FDA approves ViiV Healthcare’s dolutegravir tablet for children living with HIV

FDA approves ViiV Healthcare’s dolutegravir tablet for children living with HIV

June 12, 2020 Off By Dino Mustafić

ViiV Healthcare Friday said that the US Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir) tablets for oral suspension, used combined with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in certain young patients.

ViiV, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, explains in the press release they are pediatric patients (treatment-naïve or -experienced but INSTI- naïve) aged at least four weeks and weighing at least 3kg, as well as an extended indication to expand the use of the already approved Tivicay (dolutegravir) 50mg film-coated tablet in paediatric HIV patients weighing 20kg and above.

Deborah Waterhouse, CEO of ViiV Healthcare, expressed delight in the press release that the company’s innovative approach to science has made it possible 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.”

Chip Lyons, President and CEO of the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), said in the press release that 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.  Lyons said that barriers like those have resulted in only half of the 1.7 million 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 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,” Lyons said.

ViiV noted in the press release that the FDA approval is based on data from the ongoing P1093 and ODYSSEY (PENTA20) studies, which has 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.

Paediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. Latest statistics show there are 1.7 million children living with HIV1, 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, ViiV said.

ViiV explained that dolutegravir is 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. Prior to this, dolutegravir was indicated in the US for children from six years of age and weighing more than 30kg. 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.