On Feb. 6, the U.S. Food and Drug Administration (FDA) approved Dutrebis, a twice-daily combination tablet, for the treatment of HIV in adults and children (ages 6 and older).The new combination contains 150 mg of lamivudine (3TC, Epivir) and 300 mg of raltegravir (Isentress). Dutrebis is recommended to be taken twice a day, with or without food, and in combination with other antiretroviral drugs.
The approval of Dutrebis was based on a study, which showed that one Dutrebis combination tablet had comparable lamivudine and raltegravir exposures when compared to 150 mg of lamivudine and 400 mg of raltegravir taken separately, according to the FDA press release. Because of the higher bioavailability of raltegravir contained in Dutrebis, the dose in the combination was lowered to 300 mg.
Despite the FDA approval, the drug manufacturer, Merck Pharmaceuticals, announced that they would not be making Dutrebis commercially available in the U.S. at this time.
The decision was based on business reasons, said Pamela Eisele of Merck, who did not have a timeline for a U.S. release, but pointed out that, "The two components of Dutrebis -- raltegravir and lamivudine -- are available as single agents."
"We do plan to make Dutrebis available in select [non]-U.S. markets on a country-by-country basis," Eisele further said.