The US Food and Drug Administration has expanded the indication of the HIV drug raltegravir (Isentress, Merck) beyond adults and children aged 2 to 18 years to newborns weighing at least 2 kg, the company has announced.
Raltegravir, for use in combination with other antiretroviral agents, is the only integrase inhibitor approved in the United States for treatment of HIV-1 in newborns from birth to 4 weeks of age weighing 2 kg or more.
The expanded indication follows an open-label, multicenter clinical study evaluating raltegravir for oral suspension in 42 full-term, HIV-1-exposed newborns at high risk of acquiring HIV-1 infection from their mothers.
The study had two cohorts. In cohort 1, 16 newborns (10 with and six without exposure to raltegravir in utero) received two single doses of raltegravir: the first within 48 hours of birth and the second at 7 to 10 days of age. In cohort 2, 26 newborns (all unexposed to raltegravir in utero) received daily dosing of raltegravir for 6 weeks at different weight-based doses. All infants received a standard-of-care antiretroviral drug regimen for prevention of mother-to-child transmission and were followed up for safety for 24 weeks.
At the end of the study, all infants were HIV-1-negative and the safety profile of raltegravir was comparable to that observed in adults, the company said in a press release.
Use of raltegravir is not recommended in preterm newborns or infants weighing less than 2 kg, as no data are available in these populations. If the mother has taken raltegravir or raltegravir HD within 2 to 24 hours before delivery, the newborn’s first dose should be given between 24 to 48 hours after birth.
Full prescribing information is available online.
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