TY - JOUR
T1 - Rilpivirine versus efavirenz with tenofovir and emtricitabine in treatment-naive adults infected with HIV-1 (ECHO)
T2 - A phase 3 randomised double-blind active-controlled trial
AU - Molina, Jean Michel
AU - Cahn, Pedro
AU - Grinsztejn, Beatriz
AU - Lazzarin, Adriano
AU - Mills, Anthony
AU - Saag, Michael
AU - Supparatpinyo, Khuanchai
AU - Walmsley, Sharon
AU - Crauwels, Herta
AU - Rimsky, Laurence T.
AU - Vanveggel, Simon
AU - Boven, Katia
PY - 2011/7/16
Y1 - 2011/7/16
N2 - Background Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1. Rilpivirine, a new non-nucleoside reverse transcriptase inhibitor, has shown similar antiviral efficacy to efavirenz in a phase 2b trial with two nucleoside/nucleotide reverse transcriptase inhibitors. We aimed to assess the efficacy, safety, and tolerability of rilpivirine versus efavirenz, each combined with tenofovir-disoproxil-fumarate and emtricitabine. Methods We did a phase 3, randomised, double-blind, double-dummy, active-controlled trial, in patients infected with HIV-1 who were treatment-naive. The patients were aged 18 years or older with a plasma viral load at screening of 5000 copies per mL or greater, and viral sensitivity to all study drugs. Our trial was done at 112 sites across 21 countries. Patients were randomly assigned by a computer-generated interactive web response system to receive either once-daily 25 mg rilpivirine or once-daily 600 mg efavirenz, each with tenofovir- disoproxil-fumarate and emtricitabine. Our primary objective was to show non-inferiority (12 margin) of rilpivirine to efavirenz in terms of the percentage of patients with confirmed response (viral load
AB - Background Efavirenz with tenofovir-disoproxil-fumarate and emtricitabine is a preferred antiretroviral regimen for treatment-naive patients infected with HIV-1. Rilpivirine, a new non-nucleoside reverse transcriptase inhibitor, has shown similar antiviral efficacy to efavirenz in a phase 2b trial with two nucleoside/nucleotide reverse transcriptase inhibitors. We aimed to assess the efficacy, safety, and tolerability of rilpivirine versus efavirenz, each combined with tenofovir-disoproxil-fumarate and emtricitabine. Methods We did a phase 3, randomised, double-blind, double-dummy, active-controlled trial, in patients infected with HIV-1 who were treatment-naive. The patients were aged 18 years or older with a plasma viral load at screening of 5000 copies per mL or greater, and viral sensitivity to all study drugs. Our trial was done at 112 sites across 21 countries. Patients were randomly assigned by a computer-generated interactive web response system to receive either once-daily 25 mg rilpivirine or once-daily 600 mg efavirenz, each with tenofovir- disoproxil-fumarate and emtricitabine. Our primary objective was to show non-inferiority (12 margin) of rilpivirine to efavirenz in terms of the percentage of patients with confirmed response (viral load
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U2 - 10.1016/S0140-6736(11)60936-7
DO - 10.1016/S0140-6736(11)60936-7
M3 - Article
C2 - 21763936
AN - SCOPUS:79960381844
VL - 378
SP - 238
EP - 246
JO - The Lancet
JF - The Lancet
SN - 0140-6736
IS - 9787
ER -