Efavirenz / Truvada three-in-one pill licensed in US as Atripla

Keith Alcorn
Published: 13 July 2006

Bristol-Myers Squibb Company and Gilead Sciences Inc announced on Wednesday that the US Food and Drug Administration (FDA) has granted approval for a triple drug combination in one pill, containing BMS’s efavirenz and Gilead’s tenofovir and emtricitabine. The product will be marketed as Atripla in the United States, and is the first collaboration between companies to create a fixed-dose combination for HIV treatment.

Atripla is a once-daily drug containing 600mg of efavirenz, 300mg of tenofovir and 200mg of emtricitabine (FTC). Tenofovir and emtricitabine are already marketed in a combination tablet called Truvada. Atripla will be dosed as a single tablet with or without food. Most doctors recommend that efavirenz-containing regimens be taken before going to bed at night.

The triple combination is one of the most frequently prescribed first-line regimens for treatment of HIV infection worldwide, and the individual elements have been tested in a large international study called GS 934, which showed that the three drugs were better tolerated and resulted in a slightly superior treatment outcome over 48 weeks of follow-up when compared to AZT, 3TC and efavirenz.

The approval of Atripla will not only make the new fixed-dose combination available in the United States, but also permits its purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) programme. Plans for seeking regulatory approval in countries covered by PEPFAR programmes have not yet been announced, and nor has the price of the product for developing countries. However, the individual elements of the triple combination have already been licensed to generic manufacturers in South Africa, who have been granted non-exclusive marketing rights in sub-Saharan Africa.

In the European Union the product has not yet been submitted for regulatory approval due to the more complex marketing arrangements that will be necessary in the region. While Bristol Myers Squibb markets efavirenz in the United Kingdom, Ireland, France, Spain, Italy and Germany, Merck & Co markets efavirenz as Stocrin in the rest of the European Union.

The triple combination pill is likely to be submitted for European approval within the next few months, with marketing approval granted during the first half of 2007.