News from the FDA/CDC

FDA approves raltegravir for newborns at risk for HIV-1 infection


 

The Food and Drug Administration has approved the use of raltegravir (Isentress), in combination with other antiretrovirals, for HIV-1 exposed newborns who weigh at least 2 kg and are at high risk for acquiring HIV-1 infection from their mothers, according to a press release from Merck, the manufacturer of Isentress.

“With this FDA approval, Isentress becomes the only integrase inhibitor approved in the U.S. for the treatment of HIV-1, in combination with other antiretroviral agents, for neonates weighing at least 2 kg,” Eliav Barr, MD, senior vice president, global clinical development, infectious diseases and vaccines, Merck Research Laboratories, said in a statement.

FDA icon
The FDA approval for Merck’s integrase inhibitor was based on the results of an open-label, multicenter clinical study that evaluated the safety and pharmacokinetics of raltegravir as an oral suspension in 42 full-term newborns at risk of acquiring HIV-1 from their mothers.

The study, IMPAACT P1110, was composed of two cohorts receiving different doses of raltegravir at different time intervals. The first cohort, of 16 newborns, received two single doses of raltegravir: the first within 48 hours of birth and the second between 7 and 10 days of age. The second cohort of 26 newborns received daily doses based on weight for 6 weeks. After observation for 24 weeks, all infants were HIV-1 negative.

Raltegravir does not cure HIV-1 infection or AIDS and severe side effects have been reported, including hypersensitivity reaction and toxic epidermal necrolysis, according to the Merck release.

Raltegravir should not be used in newborns and infants weighing under 2 kg. If raltegravir has been administered to the mother 2-24 hours before delivery, the first dose for the newborn should be given between 24 and 48 hours after birth.

Next Article: