Higher rates of neuropsychiatric adverse events leading to dolutegravir discontinuation in women and older patients

HIV Medicine

Volumn 18, Issue 1, 2017, Pages 56-63

  Hoffmann, C ^a,b   Welz, T ^c   Sabranski, M ^a   Kolb, M ^c,d   Wolf, E ^e   Stellbrink, H J ^a   Wyen, C ^c,d  

^a Infektionsmedizinisches Centrum Hamburg   (Germany)

^b UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^c Praxis am Ebertplatz   (Germany)

^d UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^e MUC Research GmbH and MVZ Karlsplatz   (Germany)

Author keywords

adverse events; antiretroviral therapy; dolutegravir; HIV infection; integrase inhibitors; side effects

Indexed keywords

ABACAVIR PLUS DOLUTEGRAVIR PLUS LAMIVUDINE; CD4 ANTIGEN; COBICISTAT PLUS ELVITEGRAVIR PLUS EMTRICITABINE PLUS TENOFOVIR ALAFENAMIDE; COBICISTAT PLUS ELVITEGRAVIR PLUS EMTRICITABINE PLUS TENOFOVIR DISOPROXIL; DOLUTEGRAVIR; ELVITEGRAVIR; HLA ANTIGEN; RALTEGRAVIR; FUSED HETEROCYCLIC RINGS; INTEGRASE INHIBITOR;

ADULT; ARTICLE; CD4 LYMPHOCYTE COUNT; COHORT ANALYSIS; CONCENTRATION LOSS; DEPRESSION; DIZZINESS; DRUG WITHDRAWAL; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INSOMNIA; MAJOR CLINICAL STUDY; MALE; NERVOUSNESS; PAIN; PARESTHESIA; PRIORITY JOURNAL; RESTLESSNESS; RETROSPECTIVE STUDY; SIDE EFFECT; SLEEP DISORDER; THINKING IMPAIRMENT; ADOLESCENT; AGE; AGED; CHEMICALLY INDUCED; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; GERMANY; HIV INFECTIONS; MENTAL DISORDERS; MIDDLE AGED; OUTPATIENT; SEX DIFFERENCE; TREATMENT WITHDRAWAL; VERY ELDERLY; YOUNG ADULT;

ADOLESCENT; ADULT; AGE FACTORS; AGED; AGED, 80 AND OVER; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; GERMANY; HETEROCYCLIC COMPOUNDS, 3-RING; HIV INFECTIONS; HIV INTEGRASE INHIBITORS; HUMANS; MALE; MENTAL DISORDERS; MIDDLE AGED; OUTPATIENTS; RETROSPECTIVE STUDIES; SEX FACTORS; WITHHOLDING TREATMENT; YOUNG ADULT;

EID: 85004187482     PISSN: 14642662     EISSN: 14681293     Source Type: Journal    
DOI: 10.1111/hiv.12468     Document Type: Article

References (17)

1. Cahn P, Pozniak AL, Mingrone H et al. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet 2013; 382: 700–708.
2. Casado JL, Marín A, Romero V et al. The influence of patient beliefs and treatment satisfaction on the discontinuation of current first-line antiretroviral regimens. HIV Med 2016;17:46–55.
3. Clotet B, Feinberg J, van Lunzen J et al. Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study. Lancet 2014; 383: 2222–2231.
4. Cottrell ML, Hadzic T, Kashuba AD. Clinical pharmacokinetic, pharmacodynamic and drug-interaction profile of the integrase inhibitor dolutegravir. Clin Pharmacokinet 2013; 52: 981–994.
5. Hightower KE, Wang R, Deanda F et al. Dolutegravir (S/GSK1349572) exhibits significantly slower dissociation than raltegravir and elvitegravir from wild-type and integrase inhibitor-resistant HIV-1 integrase-DNA complexes. Antimicrob Agents Chemother 2011; 55: 4552–4559.
6. Kheloufi F, Allemand J, Mokhtari S, Default A. Psychiatric disorders after starting dolutegravir: report of four cases. AIDS 2015; 29: 1723–1725.
7. Letendre SL, Mills AM, Tashima KT et al. Piscitelli SC; extended ING116070 study team. ING116070: a study of the pharmacokinetics and antiviral activity of dolutegravir in cerebrospinal fluid in HIV-1-infected, antiretroviral therapy-naive subjects. Clin Infect Dis 2014; 59: 1032–1037.
8. Orrell C, Hagins D, Belonosova E et al. Superior efficacy of dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) fixed dose combination (FDC) compared with ritonavir (RTV) boosted atazanavir (ATV) plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in treatment-naïve women with HIV-1 infection (ARIA study). Presented at the International AIDS Conference (IAC), 18–22 July 2016, Durban, South Africa. Abstract #10215.
9. Patel DA, Snedecor SJ, Tang WY et al. 48-week efficacy and safety of dolutegravir relative to commonly used third agents in treatment-naive HIV-1–infected patients: a systematic review and network meta-analysis. PLoS ONE 2014; 9: e105653.
10. Raffi F, Jaeger H, Quiros-Roldan E et al. Once-daily dolutegravir versus twice-daily raltegravir in antiretroviral-naïve adults with HIV-1 infection (SPRING-2 study): 96 week results from a randomised, double-blind, non-inferiority trial. Lancet Infect Dis 2013; 13: 927–935.
11. Stellbrink HJ, Reynes J, Lazzarin A et al. Dolutegravir in antiretroviral-naive adults with HIV-1: 96-week results from a randomized dose-ranging study. AIDS 2013; 27: 1771–1778.
12. Trottier B, Lake J, Logue K et al. Switching to abacavir/dolutegravir/lamivudine fixed dose combination (ABC/DTG/3TC FDC) from a PI, INI or NNRTI based regimen maintains HIV suppression. 55th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17–21, 2015; San Diego, California. Abstract.
13. Usach I, Melis V, Peris JE. Non-nucleoside reverse transcriptase inhibitors: a review on pharmacokinetics, pharmacodynamics, safety and tolerability. J Int AIDS Soc 2013; 16: 1–14.
14. Van den Berk G, Oryszczyn J, Blok W et al. Unexpectedly high rate of intolerance for dolutegravir in real life Setting. Abstract 948, Conference on Retroviruses and Opportunistic Infections, Boston, Massachussetts, February 22–25, 2016.
15. Walmsley SL, Antela A, Clumeck N et al. Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection. N Engl J Med 2013; 369: 1807–1818.
16. Kandel CE, Walmsley SL. Dolutegravir - a review of the pharmacology, efficacy, and safety in the treatment of HIV. Drug Des Devel Ther 2015; 9: 3547–3555.
17. Sharrar RG, Dieck GS. Monitoring product safety in the postmarketing environment. Ther Adv Drug Saf 2013; 4: 211–219.