FDA Approves Gilead’s Single-Tablet Triple HIV Therapy Complera

Drug combines emtricibatine with rilpivirine and tenofovir disoproxil fumarate.

FDA approved Gilead Sciences’ Complera™ (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) for the treatment of HIV-1 in treatment-naive adults. The single daily tablet comprises a fixed dose combination of Gilead’s Truvada® (itself a fixed dose combination of the NRTIs emtricitabine and tenofovir disoproxil fumarate), with Tibotec Pharmaceuticals’ NNRTI rilpivirine (Edurant™). Rilpivine was approved by FDA in May for use as part of HIV combination therapy.

FDA clearance of Complera was supported by 48-week data from two Phase III active-controlled studies, Echo and Thrive, which were conducted by Tibotec to confirm the safety and efficacy of rilpivirine in comparison with efavirenz. A bioequivalence study carried out by Gilead in addition demonstrated that the co-formulated single table regimen achieved the same blood levels of each of the three drugs, compared with separate administration.  

Complera is Gilead’s second combination HIV therapy to gain FDA approval. The first, Atripla®, is a fixed-dose combination of efavirenz, emtricitabine, and tenofovir disoproxil fumarate, which is marketed by Gilead and Bristol-Myers Squibb. The drug was cleared by FDA in 2006, and by the European regulator in 2007.

Gilead reported global sales of Atripla of $2.93 billion in 2010, up 23% on 2009 sales. Truvada sales in 2010 were up 6%, to $2.65 billion, and sales of Viread® tenofovir disoproxil fumarate were up 10%, at $732.2 million.