ViiV Healthcare press release
ViiV Healthcare announced that the U.S. Food and Drug Administration (FDA) has approved Tivicay PD (dolutegravir (DTG)), for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in paediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor (INSTI)-naïve) weighing at least 2 kg.
The FDA approval follows Priority Review for this population and is supported by data from the National Institutes of Health (NIH)-funded IMPAACT 2023 study and pharmacokinetic modelling incorporating additional paediatric data. These data showed that DTG, a second-generation INSTI with a higher barrier to resistance than previous generations, reached therapeutic drug levels in term neonates with a safety profile consistent with that established in older paediatric and adult populations.
Read the full press release here.
Source : ViiV Healthcare
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