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Published on 15 August 2011

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FDA approve drug for treatment of HIV

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The US Food and Drug Administration (FDA) have approved Complera for the treatment of HIV.

Complera is a fixed dose combination drug containing emtricitabine (200mg), rilpivirine (25mg) and tenofovir (300mg). The recommended dose is one tablet per day, taken orally with a meal and the drug is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in antiretroviral treatment, with naïve adult patients.

“[Complera] is a complete regimen for tackling HIV infection in treatment naïve patients because it contains a Nonnucleoside Reverse Transcriptase Inhibitor (rilpivirine) and two Nucleoside Reverse Transcriptase Inhibitors (emtricitabine and tenofovir DF),” said a statement on FDA’s website.

The following points should be considered when initiating therapy with Complera, according to the organisation:

¥    More rilpivirine-treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure compared to subjects with HIV-1 RNA less than 100,000 copies/mL at the start of therapy.

¥    The observed virologic failure rate in rilpivirine-treated subjects conferred a higher rate of overall treatment resistance and cross-resistance to the Nonnucleoside Reverse Transcriptase Inhibitor class compared to efavirenz.

¥    More subjects treated with rilpivirine developed lamivudine/emtricitabine-associated resistance compared to efavirenz.

FDA



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