August 10, 2011

New Three-in-One HIV Med Complera Approved

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.

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Previous Comments:

Irene, Woodbridge, 2012-01-09 01:42:47
Why does this medication cost so much??? The retail cost is $2,012. My out-of-pocket payment is $475 for a 30-day supply. No wonder people are dying...they can't afford to pay for the medication. I sometimes don't refill my prescription because of other bills, i.e., food, rent, etc Can't Gilead come down on the price???

Frederick Wright, Southern California, 2011-09-03 22:58:29
Yes fear can be very deadly and facing it can be more fearful. The good news is that FDA does have an open web page for consumer to report side effects. Their is no better time for Drug Companies that like to do live experments with live patients for it is win win for them they get top dollar for ARVs and get to experiment with us and make other block buster drugs like virgra... Thing are not always as they seem and buyer beware. And remember Donal Rumsflied and Channey run Gilead in the past

Lorem Ipsum, , 2011-08-28 02:28:47
TonyC, while I can understand your concern, we HIVers *know* that without these drugs, we will die. We don't have the time to wait for long term data before approval. Many of us are reaching points where most existing drugs no longer work. So we're willing to gamble, I suppose, that a drug with a short test period may help or hurt. When you know the outcome of doing nothing, it changes your mental calculus quickly.

TonyC, New York City, 2011-08-17 02:17:05
I am a Pharmacist & in the good ole' days, the FDA took so long for ONE drug to be released...really 48 weeks of data??I would like to see LONG TERM DATA!