FDA approves raltegravir for newborns

Polly Clayden, HIV i-Base

At the end of November 2017, the US FDA approved raltegravir for treatment, in combination with other antiretrovirals, of neonates from birth to four weeks of age, weighing at least 2 kg. [1, 2]

This approval was supported by data from IMPAACT P1110 – an open label, clinical trial looking at the safety and pharmacokinetics of raltegravir oral suspension in 42 full term, HIV-exposed newborns, at high risk of vertical transmission.

Raltegravir is not recommended in pre-term newborns or infants weighing less than 2 kg, as no data are yet available in these populations. If the mother has taken raltegravir within two to 24 hours before delivery, the newborn’s first dose should be given between 24 to 48 hours after birth.


Raltegravir is now one of the few antiretrovirals approved for treating babies from birth.

Having the option to use an integrase inhibitor from birth is a significant development for paediatric HIV.


  1. Merck press release. 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. 29 November 2017.
  1. US Food and Drug Administration. Supplement approval fulfillment of postmarketing requirement raltegravir. 22 November 2017.,022145orig1s037,203045orig1s014ltr.pdf

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