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.

Rossetti, B., Ferrara, M., Taramasso, L., Bai, F., Lombardi, F., Ciccarelli, N., Durante, M., Alladio, F., Rancan, I., Montagnani, F., Di Biagio, A., D’arminio Monforte, A., Zazzi, M., Fabbiani, M., (Abstract) The effects of switching from dolutegravir/abacavir/lamivudine to bictegravir/emtricitabine/tenofoviralafenamide in virologically suppressed people living withHIV on neuropsychiatric symptoms: preliminary findingsfrom a randomised study, <<EJIAS>>, 2022; 25 (Supplement 6, October): 161-161 [https://hdl.handle.net/10807/218465]

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

Rossetti, B;Ciccarelli, N;
2022

Abstract

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.
Inglese
Rossetti, B., Ferrara, M., Taramasso, L., Bai, F., Lombardi, F., Ciccarelli, N., Durante, M., Alladio, F., Rancan, I., Montagnani, F., Di Biagio, A., D’arminio Monforte, A., Zazzi, M., Fabbiani, M., (Abstract) The effects of switching from dolutegravir/abacavir/lamivudine to bictegravir/emtricitabine/tenofoviralafenamide in virologically suppressed people living withHIV on neuropsychiatric symptoms: preliminary findingsfrom a randomised study, <<EJIAS>>, 2022; 25 (Supplement 6, October): 161-161 [https://hdl.handle.net/10807/218465]
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