European Commission approves dispersible tablets to treat pediatric HIV

The European Commission (EC) has granted marketing authorization for Tivicay (dolutegravir) 5 mg dispersible tablets, which are used in combination with other antiretroviral agents for the treatment of infection with the virus of the human immunodeficiency type 1 (HIV-1) in pediatric patients.

ViiV Healthcare, which produces the tablets, said the therapy is now approved for treatment-naïve or experienced but treatment-naïve INSTI children who are at least four weeks old and weigh at least 3 kg.

This authorization includes updated dosing recommendations for Tivicay (dolutegravir) film-coated tablets (10 mg, 25 mg and 50 mg) for children six years of age and over and weighing at least 14 kg, aligning them with the ranges of weight of the World Health Organization (WHO).

Tivicay contains dolutegravir, anot integrase strand transfer inhibitor for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors inhibit HIV integrase by binding to the active site of integrase and blocking the strand transfer step of retroviral DNA inan integration that is essential for the HIV replication cycle.

Deborah Waterhouse, Chief Executive Officer (CEO) of ViiV Healthcare, said: “Today’s clearance is a very important step in ensuring children have access to age-appropriate formulations of anti-HIV drugs. Globally, approximately 1.7 million children are living with HIV and approximately 100,000 children die of AIDS each year, which is why we will not stop doing all we can to make sure that no children living with HIV be left behind.

The marketing authorization is based on data from ongoing studies P10932 and ODYSSEY3 (PENTA20), which are being carried out in collaboration with the international pediatric research networks, IMPAACT and PENTA-ID.

Drugs East indedicated in combination with rilpivirine as a complete diet for the treatment of HIV-1 infection in adults replace the current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen for at at least six months with no history of treatment failure or known substitutions associated with resistance to one or the other antiretroviral agent.