DOVATO is indicated for the treatment of HIV-1 in adults and adolescents above 12 years weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.1

MINIMAL CHANGES in bone turnover biomarkers in both treatment arms† ‖

MINIMAL CHANGES in renal function biomarkers in both treatment arms† §

FEWER ARVs vs A 3-DRUG REGIMEN: TDF, TAF AND ABC FREE1

48-Week Results

POWERED BY DOLUTEGRAVIR AT THE CORE1

BaselineRandomisation

Week24

Week96

Week144

Week196

Screening(28 days)

• Virologically suppressed adults with HIV-1 RNA <50 copies/mL for >6 months• TAF/FTC + PI or INI or NNRTI as initial regimen• Stable TAF-containing regimen• No prior virological failure and no documented NRTI or INI resistance• HBV negative

Week48

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

Randomised Early-Switch Phase Late-Switch Phase

DOVATO (DTG 50 mg/3TC 300 mg) (n=369) DOVATO

TAF-containing regimens (n=372) DOVATO

COMPARABLE, NON-INFERIOR EFFICACY WITH 0 RESISTANCE AT 48 WEEKS2

Any Drug-Related AE, Grade 2 to

Grade 5

AEs Leading to WithdrawalAny AE

DOVATO (n=369)

17 (5%) 13 (4%)295 (80%)

TAF-containing regimens

(n=371)3 (1%) 2 (1%)292 (79%)

Cases of Resistance-Associated Mutations 0

• No confirmed virological withdrawals** on DOVATO (0) vs 1 (<1%) TAF-containing regimens— No INI mutations observed— No NRTI mutations observed (including M184V/I)

Comparative Study of DOVATO vs TAF-Containing Regimens in More Than 700 Virologically Suppressed Patients2

No Increased Risk of Virological Failure vs TAF-Containing Regimens (ITT–E Snapshot Analysis) A High Barrier to Resistance

Overall Adverse Events Were Comparable Across Both Arms at 48 Weeks2

Metabolic Parameters at 48 Weeks2

AN INNOVATIVE NEW TREATMENT FOR YOUR PATIENTS LIVING WITH HIV

POWER REIMAGINED

†The TANGO study did not determine whether these changes translate to clinical differences.

See page 2 for adverse events reported in ≥ 5% of participants in either arm.

Graph adapted from reference 2 by ViiV Healthcare

** Patients met confirmed virological withdrawal criteria if they had 1 assessment with HIV-1 RNA ≥200 copies/mL after Day 1 with an immediately prior HIV-1 RNA ≥50 copies/mL.2

INCREASED PROPORTION OF PATIENTS WITH OPTIMAL TC/HDL RATIO in the DOVATO arm while remaining constant in the TAF-containing regimens arm vs baseline

Adjusted difference: –0.3 (95% CI: –1.2, 0.7)

TAF-containing regimens0.3% DOVATO 0.5%

Proportion (%) of Patients With HIV-1 RNA ≥50 copies/mL

(n=1/369) (n=2/372)

6.5% DOVATO 6.5% TAF-containing regimens

No Virological Data

(n=24/369) (n=24/372)

93.2% DOVATO 93.0%

Proportion (%) of Patients With HIV-1 RNA <50 copies/mL

TAF-containing regimens

(n=344/369) (n=346/372)

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

Trademark 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 tabletsSee 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 S1A

DRUG-DRUG INTERACTIONS

DOVATO should not be taken with any other medicinal product containing dolutegravir or lamivudine, except where a dose adjustment of dolutegravir is indicated due to drug-drug interactions. The recommended dose of dolutegravir is 50 mg twice daily when co-administered with rifampicin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, St. John’s wort, etravirine (without boosted protease inhibitors), efavirenz, nevirapine, or tipranavir/ritonavir. In addition to the DOVATO dose, a 50 mg DTG tablet should be taken ~12 hours later.1

DOVATO should not be co-administered at the same time as polyvalent cation-antacids. Polyvalent cation-antacids are recommended to be taken 2 hours after or 6 hours before DOVATO.1

When taken with food, DOVATO and supplements or multivitamins containing calcium, iron or magnesium can be taken at the same time. If DOVATO is administered without food, supplements or multivitamins containing calcium, iron or magnesium are recommended to be taken 2 hours after or 6 hours before DOVATO.1

The combination of DOVATO with cladribine is not recommended.1

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

§Renal: Blood: Adjusted mean change from baseline for DTG + 3TC [2DR] and TAF-based regimen [TAF], respectively: Creatine (mmol/l) 6.67 [2RD], 2.19 [TAF] (P<0.001); GFR from creatine CKD-EPI (ml/min/1.73 m2) -7.8 [2DR], -3.0 [TAF] (P<0.001). Urine: % change from baseline Protein Creatine (g/mol) -2.9 [2RD], 1.6 [TAF]. ‖ Bone: Adjusted mean change from baseline (μg/L) for DTG + 3TC [2DR] and TAF-based regimen [TAF], respectively: Serum bone-specific alkaline phosphatase -0.03 [2DR], -0.34 [TAF]; Serum procollagen 1 N-terminal propeptide 9.3 [2DR], 6.4 [TAF] (P<0.05).

IMPORTANT SAFETY INFORMATION

Use of DOVATO is contraindicated in case of hypersensitivity to the active agents or to any of the excipients.1

Women who can become pregnant should undergo pregnancy testing before initiation of DOVATO. Women who can become pregnant and are taking DOVATO should use effective contraception throughout treatment. Due to the potential risk of neural tube defects, DOVATO should not be used during the first trimester unless there is no alternative.1

September 2019, PM-IE-DLL-LBND-190002

References: 1. DOVATO (dolutegravir/lamivudine) Summary of Product Characteristics. July 2019. 2. van Wyk J, Ajana F, Bisshop F, et al. Switching to DTG/3TC fixed-dose combination (FDC) is non-inferior to continuing a TAF-based regimen in maintaining virologic suppression through 48 weeks (TANGO study). Presented at: International AIDS Conference; July 21-24, 2019; Mexico City, Mexico. Slides WEAB0403LB.

Adverse events reported in ≥ 5% of participants in either arm:2

- DOVATO: nasopharyngitis 12% (43/369), upper respiratory tract infection 8% (31/369), diarrhea 8% (30/369), headache 7% (24/369), syphilis 7% (24/369), back pain 6% (21/369), fatigue 5% (20/369)

- TAF-based regimen: nasopharyngitis 11% (41/371), upper respiratory tract infection 9% (32/371), diarrhea 7% (26/371), back pain 8% (28/371), headache 5% (17/371), bronchitis 5% (20/371)