TY - JOUR
T1 - Phase 2 double-blind, randomized trial of etravirine versus efavirenz in treatment-naive patients
T2 - 48-week results
AU - Gazzard, Brian
AU - Duvivier, Claudine
AU - Zagler, Christian
AU - Castagna, Antonella
AU - Hill, Andrew
AU - Van Delft, Yvonne
AU - Marks, Stephan
PY - 2011/11/28
Y1 - 2011/11/28
N2 - Background: The Study of Etravirine Neuropsychiatric Symptoms versus Efavirenz (SENSE) trial compared etravirine with efavirenz in treatment-naive patients. The primary endpoint was neuropsychiatric adverse events up to week 12; HIV RNA suppression at week 48 was a secondary endpoint. Methods: Patients with HIV RNA more than 5000copies/ml were randomized to etravirine 400mg once daily (n=79) or efavirenz (n=78), plus two nucleoside analogues. HIV RNA less than 50copies/ml at week 48 was analysed using the time to loss of virological response (TLOVR) algorithm. Drug resistance at treatment failure and safety endpoints were also evaluated. Results: At baseline, the median CD4 + cell count was 302cells/μl and HIV RNA was 4.8log10copies/ml. In the intent to treat TLOVR analysis at week 48, 60 of 79 (76%) patients on etravirine versus 58 of 78 (74%) on efavirenz had HIV RNA less than 50copies/ml. In the on-treatment analysis, 60 of 65 (92%) taking etravirine had HIV RNA les than 50copies/ml versus 58 of 65 (89%) for efavirenz: etravirine showed noninferior efficacy versus efavirenz in both analyses (P
AB - Background: The Study of Etravirine Neuropsychiatric Symptoms versus Efavirenz (SENSE) trial compared etravirine with efavirenz in treatment-naive patients. The primary endpoint was neuropsychiatric adverse events up to week 12; HIV RNA suppression at week 48 was a secondary endpoint. Methods: Patients with HIV RNA more than 5000copies/ml were randomized to etravirine 400mg once daily (n=79) or efavirenz (n=78), plus two nucleoside analogues. HIV RNA less than 50copies/ml at week 48 was analysed using the time to loss of virological response (TLOVR) algorithm. Drug resistance at treatment failure and safety endpoints were also evaluated. Results: At baseline, the median CD4 + cell count was 302cells/μl and HIV RNA was 4.8log10copies/ml. In the intent to treat TLOVR analysis at week 48, 60 of 79 (76%) patients on etravirine versus 58 of 78 (74%) on efavirenz had HIV RNA less than 50copies/ml. In the on-treatment analysis, 60 of 65 (92%) taking etravirine had HIV RNA les than 50copies/ml versus 58 of 65 (89%) for efavirenz: etravirine showed noninferior efficacy versus efavirenz in both analyses (P
KW - antiretroviral treatment
KW - drug resistance
KW - HIV RNA
KW - nonnucleoside reverse transcriptase inhibitors
KW - nucleoside analogues
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U2 - 10.1097/QAD.0b013e32834c4c06
DO - 10.1097/QAD.0b013e32834c4c06
M3 - Article
C2 - 21881478
AN - SCOPUS:80855130709
VL - 25
SP - 2249
EP - 2258
JO - AIDS
JF - AIDS
SN - 0269-9370
IS - 18
ER -