A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population

Mark Nelson, Hans Jürgen Stellbrink, Daniel Podzamczer, D. Bánhegyi, Brian Gazzard, Andrew Hill, Yvon Van Delft, Johan Vingerhoets, Thomas Stark, Stephan Marks

Research output: Contribution to journalArticle

35 Citations (Scopus)

Abstract

Background: Although efavirenz is a universally recommended treatment for naive HIV-infected individuals, neuropsychiatric adverse events are common. Methods: The Study of Efavirenz NeuropSychiatric Events versus Etravirine (SENSE) trial is a double-blind, placebo-controlled study in which 157 treatment-naive individuals with HIV-RNA higher than 5000 copies/ml were randomized to etravirine 400 mg once daily (n = 79) or to efavirenz 600 mg once daily (n = 78), with two investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs). The primary end point was the percentage of patients with grade 1-4 drug-related treatment-emergent neuropsychiatric adverse events up to week 12. Results: The study population were 81% men and 85% whites, with a median age of 36 years, baseline CD4 cell counts of 302 cells/μl and HIV-RNA of 4.8 log10 copies/ml. In the intent-to-treat analysis, 13 of 79 individuals (16.5%) in the etravirine arm and 36 of 78 individuals (46.2%) in the efavirenz arm showed at least one grade 1-4 drug-related treatment-emergent neuropsychiatric adverse event (P <0.001). The number with at least one grade 2-4 drug-related treatment-emergent neuropsychiatric adverse event was four of 79 individuals (5.1%) in the etravirine arm and 13 of 78 individuals (16.7%) in the efavirenz arm (P = 0.019). The change in HIV-RNA to week 12 was -2.9 log10 in both treatment arms. The median rise in CD4 cell counts was 146 cells/μl in the etravirine arm and 121 cells/μl in the efavirenz arm. Conclusions: After 12 weeks, first-line treatment with etravirine 400 mg once daily with two NRTIs was associated with significantly fewer neuropsychiatric adverse events when compared with efavirenz with two NRTIs. The virological and immunological efficacy profile was similar between the two arms.

Original languageEnglish
Pages (from-to)335-340
Number of pages6
JournalAIDS
Volume25
Issue number3
DOIs
Publication statusPublished - Jan 28 2011

Fingerprint

efavirenz
etravirine
HIV-1
Reverse Transcriptase Inhibitors
Population
Nucleosides
HIV
RNA
CD4 Lymphocyte Count
Therapeutics
Pharmaceutical Preparations

Keywords

  • adverse events
  • central nervous system
  • efavirenz
  • etravirine
  • HIV clinical trials
  • HIV-RNA
  • neurological
  • nonnucleoside reverse transcriptase inhibitors
  • psychiatric

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases

Cite this

A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population. / Nelson, Mark; Stellbrink, Hans Jürgen; Podzamczer, Daniel; Bánhegyi, D.; Gazzard, Brian; Hill, Andrew; Van Delft, Yvon; Vingerhoets, Johan; Stark, Thomas; Marks, Stephan.

In: AIDS, Vol. 25, No. 3, 28.01.2011, p. 335-340.

Research output: Contribution to journalArticle

Nelson, M, Stellbrink, HJ, Podzamczer, D, Bánhegyi, D, Gazzard, B, Hill, A, Van Delft, Y, Vingerhoets, J, Stark, T & Marks, S 2011, 'A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population', AIDS, vol. 25, no. 3, pp. 335-340. https://doi.org/10.1097/QAD.0b013e3283416873
Nelson, Mark ; Stellbrink, Hans Jürgen ; Podzamczer, Daniel ; Bánhegyi, D. ; Gazzard, Brian ; Hill, Andrew ; Van Delft, Yvon ; Vingerhoets, Johan ; Stark, Thomas ; Marks, Stephan. / A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population. In: AIDS. 2011 ; Vol. 25, No. 3. pp. 335-340.
@article{29fe39d46c824f098fee06c1368d2b4b,
title = "A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population",
abstract = "Background: Although efavirenz is a universally recommended treatment for naive HIV-infected individuals, neuropsychiatric adverse events are common. Methods: The Study of Efavirenz NeuropSychiatric Events versus Etravirine (SENSE) trial is a double-blind, placebo-controlled study in which 157 treatment-naive individuals with HIV-RNA higher than 5000 copies/ml were randomized to etravirine 400 mg once daily (n = 79) or to efavirenz 600 mg once daily (n = 78), with two investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs). The primary end point was the percentage of patients with grade 1-4 drug-related treatment-emergent neuropsychiatric adverse events up to week 12. Results: The study population were 81{\%} men and 85{\%} whites, with a median age of 36 years, baseline CD4 cell counts of 302 cells/μl and HIV-RNA of 4.8 log10 copies/ml. In the intent-to-treat analysis, 13 of 79 individuals (16.5{\%}) in the etravirine arm and 36 of 78 individuals (46.2{\%}) in the efavirenz arm showed at least one grade 1-4 drug-related treatment-emergent neuropsychiatric adverse event (P <0.001). The number with at least one grade 2-4 drug-related treatment-emergent neuropsychiatric adverse event was four of 79 individuals (5.1{\%}) in the etravirine arm and 13 of 78 individuals (16.7{\%}) in the efavirenz arm (P = 0.019). The change in HIV-RNA to week 12 was -2.9 log10 in both treatment arms. The median rise in CD4 cell counts was 146 cells/μl in the etravirine arm and 121 cells/μl in the efavirenz arm. Conclusions: After 12 weeks, first-line treatment with etravirine 400 mg once daily with two NRTIs was associated with significantly fewer neuropsychiatric adverse events when compared with efavirenz with two NRTIs. The virological and immunological efficacy profile was similar between the two arms.",
keywords = "adverse events, central nervous system, efavirenz, etravirine, HIV clinical trials, HIV-RNA, neurological, nonnucleoside reverse transcriptase inhibitors, psychiatric",
author = "Mark Nelson and Stellbrink, {Hans J{\"u}rgen} and Daniel Podzamczer and D. B{\'a}nhegyi and Brian Gazzard and Andrew Hill and {Van Delft}, Yvon and Johan Vingerhoets and Thomas Stark and Stephan Marks",
year = "2011",
month = "1",
day = "28",
doi = "10.1097/QAD.0b013e3283416873",
language = "English",
volume = "25",
pages = "335--340",
journal = "AIDS",
issn = "0269-9370",
publisher = "Lippincott Williams and Wilkins",
number = "3",

}

TY - JOUR

T1 - A comparison of neuropsychiatric adverse events during 12 weeks of treatment with etravirine and efavirenz in a treatment-naive, HIV-1-infected population

AU - Nelson, Mark

AU - Stellbrink, Hans Jürgen

AU - Podzamczer, Daniel

AU - Bánhegyi, D.

AU - Gazzard, Brian

AU - Hill, Andrew

AU - Van Delft, Yvon

AU - Vingerhoets, Johan

AU - Stark, Thomas

AU - Marks, Stephan

PY - 2011/1/28

Y1 - 2011/1/28

N2 - Background: Although efavirenz is a universally recommended treatment for naive HIV-infected individuals, neuropsychiatric adverse events are common. Methods: The Study of Efavirenz NeuropSychiatric Events versus Etravirine (SENSE) trial is a double-blind, placebo-controlled study in which 157 treatment-naive individuals with HIV-RNA higher than 5000 copies/ml were randomized to etravirine 400 mg once daily (n = 79) or to efavirenz 600 mg once daily (n = 78), with two investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs). The primary end point was the percentage of patients with grade 1-4 drug-related treatment-emergent neuropsychiatric adverse events up to week 12. Results: The study population were 81% men and 85% whites, with a median age of 36 years, baseline CD4 cell counts of 302 cells/μl and HIV-RNA of 4.8 log10 copies/ml. In the intent-to-treat analysis, 13 of 79 individuals (16.5%) in the etravirine arm and 36 of 78 individuals (46.2%) in the efavirenz arm showed at least one grade 1-4 drug-related treatment-emergent neuropsychiatric adverse event (P <0.001). The number with at least one grade 2-4 drug-related treatment-emergent neuropsychiatric adverse event was four of 79 individuals (5.1%) in the etravirine arm and 13 of 78 individuals (16.7%) in the efavirenz arm (P = 0.019). The change in HIV-RNA to week 12 was -2.9 log10 in both treatment arms. The median rise in CD4 cell counts was 146 cells/μl in the etravirine arm and 121 cells/μl in the efavirenz arm. Conclusions: After 12 weeks, first-line treatment with etravirine 400 mg once daily with two NRTIs was associated with significantly fewer neuropsychiatric adverse events when compared with efavirenz with two NRTIs. The virological and immunological efficacy profile was similar between the two arms.

AB - Background: Although efavirenz is a universally recommended treatment for naive HIV-infected individuals, neuropsychiatric adverse events are common. Methods: The Study of Efavirenz NeuropSychiatric Events versus Etravirine (SENSE) trial is a double-blind, placebo-controlled study in which 157 treatment-naive individuals with HIV-RNA higher than 5000 copies/ml were randomized to etravirine 400 mg once daily (n = 79) or to efavirenz 600 mg once daily (n = 78), with two investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs). The primary end point was the percentage of patients with grade 1-4 drug-related treatment-emergent neuropsychiatric adverse events up to week 12. Results: The study population were 81% men and 85% whites, with a median age of 36 years, baseline CD4 cell counts of 302 cells/μl and HIV-RNA of 4.8 log10 copies/ml. In the intent-to-treat analysis, 13 of 79 individuals (16.5%) in the etravirine arm and 36 of 78 individuals (46.2%) in the efavirenz arm showed at least one grade 1-4 drug-related treatment-emergent neuropsychiatric adverse event (P <0.001). The number with at least one grade 2-4 drug-related treatment-emergent neuropsychiatric adverse event was four of 79 individuals (5.1%) in the etravirine arm and 13 of 78 individuals (16.7%) in the efavirenz arm (P = 0.019). The change in HIV-RNA to week 12 was -2.9 log10 in both treatment arms. The median rise in CD4 cell counts was 146 cells/μl in the etravirine arm and 121 cells/μl in the efavirenz arm. Conclusions: After 12 weeks, first-line treatment with etravirine 400 mg once daily with two NRTIs was associated with significantly fewer neuropsychiatric adverse events when compared with efavirenz with two NRTIs. The virological and immunological efficacy profile was similar between the two arms.

KW - adverse events

KW - central nervous system

KW - efavirenz

KW - etravirine

KW - HIV clinical trials

KW - HIV-RNA

KW - neurological

KW - nonnucleoside reverse transcriptase inhibitors

KW - psychiatric

UR - http://www.scopus.com/inward/record.url?scp=79551577103&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79551577103&partnerID=8YFLogxK

U2 - 10.1097/QAD.0b013e3283416873

DO - 10.1097/QAD.0b013e3283416873

M3 - Article

C2 - 21150563

AN - SCOPUS:79551577103

VL - 25

SP - 335

EP - 340

JO - AIDS

JF - AIDS

SN - 0269-9370

IS - 3

ER -