Outcome of neuropsychiatric symptoms related to an antiretroviral drug following its substitution by nevirapine: The RELAX study

E. Pedrol; J. M. Llibre; M. Tasias; A. Currán; J. M. Guardiola; E. Deig; A. Guelar; O. Martínez-Madrid; L. Tikhomirova; R. Ramírez; E. Pedrol; M. Tasias; R. Ramírez; L. Tikhomirova; S. Ruiz; A. Delegido; B. Clotet; J. M. Llibre; A. Curran; J. M. Guardiola; E. Deig; A. Guelar; M. M. Montero; I. García; C. Cortes; M. Javaloyas; L. Force; P. Barrufet; S. Valero; A. Massabeu; E. Chamarro; C. Escrich; A. Ortí; J. Gomez-Sirvent; A. Ocampo; F. Rodriguez Arrondo; O. Martínez Madrid; A. Mariño; J. Reparaz; J. A. Amiguet; M. J. Crusells; F. Orihuela; M. A. Lopez Ruz; J. Pasquau; A. Marco; S. Lopez; A. Castro; J. Santos; J. M. Cuadrado; K. Aguirrebengoa; A. Antela; J. A. Oteo; J. R. Blanco; D. Gil; P. Arazo; J. Flores

doi:10.1111/hiv.12298

Outcome of neuropsychiatric symptoms related to an antiretroviral drug following its substitution by nevirapine: The RELAX study

E. Pedrol, J. M. Llibre, M. Tasias, A. Currán, J. M. Guardiola, E. Deig, A. Guelar, O. Martínez-Madrid, L. Tikhomirova, R. Ramírez, E. Pedrol, M. Tasias, R. Ramírez, L. Tikhomirova, S. Ruiz, A. Delegido, B. Clotet, J. M. Llibre, A. Curran, J. M. GuardiolaE. Deig, A. Guelar, M. M. Montero, I. García, C. Cortes, M. Javaloyas, L. Force, P. Barrufet, S. Valero, A. Massabeu, E. Chamarro, C. Escrich, A. Ortí, J. Gomez-Sirvent, A. Ocampo, F. Rodriguez Arrondo, O. Martínez Madrid, A. Mariño, J. Reparaz, J. A. Amiguet, M. J. Crusells, F. Orihuela, M. A. Lopez Ruz, J. Pasquau, A. Marco, S. Lopez, A. Castro, J. Santos, J. M. Cuadrado, K. Aguirrebengoa, A. Antela, J. A. Oteo, J. R. Blanco, D. Gil, P. Arazo, J. Flores

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© 2015 British HIV Association. Objectives: The primary objective was to evaluate the improvement in neuropsychiatric symptoms attributed to an antiretroviral drug after that drug was substituted with nevirapine. The secondary objective was to evaluate the impact on patient adherence and quality of life. Methods: A prospective, observational study was carried out that included patients with HIV-1 plasma suppression for whom an antiretroviral drug was substituted with nevirapine because of central nervous system (CNS) side effects, a Pittsburgh Sleep Quality Index (PSQI) score>5 or a Hospital Anxiety and Depression Scale (HADS) score≥10, and who had not initiated psychoactive drug treatment during the prior 6 weeks. Evaluations were carried out at baseline and 1 and 3 months after the switch using the PSQI, HADS, Epworth Sleepiness Scale, Medical Outcomes Study-Short Form 30 items (MOS-SF-30) and Simplified Medication Adherence Questionnaire (SMAQ). Results: A total of 129 patients were included in the study. The drug substituted was mainly efavirenz (89.9%), and reasons for the switch included sleep disturbances (75.2%), anxiety (65.1%), depression (38.7%), attention disturbances (31%), and other reasons (31%), with a mean of 2.4 neuropsychiatric disturbances per patient. A statistically significant improvement was observed in all the tests evaluating neuropsychiatric symptoms and adherence at 1 and 3 months. The CD4 lymphocyte count remained stable (P=0.096). Three (2.3%) patients had a detectable plasma HIV-1 RNA at the end of the study. Nine patients (6.9%) withdrew because of nevirapine-related toxicity (rash in seven patients and hypertransaminasaemia in two patients, none of which were>grade 2). Conclusions: The switch to nevirapine from a drug causing neuropsychiatric disturbances (primarily efavirenz) in subjects with virological suppression was effective in resolving those disturbances, with an improvement in all the parameters studied. This led to better adherence to treatment and quality of life, with no detrimental effect on their immunological and virological control.

Idioma original	Inglés
Páginas (desde-hasta)	628-634
Publicación	HIV Medicine
Volumen	16
N.º	10
DOI	https://doi.org/10.1111/hiv.12298
Estado	Publicada - 1 nov 2015

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Pedrol, E., Llibre, J. M., Tasias, M., Currán, A., Guardiola, J. M., Deig, E., Guelar, A., Martínez-Madrid, O., Tikhomirova, L., Ramírez, R., Pedrol, E., Tasias, M., Ramírez, R., Tikhomirova, L., Ruiz, S., Delegido, A., Clotet, B., Llibre, J. M., Curran, A., ... Flores, J. (2015). Outcome of neuropsychiatric symptoms related to an antiretroviral drug following its substitution by nevirapine: The RELAX study. HIV Medicine, 16(10), 628-634. https://doi.org/10.1111/hiv.12298

@article{26dbd2a9421046d18a5193a80adbf44a,

title = "Outcome of neuropsychiatric symptoms related to an antiretroviral drug following its substitution by nevirapine: The RELAX study",

abstract = "{\textcopyright} 2015 British HIV Association. Objectives: The primary objective was to evaluate the improvement in neuropsychiatric symptoms attributed to an antiretroviral drug after that drug was substituted with nevirapine. The secondary objective was to evaluate the impact on patient adherence and quality of life. Methods: A prospective, observational study was carried out that included patients with HIV-1 plasma suppression for whom an antiretroviral drug was substituted with nevirapine because of central nervous system (CNS) side effects, a Pittsburgh Sleep Quality Index (PSQI) score>5 or a Hospital Anxiety and Depression Scale (HADS) score≥10, and who had not initiated psychoactive drug treatment during the prior 6 weeks. Evaluations were carried out at baseline and 1 and 3 months after the switch using the PSQI, HADS, Epworth Sleepiness Scale, Medical Outcomes Study-Short Form 30 items (MOS-SF-30) and Simplified Medication Adherence Questionnaire (SMAQ). Results: A total of 129 patients were included in the study. The drug substituted was mainly efavirenz (89.9%), and reasons for the switch included sleep disturbances (75.2%), anxiety (65.1%), depression (38.7%), attention disturbances (31%), and other reasons (31%), with a mean of 2.4 neuropsychiatric disturbances per patient. A statistically significant improvement was observed in all the tests evaluating neuropsychiatric symptoms and adherence at 1 and 3 months. The CD4 lymphocyte count remained stable (P=0.096). Three (2.3%) patients had a detectable plasma HIV-1 RNA at the end of the study. Nine patients (6.9%) withdrew because of nevirapine-related toxicity (rash in seven patients and hypertransaminasaemia in two patients, none of which were>grade 2). Conclusions: The switch to nevirapine from a drug causing neuropsychiatric disturbances (primarily efavirenz) in subjects with virological suppression was effective in resolving those disturbances, with an improvement in all the parameters studied. This led to better adherence to treatment and quality of life, with no detrimental effect on their immunological and virological control.",

keywords = "Antiretroviral toxicity, Antiretroviral treatment switch, Efavirenz, HIV, Neuropsychiatric symptoms, Nevirapine",

author = "E. Pedrol and Llibre, {J. M.} and M. Tasias and A. Curr{\'a}n and Guardiola, {J. M.} and E. Deig and A. Guelar and O. Mart{\'i}nez-Madrid and L. Tikhomirova and R. Ram{\'i}rez and E. Pedrol and M. Tasias and R. Ram{\'i}rez and L. Tikhomirova and S. Ruiz and A. Delegido and B. Clotet and Llibre, {J. M.} and A. Curran and Guardiola, {J. M.} and E. Deig and A. Guelar and Montero, {M. M.} and I. Garc{\'i}a and C. Cortes and M. Javaloyas and L. Force and P. Barrufet and S. Valero and A. Massabeu and E. Chamarro and C. Escrich and A. Ort{\'i} and J. Gomez-Sirvent and A. Ocampo and {Rodriguez Arrondo}, F. and {Mart{\'i}nez Madrid}, O. and A. Mari{\~n}o and J. Reparaz and Amiguet, {J. A.} and Crusells, {M. J.} and F. Orihuela and {Lopez Ruz}, {M. A.} and J. Pasquau and A. Marco and S. Lopez and A. Castro and J. Santos and Cuadrado, {J. M.} and K. Aguirrebengoa and A. Antela and Oteo, {J. A.} and Blanco, {J. R.} and D. Gil and P. Arazo and J. Flores",

year = "2015",

month = nov,

day = "1",

doi = "10.1111/hiv.12298",

language = "English",

volume = "16",

pages = "628--634",

journal = "HIV Medicine",

issn = "1464-2662",

number = "10",

}

Pedrol, E, Llibre, JM, Tasias, M, Currán, A, Guardiola, JM, Deig, E, Guelar, A, Martínez-Madrid, O, Tikhomirova, L, Ramírez, R, Pedrol, E, Tasias, M, Ramírez, R, Tikhomirova, L, Ruiz, S, Delegido, A, Clotet, B, Llibre, JM, Curran, A, Guardiola, JM, Deig, E, Guelar, A, Montero, MM, García, I, Cortes, C, Javaloyas, M, Force, L, Barrufet, P, Valero, S, Massabeu, A, Chamarro, E, Escrich, C, Ortí, A, Gomez-Sirvent, J, Ocampo, A, Rodriguez Arrondo, F, Martínez Madrid, O, Mariño, A, Reparaz, J, Amiguet, JA, Crusells, MJ, Orihuela, F, Lopez Ruz, MA, Pasquau, J, Marco, A, Lopez, S, Castro, A, Santos, J, Cuadrado, JM, Aguirrebengoa, K, Antela, A, Oteo, JA, Blanco, JR, Gil, D, Arazo, P & Flores, J 2015, 'Outcome of neuropsychiatric symptoms related to an antiretroviral drug following its substitution by nevirapine: The RELAX study', HIV Medicine, vol. 16, n.º 10, pp. 628-634. https://doi.org/10.1111/hiv.12298

TY - JOUR

T1 - Outcome of neuropsychiatric symptoms related to an antiretroviral drug following its substitution by nevirapine: The RELAX study

AU - Pedrol, E.

AU - Llibre, J. M.

AU - Tasias, M.

AU - Currán, A.

AU - Guardiola, J. M.

AU - Deig, E.

AU - Guelar, A.

AU - Martínez-Madrid, O.

AU - Tikhomirova, L.

AU - Ramírez, R.

AU - Pedrol, E.

AU - Tasias, M.

AU - Ramírez, R.

AU - Tikhomirova, L.

AU - Ruiz, S.

AU - Delegido, A.

AU - Clotet, B.

AU - Llibre, J. M.

AU - Curran, A.

AU - Guardiola, J. M.

AU - Deig, E.

AU - Guelar, A.

AU - Montero, M. M.

AU - García, I.

AU - Cortes, C.

AU - Javaloyas, M.

AU - Force, L.

AU - Barrufet, P.

AU - Valero, S.

AU - Massabeu, A.

AU - Chamarro, E.

AU - Escrich, C.

AU - Ortí, A.

AU - Gomez-Sirvent, J.

AU - Ocampo, A.

AU - Rodriguez Arrondo, F.

AU - Martínez Madrid, O.

AU - Mariño, A.

AU - Reparaz, J.

AU - Amiguet, J. A.

AU - Crusells, M. J.

AU - Orihuela, F.

AU - Lopez Ruz, M. A.

AU - Pasquau, J.

AU - Marco, A.

AU - Lopez, S.

AU - Castro, A.

AU - Santos, J.

AU - Cuadrado, J. M.

AU - Aguirrebengoa, K.

AU - Antela, A.

AU - Oteo, J. A.

AU - Blanco, J. R.

AU - Gil, D.

AU - Arazo, P.

AU - Flores, J.

PY - 2015/11/1

Y1 - 2015/11/1

N2 - © 2015 British HIV Association. Objectives: The primary objective was to evaluate the improvement in neuropsychiatric symptoms attributed to an antiretroviral drug after that drug was substituted with nevirapine. The secondary objective was to evaluate the impact on patient adherence and quality of life. Methods: A prospective, observational study was carried out that included patients with HIV-1 plasma suppression for whom an antiretroviral drug was substituted with nevirapine because of central nervous system (CNS) side effects, a Pittsburgh Sleep Quality Index (PSQI) score>5 or a Hospital Anxiety and Depression Scale (HADS) score≥10, and who had not initiated psychoactive drug treatment during the prior 6 weeks. Evaluations were carried out at baseline and 1 and 3 months after the switch using the PSQI, HADS, Epworth Sleepiness Scale, Medical Outcomes Study-Short Form 30 items (MOS-SF-30) and Simplified Medication Adherence Questionnaire (SMAQ). Results: A total of 129 patients were included in the study. The drug substituted was mainly efavirenz (89.9%), and reasons for the switch included sleep disturbances (75.2%), anxiety (65.1%), depression (38.7%), attention disturbances (31%), and other reasons (31%), with a mean of 2.4 neuropsychiatric disturbances per patient. A statistically significant improvement was observed in all the tests evaluating neuropsychiatric symptoms and adherence at 1 and 3 months. The CD4 lymphocyte count remained stable (P=0.096). Three (2.3%) patients had a detectable plasma HIV-1 RNA at the end of the study. Nine patients (6.9%) withdrew because of nevirapine-related toxicity (rash in seven patients and hypertransaminasaemia in two patients, none of which were>grade 2). Conclusions: The switch to nevirapine from a drug causing neuropsychiatric disturbances (primarily efavirenz) in subjects with virological suppression was effective in resolving those disturbances, with an improvement in all the parameters studied. This led to better adherence to treatment and quality of life, with no detrimental effect on their immunological and virological control.

AB - © 2015 British HIV Association. Objectives: The primary objective was to evaluate the improvement in neuropsychiatric symptoms attributed to an antiretroviral drug after that drug was substituted with nevirapine. The secondary objective was to evaluate the impact on patient adherence and quality of life. Methods: A prospective, observational study was carried out that included patients with HIV-1 plasma suppression for whom an antiretroviral drug was substituted with nevirapine because of central nervous system (CNS) side effects, a Pittsburgh Sleep Quality Index (PSQI) score>5 or a Hospital Anxiety and Depression Scale (HADS) score≥10, and who had not initiated psychoactive drug treatment during the prior 6 weeks. Evaluations were carried out at baseline and 1 and 3 months after the switch using the PSQI, HADS, Epworth Sleepiness Scale, Medical Outcomes Study-Short Form 30 items (MOS-SF-30) and Simplified Medication Adherence Questionnaire (SMAQ). Results: A total of 129 patients were included in the study. The drug substituted was mainly efavirenz (89.9%), and reasons for the switch included sleep disturbances (75.2%), anxiety (65.1%), depression (38.7%), attention disturbances (31%), and other reasons (31%), with a mean of 2.4 neuropsychiatric disturbances per patient. A statistically significant improvement was observed in all the tests evaluating neuropsychiatric symptoms and adherence at 1 and 3 months. The CD4 lymphocyte count remained stable (P=0.096). Three (2.3%) patients had a detectable plasma HIV-1 RNA at the end of the study. Nine patients (6.9%) withdrew because of nevirapine-related toxicity (rash in seven patients and hypertransaminasaemia in two patients, none of which were>grade 2). Conclusions: The switch to nevirapine from a drug causing neuropsychiatric disturbances (primarily efavirenz) in subjects with virological suppression was effective in resolving those disturbances, with an improvement in all the parameters studied. This led to better adherence to treatment and quality of life, with no detrimental effect on their immunological and virological control.

KW - Antiretroviral toxicity

KW - Antiretroviral treatment switch

KW - Efavirenz

KW - HIV

KW - Neuropsychiatric symptoms

KW - Nevirapine

U2 - 10.1111/hiv.12298

DO - 10.1111/hiv.12298

M3 - Article

SN - 1464-2662

VL - 16

SP - 628

EP - 634

JO - HIV Medicine

JF - HIV Medicine

IS - 10

ER -

Outcome of neuropsychiatric symptoms related to an antiretroviral drug following its substitution by nevirapine: The RELAX study

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