FDA paediatric version of dolutegravir to treat children

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The US Food and Drug Administration (FDA) granted a new indication to a paediatric version of dolutegravir (Tivicay PD, ViiV Healthcare) tablets for oral suspension, which are used in combination with other antiretroviral agents to treat children with HIV who are at least 4 weeks old and weighting at least 3 kg.

In addition, the FDA expanded the use of the already approved Tivicay 50 mg film-coated tablets for children with HIV who weigh 20 kg or more. The medications can be used in children who are treatment-nave or experienced but INSTI-naive.

Dolutegravir is the first integrase inhibitor available as a dispersible tablet for oral suspension for children as young as 4 weeks of age and weighing at least 3 kg. Prior to this, dolutegravir was indicated in the US for children from 6 years of age and weighing more than 30 kg. This step will expand the use of dolutegravir by providing an age-appropriate formulation to a younger population and will help to close the gap between HIV treatment options available for adults and children.

The FDA approval is based on data from the ongoing P10936 and ODYSSEY7 (PENTA20) studies, which have been generated from ViiV Healthcare’s collaborations with the division of Aids (DAIDS) at the US National Institutes of Health (NIH) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) for P1093, and the Paediatric European Network for Treatment of AIDS (Penta) and the Medical Research Council (MRC) Clinical Trials Unit at University College London for ODYSSEY.

P1093 is a safety, tolerability and dose finding registrational study in children aged 4 weeks to 18 years being conducted by the IMPAACT network in the US, Brazil, Thailand, South Africa, Zimbabwe, Kenya and Tanzania.

ODYSSEY (Penta20) is a randomised control efficacy trial in first and second- line treatment, in children aged 4 weeks to 18 years being conducted by the PENTA network in Europe, South America, Thailand, Uganda, Zimbabwe, and South Africa. Originally designed to support World Health Organisation (WHO) guideline recommendations by WHO weight bands, this study will now also provide data to support revised dosing and continue to 96 weeks.

Paediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. Latest statistics show there are 1.7m children living with HIV, and the majority of Aids-related deaths among children still occur during the first five years of life. Major obstacles persist for children, such as continued mother-to-child transmission, the availability of HIV testing, slow initiation of treatment and poor availability of optimised paediatric formulations of antiretrovirals, according to UNAIDS.

“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. Barriers like these have resulted in only half of the 1.7m children living with HIV accessing the lifesaving treatment they need – and even fewer still reaching viral suppression. Families affected by HIV will benefit from ViiV’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,” said. Chip Lyons, the president and CEO of the Elizabeth Glaser Paediatric AIDS Foundation.

Through its voluntary licensing policy and partnerships, ViiV enables generic versions of dolutegravir to be manufactured and sold royalty-free in all least-developed, low-income, lower-middle-income and sub-Saharan Africa countries, as well as some upper-middle-income countries.

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