Complera, a complete single-tablet regimen containing Janssen Therapeutics’ Edurant (rilpivirine) and Gilead Sciences’ Viread (tenofovir) and Emtriva (emtricitabine), was approved August 10 by the U.S. Food and Drug Administration (FDA), according to an announcement by Gilead. Complera, the second all-in-one fixed-dose combination tablet for people living with HIV, is approved for those starting antiretroviral (ARV) therapy for the first time.
The approval of Complera is supported by 48-week data from two Phase III randomized studies (ECHO and THRIVE) conducted by Tibotec, a subsidiary of Janssen, evaluating the safety and efficacy of Edurant compared to Sustiva (efavirenz) among first-time treatment takers, with both drugs typically used in combination with Truvada (tenofovir plus emtricitabine). Both regimens were comparable in terms of efficacy, with fewer volunteers in the Edurant group experiencing side effects, notably the central nervous system problems associated with Sustiva use.
A bioequivalence study, conducted by Gilead, demonstrated that the co-formulated single-tablet regimen achieved the same levels of medication in the blood as Edurant plus Viread and Emtriva.
Complera is the second complete ARV treatment regimen for HIV available to first-time treatment takers in a single once-daily pill. The first, Atripla (efavirenz plus Truvada), is marketed by Gilead and Bristol-Myers Squibb and was approved by the FDA in July 2006.
Several points should be considered before initiating therapy with Complera, according to the Gilead announcement. First, people starting treatment with high viral loads (100,000 copies or higher) were more likely to experience virologic failure while using Edurant in clinical trials, compared with those taking Sustiva. Also, when treatment failed, those taking Edurant were more likely to develop resistance to the drugs in their regimen than those taking Sustiva. Finally, Complera is not recommended for patients younger than 18 years of age, nor is it recommended for patients with moderate/severe kidney problems.
Gilead first entered into a license and collaboration agreement with Tibotec for the development and commercialization of Complera in July 2009. Under the terms of the agreement, Gilead will assume the lead role in the manufacturing, registration, distribution and commercialization of Complera in the United States, Canada, Brazil, the European Union, Australia and New Zealand. Janssen will be responsible for the commercialization of Edurant as a stand-alone drug, a non-nucleoside reverse transcriptase inhibitor, and will hold rights to co-sell Complera in these territories.
A marketing application for the fixed-dose combination tablet is currently pending in the European Union.
To learn more about Complera, click here.