Effect of Treatment With Efavirenz on Neuropsychiatric Adverse Events of Interferon in HIV/HCV-Coinfected Patients

Quereda, Carmen; Corral, Íñigo; Moreno, Ana; Pérez-Elías, María Jesús; Casado, José L.; Dronda, Fernando; Rodríguez-Sagrado, Miguel Ángel; Hernández, Beatríz; Moreno, Santiago

doi:10.1097/qai.0b013e31817bbeb9

Cited by 20 publications

(11 citation statements)

References 10 publications

(13 reference statements)

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“…Based on available evidence, patients already established on efavirenz who were treated with interferon for co-infection with hepatitis C generally tolerated the regimen [36]. Interferon itself is associated with neuropsychiatric side effects, prominently depression, but higher rates of depression were not noted in the efavirenz population as compared to controls.…”

Section: Co-infection With Hepatitis Cmentioning

confidence: 92%

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A Systematic Review of the Psychiatric Side-Effects of Efavirenz

2011

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Concerns regarding the use of efavirenz in patients with a history of mental illness may predispose clinicians to not offer this agent to psychiatrically ill populations in spite of the convenience of once daily dosing, which can result in improved adherence in these at-risk populations. This systematic review examines the current data regarding the neuropsychiatric effects of efavirenz, and also attempts to provide guidance to clinicians using efavirenz to treat patients with mental illness. The review identified high rates of neuropsychiatric side effects including vivid dreams, insomnia and mood changes in approximately 50% of patients who initiate efavirenz. The effects begin quickly, commonly peak in the first 2 weeks, and are generally mild and transient in nature. Isolated case reports and uncontrolled data suggest higher rates of severe side effects; however, there is no clear evidence of a broadly increased risk of suicide or dangerous behavior for patients taking efavirenz as part of their antiretroviral regimen.

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Section: Co-infection With Hepatitis Cmentioning

confidence: 92%

“…Queredaet al [36] Prospective cohort of co-infected patients (HIV and Hepatitis C) who initiated interferon.…”

Section: Co-infection With Hepatitis Cmentioning

confidence: 99%

A Systematic Review of the Psychiatric Side-Effects of Efavirenz

2011

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“…Additionally, depression occurred at similar but low rates in both the RPV and EFV groups. Data from previous studies that evaluated depression in patients treated with EFV are conflicting, with some investigators reporting a link between increased depression and EFV [19,21,42], while others failed to find any such association [20,43,44]. Patients who discontinue highly active ARV therapy because of AEs do so mainly within the first few months following therapy initiation [3,45].…”

Section: Tolerability Of Rilpivirine Vs Efavirenz 395mentioning

confidence: 94%

Neurological and psychiatric tolerability of rilpivirine (TMC278) vs. efavirenz in treatment‐naïve, HIV‐1‐infected patients at 48 weeks

Mills¹,

Antinori

Clotet

et al. 2013

HIV Medicine

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ObjectivesThe aim of the study was to compare the neuropsychiatric safety and tolerability of rilpivirine (TMC278) vs. efavirenz in a preplanned pooled analysis of data from the ECHO and THRIVE studies which compared the safety and efficacy of the two drugs in HIV-1 infected treatment naïve adults. MethodsECHO and THRIVE were randomized, double-blind, double-dummy, 96-week, international, phase 3 trials comparing the efficacy, safety and tolerability of rilpivirine 25 mg vs. efavirenz 600 mg once daily in combination with two background nucleoside/tide reverse transcriptase inhibitors. Safety and tolerability analyses were conducted when all patients had received at least 48 weeks of treatment or discontinued earlier. Differences between treatments in the incidence of neurological and psychiatric adverse events (AEs) of interest were assessed in preplanned statistical analyses using Fisher's exact test. ResultsAt the time of the week 48 analysis, the cumulative incidences in the rilpivirine vs. efavirenz groups of any grade 2-4 treatment-related AEs and of discontinuation because of AEs were 16% vs. 31% (P < 0.0001) and 3% vs. 8% (P = 0.0005), respectively. The incidence of treatmentrelated neuropsychiatric AEs was 27% vs. 48%, respectively (P < 0.0001). The incidence of treatment-related neurological AEs of interest was 17% vs. 38% (P < 0.0001), and that of treatment-related psychiatric AEs of interest was 15% vs. 23% (P = 0.0002). Dizziness and abnormal dreams/nightmares occurred significantly less frequently with rilpivirine vs. efavirenz (P < 0.01). In both groups, patients with prior neuropsychiatric history tended to report more neuropsychiatric AEs but rates remained lower for rilpivirine than for efavirenz. ConclusionsRilpivirine was associated with fewer neurological and psychiatric AEs of interest than efavirenz over 48 weeks in treatment-naïve, HIV-1-infected adults. Under current guidelines, the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV) is recommended as a preferred component of ARV regimens for treatment-naïve patients [11]. EFV has good overall tolerability but has been associated with some AE-related concerns, particularly neuropsychiatric symptoms that typically begin shortly after therapy initiation [12][13][14]. An analysis of four phase 2/3 controlled clinical trials has shown that 53% of EFV vs. 25% of control recipients reported central nervous system AEs (all grades) [1,3]. While EFV-associated neuropsychiatric AEs are often transient, symptoms such as abnormal dreams, dizziness, somatization, irritability and stress can persist in some instances for several months to years [15][16][17][18][19][20], and patients may experience symptoms of depression at any time during treatment [12,13].Several studies have compared the incidences of neuropsychiatric AEs with EFV-based vs. non-EFV-based ARV regimens [21][22][23][24]. Maintenance of virological control and significant improvement in neuropsychiatric AEs were demonstrated by switching from an EFV-to a nevirapinebase...

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“…Consider liver biopsy particularly for those with genotype 1 or 4 infection where the results of HCV therapy remain Table 3 Interactions between antiretroviral agents and anti-hepatitis C virus (HCV) therapy [186][187][188][189][190][191][192]239] [198,200,201]. The risk-benefit of liver biopsy should be considered in the individual patient.…”

Section: General Principles Of Anti-hcv Therapymentioning

confidence: 99%

British HIV Association guidelines for the management of coinfection with HIV‐1 and hepatitis B or C virus 2010

et al. 2009

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Effect of Treatment With Efavirenz on Neuropsychiatric Adverse Events of Interferon in HIV/HCV-Coinfected Patients

Abstract: Neuropsychiatric adverse events are common in HIV/HCV patients receiving IFN, usually mild or moderate. EFV may favor symptoms of mood disorders, although it was not related to an increased risk of significant depression requiring specific treatment.

Cited by 20 publications

References 10 publications

A Systematic Review of the Psychiatric Side-Effects of Efavirenz

A Systematic Review of the Psychiatric Side-Effects of Efavirenz

Neurological and psychiatric tolerability of rilpivirine (TMC278) vs. efavirenz in treatment‐naïve, HIV‐1‐infected patients at 48 weeks

British HIV Association guidelines for the management of coinfection with HIV‐1 and hepatitis B or C virus 2010

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