Phase 2 double-blind, randomized trial of etravirine versus efavirenz in treatment-naive patients: 48-week results

Brian Gazzard, Claudine Duvivier, Christian Zagler, Antonella Castagna, Andrew Hill, Yvonne Van Delft, Stephan Marks

Research output: Contribution to journalArticlepeer-review

Abstract

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

Original languageEnglish
Pages (from-to)2249-2258
Number of pages10
JournalAIDS (London, England)
Volume25
Issue number18
DOIs
Publication statusPublished - Nov 28 2011

Keywords

  • antiretroviral treatment
  • drug resistance
  • HIV RNA
  • nonnucleoside reverse transcriptase inhibitors
  • nucleoside analogues

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

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