ViiV HEALTHCARE ADVANCES PAEDIATRIC HIV REGULATORY SUBMISSIONS WITH FDA PRIORITY REVIEW FOR TIVICAY PD AND EMA VALIDATION OF MARKETING APPLICATION FOR TIVICAY

London, 22 June 2026 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) to extend the use of Tivicay PD (dolutegravir (DTG)) to newborns from birth. The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 25, 2026.

The European Medicines Agency (EMA) has also validated the marketing application for Tivicay, as the company continues to focus on addressing one of the most persistent gaps in care by expanding age-appropriate treatment options for the earliest stage of life.¹

DTG is a second-generation integrase strand transfer inhibitor (INSTI) with a higher barrier of resistance than previous generations. Without timely diagnosis and treatment, HIV can progress rapidly in infants, with around 50% of untreated infants living with HIV dying by age two, underscoring the importance of effective treatment options from birth.²

Important Safety Information (ISI) for TIVICAY (dolutegravir) tablets, for oral use and TIVICAY PD (dolutegravir) tablets for oral suspension

The following ISI is based on the highlights section of the Prescribing Information for Tivicay. These highlights do not include all the information needed to use TIVICAY safely and effectively. See full prescribing information for TIVICAY.

Indications and Usage

TIVICAY and TIVICAY PD are a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in paediatric patients (treatment-naïve or -experienced but INSTI-naïve) aged at least 4 weeks and weighing at least 3 kg.

TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.

Contraindications

• Previous hypersensitivity reaction to dolutegravir.
• Coadministration with dofetilide.

Warnings and Precautions

• Hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported. Discontinue TIVICAY or TIVICAY PD and other suspect agents 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 dolutegravir-containing regimens. Patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations. 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 dolutegravir should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects. Counsel adolescents and adults of childbearing potential to use effective contraception.
• Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy. 
• TIVICAY tablets and TIVICAY PD tablets for oral suspension are not interchangeable.

 Adverse Reactions

• The most common adverse reactions of moderate to severe intensity and incidence at least 2% (in those receiving TIVICAY in any one adult trial) are insomnia, fatigue, and headache.

Drug Interactions

• Refer to the full prescribing information for important drug interactions with TIVICAY or TIVICAY PD. 
• Drugs that are metabolic inducers may decrease the plasma concentrations of dolutegravir. 
• TIVICAY or TIVICAY PD should be taken 2 hours before or 6 hours after taking cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. When taken with food, TIVICAY and supplements containing calcium or iron can be taken at the same time.

Use in Specific Populations 

• Pregnancy: An alternative treatment to dolutegravir 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 adolescents and adults of childbearing potential.

Please see full US prescribing information available at:
https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Tivicay/pdf/TIVICAY-PI-PIL.PDF#page=1

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