PMID- 33051194 OWN - NLM STAT- MEDLINE DCOM- 20220627 LR - 20230703 IS - 2047-9956 (Print) IS - 2047-9964 (Electronic) IS - 2047-9956 (Linking) VI - 29 IP - 4 DP - 2022 Jul TI - Discontinuation due to neuropsychiatric adverse events with efavirenz- and dolutegravir-based antiretroviral therapy: a comparative real-life study. PG - 207-211 LID - 10.1136/ejhpharm-2020-002374 [doi] AB - OBJECTIVES: Despite the high efficacy of antiretroviral treatment, no drug is free from adverse events (AEs). Efavirenz (EFV) and dolutegravir (DTG) are antiretroviral drugs for which neuropsychiatric adverse events (NPAEs) have been described. This study evaluated the safety and tolerability of DTG-based and EFV-based antiretroviral regimens in HIV-infected patients. METHODS: A retrospective observational study was carried out in HIV-infected patients who started DTG- or EFV-based antiretroviral treatment from January 2008 to December 2018 at a reference hospital in north-western Spain. Epidemiological, clinical and immunovirological data were recorded. A statistical analysis was performed with SPSS software. RESULTS: A total of 282 DTG- and 148 EFV-based therapies were initiated. During follow-up, statistically significant differences have been found between the rate of patients who discontinued DTG and EFV due to AEs (12.1% vs 35.8%, p<0.001) and the main AEs in both groups, NPAEs (8.2% vs 25.0%, p<0.001). Female gender (OR 2.610 (95% CI 1.327 to 5.133), p=0.005) was associated with discontinuations due to AEs. Patients with documented psychiatric disorders were at higher risk of discontinuation due to NPAEs (OR 4.782 (95% CI 1.190 to 19.220), p=0.027). The multivariate analysis showed a 61.2% risk reduction in benzodiazepine prescriptions in patients treated with DTG. In both groups, patients needed consultation and follow-up in the psychiatry unit (16.9% in the EFV group and 8.9% in the DTG group, p=0.021). CONCLUSIONS: We found a high rate of discontinuations due to AEs and NPAEs, prescription of benzodiazepines and a requirement for consultation in a psychiatric unit in both treatment groups, especially with EFV. CI - (c) European Association of Hospital Pharmacists 2022. No commercial re-use. See rights and permissions. Published by BMJ. FAU - Fernandez-Bargiela, Noelia AU - Fernandez-Bargiela N AUID- ORCID: 0000-0002-8605-1313 AD - Service of Pharmacy, Universitary Hospital of A Coruna (CHUAC), SERGAS, A Coruna, Spain. FAU - Rotea-Salvo, Sandra AU - Rotea-Salvo S AD - Service of Pharmacy, Universitary Hospital of A Coruna (CHUAC), SERGAS, A Coruna, Spain. FAU - Margusino-Framinan, Luis AU - Margusino-Framinan L AD - Service of Pharmacy, Universitary Hospital of A Coruna (CHUAC), SERGAS, A Coruna, Spain. AD - Division of Clinical Virology, Biomedical Research Institute of A Coruna (INIBIC), University Hospital of A Coruna (CHUAC), SERGAS, Universitary of A Coruna, A Coruna, Spain. FAU - Balboa-Barreiro, Vanesa AU - Balboa-Barreiro V AD - Clinical Epidemiology and Biostatistics Unit, Biomedical Research Institute of A Coruna (INIBIC), Universitary Hospital of A Coruna (CHUAC), SERGAS, Universitary of A Coruna (UDC), A Coruna, Spain. FAU - Martin-Herranz, Isabel AU - Martin-Herranz I AD - Service of Pharmacy, Universitary Hospital of A Coruna (CHUAC), SERGAS, A Coruna, Spain. FAU - Castro-Iglesias, Angeles AU - Castro-Iglesias A AD - Division of Clinical Virology, Biomedical Research Institute of A Coruna (INIBIC), University Hospital of A Coruna (CHUAC), SERGAS, Universitary of A Coruna, A Coruna, Spain. AD - Service of Infectious Internal Medicine, Universitary Hospital of A Coruna (CHUAC), SERGAS, A Coruna, Spain. FAU - Mena-De-Cea, Alvaro AU - Mena-De-Cea A AD - Division of Clinical Virology, Biomedical Research Institute of A Coruna (INIBIC), University Hospital of A Coruna (CHUAC), SERGAS, Universitary of A Coruna, A Coruna, Spain. AD - Service of Infectious Internal Medicine, Universitary Hospital of A Coruna (CHUAC), SERGAS, A Coruna, Spain. FAU - Lopez-Calvo, Soledad AU - Lopez-Calvo S AD - Division of Clinical Virology, Biomedical Research Institute of A Coruna (INIBIC), University Hospital of A Coruna (CHUAC), SERGAS, Universitary of A Coruna, A Coruna, Spain. AD - Service of Infectious Internal Medicine, Universitary Hospital of A Coruna (CHUAC), SERGAS, A Coruna, Spain. FAU - Vazquez-Rodriguez, Pilar AU - Vazquez-Rodriguez P AD - Division of Clinical Virology, Biomedical Research Institute of A Coruna (INIBIC), University Hospital of A Coruna (CHUAC), SERGAS, Universitary of A Coruna, A Coruna, Spain. AD - Service of Infectious Internal Medicine, Universitary Hospital of A Coruna (CHUAC), SERGAS, A Coruna, Spain. FAU - Miguez-Rey, Enrique AU - Miguez-Rey E AD - Division of Clinical Virology, Biomedical Research Institute of A Coruna (INIBIC), University Hospital of A Coruna (CHUAC), SERGAS, Universitary of A Coruna, A Coruna, Spain. AD - Service of Infectious Internal Medicine, Universitary Hospital of A Coruna (CHUAC), SERGAS, A Coruna, Spain. FAU - Cid-Silva, Purificacion AU - Cid-Silva P AUID- ORCID: 0000-0002-3227-8002 AD - Service of Pharmacy, Universitary Hospital of A Coruna (CHUAC), SERGAS, A Coruna, Spain purificacion.cid.silva@sergas.es. AD - Division of Clinical Virology, Biomedical Research Institute of A Coruna (INIBIC), University Hospital of A Coruna (CHUAC), SERGAS, Universitary of A Coruna, A Coruna, Spain. LA - eng PT - Journal Article PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20201013 PL - England TA - Eur J Hosp Pharm JT - European journal of hospital pharmacy : science and practice JID - 101578294 RN - 0 (Alkynes) RN - 0 (Benzoxazines) RN - 0 (Cyclopropanes) RN - 0 (Heterocyclic Compounds, 3-Ring) RN - 0 (Oxazines) RN - 0 (Piperazines) RN - 0 (Pyridones) RN - DKO1W9H7M1 (dolutegravir) RN - JE6H2O27P8 (efavirenz) SB - IM MH - Alkynes MH - Benzoxazines/adverse effects MH - Cyclopropanes MH - Female MH - *HIV Infections/drug therapy/epidemiology MH - *Heterocyclic Compounds, 3-Ring/adverse effects MH - Humans MH - Oxazines MH - Piperazines MH - Pyridones PMC - PMC9251157 OTO - NOTNLM OT - HIV & AIDS OT - adverse effects OT - clinical pharmacy OT - infectious diseases OT - side effects of drugs COIS- Competing interests: None declared. EDAT- 2020/10/15 06:00 MHDA- 2022/06/28 06:00 PMCR- 2023/07/01 CRDT- 2020/10/14 09:11 PHST- 2020/05/19 00:00 [received] PHST- 2020/07/19 00:00 [revised] PHST- 2020/08/18 00:00 [accepted] PHST- 2020/10/15 06:00 [pubmed] PHST- 2022/06/28 06:00 [medline] PHST- 2020/10/14 09:11 [entrez] PHST- 2023/07/01 00:00 [pmc-release] AID - ejhpharm-2020-002374 [pii] AID - 10.1136/ejhpharm-2020-002374 [doi] PST - ppublish SO - Eur J Hosp Pharm. 2022 Jul;29(4):207-211. doi: 10.1136/ejhpharm-2020-002374. Epub 2020 Oct 13.