FDA has approved raltegravir, an integrase inhibitor for the treatment of HIV-1 in combination with other antiretroviral agents, in newborn infants weighing at least 2 kg. Raltegravir was initially approved in 2007 for the treatment of HIV-1 infection in adolescents and adults. It acts by inhibiting the insertion of HIV-1 DNA into human DNA with the help of the integrase enzyme, demonstrating rapid antiviral activity. Dosage The first dose should be given 24 to 48 hours after birth if the mother has taken raltegravir within 2 to 24 hours before delivery.
Approval The approval of this drug was based on results from a clinical study, IMPAACT P1110. The study evaluated raltegravir oral suspension in 42 full-term HIV-1 exposed newborns at high risk for getting HIV-1 infection from their mothers. One cohort having 16 newborns was given 2 single doses of raltegravir oral suspension. The first…
