Long-Term Neuropsychiatric Disorders on Efavirenz-Based Approach
Long-Term Neuropsychiatric Disorders on Efavirenz-Based Approach
Background: Efavirenz has been associated with neuropsychiatric disorders, although little is known about its long-term toxicity.
Objective: To assess neuropsychiatric disorders and their relation to efavirenz plasma levels as well as quality of life, psychologic status, and adherence in HIV-infected patients on long-term efavirenz-based antiretroviral therapy.
Methods: Cross-sectional study comparing 60 patients on an efavirenz-based approach (EFV group) and 60 patients on a protease inhibitor-containing regimen (PI group) for at least 1 year. Adverse events, efavirenz plasma levels, quality of life, psychologic status, and adherence were assessed.
Results: The mean time on treatment was 91.1 ± 39.5 weeks in the EFV group and 119.9 ± 67.4 weeks in the PI group. Mild dizziness, sadness, mood changes, irritability, lightheadedness, nervousness, impaired concentration, abnormal dreams, and somnolence were reported more frequently in the EFV group than in the PI group ( P < 0.05). Forty-nine of 60 patients presented with therapeutic efavirenz plasma levels (range: 1.0-4.0 mg/L). Efavirenz plasma levels were similar in subjects with and without neuropsychiatric disorders. No significant differences were found between the EFV group and the PI group regarding quality of life and psychologic status. Sixty percent of patients in the EFV group and 55% in the PI group reported adherence =95%.
Conclusions: Mild and clinically tolerable neuropsychiatric disorders may persist in patients after a mean of 2 years using an efavirenz-based approach. Quality of life and psychologic status remained good in both study groups. Interventions to enhance long-term adherence should be applied in clinical practice.
The suppression of HIV replication using highly active antiretroviral therapy seems to require the lifelong maintenance of such therapy. Chronic adherence may become deeply complicated, particularly when patients do not perceive any symptom associated with the illness and when the medication needs to be taken in such a strict fashion. Moreover, another important obstacle to proper therapeutic adherence is the presence of adverse events. It seems clear that antiretroviral therapy may somehow limit a patient's quality of life, becoming a main reason for treatment discontinuation.
After the commercialization of efavirenz as a new antiretroviral drug for the control of HIV infection, its use was associated with the onset of neuropsychiatric disturbances. Such disorders are usually mild and transient and generally disappear within a few weeks. However, token cases of psychosis, major depression, and suicidal ideation have also been described.
With the exception of a few studies, the assessment of efavirenz toxicity has focused on the short-term follow-up. In our experience, 13% of patients reported persistent neuropsychiatric disorders 1 year after starting efavirenz treatment. Nevertheless, data on long-term efavirenz toxicity are still scarce. This study assesses the prevalence of neuropsychiatric disorders among patients taking efavirenz for more than 1 year.
Background: Efavirenz has been associated with neuropsychiatric disorders, although little is known about its long-term toxicity.
Objective: To assess neuropsychiatric disorders and their relation to efavirenz plasma levels as well as quality of life, psychologic status, and adherence in HIV-infected patients on long-term efavirenz-based antiretroviral therapy.
Methods: Cross-sectional study comparing 60 patients on an efavirenz-based approach (EFV group) and 60 patients on a protease inhibitor-containing regimen (PI group) for at least 1 year. Adverse events, efavirenz plasma levels, quality of life, psychologic status, and adherence were assessed.
Results: The mean time on treatment was 91.1 ± 39.5 weeks in the EFV group and 119.9 ± 67.4 weeks in the PI group. Mild dizziness, sadness, mood changes, irritability, lightheadedness, nervousness, impaired concentration, abnormal dreams, and somnolence were reported more frequently in the EFV group than in the PI group ( P < 0.05). Forty-nine of 60 patients presented with therapeutic efavirenz plasma levels (range: 1.0-4.0 mg/L). Efavirenz plasma levels were similar in subjects with and without neuropsychiatric disorders. No significant differences were found between the EFV group and the PI group regarding quality of life and psychologic status. Sixty percent of patients in the EFV group and 55% in the PI group reported adherence =95%.
Conclusions: Mild and clinically tolerable neuropsychiatric disorders may persist in patients after a mean of 2 years using an efavirenz-based approach. Quality of life and psychologic status remained good in both study groups. Interventions to enhance long-term adherence should be applied in clinical practice.
The suppression of HIV replication using highly active antiretroviral therapy seems to require the lifelong maintenance of such therapy. Chronic adherence may become deeply complicated, particularly when patients do not perceive any symptom associated with the illness and when the medication needs to be taken in such a strict fashion. Moreover, another important obstacle to proper therapeutic adherence is the presence of adverse events. It seems clear that antiretroviral therapy may somehow limit a patient's quality of life, becoming a main reason for treatment discontinuation.
After the commercialization of efavirenz as a new antiretroviral drug for the control of HIV infection, its use was associated with the onset of neuropsychiatric disturbances. Such disorders are usually mild and transient and generally disappear within a few weeks. However, token cases of psychosis, major depression, and suicidal ideation have also been described.
With the exception of a few studies, the assessment of efavirenz toxicity has focused on the short-term follow-up. In our experience, 13% of patients reported persistent neuropsychiatric disorders 1 year after starting efavirenz treatment. Nevertheless, data on long-term efavirenz toxicity are still scarce. This study assesses the prevalence of neuropsychiatric disorders among patients taking efavirenz for more than 1 year.