The effects of switching from dolutegravir/abacavir/ lamivudine to bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed people living with HIV on neuropsychiatric symptoms: preliminary findings from a randomised study

Background: Central nervous system adverse events (AE) occur with various antiretrovirals (ARVs) and have been a cause of discontinuation of dolutegravir-containing ART, especially when used in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF arm) is associated with a reduction in severity and incidence of neuropsychiatric symptoms compared to continued dolutegravir/abacavir/lamivudine (DTG/ABC/3TC arm). Quality of life, suicide risk, cognitive impairment and other selfreported symptoms (using validated questionnaires) were also evaluated. Materials and methods: DOBINeuro is an ongoing, 12-month, open label, randomised trial enrolling PLWHIV treated with DTG/ABC/3TC for >6 months and with HIV-1 RNA (VL) <50 copies/mL for >12 months. Exclusion criteria include previous AIDS events, active alcohol intake or substance abuse, major psychiatric disorders, history of virological failure on InSTI and HBsAg+. At baseline (BL) PLWHIV were randomised to continue DTG/ABC/3TC or switch to B/F/TAF. Here we describe preliminary findings at 3 months (3M) follow-up. Results: We included 34 PLWHIV (73% males, median age 51 years, median CD4 693 cells/mm3): 17 were randomised to continue DTG/ABC/3TC and 17 to switch to B/F/TAF (Table 1). At BL, clinical and laboratory characteristics were homogeneous in the two arms; overall, 14.7% of participants showed cognitive impairment at BL (def. global Z score ≤-1) with no difference between arms. At 3 months no significant differences were observed between and within arms regarding self-reported adherence, quality of life assessment and suicide risk. Being depressed (p = 0.029) and having muscle aches (p = 0.017) were less frequently reported with B/F/TAF at 3M than at BL. VL was confirmed <50 copies/mL for all participants in both arms. Only two non-serious AE were reported: one grade 3 triglycerides with DTG/ABC/3TC and one self-limited episode of abdominal pain with B/F/TAF, which was not treatment-related and did not lead to drug discontinuation. Conclusions: Switch from DTG/ABC/3TC to B/F/TAF in virologically suppressed PLWHIV was associated with improvement in two reported symptoms. Further data from the 12-month study followup are required to evaluate the potential impact on the incidence and severity of neuropsychiatric symptoms of treatment switch to B/F/TAF compared to continued DTG/ABC/3TC.