Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life

Study Overview
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Brief Summary
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The neurological and psychiatric adverse effects of antiretroviral drugs is a concern for clinicians and people living with HIV. In addition, clinical trials conducted prior to market authorization often have stric inclusion and exclusion criteria in terms of age, co-morbidity or co-medication, and the patients included in the studies are not always representative of the population for whom the drugs will be prescribed in real life. We propose a prospective cohort study to assess the occurrence of neurological and psychiatric adverse events in HIV+ patients starting an association with dolutegravir or bictegravir. Patients will be included on the day dolutegravir or bictegravir is prescribed. Neurological and psychiatric disorders will be assessed using self-administered questionnaires, at inclusion, one month, three months and six months.

Official Title
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Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life (NEPALE)

Conditions
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HIV+ Patients

Intervention / Treatment
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* Other: assessment of neurological and psychiatric disorders by self-administered questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age ≥ 18 years HIV-infected Initiation or modification of antiretroviral therapy, and starting a therapeutic combination including dolutegravir or bictegravir Exclusion criteria: Intolerance to dolutegravir or bictegravir Addiction to a psychoactive product (drugs or medications) with the exception of amyl nitriles (poppers) and occasional recreational cannabis Alcohol consumption >10 standard drinks/week Active HCV coinfection Pregnant or breastfeeding woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: assessment of neurological and psychiatric disorders by self-administered questionnaires|Patients will be included on the day dolutegravir or bictegravir is prescribed. Neurological and psychiatric disorders will be assessed using self-administered questionnaires, at inclusion, one month, three months and six months.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of at least one of the following neurological or psychiatric disorders | depression, defined by a CES-D score ≥ 17 for men and ≥ 23 for women anxiety, defined by a STAI score ≥ 56 (high anxiety); a score > 65 indicating very high anxiety; pathological fatigue, defined by a score on the EMIF-SEP scale ≥ 45/100; presence of a neurological symptom identified by the QES questionnaire. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dolutegravir, dictegravir, Neurological disorder, Psychiatric disorder, HIV integrase Inhibitors, Adverse drug event