Public health agency the US Food and Drug Administration reported on Friday that it has awarded approval for Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension for the treatment of HIV-1 infection in paediatric patients under its priority review designation.

The agency has approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension to treat HIV-1 infection in paediatric patients at least four weeks old and weighing at least three kg (6.61 pounds), in combination with other antiretroviral treatments, who have never been treated for HIV or who have been treated, but not with an integrase strand transferase inhibitor (INSTI) class drug.

Approval of Tivicay and Tivicay PD has been granted to ViiV Healthcare.

Additionally, the safety and effectiveness of Tivicay and Tivicay PD were supported by a trial that included 75 HIV-1–infected infants, children and adolescents four weeks to less than 18 years old. At 24 weeks, 62% of paediatric patients taking Tivicay or Tivicay PD had an undetectable viral load and at 48 weeks, 69% had an undetectable viral load, concluded the agency.