to date in North America to focus on women with HIV • The GRACE study is fully enrolled (287 women, 142 men), demonstrating that HIV-infected women from North America, including women of color, can be successfully recruited to participate in clinical trials of antiretrovirals • In this 24-week interim analysis of the first 203 patients (180 women and 23 men): • Response rates were within the expected range based on previous clinical trials of darunavir/ritonavir in treatment-experienced patients • Adverse events among women were generally similar to those seen in other studies of darunavir/ritonavir in treatment-experienced patients • Approximately one-quarter of women discontinued the study prior to Week 24; reasons were generally unrelated to adverse events or virologic failure • Sex- and race-based comparisons will be available at the Week 48 primary analysis for all 429 patients

5. Acknowledgments  The patients and their families  The GRACE Study Group  Co-investigators  Active GRACE Study Sites in North America: Canada 4 sites Vancouver, BC, Canada MIDWEST 6 sites NORTHEAST 16 sites Hamilton, Ontario, Canada Montreal, Quebec, Canada WA Toronto, Ontario Canada ME MT ND MN VT OR NH ID NY WI NY MA SD MI RI WY CT NV IA PA NJ NE OH IN DE UT CO MD CA IL WV KS VA KY MO NC AZ TN OK NM SC AR MS TX AL GA LA WEST 7 sites Puerto Rico 3 sites FL SOUTHEAST 29 sites Puerto Rico  Principal investigators: Aberg, Judith A., MD • Albrecht, Helmut, MD • Albrecht, Mary A., MD • Barker, David E., MD • Brar, Indira, MD • Bullock, Delia, MD • Burdge, David, FRCP, MD • Cadden, Joseph, MD • Casey, Kathleen K., MD • Catalla, Robert, MD • Clark, Rebecca, MD • Clough, Lisa, MD • Condoluci, David V., MD • Currier, Judith, MD • Davis, Charles, MD • Diaz, Leslie, MD • Elion, Richard A., MD • Feinberg, Judith, MD • Garcia, Fernando, MD; Gathe, Jr., Joseph C., MD; Goulston, Claudia, MD • Haas, David W., MD • Hagins, Debbie, MD • Hanna, Barbara, MD • Hicks, Charles B., MD • Hodder, Sally, MD • Jayaweera, Dushyantha T., MD • Kadlecik, Peter, MD • Kanter, Tim, MD • Kumar, Princy, MD • Lennox, Jeffrey L., MD • Martorell, Claudia T., MD • Morales Ramirez, Javier, MD • Myers, Jr., Robert A., MD • Ortiz, Roberto, MD • Osiyemi, Olayemi O., MD • Patterson, Kristine B., MD • Pearce, Daniel D., DO • Pegram, P. Samuel, MD • Pollard, Richard B., MD • Presti, Rachel, MD • Puga, Ana, MD • Race, Elizabeth, MD • Rachlis, Anita, MD • Ramgopal, Moti, MD • Rawlings, M. Keith., MD • Saag, Michael S., MD • Santiago, Steven, FAAFP, MD • Scribner, Anita R., MD • Sepulveda, Gladys E., MD • Skolnik, Paul, MD • Smaill, Fiona, MD • Smith, Kimberly, MD • Smith, Stephen M., MD • Squires, Kathleen, MD • Tedaldi, Ellen, MD • Thompson, Melanie A., MD • Townsend, Gregory, MD • Tsoukas, Christos M., MD • Wade, Barbara H., MD • Witt, Mallory D., MD • Workowski, Kimberly, FACP, MD • Wright, David P., MD • Yin, Michael, MD • Zorrilla, Carmen D., MD