Universität zu Köln

Hoffmann, C., Welz, T., Sabranski, M., Kolb, M., Wolf, E., Stellbrink, H-J and Wyen, C. (2017). Higher rates of neuropsychiatric adverse events leading to dolutegravir discontinuation in women and older patients. HIV Med., 18 (1). S. 56 - 64. HOBOKEN: WILEY-BLACKWELL. ISSN 1468-1293

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Abstract

ObjectivesDolutegravir (DTG), a second-generation integrase strand transfer inhibitor (INSTI), is now among the most frequently used antiretroviral agents. However, recent reports have raised concerns about potential neurotoxicity. MethodsWe performed a retrospective analysis of a cohort of HIV-infected patients who had initiated an INSTI in two large German out-patient clinics between 2007 and 2016. We compared discontinuation rates because of adverse events (AEs) within 2 years of starting treatment with dolutegravir, raltegravir or elvitegravir/cobicistat. We also evaluated factors associated with dolutegravir discontinuation. ResultsA total of 1950 INSTI-based therapies were initiated in 1704 patients eligible for analysis within the observation period. The estimated rates of any AE and of neuropsychiatric AEs leading to discontinuation within 12 months were 7.6% and 5.6%, respectively, for dolutegravir (n = 985), 7.6% and 0.7%, respectively, for elvitegravir (n = 287), and 3.3% and 1.9%, respectively, for raltegravir (n = 678). Neuropsychiatric AEs leading to dolutegravir discontinuation were observed more frequently in women [hazard ratio (HR) 2.64; 95% confidence interval (CI) 1.23-5.65; P = 0.012], in patients older than 60 years (HR: 2.86; 95% CI: 1.42-5.77; P = 0.003) and in human leucocyte antigen (HLA)-B*5701-negative patients who initiated abacavir at the same time (HR: 2.42; 95% CI: 1.38-4.24; P = 0.002). ConclusionsIn this large cohort, the rate of discontinuation of dolutegravir because of neuropsychiatric adverse events was significantly higher than for other INSTIs, at almost 6% within 12 months. Despite the limitations of this retrospective study, the almost three-fold higher discontinuation rates observed amongst women and older patients underscore the need for further investigation, especially in patient populations usually underrepresented in clinical trials.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Hoffmann, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED Welz, T. UNSPECIFIED UNSPECIFIED UNSPECIFIED Sabranski, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kolb, M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolf, E. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stellbrink, H-J UNSPECIFIED UNSPECIFIED UNSPECIFIED Wyen, C. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-243445
DOI:	10.1111/hiv.12468
Journal or Publication Title:	HIV Med.
Volume:	18
Number:	1
Page Range:	S. 56 - 64
Date:	2017
Publisher:	WILEY-BLACKWELL
Place of Publication:	HOBOKEN
ISSN:	1468-1293
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ANTIRETROVIRAL-NAIVE ADULTS; ONCE-DAILY DOLUTEGRAVIR; HIV-1 INFECTION; DOUBLE-BLIND; RALTEGRAVIR Multiple languages Infectious Diseases Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/24344