XVIII International AIDS Conference 18-23 July 2010, Vienna, Austria Shionogi-ViiV Healthcare LLC Once-Daily S/GSK1349572 as Part of Combination Therapy.

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XVIII International AIDS Conference July 2010, Vienna, Austria Shionogi-ViiV Healthcare LLC Once-Daily S/GSK as Part of Combination Therapy in Antiretroviral Naïve Adults: Rapid and Potent Antiviral Responses in the interim 16-Week Analysis from SPRING-1 (ING112276) Jose Arribas 1, Adriano Lazzarin 2, Francois Raffi 3, Aza Rakhmanova 4, Gary Richmond 5, Jurgen Rockstroh 6, Jan van Lunzen 7, Ben Young 8, Steve Almond 9, Cindy Brothers 10, Sherene Min 10, and Garrett Nichols 10 on behalf of the extended SPRING-1 team 1 Hosp La Paz. IdiPAZ, Madrid, Spain; 2 Vita-Salute San Raffaele Univ, Milan, Italy; 3 Univ Hosp, Nantes, France; 4 Botkin Hosp, St. Petersburg, Russia; 5 Broward Health, Ft Lauderdale, FL; 6 Univ of Bonn, Germany; 7 Univ Med Ctr Hamburg-Eppendorf; 8 Rocky Mtn CARES/DIDC, Denver, CO and Health Connections Intl, Amsterdam; 9 GlaxoSmithKline, Oakville, Canada and 10 RTP, USA

XVIII International AIDS Conference, July 2010, Vienna, Austria S/GSK : Attributes of a Next Generation INI ●Once daily, unboosted 1 ●Low PK variability and predictable exposure- response relationship 2,3 ●Low potential for drug interactions 2 ●Improved in vitro resistance profile including higher genetic barrier to resistance 4,5,6 ●Highly potent antiviral activity in a ph2a study 1 Dosing periodFollow-up period (BL) (FU) Day Mean Change from Baseline in HIV-1 RNA (log 10 copies/mL) 2 mg 10 mg 50 mg PBO 1.Lalezari J. IAS 2009, Cape Town, abstract TUAB Min S, et al. IAS 2009, Cape Town, abstract WEPEA Song I, et al. IAS 2009, Cape Town, abstract WEPEB Sato A, et al. IAS 2009, Cape Town, abstract WEPEA Underwood M, et al. IAS 2009, Cape Town, abstract WEPEA Seki T, et al. CROI 2010, Poster abstract J-122.

XVIII International AIDS Conference, July 2010, Vienna, Austria ING Study Design ●Phase IIb dose-ranging, partially-blinded trial ●N~200 therapy-naïve patients ●All arms include 2 NRTI backbone given once daily ●Primary endpoint: % <50 copies/mL at 16 weeks (TLOVR) HIV-1 RNA >1000c/mL, 1:1:1:1 Randomization HIV-1 RNA >1000c/mL, 1:1:1:1 Randomization EFV 600 mg mg mg mg 572 Selected Dose after Week Selected Dose after Week 48 EFV 600 mg Wk 16 dose selection Wk 24 dose confirmation

XVIII International AIDS Conference, July 2010, Vienna, Austria mg (N=53) mg (N=51) mg (N=51) EFV 600mg (N=50) Total (N=205) Age (Median and range in years)32 (21 – 61)38 (20-64)37 (22 – 55)40 (20 – 79)37 (20 – 79) Male gender42 (79%)46 (90%)45 (88%)44 (88%)177 (86%) Race African American/African Heritage7 (13%)6 (12%)8 (16%)4 (8%)25 (12%) White41 (77%)42 (82%)38 (75%)43 (86%)164 (80%) Other5 (10%)3 (6%)5 (10%)4 (8%)17 (8%) Baseline HIV-1 RNA Mean (log10 copies/mL) > copies/mL11 (21%)10 (20%)12 (24%)11 (22%)44 (21%) Baseline CD4+ (cells/mm 3 ) Mean <30030 (57%)20 (39%)24 (47%)24 (48%)98 (48%) Investigator-selected NRTIs TDF/FTC36 (68%)34 (67%) 34 (68%)138 (67%) ABC/3TC17 (32%)17 (33%) 16 (32%)67 (33%) Baseline Characteristics

XVIII International AIDS Conference, July 2010, Vienna, Austria Rapid and Robust Antiviral Activity: Primary Efficacy Analysis Note: 95% confidence intervals are derived using the normal approximation. Proportion (%) <50 copies/mL (TLOVR) 96% 92% 90% 60% Time to <50 copies/mL shorter for S/GSK arms than EFV (each p<0.001 vs. EFV, log-rank test) BLW1W2W4W8W12W16

XVIII International AIDS Conference, July 2010, Vienna, Austria Primary Outcomes: % <50 Copies/mL (TLOVR) at Week 16 Outcome mg (N=53) mg (N=51) mg (N=51) EFV 600mg (N=50) Responder51 (96%)47 (92%)46 (90%)30 (60%) Reason for non-response (virologic)2 (4%) 3 (6%)15 (30%) Discontinued for insufficient viral load response1 (2%)000 Never suppressed through Week 161 (2%)2 (4%) 15 (30%) Rebound001 (2%)0 Reason for non-response (discontinuations)02 (4%) 5 (10%) Adverse event (discontinued)01 (2%)04 (8%) Protocol deviation01 (2%) 0 Lost to follow-up001 (2%)0 Decision to discontinue study by subject0001 (2%)

XVIII International AIDS Conference, July 2010, Vienna, Austria Primary Outcomes: % <50 Copies/mL (TLOVR) at Week 16 Outcome mg (N=53) mg (N=51) mg (N=51) EFV 600mg (N=50) Responder51 (96%)47 (92%)46 (90%)30 (60%) Reason for non-response (virologic)2 (4%) 3 (6%)15 (30%) ABC/3TC subgroup (n=67)1124 TDF/FTC subgroup (n=138)11111 Reason for non-response (discontinuations)02 (4%) 5 (10%) ABC/3TC subgroup (n=67)0113 TDF/FTC subgroup (n=138)0112

XVIII International AIDS Conference, July 2010, Vienna, Austria Protocol-Defined Virologic Failures ●Rebound: confirmed HIV-1 RNA ≥400c/mL following suppression to 0.5 log10 above nadir ●Non-response: confirmed HIV-1 RNA ≥400c/mL at Week 24 without prior suppression or <1.0log10 decrease by Week 4 unless <400c/mL ●As of Week 16, only two confirmed virologic failures identified: Subject A: TDF/FTC + 10mg S/GSK ●Rebound at Week 4 ●On-treatment GT/PT: –Only M184M/V detected –No INI-assoc substitutions or changes in PT ●<1.0 log 10 decrease by Week 4 ●On-treatment GT/PT: –No changes detected ●Subject continues on study Subject B: TDF/FTC + EFV Week Week

XVIII International AIDS Conference, July 2010, Vienna, Austria Median (IQR) CD4+ Cell Counts (cells/mm 3 ) Timepoint mg (N=53) mg (N=51) mg (N=51) 572 Subtotal (N=155) EFV 600mg (N=50) Baseline 289 (220 – 394) 330 (242 – 410) 305 (248 – 374) 305 (242 – 400) 308 (244 – 380) Week 16 Change from Baseline (95 – 276) (86 – 227) (94 – 227) (88 – 242) (66 – 226)

XVIII International AIDS Conference, July 2010, Vienna, Austria AEs (by System Organ Class) Reported in >1 Subject on Investigational Product ●No SAEs related to S/GSK –One SAE deemed related to EFV (suicide attempt) ●Events leading to withdrawal: –S/GSK (n=1): dyspepsia –EFV (n=4): abnormal dreams, suicide attempt, drug intolerance, drug hypersensitivity mg (N=53) mg (N=51) mg (N=51) 572 Subtotal (N=155) EFV 600mg (N=50) Grade 2-4 Drug Related (all)3 (6%)2 (4%)4 (8%)9 (6%)9 (18%) Gastrointestinal1 (2%) 3 (2%)2 (4%) Psychiatric disorders00003 (6%) Skin disorders00002 (4%) General disorders1 (2%)0 2 (1%)1 (2%) Serious Adverse Events (all)3 (6%)1 (2%)2 (4%)6 (4%)3 (6%) AEs Leading to WD/IP Discontinuation01 (2%)01 (<1%)4 (8%)

XVIII International AIDS Conference, July 2010, Vienna, Austria Laboratory Values ●Treatment-emergent lab abnormalities of grade 3 or higher (DAIDS) were rare –Incidence: S/GSK /155 (7%) vs. EFV 5/50 (10%) –No relationship between S/GSK dose and lab abnormalities ●Change from BL in lipids more favorable for S/GSK –LDL Mean  from BL: mmol/L (572 arms) vs mmol/L (EFV) CholHDLLDLTrig Lipid Parameter Week 16 Change from Baseline (mmol/L) mg572 25mg572 50mgEFV 600mg

XVIII International AIDS Conference, July 2010, Vienna, Austria Conclusions ●S/GSK administered once-daily without a PK booster was generally well tolerated, with potent antiviral activity at all doses explored in this study ●Time to undetectable viral load was significantly shorter in all of the S/GSK arms vs. EFV ●Based upon this data, 50mg has been selected for Phase 3 studies of INI-naïve subjects –All subjects in the study continue on their randomized regimen until Week 48 ●These data fully support progression of S/GSK into Phase 3 evaluation

XVIII International AIDS Conference, July 2010, Vienna, Austria Acknowledgments We thank everyone who has contributed to the success of this study, including: All of our study participants and their families The SPRING-1 Clinical Investigators and their staff: France: J Reynes, L Cotte, F Raffi, C Katlama, P Yeni, J-M Molina Germany: J van Lunzen, H-J Stellbrink, M Stoll, T Lutz Italy: G Carosi, F Maggiolo, G Rizzardini, A Lazzarin Russia: O Tsybakova, E Voronin, A Rakhmanova Spain: F Pulido, J Arribas, S Moreno-Guillen, J Gatell, B Clotet United States: E DeJesus, F Felizarta, T Hawkins, J Lalezari, L McCurdy, G Richmond, S Schneider, L Sloan, J Torres, B Young, T Vanig, M Mustafa, A LaMarca And the extended ViiV Healthcare-Shionogi-GlaxoSmithKline SPRING-1 study team