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.