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IMPAACT P1093 Informs FDA Decision to Approve First-ever Dolutegravir Dispersible Tablet for Treatment of Children living with HIV

Data from IMPAACT P1093 and the ODYSSEY (PENTA20) study have informed the U.S. Food and Drug Administration (FDA) decision to approve the first-ever dispersible tablet formulation of Tivicay PD (dolutegravir) tablets for children as young as four weeks of age.

June 2020

Study Results

15 June 2020

We are delighted and proud that data from IMPAACT P1093 and the ODYSSEY (PENTA20) study have informed the United States (U.S.) Food and Drug Administration (FDA) decision to approve the first-ever dispersible tablet formulation of Tivicay PD (dolutegravir) tablets for children as young as four weeks of age and weighing at least 3 kg (or about 6.5 pounds).

Prior to this approval, dolutegravir was indicated in the U.S. for children from six years of age and weighing more than 30 kg (or about 66 pounds).

IMPAACT P1093 is an ongoing pharmacokinetic (PK), safety and dose-finding study of dolutegravir in combination antiretroviral treatment regimens in infants, children, and adolescents living with HIV. The study has enrolled more than 180 children at 34 research sites in Botswana, Brazil, Kenya, South Africa, Tanzania, Thailand, Uganda, the U.S., and Zimbabwe.

This approval is a crucial milestone in providing easier and more optimal HIV treatment options for children worldwide, which is a key pillar of the IMPAACT Network’s mission. The Network leadership is enormously grateful to the study participants and their parents/guardians, to the site staff and communities, and to the protocol team and collaborators who made this achievement possible.