FDA approves Tivicay and Tivicay PD for treatment of HIV-1 in kids

The US Food and Drug Administration (FDA) has approved Viiv Healthcare’s Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension to treat HIV-1 in children aged at least 4 weeks and who weigh at least 3 kilograms.¹ They are for use in combination with other antiretroviral drug therapies. The drugs are meant to treat either children who have never been treated for HIV or children who have never been treated with an integrase strand transferase inhibitor (INSTI) class drug. The application was given a Priority Review designation.

The drug’s safety and efficacy were shown by a trial that included 75 infants, children, and adolescents who were HIV-1 infected. In the trial both the researchers and participants knew that a treatment was being given. Following 24 weeks of treatment, 62% of the patients who had been given Tivicay or Tivicay PD had an undetectable viral load and after 48 weeks of treatments it had grown to 69%. Additionally, many of the study participants were found to have higher levels of certain cells, like CD4, that can aid in fighting off infection.

In the press release for the approval Debra Birnkrant, MD, director of the Division of Antivirals in FDA’s Center for Drug Evaluation and Research spoke about why the approval was so important, saying, “For babies and young children with HIV, getting treatment early is very important. HIV can progress more quickly in children than adults. 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. Today’s approval gives our youngest HIV patients more options, helping them live longer, healthier lives.”

Reference:

1. US Food and Drug Administration. FDA approves drug to treat infants and children with HIV. US Food and Drug Administration. Published June 12, 2020. Accessed June 15, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-drug-treat-infants-and-children-hiv