Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial
Abstract Introduction Central nervous system adverse events (AE) have been a cause of discontinuation of dolutegravir-containing therapy, especially in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/...
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Adis, Springer Healthcare
2024-11-01
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| Series: | Infectious Diseases and Therapy |
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| Online Access: | https://doi.org/10.1007/s40121-024-01083-1 |
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| author | Barbara Rossetti Micol Ferrara Lucia Taramasso Francesca Bai Francesca Lombardi Nicoletta Ciccarelli Miriam Durante Francesca Alladio Federica Bonazza Ilaria Rancan Francesca Montagnani Antonio Di Biagio Antonella d’Arminio Monforte Maurizio Zazzi Massimiliano Fabbiani for DOBINeuro study group |
| author_facet | Barbara Rossetti Micol Ferrara Lucia Taramasso Francesca Bai Francesca Lombardi Nicoletta Ciccarelli Miriam Durante Francesca Alladio Federica Bonazza Ilaria Rancan Francesca Montagnani Antonio Di Biagio Antonella d’Arminio Monforte Maurizio Zazzi Massimiliano Fabbiani for DOBINeuro study group |
| author_sort | Barbara Rossetti |
| collection | DOAJ |
| description | Abstract Introduction Central nervous system adverse events (AE) have been a cause of discontinuation of dolutegravir-containing therapy, especially in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was associated with a reduction in severity and incidence of neuropsychiatric symptoms compared to continued dolutegravir/abacavir/lamivudine (DTG/ABC/3TC). Methods DOBINeuro is a randomized trial enrolling people living with HIV (PLWH) treated with DTG/ABC/3TC for > 6 months and with HIV-RNA < 50 cps/ml for > 12 months. At baseline, PLWH are randomized to continue DTG/ABC/3TC or switch to BIC/FTC/TAF. The original sample size was 50 PLWH per arm, but the enrollment was prematurely stopped due to a delayed recruitment process. Neuropsychiatric symptoms were evaluated by the self-report Symptom Checklist (SCL)-90-R and the Mini-International Neuropsychiatric Interview Plus. Results A total of 41 PLWH were enrolled and underwent randomization: 20 were randomized to continue DTG/ABC/3TC and 21 to switch to BIC/FTC/TAF. At baseline, clinical and laboratory characteristics were homogeneous in the two arms. Switching from DTG/ABC/3TC to BIC/FTC/TAF in virologically suppressed PLWH was associated with an improvement in sleep disorders but not in any other neuropsychiatric symptom. Conclusions Although limited by a low sample size, this study suggests neuropsychiatric tolerability may improve when switching virologically suppressed PLWH from DTG to BIC-based strategies. |
| format | Article |
| id | doaj-art-e076019e46d44209aed3ea3487348fff |
| institution | Kabale University |
| issn | 2193-8229 2193-6382 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Adis, Springer Healthcare |
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| series | Infectious Diseases and Therapy |
| spelling | doaj-art-e076019e46d44209aed3ea3487348fff2025-02-02T12:35:16ZengAdis, Springer HealthcareInfectious Diseases and Therapy2193-82292193-63822024-11-0114129330410.1007/s40121-024-01083-1Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro TrialBarbara Rossetti0Micol Ferrara1Lucia Taramasso2Francesca Bai3Francesca Lombardi4Nicoletta Ciccarelli5Miriam Durante6Francesca Alladio7Federica Bonazza8Ilaria Rancan9Francesca Montagnani10Antonio Di Biagio11Antonella d’Arminio Monforte12Maurizio Zazzi13Massimiliano Fabbiani14for DOBINeuro study groupInfectious and Tropical Diseases Unit, University Hospital of SienaUnit of Infectious Diseases, Department of Medical Sciences, University of TorinoInfectious Diseases Clinic, Department of Internal Medicine, IRCCS Policlinico San Martino HospitalClinic of Infectious Diseases, Department of Health Sciences, ASST Santi Paolo e Carlo, University of MilanInfectious Diseases Unit, UOC Infectious Diseases, Fondazione Policlinico Universitario A. Gemelli IRCCSFaculty of Psychology eCampus UniversityDepartment of Medical Biotechnologies, University of SienaUnit of Infectious Diseases, Department of Medical Sciences, University of TorinoClinic of Infectious Diseases, Department of Health Sciences, ASST Santi Paolo e Carlo, University of MilanInfectious and Tropical Diseases Unit, University Hospital of SienaInfectious and Tropical Diseases Unit, University Hospital of SienaDepartment of Health Sciences, Infectious Diseases Clinic, San Martino Hospital-IRCCS, University of GenoaClinic of Infectious Diseases, Department of Health Sciences, ASST Santi Paolo e Carlo, University of MilanDepartment of Medical Biotechnologies, University of SienaInfectious and Tropical Diseases Unit, University Hospital of SienaAbstract Introduction Central nervous system adverse events (AE) have been a cause of discontinuation of dolutegravir-containing therapy, especially in combination with abacavir. The main aim of the study was to evaluate whether the switch to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) was associated with a reduction in severity and incidence of neuropsychiatric symptoms compared to continued dolutegravir/abacavir/lamivudine (DTG/ABC/3TC). Methods DOBINeuro is a randomized trial enrolling people living with HIV (PLWH) treated with DTG/ABC/3TC for > 6 months and with HIV-RNA < 50 cps/ml for > 12 months. At baseline, PLWH are randomized to continue DTG/ABC/3TC or switch to BIC/FTC/TAF. The original sample size was 50 PLWH per arm, but the enrollment was prematurely stopped due to a delayed recruitment process. Neuropsychiatric symptoms were evaluated by the self-report Symptom Checklist (SCL)-90-R and the Mini-International Neuropsychiatric Interview Plus. Results A total of 41 PLWH were enrolled and underwent randomization: 20 were randomized to continue DTG/ABC/3TC and 21 to switch to BIC/FTC/TAF. At baseline, clinical and laboratory characteristics were homogeneous in the two arms. Switching from DTG/ABC/3TC to BIC/FTC/TAF in virologically suppressed PLWH was associated with an improvement in sleep disorders but not in any other neuropsychiatric symptom. Conclusions Although limited by a low sample size, this study suggests neuropsychiatric tolerability may improve when switching virologically suppressed PLWH from DTG to BIC-based strategies.https://doi.org/10.1007/s40121-024-01083-1HIVBictegravirNeuropsychiatric symptomsSwitch |
| spellingShingle | Barbara Rossetti Micol Ferrara Lucia Taramasso Francesca Bai Francesca Lombardi Nicoletta Ciccarelli Miriam Durante Francesca Alladio Federica Bonazza Ilaria Rancan Francesca Montagnani Antonio Di Biagio Antonella d’Arminio Monforte Maurizio Zazzi Massimiliano Fabbiani for DOBINeuro study group Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial Infectious Diseases and Therapy HIV Bictegravir Neuropsychiatric symptoms Switch |
| title | Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial |
| title_full | Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial |
| title_fullStr | Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial |
| title_full_unstemmed | Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial |
| title_short | Evolution of Self-reported Neuropsychiatric Symptoms After Switching from Dolutegravir/Abacavir/Lamivudine to Bictegravir/Emtricitabine/Tenofovir Alafenamide: Results from the Randomized DOBINeuro Trial |
| title_sort | evolution of self reported neuropsychiatric symptoms after switching from dolutegravir abacavir lamivudine to bictegravir emtricitabine tenofovir alafenamide results from the randomized dobineuro trial |
| topic | HIV Bictegravir Neuropsychiatric symptoms Switch |
| url | https://doi.org/10.1007/s40121-024-01083-1 |
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