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† §

TDF, TAF AND ABC FREE 1-3

48-Week Results

POWERFUL DURABLE EFFICACY2,3

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

HIGH BARRIER TO RESISTANCE2,3

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 Patients3

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 Weeks3

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 �����������

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-containingregimens

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)

Trademark is owned by or licensed to the ViiV Healthcare group of companies. ©2020 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.

DRUG-DRUG INTERACTIONS

DOVATO should not be taken with any other medicinal product containing dolutegravir, lamivudine or emtricitabine, 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

April 2020 PM-IE-DLL-LBND-190005

§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).

References: 1. Dovato Summary of Product Characteristics. Available from www.medicines.ie. Last accessed: April 2020 2. Cahn P et al. J Acquir Immunde Defic Syndr . 2020;83(3):310-318 3. Van Wyk J;IAS;2019;1-16

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.

IMPORTANT SAFETY INFORMATION

Contraindications:1

- hypersensitivity to the active agents or to any of the excipients

- co-administration with medicinal products with narrow therapeuticwindows, that are substrates of organic cation transporter (OCT) 2, includingbut not limited to fampridine (also known as dalfampridine).

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

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

- DOVATO: nasopharyngitis 12% (43/369), upper respiratory tractinfection 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 respiratorytract infection 9% (32/371), diarrhea 7% (26/371), back pain 8% (28/371),headache 5% (17/371), bronchitis 5% (20/371)

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. Do not breast-feed. 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. MA Nr: EU/1/19/1370/001. MA holder: ViiV Healthcare BV, Huis ter Heideweg 62, 3705 LZ Zeist, Netherlands. Legal Category: POM A. Date of preparation of API: April 2020. Code: PI-5713. Further information available from GlaxoSmithKline, 12 Riverwalk, Citywest, Business Campus, Dublin 24. Tel: 01-4955000.

Abridged Prescribing Information Dovato (dolutegravir 50mg/lamivudine 300mg) tablets

See Summary of Product Characteristics (SmPC) before prescribing. Presentation: Film-coated tablet containing dolutegravir sodium equivalent to 50 mg dolutegravir and 300 mg lamivudine debossed with “SV-137” on one face. Indication: 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.Co-administration with substrates of OCT-2 with narrow therapeutic windows, such as fampridine. Special 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.