Neurological Monitoring in Patients Switching From Dolutegravir Based Regimen to Bictegravir Based Regimen

The Effects of Switching From Dolutegravir/Lamivudine/Abacavir (d/l/a) to Bictegravir/Emtricitabine/Tenofovir Alafenamide (b/f/Taf) in Patients With Suppressed Viral Load on Neuropsychiatric Side Effects and Neurocognitive Function

Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir.

Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir. The main outcome measure will be a global severity index (GSI) of neuropsychiatric symptoms arising from 10 symptom domains, including somatization, obsessive-compulsiveness, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism. The secondary outcomes are to compare, between arms and during follow up, neuropsychiatric symptoms severity, neurocognitive performance, changes in self-reported symptoms, adherence and HR-QoL, correlation between symptoms (neuropsychiatric and other), drug exposure and HR-QoL, proportion of adverse events, proportion of virological failures and antiretrovirals resistance at virological failure.

Inclusion Criteria:

• Age >18 years
• HIV-1 infection
• HIV RNA <50 copies/mL >12 months (including patients with 1 blip 50-200 cp/mL before screening, not confirmed)
• On treatment with dolutegravir/abacavir/lamivudine >6 months

Exclusion Criteria:

• Previous AIDS events
• Pregnancy or pregnancy plan
• Decompensated cirrhosis (B or C CPT status)
• Intake of alcohol, substances, other drugs that may affect neurocognitive performances
• Necessity to receive drugs that may require dosing adjustment of dolutegravir or bictegravir
• Certified diagnosis of major depression, psychosis, history of suicidal attempts
• Treatment with antidepressants or antipsychotic drugs
• History of virological failure with INSTIs
• Lack of knowledge of italian language
• Impossibility to obtain informed written consent
• HBsAg positivity
• Estimated glomerular filtration rate by CK-EPI <50 mL/min per 1.73 m2