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A randomized crossover study to compare efavirenz and etravirine treatment

Efavirenz (EFV) causes neuropsychiatric side-effects and an unfavourable blood lipid profile. We investigated the effect of replacing EFV with etravirine (ETR) on patient preference, sleep, anxiety and lipid levels. Study participants did not complain of side-effects, had tolerated EFV for at least... Full description

Journal Title: AIDS (London England) 2011, Vol.25 (1), p.57-63
Main Author: NGUYEN, Alain
Other Authors: CALMY, Alexandra , HIRSCHEL, Bernard , DELHUMEAU, Cécile , MERCIER, Isabelle K , CAVASSINI, Matthias , FAYET-MELLO, Aurélie , ELZI, Luigia , GENNE, Daniel , RAUCH, Andri , BERNASCONI, Enos
Format: Electronic Article Electronic Article
Language: English
Subjects:
Publisher: Hagerstown, MD: Lippincott Williams & Wilkins
ID: ISSN: 0269-9370
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title: A randomized crossover study to compare efavirenz and etravirine treatment
format: Article
creator:
  • NGUYEN, Alain
  • CALMY, Alexandra
  • HIRSCHEL, Bernard
  • DELHUMEAU, Cécile
  • MERCIER, Isabelle K
  • CAVASSINI, Matthias
  • FAYET-MELLO, Aurélie
  • ELZI, Luigia
  • GENNE, Daniel
  • RAUCH, Andri
  • BERNASCONI, Enos
subjects:
  • Adult
  • AIDS/HIV
  • Antibiotics. Antiinfectious agents. Antiparasitic agents
  • Antiretroviral Therapy, Highly Active
  • Antiviral agents
  • Anxiety Disorders - chemically induced
  • Anxiety Disorders - psychology
  • Benzoxazines - adverse effects
  • Benzoxazines - therapeutic use
  • Biological and medical sciences
  • CD4 Lymphocyte Count
  • Drug Administration Schedule
  • Female
  • HIV Infections - drug therapy
  • HIV Infections - psychology
  • HIV Protease Inhibitors - adverse effects
  • HIV Protease Inhibitors - therapeutic use
  • HIV-1
  • Human immunodeficiency virus
  • Human viral diseases
  • Humans
  • Infectious diseases
  • Male
  • Medical sciences
  • Middle Aged
  • Pharmacology. Drug treatments
  • Practice Guidelines as Topic
  • Pyridazines - administration & dosage
  • Pyridazines - adverse effects
  • Pyridazines - therapeutic use
  • Sleep Initiation and Maintenance Disorders - chemically induced
  • Sleep Initiation and Maintenance Disorders - psychology
  • Surveys and Questionnaires
  • Treatment Outcome
  • Viral diseases
  • Viral diseases of the lymphoid tissue and the blood. Aids
ispartof: AIDS (London England), 2011, Vol.25 (1), p.57-63
description: Efavirenz (EFV) causes neuropsychiatric side-effects and an unfavourable blood lipid profile. We investigated the effect of replacing EFV with etravirine (ETR) on patient preference, sleep, anxiety and lipid levels. Study participants did not complain of side-effects, had tolerated EFV for at least 3 months, with less than 50 copies/ml HIV-RNA. After randomization, the ETR-first group started with ETR (400 mg daily) [DOSAGE ERROR CORRECTED] with EFV-placebo and the EFV-first group with EFV with ETR-placebo. After 6 weeks, both groups switched to the alternate regimen. Nucleoside reverse transcriptase inhibitors were continued without any change. The primary end point was patient preference for the first or the second regimen, assessed after 12 weeks. Fifty-eight patients were enrolled with a median CD4 cell count of 589 cells/μl and the duration of previous EFV therapy was 3.9 years. Fifty-five patients completed the study. When asked about treatment preference after 12 weeks, 16 preferred EFV and 22 preferred ETR, whereas 17 did not express a preference (P = NS). Patients who continued EFV during the first phase of the trial preferred EFV (15/21, 71%), whereas patients who started with ETR were more likely to prefer ETR (n = 16/17, 94%). This order effect was strongly significant (P < 0.0001). Quality of sleep, depression, anxiety and stress scores did not differ significantly between groups. Median plasma cholesterol levels decreased by 0.7 mmol (29 mg/100 ml) after replacing EFV with ETR (P < 0.002). After substitution of EFV by ETR, patients did not express a significant preference for ETR. There was no measurable effect on neuropsychiatric symptoms and sleep. Cholesterol decreased.
language: eng
source:
identifier: ISSN: 0269-9370
fulltext: no_fulltext
issn:
  • 0269-9370
  • 1473-5571
url: Link


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titleA randomized crossover study to compare efavirenz and etravirine treatment
creatorNGUYEN, Alain ; CALMY, Alexandra ; HIRSCHEL, Bernard ; DELHUMEAU, Cécile ; MERCIER, Isabelle K ; CAVASSINI, Matthias ; FAYET-MELLO, Aurélie ; ELZI, Luigia ; GENNE, Daniel ; RAUCH, Andri ; BERNASCONI, Enos
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descriptionEfavirenz (EFV) causes neuropsychiatric side-effects and an unfavourable blood lipid profile. We investigated the effect of replacing EFV with etravirine (ETR) on patient preference, sleep, anxiety and lipid levels. Study participants did not complain of side-effects, had tolerated EFV for at least 3 months, with less than 50 copies/ml HIV-RNA. After randomization, the ETR-first group started with ETR (400 mg daily) [DOSAGE ERROR CORRECTED] with EFV-placebo and the EFV-first group with EFV with ETR-placebo. After 6 weeks, both groups switched to the alternate regimen. Nucleoside reverse transcriptase inhibitors were continued without any change. The primary end point was patient preference for the first or the second regimen, assessed after 12 weeks. Fifty-eight patients were enrolled with a median CD4 cell count of 589 cells/μl and the duration of previous EFV therapy was 3.9 years. Fifty-five patients completed the study. When asked about treatment preference after 12 weeks, 16 preferred EFV and 22 preferred ETR, whereas 17 did not express a preference (P = NS). Patients who continued EFV during the first phase of the trial preferred EFV (15/21, 71%), whereas patients who started with ETR were more likely to prefer ETR (n = 16/17, 94%). This order effect was strongly significant (P < 0.0001). Quality of sleep, depression, anxiety and stress scores did not differ significantly between groups. Median plasma cholesterol levels decreased by 0.7 mmol (29 mg/100 ml) after replacing EFV with ETR (P < 0.002). After substitution of EFV by ETR, patients did not express a significant preference for ETR. There was no measurable effect on neuropsychiatric symptoms and sleep. Cholesterol decreased.
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languageeng
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subjectAdult ; AIDS/HIV ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiretroviral Therapy, Highly Active ; Antiviral agents ; Anxiety Disorders - chemically induced ; Anxiety Disorders - psychology ; Benzoxazines - adverse effects ; Benzoxazines - therapeutic use ; Biological and medical sciences ; CD4 Lymphocyte Count ; Drug Administration Schedule ; Female ; HIV Infections - drug therapy ; HIV Infections - psychology ; HIV Protease Inhibitors - adverse effects ; HIV Protease Inhibitors - therapeutic use ; HIV-1 ; Human immunodeficiency virus ; Human viral diseases ; Humans ; Infectious diseases ; Male ; Medical sciences ; Middle Aged ; Pharmacology. Drug treatments ; Practice Guidelines as Topic ; Pyridazines - administration & dosage ; Pyridazines - adverse effects ; Pyridazines - therapeutic use ; Sleep Initiation and Maintenance Disorders - chemically induced ; Sleep Initiation and Maintenance Disorders - psychology ; Surveys and Questionnaires ; Treatment Outcome ; Viral diseases ; Viral diseases of the lymphoid tissue and the blood. Aids
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1CALMY, Alexandra
2HIRSCHEL, Bernard
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4MERCIER, Isabelle K
5CAVASSINI, Matthias
6FAYET-MELLO, Aurélie
7ELZI, Luigia
8GENNE, Daniel
9RAUCH, Andri
10BERNASCONI, Enos
11Swiss HIV Cohort Study
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0A randomized crossover study to compare efavirenz and etravirine treatment
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descriptionEfavirenz (EFV) causes neuropsychiatric side-effects and an unfavourable blood lipid profile. We investigated the effect of replacing EFV with etravirine (ETR) on patient preference, sleep, anxiety and lipid levels. Study participants did not complain of side-effects, had tolerated EFV for at least 3 months, with less than 50 copies/ml HIV-RNA. After randomization, the ETR-first group started with ETR (400 mg daily) [DOSAGE ERROR CORRECTED] with EFV-placebo and the EFV-first group with EFV with ETR-placebo. After 6 weeks, both groups switched to the alternate regimen. Nucleoside reverse transcriptase inhibitors were continued without any change. The primary end point was patient preference for the first or the second regimen, assessed after 12 weeks. Fifty-eight patients were enrolled with a median CD4 cell count of 589 cells/μl and the duration of previous EFV therapy was 3.9 years. Fifty-five patients completed the study. When asked about treatment preference after 12 weeks, 16 preferred EFV and 22 preferred ETR, whereas 17 did not express a preference (P = NS). Patients who continued EFV during the first phase of the trial preferred EFV (15/21, 71%), whereas patients who started with ETR were more likely to prefer ETR (n = 16/17, 94%). This order effect was strongly significant (P < 0.0001). Quality of sleep, depression, anxiety and stress scores did not differ significantly between groups. Median plasma cholesterol levels decreased by 0.7 mmol (29 mg/100 ml) after replacing EFV with ETR (P < 0.002). After substitution of EFV by ETR, patients did not express a significant preference for ETR. There was no measurable effect on neuropsychiatric symptoms and sleep. Cholesterol decreased.
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0Adult
1AIDS/HIV
2Antibiotics. Antiinfectious agents. Antiparasitic agents
3Antiretroviral Therapy, Highly Active
4Antiviral agents
5Anxiety Disorders - chemically induced
6Anxiety Disorders - psychology
7Benzoxazines - adverse effects
8Benzoxazines - therapeutic use
9Biological and medical sciences
10CD4 Lymphocyte Count
11Drug Administration Schedule
12Female
13HIV Infections - drug therapy
14HIV Infections - psychology
15HIV Protease Inhibitors - adverse effects
16HIV Protease Inhibitors - therapeutic use
17HIV-1
18Human immunodeficiency virus
19Human viral diseases
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21Infectious diseases
22Male
23Medical sciences
24Middle Aged
25Pharmacology. Drug treatments
26Practice Guidelines as Topic
27Pyridazines - administration & dosage
28Pyridazines - adverse effects
29Pyridazines - therapeutic use
30Sleep Initiation and Maintenance Disorders - chemically induced
31Sleep Initiation and Maintenance Disorders - psychology
32Surveys and Questionnaires
33Treatment Outcome
34Viral diseases
35Viral diseases of the lymphoid tissue and the blood. Aids
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7ELZI, Luigia
8GENNE, Daniel
9RAUCH, Andri
10BERNASCONI, Enos
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titleA randomized crossover study to compare efavirenz and etravirine treatment
authorNGUYEN, Alain ; CALMY, Alexandra ; HIRSCHEL, Bernard ; DELHUMEAU, Cécile ; MERCIER, Isabelle K ; CAVASSINI, Matthias ; FAYET-MELLO, Aurélie ; ELZI, Luigia ; GENNE, Daniel ; RAUCH, Andri ; BERNASCONI, Enos
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6Anxiety Disorders - psychology
7Benzoxazines - adverse effects
8Benzoxazines - therapeutic use
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13HIV Infections - drug therapy
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31Sleep Initiation and Maintenance Disorders - psychology
32Surveys and Questionnaires
33Treatment Outcome
34Viral diseases
35Viral diseases of the lymphoid tissue and the blood. Aids
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1CALMY, Alexandra
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4MERCIER, Isabelle K
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9RAUCH, Andri
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1CALMY, Alexandra
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7ELZI, Luigia
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9RAUCH, Andri
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atitleA randomized crossover study to compare efavirenz and etravirine treatment
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volume25
issue1
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pages57-63
issn0269-9370
eissn1473-5571
abstractEfavirenz (EFV) causes neuropsychiatric side-effects and an unfavourable blood lipid profile. We investigated the effect of replacing EFV with etravirine (ETR) on patient preference, sleep, anxiety and lipid levels. Study participants did not complain of side-effects, had tolerated EFV for at least 3 months, with less than 50 copies/ml HIV-RNA. After randomization, the ETR-first group started with ETR (400 mg daily) [DOSAGE ERROR CORRECTED] with EFV-placebo and the EFV-first group with EFV with ETR-placebo. After 6 weeks, both groups switched to the alternate regimen. Nucleoside reverse transcriptase inhibitors were continued without any change. The primary end point was patient preference for the first or the second regimen, assessed after 12 weeks. Fifty-eight patients were enrolled with a median CD4 cell count of 589 cells/μl and the duration of previous EFV therapy was 3.9 years. Fifty-five patients completed the study. When asked about treatment preference after 12 weeks, 16 preferred EFV and 22 preferred ETR, whereas 17 did not express a preference (P = NS). Patients who continued EFV during the first phase of the trial preferred EFV (15/21, 71%), whereas patients who started with ETR were more likely to prefer ETR (n = 16/17, 94%). This order effect was strongly significant (P < 0.0001). Quality of sleep, depression, anxiety and stress scores did not differ significantly between groups. Median plasma cholesterol levels decreased by 0.7 mmol (29 mg/100 ml) after replacing EFV with ETR (P < 0.002). After substitution of EFV by ETR, patients did not express a significant preference for ETR. There was no measurable effect on neuropsychiatric symptoms and sleep. Cholesterol decreased.
copHagerstown, MD
pubLippincott Williams & Wilkins
pmid21076278
doi10.1097/QAD.0b013e32833f9f63