GSK plc · LSE:GSK
GSK — ViiV Healthcare — Investor Day (July 2018)
19 slides from GSK's investor day presentation, Jul 24, 2018
Slide 1: ViiV Healthcare Investor and Analyst Update
ViiV Healthcare Investor and Analyst Update 24 July 2018
Slide 2: Cautionary statement regarding forward looking statements
Cautionary statement regarding forward looking statements This presentation may contain forward-looking statements. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly t
Slide 3: ViiV Healthcare Investor and Analyst Update
ViiV Healthcare Investor and Analyst Update David Redfern, Chairman Deborah Waterhouse, CEO John Pottage, Chief Scientific and Medical Officer Kimberly Smith, Head of Global Research and Medical Strategy 3
Slide 4: International AIDS Conference - Amsterdam
International AIDS Conference - Amsterdam 4
Slide 5: Our ambitious mission: to leave no person living with HIV behind
Our ambitious mission To leave no person living with HIV behind 5
Slide 6: Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity
Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patients Juluca DTG + CARLA* 3TC ViiV Healthcare’s first 2-drug The next step in the 2DR era, The long acting 2DR regimen (2DR) once-daily, DTG + 3TC is the first 2DR for injectable of single-pill, that combines t
Slide 7: A two drug regimen could spare more than 20,000 medicines over a lifetime
A two drug regimen could spare more than 20,000 medicines over a lifetime Based on a patient living with HIV on treatment for 55 years 7
Slide 8: The GEMINI 1 & 2 studies
The GEMINI 1 & 2 studies 8
Slide 9: Introduction
Introduction • The requirement for lifelong ART for HIV infection has highlighted interest in 2DRs to minimize cumulative drug exposure1 • Lower ARV exposure may translate to less long-term drug toxicity • The potency, safety, and high resistance barrier of DTG make it an optimal core agent for 2-dr
Slide 10: GEMINI-1 and -2 Phase III Study Design
GEMINI-1 and -2 Phase III Study Design Identically designed, randomized, double-blind, parallel-group, multicenter, noninferiority studies Screening Double-blind Open-label Continuation (28 d) 1:1 phase phase phase DTG + 3TC (N=716) DTG + 3TC • ART-naive adults • VL 1000-500,000 c/mL DTG + TDF/FTC (
Slide 11: Demographic and Baseline Characteristics for the Pooled GEMINI-1 and -2 Population
Demographic and Baseline Characteristics for the Pooled GEMINI-1 and -2 Population DTG + 3TC DTG + TDF/FTC Characteristic (N=716) (N=717) Age, median (range), y 32.0 (18-72) 33.0 (18-70) ≥50 y, n (%) 65 (9) 80 (11) Female, n (%) 113 (16) 98 (14) Race, n (%) African American/African heritage 99 (14)
Slide 12: Pooled Snapshot Outcomes at Week 48: ITT-E and Per Protocol Populations
Pooled Snapshot Outcomes at Week 48: ITT-E and Per Protocol Populations Virologic outcome Adjusted treatment difference (95% CI)a ITT-E DTG + 3TC (N=716) DTG + TDF/FTC (N=717) PPb DTG + 3TC (N=694) DTG + TDF/FTC (N=693) DTG + TDF/FTC DTG + 3TC 100 9193 9394 -1.7 ITT-E HIV-1 RNA <50 c/mL, % 80 -4.4 1
Slide 13: Snapshot Analysis by Visit: Pooled ITT-E Population
Snapshot Analysis by Visit: Pooled ITT-E Population 100 93 91 93 87 89 90 HIV-1 RNA <50 c/mL, % 80 72 85 89 88 93 90 91 60 70 40 DTG + 3TC (n=716) DTG + TDF/FTC (n=717) 20 CD4+ cell count (cells/mm3) Adjusted mean change DTG + 3TC 224 0 0 from baseline at Week 48a DTG + TDF/FTC 218 -20 -4 0 4 8 12 1
Slide 14: Pooled Outcomes at Week 48 Stratified by Baseline HIV-1 RNA and CD4+ Cell Count
Pooled Outcomes at Week 48 Stratified by Baseline HIV-1 RNA and CD4+ Cell Count: Snapshot and TRDF Analysis Snapshot Analysis TRDF Analysis 98 98 99 97 98 98 98100 100 91 94 92 90 93 93 93 100 79 HIV-1 RNA <50 c/mL, % 80 80 Without TRDF, % 60 60 40 40 20 20 526 531 129 138 605 618 50 51 566 553 138
Slide 15: Confirmed Virologic Withdrawals Through Week 48: ITT-E Population
Confirmed Virologic Withdrawals Through Week 48: ITT-E Population • Low rates of virologic withdrawals were observed at Week 48 GEMINI 1 GEMINI 2 Pooled DTG + DTG + DTG + DTG + 3TC TDF/FTC DTG + 3TC TDF/FTC DTG + 3TC TDF/FTC Variable, n (%) (N=356) (N=358) (N=360) (N=359) (N=716) (N=717) CVW 4 (1) 2
Slide 16: Adverse Events: Pooled ITT-E Population
Adverse Events: Pooled ITT-E Population DTG + DTG + 3TC TDF/FTC n (%) (N=716) (N=717) Any AE 543 (76) 579 (81) AE occurring in ≥5% of participants in either group Headache 71 (10) 75 (10) Diarrhea 68 (9) 77 (11) Nasopharyngitis 55 (8) 78 (11) Upper respiratory tract infection 56 (8) 44 (6) Nausea 27
Slide 17: Conclusions
Conclusions • GEMINI-1 and-2 results demonstrate noninferior virologic efficacy for the 2DR DTG + 3TC vs the 3DR DTG + TDF/FTC at Week 48 • Both DTG + 3TC and DTG + TDF/FTC were associated with low rates of confirmed virologic withdrawals through Week 48 – No treatment-emergent INSTI or NRTI mutatio
Slide 18: Highly innovative pipeline
Highly innovative pipeline Pipeline strategy New treatment Prevention cabotegravir paradigm = 2DR long-acting* Current standard of care = HAART/legacy drugs Long-acting Treatment Search for Regimens Remission and Cure cabotegravir + rilpivirine* Dolutegravir-based Regimens Tivicay Triumeq New MOA at
Slide 19: Q&A
Q&A 19