FDA OKs Isentress Indication for HIV-1 Exposed Newborns

NOVEMBER 29, 2017
The FDA has extended the approval of raltegravir (Isentress, Merck), an integrase inhibitor for use in combination with other antiretroviral agents, for the treatment of HIV-1 in newborn infants weighing at least 2 kg, according to a company statement.

The FDA initially approved raltegravir in 2007 for the treatment of HIV-1 infection in adolescents and adults. It works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme and has demonstrated rapid antiviral activity.

The newborn’s first dose should be given 24 to 48 hours after birth if the mother has taken raltegravir within 2 to 24 hours before delivery.

The approval is based on results from a clinical study, known as IMPAACT P1110, evaluating raltegravir for oral suspension in 42 full-term HIV-1 exposed newborns at high risk for acquiring HIV-1 infection from their mothers. In the trial, 1 cohort of 16 newborns received 2 single doses of raltegravir for oral suspension. The first dose was given within 48 hours of birth and the second at 7 to 10 days of age. The second cohort of 26 newborns received daily dosing of raltegravir for oral suspension for 6 weeks at different weight-based doses.

All the newborn infants received a standard of care antiretroviral drug regimen for the prevention of HIV transmission from the mother and were followed for safety for 24 weeks. At the end of the study, all patients were HIV-1 negative.

The most commonly reported adverse effects associated with raltegravir included headache, insomnia, nausea, dizziness, and fatigue. There are no data available for the use of raltegravir in pre-term newborns or infants weighing less than 2 kg.


Merck receives FDA approval for Isentress® (raltegravir), in combination with other antiretroviral agents, for the treatment of HIV-1 infection in newborns weighing at least 2 kg [news release]. Kenilworth, NJ: November 29, 2017. mrknewsroom.com/news-release/prescription-medicine-news/merck-receives-fda-approval-isentress-raltegravir-combinatio. Accessed November 29, 2017.