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.
Study Type
OBSERVATIONAL
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.
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.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.