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The FDA Just Got Your Baby's Back

Baby Got Back

FDA approves new HIV treatment for infants, including newborns.

The Food and Drug Administration has approved the first ever treatment for HIV in newborns. The drug, Isentress, has been approved for infants from birth to four weeks old that weigh at least two kilograms (around four-and-a-half pounds).

Isentress, produced and manufactured by Merck, was originally approved in 2007 when it became the first integrase inhibitor developed for HIV treatment in adults. The FDA’s latest approval authorizing the drug to be used on infants is based in part on the promising clinical study, IMPAACT P1110, which evaluated the safety of Isentress in HIV-positive babies as young as 48-hours old.

So far, Isentress is approved as part of combination therapy in 112 countries for treatment of HIV in adults and adolescents. Of those countries, 69 have also approved its use in children over 2, and 33 countries have approved it for babies four weeks old and older. The drug is the only HIV treatment approved in the United States to be used on babies so young. The use of Isentress is not recommended in pre-term (premature) newborns or infants weighing less than two kilograms.

“Because clinical research on the use of antiretroviral drugs to treat newborns with HIV-1 infection has been limited, few antiretroviral agents are approved for this population,” Dr. Eliav Barr, senior vice president of infectious diseases global clinical development at Merck Research Laboratories, said in a statement. “This achievement underscores Merck’s unwavering commitment to the development of treatment options for HIV-1.”

Researchers warn that serious side effects have been reported including severe rashes, such as those associated with Stevens-Johnson syndrome, a hypersensitivity reaction that can be fatal. If severe rashes occur, immediately stop the use of Isentress. Parents are also cautioned to be especially observant and check in frequently with their doctor about their baby’s progress.

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