FDA Approves Dispersible Tablet Treatment for HIV

By Adam Hochron
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The FDA has approved dolutegravir as the first dispersible tablet for children living with HIV, according to a press release from the manufacturer. 

With the approval, the drug can be used in combination with other antiretroviral agents by children at least 4 weeks old and weighing at least 3kg, according to the release. There are more than one million children living with HIV, with most AIDS-related deaths among children occurring in the first five years, the release notes. 

“Children are often forgotten in this 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,” said Chip Lyons, President and CEO of the Elizabeth Glaser Pediatric AIDS Foundation. “Barriers like these 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.” 

Dolutegravir had been previously approved in the US for children at least six years old or older and weighing at least 30kg. The most recent approval is for an “age-appropriate formulation” for younger patients and will “help to close the gap between HIV treatment options available for adults and children,” the release notes. 

“The development and availability of age-appropriate formulations is essential in ensuring children have access to life-saving HIV treatments from an early age as they grow,” said Debora Waterhouse, CEO of ViiV Healthcare. “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.” 

The most common moderate to severe adverse reactions to the treatment include insomnia, fatigue, and headache. 

The European Medicines Agency is currently reviewing two versions of the therapy. 

 

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