ViiV Healthcare receives EU Marketing Authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe

ViiV Healthcare receives EU Marketing Authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe

-          Dolutegravir is the first integrase inhibitor available as a dispersible tablet for children weighing at least 3kg and from four weeks of age

-          The authorisation is an important step in fulfilling ViiV Healthcare’s commitment to bring optimised paediatric formulations of dolutegravir to children

London,  13 January 2021 – ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Commission has granted Marketing Authorisation for Tivicay (dolutegravir) 5mg dispersible tablets, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in paediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least four weeks and weighing at least 3kg. This authorisation includes updated dosing recommendations, for Tivicay (dolutegravir) film-coated tablets (10mg, 25mg and 50mg) for children 6 years and older and weighing at least 14kg, bringing these in line with the World Health Organization weight bands.

Deborah Waterhouse, CEO of ViiV Healthcare, said: “Today’s authorisation is a really important milestone towards enabling children to have access to age-appropriate formulations of HIV medicine. Globally there are approximately 1.7 million children living with HIV and around 100,000 children dying each year from AIDS which is why we won’t stop doing all that we can to ensure that no child living with HIV is left behind.”

The EU Marketing Authorisation follows the US Food and Drug Administration (FDA) approval of Tivicay PD in 2020[i], providing an age-appropriate formulation of dolutegravir for a younger population to help to close the gap between HIV treatment options available for adults and children.

Amanda Ely, CEO of CHIVA (Children’s HIV Association) said: “As an organisation, we continue our efforts to help support young people and families living with HIV manage the challenges of lifelong treatment and today’s authorisation helps to do this. Today’s news is a positive step forward in helping the many children and infants who may struggle to take their medicines in tablet form.”

The Marketing Authorisation is based on data from the ongoing P1093[ii] and ODYSSEY[iii] (PENTA20) studies, which are being conducted in collaboration with international paediatric research networks, IMPAACT and PENTA-ID.  

[i] Tivicay (dolutegravir) US Prescribing Information. July 2020. 

[ii] Clinicaltrials.gov. (2019). PH3b, DTG Study in HIV-1 Subjects Completing IMPAACT Study P1093. Available at: https://clinicaltrials.gov/ct2/show/NCT03016533 Last accessed: October 2020.

[iii] Clinicaltrials.gov. (2019). A Randomised Trial of Dolutegravir (DTG)-Based Antiretroviral Therapy vs. Standard of Care (SOC) in Children With HIV Infection Starting First-line or Switching to Second-line. Available at: https://clinicaltrials.gov/ct2/show/NCT02259127?term=PENTA20&draw=2&rank=1 Last accessed: October 2020.