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On October 16, the U.S. Food and Drug Administration (FDA) approved raltegravir (RGV or Isentress™) tablets for use in combination with other antiretroviral agents in the treatment of antiretroviral-experienced adults with drug-resistant strains of HIV. Of note is the fact that
[RGV] is the first agent of the pharmacological class known as HIV integrase ... inhibitors, designed to interfere with the enzyme that HIV-1 needs to multiply.4 ... When used with other anti-HIV medicines, [RGV] may reduce the amount of HIV in the blood and may increase white blood cells, called CD4+ (T) cells, that help fight off other infections. ... The most common adverse events reported with [RGV] were diarrhea, nausea, and headache. Blood tests also showed abnormal elevated levels of a muscle enzyme in some patients receiving [RGV]. Caution is advised when using [RGV] in patients at increased risk for certain types of muscle problems, including those who use other medications that can cause muscle problems. ... The long-term effects of [RGV] are not known, and its safety and effectiveness in children less than 16 years of age … [have] not been studied. [RGV] also has not been studied in pregnant women. (FDA, 2007)
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Winter 2008 Newsletter / Volume 9, Issue 2
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