The US Food and Drug Administration (FDA) has approved the first dispersible tablet formulation of dolutegravir (Tivicay PD, ViiV Healthcare) to treat HIV-1 infection in children at least 4 weeks old and weighing at least 3 kg (6.61 pounds) in combination with other antiretroviral medications.
The FDA has also expanded the use of the already approved dolutegravir (Tivicay) 50-mg film-coated tablets to children with HIV who weigh 20 kg or more.
Both dolutegravir formulations are for use in children who have never been treated for HIV or those who have been treated but not with an integrase strand transferase inhibitor (INSTI).
The two products cannot be substituted for one another on a milligram per milligram basis, the FDA said in a news release.
"For babies and young children with HIV, getting treatment early is very important [as] HIV can progress more quickly in children than adults," Debra Birnkrant, MD, director, Division of Antivirals, FDA Center for Drug Evaluation and Research, said in the news release.
"While the incidence of pediatric HIV infections continues to decline, the availability and early initiation of effective treatment are critical for infants and children living with HIV. Tivicay and Tivicay PD are taken once daily, which could help patients and caregivers better adhere to the regimen," Birnkrant explained.
Studies have shown that the safety, effectiveness, and pharmacokinetics of both formulations in HIV-infected children as young as 4 weeks are comparable to adults taking dolutegravir, the FDA said.
At 24 weeks, 62% of children taking Tivicay or Tivicay PD had an undetectable viral load and at 48 weeks, 69% had an undetectable viral load.
ViiV Healthcare CEO Deborah Waterhouse said the availability of dispersible dolutegravir — the first integrase inhibitor available as a dispersible tablet for oral suspension — will make it easier for young children to take the medication.
"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," she said in a company news release.
"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," Waterhouse added.
Full prescribing information for Tivicay and Tivicay PD are available online.
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Cite this: FDA OKs First Dispersible Form of Dolutegravir for Infants - Medscape - Jun 15, 2020.