Dutrebis, New HIV Drug, Approved by FDA, but Not Commercially Available

February 10, 2015

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 it 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.

Warren Tong is the senior science editor for and

Follow Warren on Twitter: @WarrenAtTheBody.

Copyright © 2015 Remedy Health Media, LLC. All rights reserved.


No comments have been made.

Add Your Comment:
(Please note: Your name and comment will be public, and may even show up in
Internet search results. Be careful when providing personal information! Before
adding your comment, please read's Comment Policy.)

Your Name:

Your Location:

(ex: San Francisco, CA)

Your Comment:

Characters remaining:


The content on this page is free of advertiser influence and was produced by our editorial team. See our content and advertising policies.