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FDA approves fixed-dose combo for HIV-1

Issue: September 2011

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The FDA has approved a new fixed-dose emtricitabine-rilpivirine-tenofovir disoproxil fumarate combination therapy for the treatment of HIV-1 in treatment-naive adults, according to an FDA press release.

The recommended dose of the new therapy (Complera, Gilead) is once-daily 200 mg emtricitabine, 25 mg rilpivirine and 300 mg tenofovir disoproxil fumarate in tablet form.

When initiating therapy, the FDA said to consider the following points:

• More rilpivirine-treated (Edurant, Tibotec Therapeutics) patients with HIV-1 RNA 1 of more than 100,000 copies/mL at beginning of therapy experienced virologic failure vs. patients with HIV-1 RNA of less than 100,000 copies/mL at the start of therapy.
• The observed virologic failure rate in rilpivirine-treated patients conferred a higher rate of overall treatment resistance and cross-resistance to the non-nucleoside reverse transcriptase inhibitor class compared with efavirenz (Sustiva, Bristol-Myers Squibb).
• More patients treated with rilpivirine developed lamivudine/emtricitabine-associated resistance vs. efavirenz.

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

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