Low scientific relevance due to the marketing of new treatments, and expected inclusion difficulties

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.

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

HIV infected patients who need to initiate or modify antiretroviral therapy, and starting a combination of antiretroviral agents including dolutegravir or bictegravir.