Rapid: 72.0% at Week 4

Powerful: 91.5% at Week 48

Durable: 86.0% at Week 96

DOVATO Virological Suppression

Study Visit (weeks)

Prop

orti

on (%

) of P

atie

nts

Wit

hH

IV-1

RN

A <5

0 co

pies

/mL

0

40

20

60

100

80

4 8 12 16 24 36 9648

70.2%

93.3%

72.0% 91.5%

DTG + TDF/FTC (n=717; pooled)

DOVATO (n=716; pooled)

89.5%

86.0%

60 72 84

Dovato is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

POWERED BY DOLUTEGRAVIR AT THE CORE

2 Fully Powered, Phase III, Double-Blind Clinical Trials With More Than 1,400 Treatment-Naïve Patients Combined1

BaselineRandomisation

Double-Blind Phase Open-Label Phase

Week 96 Week 144Screening (28 days) Week 48Primary Endpoint:

Proportion of patients with plasma HIV-1 RNA <50 copies/mL (by Snapshot algorithm; ITT–E)

GEMINI-1 and GEMINI-2 (pooled)• Treatment-naïve adults (≥18 years old)• Screening viral load 1,000 to 500,000 copies/mL• HBV negative• No major resistance-associated mutations• CrCL > 50mL/min

DOVATO (n=716)

DTG 50 mg + TDF/FTC 300 mg/200 mg (n=717)

DTG 50 mg + 3TC 300 mg used in the GEMINI studies.

DURABLE, NON-INFERIOR EFFICACY WITH 0 RESISTANCE vs A 3-DRUG REGIMEN1

FEWER ANTIRETROVIRALS vs A 3-DRUG REGIMEN: TDF, TAF AND ABC FREE2

Metabolic Parameters at Week Overall, adverse event profiles were comparable across both arms Changes in bone turnover biomarkers significantly favour

DOVATO vs DTG + TDF/FTC. The Gemini studies did not determine whether these changes translate to clinical differences.

Improvements in TC/HDL ratio occurred in both arms with a statistically greater reduction in the DTG + TDF/FTC arm

• Any AE: DOVATO 83% (591/716) vs DTG + TDF/FTC 85% (609/717)

• AEs leading to withdrawal: DOVATO 3% (24/716) vs DTG + TDF/FTC 3% (23/717)

Lower Rate of Drug-Related Adverse Events vs DTG + TDF/FTC1?

20% DOVATO (140/716) 25% DTG + TDF/FTC

(179/717)vs

96-Week Results

Rapid, Powerful and Durable Efficacy

ITT–E Snapshot analysis.

Adjusted difference: –3.4 (95% CI: –6.7, 0.0)

Adapted from Cahn et al, 2019.1

Changes in renal function biomarkers significantly favour DOVATO vs DTG + TDF/FTC‡

— AEs due to renal and urinary disorders were comparable across both arms (~5%)4 The Gemini studies did not determine whether these changes

translate to clinical differences.

AN INNOVATIVE NEW TREATMENT FOR YOUR PATIENTS LIVING WITH HIV

POWER REIMAGINED

†The relative risk ratio (95% CI) for DOVATO vs DTG + TDF/FTC was 0.78 (0.64, 0.95).1

0 Cases of Resistance-Associated Mutations In Both Arms

• No treatment-emergent NRTI mutations (including M184V/I) observed

• No treatment-emergent INI mutations observed

• Few confirmed virological withdrawals on DOVATO (11 [1.5%]) vs DTG + TDF/FTC (7 [1.0%])*

* Patients met confirmed virological withdrawal criteria if a second and consecutive HIV-1 RNA value met any of the following definitions: decrease from baseline in HIV-1 RNA of <1 log10 copies/mL unless HIV-1 RNA <200 copies/mL by Week 12; confirmed plasma HIV-1 RNA of ≥200 copies/mL after confirmed consecutive HIV-1 RNA <200 copies/mL.1

Abbreviations: 3TC=lamivudine; ABC=abacavir; AE=adverse event; DTG=dolutegravir; FTC=emtricitabine; HBV=hepatitis B virus; INI=integrase inhibitor; ITT–E=intent-to-treat exposed; NRTI=nucleoside reverse transcriptase inhibitor; TAF=tenofovir alafenamide; TC/HDL=total cholesterol/high-density lipoprotein cholesterol; TDF=tenofovir disoproxil fumarate.

DOVATO is owned by or licensed to the ViiV Healthcare group of companies.©2019 ViiV Healthcare group of companies or its licensor.

Adverse events should be reported. For Ireland, adverse events should be reported directly to the HPRA; Freepost, Pharmacovigilance Section, Health Products Regulatory Authority, Earlsfort Terrace, Dublin 2, Tel: +353 1 676 4971, medsafety@hpra.ie. Adverse events should also be

reported to GlaxoSmithKline on 1800 244 255.

Adverse events should be reported. For the UK, reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221441.

Prescribing Information Dovato dolutegravir 50mg/lamivudine 300mg tablets See Summary of Product Characteristics (SmPC) before prescribingIndication: HIV-1 in adults & adolescents above 12 years of age weighing >40kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. Dosing: One tablet once daily with or without food. Use an additional 50mg tablet of dolutegravir approximately 12 hours after the dose of Dovato when co-administered with efavirenz, nevirapine, tipranavir/ritonavir, etravirine (without boosted PI), carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St John’s Wort or rifampicin. Elderly: Limited data in 65+ yrs. Not recommended in patients with creatinine clearance < 50 mL/min. Caution in severe hepatic impairment. Contraindications: Hypersensitivity to any ingredient. Warnings/precautions: Risk of hypersensitivity reactions. Discontinue dolutegravir and other suspect agents immediately. Risks of osteonecrosis, immune reactivation syndrome. Monitor LFTs in Hepatitis B/C co-infection and ensure effective Hepatitis B therapy. Caution with metformin: monitor renal function and consider metformin dose adjustment. Use with etravirine requires boosted PI or increased dose of dolutegravir. Use with Mg/Al-containing antacids requires dosage separation. Use with calcium, multivitamins or iron also requires dosage separation if not taken at the same time with food. Use with cladribine or emtricitabine not recommended. When possible, avoid chronic co-administration of sorbitol or other osmotic acting alcohols (see SmPC

section 4.5). If unavoidable, consider more frequent viral load monitoring Pregnancy/ lactation: The safety and efficacy has not been studied in pregnancy. Before initiating dolutegravir, women of childbearing potential (WOCBP) should undergo pregnancy testing. WOCBP who are taking dolutegravir should use effective contraception. Dolutegravir should not be used during the first trimester due to the potential risk of neural tube defects, unless there is no alternative. Dolutegravir should only be used during the second and third trimester of pregnancy when the expected benefit justifies the potential risk to the foetus. Avoid breast-feeding. Side effects: See SmPC for full details. Headache, GI disturbance, insomnia, abnormal dreams, depression, anxiety, dizziness, somnolence, rash, pruritus, alopecia, fatigue, arthralgia, myalgia, hypersensitivity, suicidal ideation or suicide attempt, hepatitis, blood dyscrasias, acute hepatic failure, pancreatitis, angioedema, rhabdomyolysis, lactic acidosis, peripheral neuropathy. Elevations of ALT, AST and CPK. Basic NHS costs: £656.26 for 30 tablets (EU/1/19/1370/001). MA holder: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands. Further information available from Customer Contact Centre, GlaxoSmithKline UK Ltd, Stockley Park West, Uxbridge, Middlesex UB11 1BT.POM S1ATrade marks are owned by or licensed to the ViiV Healthcare group of companies. Date of approval: July 2019 PI-2451

Date of preparation: December 2019 PM-GB-DLL-WCNT-190003

References: 1. Cahn P, Sierra Madero J, Arribas J, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naïve adults with HIV-1 infection: 96-week results from the GEMINI studies. Presented at: International AIDS Conference; July 21-24, 2019; Mexico City, Mexico. Slides WEAB0404LB. 2. DOVATO Summary of Product Characteristics. July 2019. 3. Data on file. GEMINI-1 and GEMINI-2 96-week renal and urinary disorders/adverse events: REF-31232. ViiV Healthcare group of companies. Research Triangle Park, NC.