ViiV Healthcare, a GSK company focused on HIV treatment, has received the US Food and Drug Administration (FDA) approval for Tivicay PD (dolutegravir) tablets for, in combination with other antiretroviral agents for to treat HIV type 1 (HIV-1) infection in children.

Tivicay PD was indicated to treat paediatric patients aged minimum of four weeks and 3kg weight, along with an extended indication to expand the use of the Tivicay (dolutegravir) 50mg film-coated tablet in paediatric HIV patients weighing 20kg and above.

Dolutegravir is an integrase strand transfer inhibitor which, in combination with other antiretroviral agents, has the potential to treat HIV. The integrase inhibitor binds to the HIV integrase active site and blocks the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration.

ViiV Healthcare CEO Deborah Waterhouse said: “I am delighted that our innovative approach to science has enabled us to achieve FDA approval of the first-ever dispersible tablet formulation of dolutegravir, now making it easier for young children to take this medication by dispersing the tablet in water.

“The development and availability of age-appropriate formulations is essential in ensuring children have access to life-saving HIV treatments from an early age and as they grow.

“The support of our partners has been integral for this regulatory approval. We now need to continue our efforts to ensure this new dispersible formulation is available to children who need it around the world, in line with our mission to leave no person living with HIV behind.”

ViiV Healthcare offers a voluntary licensing policy to support the generic versions of dolutegravir

The company claimed that dolutegravir marks the first integrase inhibitor, available as a dispersible tablet for oral suspension for children as young as four weeks of age and weighing at least 3kg, following dolutegravir indication for US children from six years of age and weighing more than 30kg.

Also, the expanded indication will enable the use of dolutegravir in an age-appropriate formulation and will address the HIV treatment gap between adults and children.

ViiV Healthcare is offering voluntary licensing policy, enabling the manufacture of generic versions of dolutegravir, and royalty-free sale in least-developed, low-income, lower-middle-income and sub-Saharan Africa countries, along with some upper-middle-income countries.

In addition, the company has worked with the Clinton Health Access Initiative (CHAI) and Unitaid since 2018 to ensure the development and introduction of optimised paediatric formulations of dolutegravir to help the children most affected by HIV,

Under the partnership, two generic manufacturers including Mylan and Macleods Pharmaceuticals have secured sub-licences for paediatric dolutegravir from the Medicines Patent Pool (MPP).

The European Medicines Agency (EMA) is currently reviewing both Tivicay PD and the extended indication of the existing Tivicay 50mg film-coated tablet.

Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) president and CEO Chip Lyons said: “Children are often forgotten in the global fight to end HIV/AIDS and face a unique set of challenges, particularly when HIV medication and treatments are often hard to swallow or tolerate.

“Families affected by HIV will benefit from ViiV Healthcare’s development of child-friendly formulations that aim to close the gap between treatment options available for adults and children. This tailored approach to paediatric treatment of HIV will help meet the urgent needs of this vulnerable population.”