ViiV HEALTHCARE TO PRESENT LONG-TERM SAFETY AND EFFICACY DATA FOR 2-DRUG REGIMEN DOVATO (DOLUTEGRAVIR/LAMIVUDINE) ALONGSIDE OTHER KEY RESEARCH ADVANCES AT THE HIV GLASGOW 2020 CONGRESS

London, 30 September 2020 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders will be presenting 25 abstracts during the HIV Glasgow 2020 congress, being held virtually 5-8 October. Research will be presented from across its diverse portfolio of late-stage pipeline and licensed HIV treatments as well as findings from one of the largest, global, HIV patient-reported outcomes studies to date.

Key data presentations will include:

• GEMINI 144-week and TANGO 96-week pivotal trial data that build upon the existing efficacy and safety profile of 2-drug regimen dolutegravir plus lamivudine in treatment naïve adults with HIV-1 and Dovato (dolutegravir/lamivudine) in virologically suppressed adults with HIV-1^1,2 
• STAT 24-week data which evaluated Dovato for rapid initiation of treatment after diagnosis in adults with HIV-1³ 
• FLAIR 124-week findings for long-acting investigational cabotegravir and rilpivirine that further define its efficacy and safety profile, an analysis from the Phase 3 clinical development programme on factors influencing viral response to long-acting cabotegravir and rilpivirine, as well as an analysis of ATLAS-2M 48-week data of key outcomes in women, an often-under-represented population in clinical trials^4,5,6 
• Positive Perspectives Wave 2 data exploring gaps in achieving optimal self-rated health; challenges of a new HIV diagnosis in old age; self-care and involvement in HIV care.^7,8,9,10

ViiV Healthcare will also be hosting a virtual media event (9 October 2020, 13:00-14:00 BST) for registered journalists, looking at how the introduction of 2DRs and their growing evidence base can impact the HIV treatment paradigm. The session will reflect on clinical findings presented at HIV Glasgow and how they will potentially impact people living with HIV who are taking medications over a lifetime. Speakers include renowned HIV specialist Pedro Cahn M.D., who has been at the forefront of 2DR development in HIV. To register for the event, email: info@viivmediaevent.co.uk.

Kimberly Smith, Head of Research & Development, ViiV Healthcare, said: “The advances we will be presenting from across the portfolio reflect our continued commitment to addressing the challenges of HIV and delivering therapies that really make a difference in people’s lives. Dovato has already delivered impressive safety and efficacy results for both treatment-naïve and treatment-experienced adults living with HIV. The new long-term results presented at Glasgow will go even further to characterise the durability of and resistance profile for this treatment. We’re excited to participate in the congress and share our latest findings with the community.”

Key abstracts to be presented by ViiV Healthcare and study partners at HIV Glasgow 2020:

Week 144 findings from the GEMINI 1 & 2 studies evaluating dolutegravir plus lamivudine in treatment-naïve HIV-1 adults: The GEMINI studies were set up to see if treatment-naïve adults with HIV-1 could get the same level of viral suppression by taking two drugs instead of three.^11,12 These three-year data will build upon 96-week results, which demonstrated the non-inferior efficacy of dolutegravir plus lamivudine compared to the 3-drug regimen off dolutegravir plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), with no treatment-emergent resistance.¹³

Week 96 data from the TANGO study evaluating Dovato in treatment-experienced HIV-1 adults: The TANGO study was established to determine if virally suppressed people living with HIV can reduce the number of medicines in their HIV treatment regimen, while maintaining viral suppression.¹⁴ The two-year data will provide further indication of Dovato’s efficacy, safety and tolerability in this group of participants, following 48-week data which showed non-inferior efficacy for Dovato compared to continuation of a tenofovir alafenamide fumarate (TAF)-containing regimen of at least three drugs, with no confirmed virologic withdrawals and no resistance in the Dovato arm of the study.¹⁵

Week 24 findings from the STAT study assessing dolutegravir plus lamivudine in a Test and Treat setting: The Phase IIIb STAT study evaluates the feasibility, efficacy and safety of Dovato in a rapid Test and Treat model of care increasingly seen in clinical practice, with treatment initiated within 14 days of diagnosis before baseline HBV co-infection status, renal function and resistance test results were available.³

Week 124 findings from Phase 3 FLAIR study of investigational cabotegravir and rilpivirine long-acting: The FLAIR study was designed to assess non-inferiority of the once-monthly regimen of long-acting cabotegravir and rilpivirine compared to daily, oral Triumeq (abacavir/dolutegravir/lamivudine).¹⁶ Data to be presented at HIV Glasgow 2020 will provide insights into the tolerability, safety and efficacy of long-acting cabotegravir and rilpivirine maintenance therapy for people living with HIV-1 infection who switched at Week 100 from the Triumeq arm to the regimen of cabotegravir and rilpivirine.⁴

Multivariable and baseline factor analyses across ATLAS, FLAIR, and ATLAS-2M influencing viral response to investigational long-acting cabotegravir and rilpivirine: The Phase 3 development programme of long-acting cabotegravir and rilpivirine was designed to demonstrate its efficacy and safety when dosed once-monthly in ATLAS and FLAIR, and every two months in ATLAS-2M. Findings to be presented at HIV Glasgow 2020 will provide further insights from the clinical development programme into the participant and viral factors that influence virologic outcomes to long-acting cabotegravir and rilpivirine.⁵

A 48-week subgroup analysis in women from the ATLAS-2M study of investigational long-acting cabotegravir and rilpivirine administered every two months compared to once monthly: The ATLAS-2M study was designed to assess the non-inferiority and safety of long-acting cabotegravir and rilpivirine administered every two months compared to once-monthly administration.¹⁷ This subgroup analysis will compare the outcomes of women who participated in the ATLAS-2M study, which previously demonstrated in 48-week data that long-acting cabotegravir and rilpivirine administered every two months was non-inferior and as safe as its once-monthly dosing.¹⁸ This analysis of 280 women across 13 countries will further characterize this investigational treatment in key populations who are often underrepresented in clinical trials and is reflective of ViiV Healthcare’s commitment to all people living with HIV.⁶

Positive Perspectives Wave 2 study results: The data will reveal differences in perceptions of HIV care based on age, gender and sexual orientation with a special focus on Europe in one of the posters. The Positive Perspectives study describes the experiences and concerns of more than 2,300 people living with HIV from 25 countries. At HIV Glasgow 2020, the data presented will show how these perceptions of HIV care can impact their health – from worries about treatment side effects to confiding in healthcare providers and self-care.^7,8,9,10

The full list of ViiV Healthcare data to be presented at HIV Glasgow is outlined below:

About Dovato (dolutegravir/lamivudine)
Dovato is a once-daily, single-pill, 2-drug regimen (2DR) that combines the integrase strand transfer inhibitor (INI) dolutegravir (Tivicay, 50 mg) with the NRTI lamivudine (Epivir, 300 mg).¹⁹

Dovato (dolutegravir 50 mg/ lamivudine 300 mg tablets) is authorised in the EU for the treatment of 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 INI class, or lamivudine. In the US, Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no ARV treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato.²⁰

Like a dolutegravir-based three-drug regimen, Dovato uses two drugs to inhibit the viral cycle at two different sites. INIs, like dolutegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Lamivudine is an NRTI that works by interfering with the conversion of viral ribonucleic acid (RNA) into deoxyribonucleic acid (DNA) which in turn stops the virus from multiplying.¹⁹

Dovato is approved in the US, Europe, Japan and other countries worldwide. Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

Important Safety Information for Dovato The following safety information is based on the Highlights section of the Prescribing Information for Dovato. Please consult the full Prescribing Information for all the labelled safety information for Dovato.

WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-1): EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV

• All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating Dovato. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If Dovato is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen
• Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of Dovato. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment

DOSAGE AND ADMINISTRATION

• Prior to or when initiating Dovato, test patients for HBV infection. 
• Pregnancy Testing: Perform pregnancy testing before initiation of Dovato in individuals of childbearing potential 
• One tablet taken orally once daily with or without food 
• The dolutegravir dose (50 mg) in Dovato is insufficient when co-administered with carbamazepine or rifampin. If Dovato is co-administered with carbamazepine or rifampin, take one tablet of Dovato once daily, followed by an additional dolutegravir 50-mg tablet, approximately 12 hours from the dose of Dovato

CONTRAINDICATIONS

• Prior hypersensitivity reaction to dolutegravir or lamivudine 
• Coadministration with dofetilide

WARNINGS AND PRECAUTIONS

• Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with dolutegravir. Discontinue Dovato immediately if signs or symptoms of hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction 
• Hepatotoxicity has been reported in patients receiving a dolutegravir-containing regimen. Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with Dovato. Monitoring for hepatotoxicity is recommended
• Embryo-fetal toxicity may occur when used at the time of conception and in early pregnancy. An alternative treatment to Dovato should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects. Counsel individuals of childbearing potential to use effective contraception 
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues 
• Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy

ADVERSE REACTIONS The most common adverse reactions (all grades) observed in ≥2% (in those receiving Dovato) were headache, nausea, diarrhoea, insomnia, fatigue, and anxiety.

DRUG INTERACTIONS

• Dovato is a complete regimen for the treatment of HIV-1 infection; therefore, coadministration with other antiretroviral drugs for the treatment of HIV-1 infection is not recommended 
• Refer to the full prescribing information for important drug interactions with Dovato

USE IN SPECIFIC POPULATIONS

• Pregnancy: An alternative treatment to Dovato should be considered at the time of conception through the first trimester due to the risk of neural tube defects 
• Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission. 
• Females and males of reproductive potential: Pregnancy testing and contraception are recommended in individuals of childbearing potential 
• Renal Impairment: Dovato is not recommended in patients with creatinine clearance less than 50 mL/min 
• Hepatic Impairment: Dovato is not recommended in patients with severe hepatic impairment (Child-Pugh Score C)

Please refer to the full European Summary of Product Characteristics for Dovato for full prescribing information, including contraindications, special warnings and precautions for use. For the US, please refer to the US Prescribing Information.

About the long-acting regimen of cabotegravir and rilpivirine²¹
The long-acting regimen of cabotegravir and rilpivirine is an investigational regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL). The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, INSTIs, like cabotegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which in turn stops the virus from multiplying.

Cabotegravir and rilpivirine long-acting is approved in Canada under the brand name CABENUVA. Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

Cabotegravir oral tablets for short-term treatment in conjunction with CABENUVA are also approved in Canada under the brand name VOCABRIA.

Important Safety Information for CABENUVA Indications and clinical use: CABENUVA (cabotegravir and rilpivirine extended release injectable suspensions) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in patients who are virologically stable and suppressed (HIV-1 RNA <50 copies/mL).

VOCABRIA (cabotegravir tablets) is indicated, in combination with EDURANT (rilpivirine tablets), as a complete regimen for short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically stable and suppressed (HIV-1 RNA <50 copies/mL) as: An oral lead-in to assess tolerability of cabotegravir prior to initiating CABENUVA

Oral bridging therapy for missed CABENUVA injections

• Geriatrics (>65 years of age): Not sufficiently studied to determine if they respond differently than patients <65 years of age 
• Paediatrics (<18 years of age): Safety and efficacy not established

Contraindications:
In combination with:

• Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, and phenytoin 
• Antimycobacterials: Rifabutin, rifampin, rifapentine 
• Glucocorticoid: Systemic dexamethasone (more than a single dose) 
• St John’s wort (Hypericum perforatum)

Relevant warnings and precautions:

• Should not be used in patients with known or suspected resistance to cabotegravir or rilpivirine 
• Patients may still develop opportunistic infections and other complications of HIV infection 
• Risk of transmission: precautions should be taken 
• Depressive disorders
• Hepatotoxicity (serum transaminase elevations) 
• Hepatic adverse events; increased risk for worsening or development of transaminase elevations in patients with hepatitis B or C co-infection or marked elevations in transaminases prior to treatment; monitoring of liver chemistries is recommended 
• Loss of virologic response due to drug interactions; review concomitant medications during therapy 
• Caution when used in combination with drugs that have a risk of Torsade de Pointes 
• Skin and hypersensitivity reactions; discontinue immediately if signs or symptoms develop 
• Administer the oral lead-in dosing prior to administration of CABENUVA to help identify patients who may be at risk of a hypersensitivity reaction 
• Residual concentrations of cabotegravir and rilpivirine injections may remain in the systemic circulation of patients for up to 12 months or longer 
• Risk of resistance due to treatment discontinuation 
• Post-injection reactions within minutes after the injection of rilpivirine, including dyspnea, agitation, abdominal cramping, flushing, sweating, oral numbness, and changes in blood pressure. Reported in <0.5% of subjects and began to resolve minutes after the injection, and may have been associated with inadvertent (partial) IV administration 
• Insufficient data in pregnant women; should not be used unless the potential benefits outweigh the potential risks 
• HIV-1-infected mothers should not breastfeed their infants if receiving CABENUVA

For more information:
Please consult the Product Monograph at cabenuvapm.viivhealthcare.ca for additional important information relating to adverse reactions, drug interactions, and dosing. The Product Monograph is also available by calling 1-877-393-8448. To report an adverse event, please call 1-877-393-8448.

About Rukobia²²
The active ingredient in Rukobia is fostemsavir. Fostemsavir is a first-in-class HIV-1 attachment inhibitor. After oral administration, fostemsavir is converted to temsavir, which is then absorbed and exerts antiviral activity by attaching directly to the glycoprotein 120 (gp120) subunit on the surface of the virus, thereby blocking HIV from attaching to host immune system CD4+ T-cells and preventing the virus from infecting those cells and multiplying. As Rukobia is the first antiretroviral therapy to target this step of the viral cycle, there is no demonstrated resistance to other classes of antiretrovirals, which may help patients who have become resistant to most other medicines.

RUKOBIA is approved in the US. Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

Important Safety Information (ISI)
The following ISI is based on the Highlights section of the Prescribing Information for RUKOBIA. Please consult the full Prescribing Information for the complete safety information for RUKOBIA.

INDICATIONS AND USAGE

• RUKOBIA, a human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

DOSAGE AND ADMINISTRATION

• One tablet taken twice daily with or without food.

DOSAGE FORMS AND STRENGTHS

• Extended-release tablets: 600 mg

CONTRAINDICATIONS

• Hypersensitivity to fostemsavir or any of the components of the formulation. 
• Coadministration with strong cytochrome P450 (CYP)3A inducers as significant decreases in temsavir plasma concentrations may occur, which may result in loss of virologic response.

WARNINGS AND PRECAUTIONS

• Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapies. 
• QTc prolongation: Use RUKOBIA with caution in patients with a history of QTc prolongation or with relevant pre-existing cardiac disease or who are taking drugs with a known risk of Torsade de Pointes. 
• Elevations in hepatic transaminases in patients with hepatitis B or C virus co-infection: Elevations in hepatic transaminases were observed in a greater proportion of subjects with HBV and/or HCV co-infection compared with those with HIV mono-infection.

• The most common adverse reaction (all grades) observed in ≥5% of subjects was nausea.

DRUG INTERACTIONS

• See full prescribing information for complete list of significant drug interactions. 
• Doses of oral contraceptives should not contain more than 30 mcg of ethinyl estradiol per day.

USE IN SPECIFIC POPULATIONS

• Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission.

About ViiV Healthcare
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company’s aims are to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit https://www.gsk.com/en-gb/about-us/.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principle risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic. 

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