The Food and Drug Administration (FDA) on Wednesday approved the once-daily pill Complera for patients not previously treated for HIV.

Complera, made by Gilead Sciences Inc., combines tenofovir/emtricitabine (Truvada) with rilpivirine (Edurant), a Johnson & Johnson drug that received FDA approval in May. The combination treatment will cost approximately $1,705 a month.

A statement by Gilead said the approval of Complera was supported by data from two 48-week, Phase III studies -- ECHO and THRIVE -- that compared rilpivirine to efavirenz (Sustiva), made by Bristol-Myers Squibb Co., in treatment-naive adults with HIV-1 infection. Most patients in the rilpivirine study arm received Truvada as well.

Gilead stressed consideration of the following before starting patients on Complera:

• Complera is not recommended for use in patients under age 18.
• Virologic failure was more common in subjects in the rilpivirine arm who had a baseline HIV-1 RNA of greater than 100,000 copies/mL.
• Compared to those in the efavirenz arm, virologic failure rate in rilpivirine-treated subjects conferred a higher overall rate of treatment resistance and cross-resistance to the non-nucleoside reverse transcriptase inhibitor class.
• More subjects treated with rilpivirine developed lamivudine/emtricitabine-associated resistance compared to efavirenz.

Further, Complera has boxed warnings concerning lactic acidosis/severe hepatomegaly with steatosis and post-treatment acute exacerbation of hepatitis B.

For more information, visit www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm267592.htm.

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