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FDA expands Isentress indication for HIV-1 exposed full-term newborns
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The FDA has approved expanded indication of Isentress to include HIV-1 exposed full-term neonates, from birth to 4 weeks of age.
Isentress (raltegravir, Merck) is now indicated in combination with other antivirals for treating HIV-1 in pediatric patients weighing at least 2 kg, according to a statement from the FDA.
A phase 1 safety and pharmacokinetics study of raltegravir for oral suspension was conducted in 42 full-term neonates (52% male) at high risk of acquiring HIV-1 infection. The patients were divided into two cohorts, with cohort 1 (16 neonates) receiving 2 single doses of raltegravir for oral suspension, including the first within 48 hours of birth and the second at days 7 to 10 of age.
Cohort 2 (28 neonates) received daily dosing of raltegravir for oral suspension for 6 weeks, including 1.5 mg/kg once daily starting within 48 hours of birth through day 7; 3 mg/kg twice daily on days 8 to 28 of age; and 6 mg mg/kg twice daily on days 29 to 42 of age. Six patients in cohort 1 and all patients in cohort 2 were unexposed to raltergravir in utero.
Nucleic acid test at birth, week 6 and week 24 was used to measure HIV-1 status, and all patients were HIV-1 negative at the completion of the study.
No drug-related clinical adverse reactions and three drug-related laboratory adverse reactions were reported, with the safety profile in neonates generally similar to that observed in older patients treated with raltegravir, the FDA reported.
The FDA noted that raltegravir is not recommended in pre-term neonates or in pediatric patients weighing less than 2 kg. The agency also noted that if the mother has taken Isentress or Isentress HD between 2 to 24 hours prior to delivery, the first dose for the neonate should be given between 24 and 48 hours after birth.