21st International AIDS Conference; July 18-22, 2016; Durban, South Africa J Lake, 1 B Trottier, 2 J Garcia-Diaz, 3 H Edelstein, 4 P Kumar, 5 UF Bredeek, 6 M Loutfy, 7 C Brennan, 8 J Koteff, 8 B Wynne, 9 J Hopking, 10 M Aboud 11 Switching to Dolutegravir/Abacavir/Lamivudine Fixed Dose Combination (DTG/ABC/3TC FDC) from a PI, INI or NNRTI Based Regimen Maintains HIV Suppression at 48 Weeks 1 University of California, Los Angeles, CA, USA; 2 Clinique Médicale l‘Actuel, Montreal, QC, Canada; 3 Ochsner Clinic Foundation, New Orleans, LA, USA; 4 Highland Hospital, Alameda Health System, Oakland, CA, USA; 5 Georgetown University, Washington, DC, USA; 6 Metropolis Medical, San Francisco, CA, USA; 7 Maple Leaf Research, Toronto, Ontario, Canada; 8 ViiV Healthcare, Research Triangle Park, NC, USA; 9 ViiV Healthcare, Collegeville, PA, USA; 10 GlaxoSmithKline, London, United Kingdom; 11 ViiV Healthcare, London, United Kingdom

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa DTG/ABC/3TC (Triumeq) is a complete regimen built around DTG, an unboosted INSTI with a high barrier to resistance First approval of DTG/ABC/3TC: August 2014 in North America The study enrolled April 2014 to Oct 2014 STRIIVING was conducted to evaluate the efficacy, safety, tolerability, and treatment satisfaction of switching to DTG/ABC/3TC in subjects stable and suppressed on a variety of regimens Introduction Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203.

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Primary endpoint at 24 weeks: VL <50 c/mL (Snapshot) Inclusion criteria Virologically suppressed (confirmed HIV-1 RNA <50 c/mL) HLA ‑ B*5701 negative 2 NRTIs + PI/r Open-label, randomized 1:1 DTG/ABC/3TC 0 Week 24 Screening Week 48 Countries: US, Canada, Puerto Rico Current ART a a Stable suppressive current ART with 2 NRTIs plus either a PI, an NNRTI, or an INI. ≥40% PIs, at least 25% INIs. 90% power based on 10% non-inferiority margin (estimated response rate = 85%). Assessments CD4 cell count changes Clinical and laboratory safety Lipids, renal, bone, and cardiovascular changes Development of resistance Treatment satisfaction DTG/ABC/3TC STRIIVING Study Design Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203.

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Subjects randomized to DTG/ABC/3TC on Day 1 who received at least 1 dose of DTG/ABC/3TC → Early-switch Subjects randomized to continue current ART on Day 1, completed Early Switch Phase at W24, and received at least 1 dose of DTG/ABC/3TC upon switching at Week 24 → Late-switch Study Populations Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Treatment armData included Early-switch Day 1 to Week 24 Day 1 to Week 48 Late-switchWeek 24 to Week 48

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Study Disposition: Week 48 Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Randomized and treated DTG/ABC/3TC (n=275) Randomized and treated cART (n=278) Screened (N=841) Completed Wk 48 (N=230, 84%) Late switch to DTG/ABC/3TC (N=244) Completed Wk 48 (N=230, 94%) Early Switch group DTG/ABC/3TC Discontinuations: Day 1- Week 24Day 1- Week 48 Adverse event10 (4%) Lack of efficacy (virologic failure) 00 Protocol deviation15 (5%) Stopping criteria met00 Lost to follow-up3 (1%)8 (3%) Investigator discretion3 (1%)5 (2%) Withdrew consent4 (1%)6(2%) Per sponsor request 1 (<1%)0 Late Switch group DTG/ABC/3TC Discontinuations: Week Adverse event4 (2%) Lack of efficacy (virologic failure) 0 Protocol deviation1 (<1%) Stopping criteria met1 (<1%) Lost to follow-up3 (1%) Investigator discretion0 Withdrew consent5 (2%) Completed Wk 24 (N=239, 87%) Completed Wk 24 (N=245, 88%)

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa STRIIVING 48 Week Early Switch Arm Week 24 Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. a ITT-E analysis. DTG/ABC/3TC, Day 1–Week 24 (n=275) a Switch to DTG/ABC/3TC, Week 24–Week 48 (n=244) b DTG/ABC/3TC, Day 1–Week 48 (n=275) b cART, Day 1–Week 24 (n=278) a

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa STRIIVING 48 Week Early Switch Arm Week 24 and 48 Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. DTG/ABC/3TC, Day 1–Week 24 (n=275) a Switch to DTG/ABC/3TC, Week 24–Week 48 (n=244) b DTG/ABC/3TC, Day 1–Week 48 (n=275) cART, Day 1–Week 24 (n=278) a a ITT-E analysis.

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa STRIIVING 48 Week Late Switch Arm 24 Weeks Post Switch Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Switch to DTG/ABC/3TC, Week 24–Week 48 (n=244)

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa 4% of the Early Switch group discontinued treatment due to AEs at Week 24, with none between Weeks 24 and 48; 2% of the Late Switch group discontinued treatment due to AEs between Weeks 24 and 48 Week 24 and 48 Snapshot Outcomes Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Early Switch DTG/ABC/3TC N=275 n (%) Day 1 to Wk 24 Virologic Success233 (85) Virologic Non-response3 (1) Data in window not below threshold3 (1) Discontinued while VL not <50*0 No Virologic Data39 (14) Discontinued due to AE or death10 (4) Discontinued for other reasons a 25 (9) Missing data during window but on study 4 (1) *Includes categories: Discontinued for lack of efficacy and Discontinued for other reason while not below threshold

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa 4% of the Early Switch group discontinued treatment due to AEs at Week 24, with none between Weeks 24 and 48; 2% of the Late Switch group discontinued treatment due to AEs between Weeks 24 and 48 Week 24 and 48 Snapshot Outcomes Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Early Switch DTG/ABC/3TC N=275 n (%) Day 1 to Wk 24 DTG/ABC/3TC N=275 n (%) Day 1 to Wk 48 Virologic Success233 (85)227 (83) Virologic Non-response3 (1)1 (<1) Data in window not below threshold3 (1)1 (<1) Discontinued while VL not <50*00 No Virologic Data39 (14)47 (17) Discontinued due to AE or death10 (4) Discontinued for other reasons a 25 (9)32 (12) Missing data during window but on study 4 (1)5 (2) *Includes categories: Discontinued for lack of efficacy and Discontinued for other reason while not below threshold

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa 4% of the Early Switch group discontinued treatment due to AEs at Week 24, with none between Weeks 24 and 48; 2% of the Late Switch group discontinued treatment due to AEs between Weeks 24 and 48 Week 24 and 48 Snapshot Outcomes Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Early SwitchLate Switch DTG/ABC/3TC N=275 n (%) Day 1 to Wk 24 DTG/ABC/3TC N=275 n (%) Day 1 to Wk 48 DTG/ABC/3TC N=244 n (%) Wk 24 to Wk 48 Virologic Success233 (85)227 (83)224 (92) Virologic Non-response3 (1)1 (<1)3 (<1) Data in window not below threshold3 (1)1 (<1)3 (<1) Discontinued while VL not <50*000 No Virologic Data39 (14)47 (17)17 (7) Discontinued due to AE or death10 (4) 4 (2) Discontinued for other reasons25 (9)32 (12)7 (3) Missing data during window but on study 4 (1)5 (2)6 (2) *Includes categories: Discontinued for lack of efficacy and Discontinued for other reason while not below threshold

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa No subjects met protocol-defined virologic failure in either study arm 4 subjects >50 at Week 48 window: ES (51), LS (54, 53, 156); All 4 resuppressed < 50 c/mL Virologic Endpoints: DTG/ABC/3TC Early SwitchLate Switch DTG/ABC/3TC N=275 Day 1 to Wk 24 DTG/ABC/3TC N=275 Day 1 to Wk 48 DTG/ABC/3TC N=244 Wk 24 to Wk 48 PDVF a 000 Viral load ≥50 c/mL (snapshot)3 (1%)1 (<1)3 (1%) Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. a Subjects with HIV-1 RNA ≥400 c/mL on 2 consecutive assessments any time after randomization are withdrawn = meets protocol defined virologic failure.

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Adverse Events: DTG/ABC/3TC Overall Summary Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Early Switch DTG/ABC/3TC N=275 n (%) Day 1 to Wk 24 Any adverse event, n (%)180 (65) Any drug-related event (occurring ≥2% of subjects in either arm) 57 (21) Nausea20 (7) Diarrhea9 (3) Fatigue9 (3) Headache7 (3) Insomnia5 (2) Dizziness5 (2) Abnormal dreams5 (2) Any serious event a 6 (2) Any fatal event a 1 (<1) Discontinuations due to AE or death10 (4) a None were considered drug-related events.

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Adverse Events: DTG/ABC/3TC Overall Summary Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Early Switch DTG/ABC/3TC N=275 n (%) Day 1 to Wk 24 DTG/ABC/3TC N=275 n (%) Day 1 to Wk 48 Any adverse event, n (%)180 (65)206 (75) Any drug-related event (occurring ≥2% of subjects in either arm) 57 (21)60 (22) Nausea20 (7) Diarrhea9 (3) Fatigue9 (3) Headache7 (3) Insomnia5 (2) Dizziness5 (2) Abnormal dreams5 (2)4 (1) Any serious event a 6 (2)9 (3) Any fatal event a 1 (<1) Discontinuations due to AE or death10 (4) a None were considered drug-related events.

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Adverse Events: DTG/ABC/3TC Overall Summary Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Early SwitchLate Switch DTG/ABC/3TC N=275 n (%) Day 1 to Wk 24 DTG/ABC/3TC N=275 n (%) Day 1 to Wk 48 DTG/ABC/3TC N=244 n (%) Wk 24 to Wk 48 Any adverse event, n (%)180 (65)206 (75)146 (60) Any drug-related event (occurring ≥2% of subjects in either arm) 57 (21)60 (22)32 (13) Nausea20 (7) 9 (4) Diarrhea9 (3) 3 (1) Fatigue9 (3) 3 (1) Headache7 (3) 6 (2) Insomnia5 (2) 6 (2) Dizziness5 (2) 2 (<1) Abnormal dreams5 (2)4 (1)3 (1) Any serious event a 6 (2)9 (3)6 (2) Any fatal event a 1 (<1) Discontinuations due to AE or death10 (4) 4 (2) a None were considered drug-related events.

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Common Adverse Events: DTG/ABC/3TC (≥5% in Any Treatment) Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Early Switch DTG/ABC/3TC N=275 n (%) Day 1 to Wk 24 Nausea27 (10) Upper respiratory tract infection20 (7) Diarrhea20 (7) Fatigue19 (7) Headache13 (5) Cough14 (5) Insomnia10 (4) Nasopharyngitis10 (4)

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Common Adverse Events: DTG/ABC/3TC (≥5% in Any Treatment) Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Early Switch DTG/ABC/3TC N=275 n (%) Day 1 to Wk 24 DTG/ABC/3TC N=275 n (%) Day 1 to Wk 48 Nausea27 (10)28 (10) Upper respiratory tract infection20 (7)35 (13) Diarrhea20 (7) Fatigue19 (7)22 (8) Headache13 (5)17 (6) Cough14 (5)17 (6) Insomnia10 (4)14 (5) Nasopharyngitis10 (4)13 (5)

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Common Adverse Events: DTG/ABC/3TC (≥5% in Any Treatment) Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203. Early SwitchLate Switch DTG/ABC/3TC N=275 n (%) Day 1 to Wk 24 DTG/ABC/3TC N=275 n (%) Day 1 to Wk 48 DTG/ABC/3TC N=244 n (%) Wk 24 to Wk 48 Nausea27 (10)28 (10)15 (6) Upper respiratory tract infection20 (7)35 (13)22 (9) Diarrhea20 (7) 9 (4) Fatigue19 (7)22 (8)6 (2) Headache13 (5)17 (6)10 (4) Cough14 (5)17 (6)6 (2) Insomnia10 (4)14 (5)9 (4) Nasopharyngitis10 (4)13 (5)6 (2)

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Efficacy – The virologic response rate was maintained through 48 weeks in the Early Switch group – In the Late Switch group, virologic suppression was observed in 92% of subjects on DTG/ABC/3TC (24 weeks post-switch) – There were no PDVFs in the study Tolerability – There were no further discontinuations due to AEs in the Early Switch arm post-Week 24 – Low rates of discontinuations in the Late Switch arm (2%) Summary – Data through 48 weeks support switching to DTG/ABC/3TC once daily for HIV ‑ 1 subjects on stable suppressive cART Conclusions Lake et al. AIDS 2016; Durban, South Africa. Abstract THAB0203.

21st International AIDS Conference; July 18-22, 2016; Durban, South Africa Acknowledgments We thank everyone who has contributed to the success of this study, including – All study participants and their families – The GlaxoSmithKline and ViiV Healthcare study teams – PPD – The clinical investigators and their staff CanadaUnited States BarilLeBlancBaxterDretlerHiteMartorellRashbaumShikuma ConwayLogueBensonDube Hoffman- TerryMcDonaldRhameShon de WetLoutfyBhattiEdelsteinHsiaoMeierRichmondSimon FraserRachlisBlickEvans/MartinHuhnMillsRiddellSloan KasperTrottierBolanFeinbergJainMounzerRuaneSmall/Khoury WalmsleyBredeekFelizartaJayaweeraNahass Salazar/ RodriguezStefanic BrennanFifeL. JohnsonNewmanScarsellaVan Dam Puerto RicoBrinsonFlammM. JohnsonNguyenSchneiderVanig MarquezCalvoGallantKinderNovakSchraderWade Melendez- Rivera Chang/P. JohnsonGarcia-DiazKleinOsiyemiScottWard Santiago ColonCunninghamGrossbergKumarParksScribnerWheeler ZorrillaCutroHaginsLakePieroneSha DeJesusHareLalezariPrelutskyShalit DietzHenryLewisRamgopalShamblaw