U.S. FDA APPROVES ViiV HEALTHCARE’S TIVICAY PD, HELPING CLOSE A CRITICAL HIV TREATMENT GAP FOR YOUNG CHILDREN 

London, 26 August 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 approved Tivicay PD (dolutegravir (DTG)), for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor (INSTI)-naïve) weighing at least 2 kg.

Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “Today’s approval of Tivicay PD expands the options available for paediatric HIV care, giving families and clinicians in the U.S. greater choice from the very beginning of life. For ViiV Healthcare, it reflects our commitment to bringing INSTI-based innovation to children and addressing persistent gaps in HIV care. This progress has been made possible through vital collaboration with the HIV community, united by a shared focus on ensuring children living with HIV are not left behind.”

The FDA approval follows Priority Review for this population and is supported by data from the National Institutes of Health (NIH)-funded IMPAACT 2023 study and pharmacokinetic (PK) modelling incorporating additional paediatric data. These data showed that DTG, a second-generation INSTI with a higher barrier to resistance than previous generations, reached therapeutic drug levels in term neonates with a safety profile consistent with that established in older paediatric and adult populations.

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 pediatric patients (treatment-naïve or -experienced but INSTI-naïve) weighing at least 2 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.

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.

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.

Please see full US Prescribing Information available at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Tivicay/pdf/TIVICAY-PI-PIL-IFU.PDF

About the National Institutes of Health (NIH)

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