Shots:
- The US FDA has approved Tivicay PD (dolutegravir) in combination with other antiretrovirals for HIV-1 treatment in pediatric pts weighing ≥2kg, incl. treatment-naïve or experienced pts who have not previously received an INSTI
- The FDA decision follows Priority Review & is supported by data from the NIH-funded IMPAACT 2023 study & pediatric PK modeling. Results showed therapeutic dolutegravir levels in term neonates, with a safety consistent with older pediatric & adult pts
- Tivicay & Tivicay PD contain dolutegravir, an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase & prevents viral DNA integration for use with other antiretrovirals
Ref: Businesswire | Image: ViiV Healthcare | Press Release
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