FDA Approves Complera (Edurant + Truvada), a Second "All-in-One" Option for First-Line HIV Treatment

Executive Editor

When it comes to single-pill HIV treatment regimens in the U.S., Atripla is no longer the only game in town. The U.S. Food and Drug Administration has just approved Complera, a once-daily tablet that contains Truvada (tenofovir/FTC) and the NNRTI Edurant (rilpivirine).

The approval of Complera has been highly anticipated for months. The drugs within the pill are similar to Atripla, which contains Truvada and an older NNRTI, Sustiva (Stocrin, efavirenz). In fact, Complera has frequently been referred to informally as "Btripla" by researchers, health care professionals and advocates. In a head-to-head study, the drugs that comprise Complera generally did just as good a job at controlling viral load as the drugs that comprise Atripla, but generally caused fewer side effects -- particularly the vivid dreams and neurological effects that are often associated with Sustiva. (That having been said, insomnia was one of the most common moderate-to-severe side effects experienced by people taking Edurant in its pre-approval studies, along with headache and psychiatric disorders.)

There are a few notable differences between Complera and Atripla. Unlike Atripla, Complera must be taken with a meal. In addition, Complera may be less likely to work in people who start HIV treatment with a viral load above 100,000. And when the drug fails to work, it may be more likely to lead to resistance to other NNRTIs, as well as the NRTIs Epivir (lamivudine, 3TC) and Emtriva (emtricitabine, FTC), which are components of other fixed-dose combination drugs such as Truvada and Epzicom.

It remains to be seen how Complera is factored into official U.S. treatment guidelines for first-line antiretroviral therapy. The guidelines, which are usually updated approximately once per year, were last revised in January. Atripla is one of five first-line regimens recommended by the guidelines. Edurant, the key drug that makes Complera different from Atripla, was not approved by the FDA until well after those revised guidelines were released.

Respected HIV physician Paul Sax, M.D., offers his perspective on the most important things to know about Complera in a recent article. Meanwhile, for more detailed information on the FDA's approval of Complera (including side effects, potential drug interactions and study data), read the official announcement. You can also learn more about Edurant in this interview with Cal Cohen, M.D., earlier this year.