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French Cohort / Integrase inhibitors and neuropsychiatric adverse events in a large prospective cohort
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trying to sort through the various studies on this topic from CROI 2 years ago age so that older age appeared to b associated and so was higher dolutegravir levels, perhaps age increased levels, just a speculation on my part. But in trying to sort through this question there appear to be lots of potential variables that could be relevant including of note having a prior history of psychiatric or neuropsychiatric issues, in which I would include perhaps a history of serious substance abuse like heroin, IDU, cocaine, party drugs, ecstasy, meth. - all of which might cause some psychiatric issues in a person that could be relevant to experiencing some of these neuropsychiatric adverse events which include depression, anxiety, suicidality, insomnia. HIV itself and lifestyle can be relevant to having experienced those neyropsychistric AEs, and perhaps increase risk for experiencing a neuropsychiatric adverse events on ARTs. Perhaps long term depression and anxiety related to HIV might be a factor. Many HIV+ have a history of trauma either in early age or as adolescents or young adults. Jules
French Cohort at IAC see below following these 2 additional reports and links - Integrase inhibitors and neuropsychiatric adverse events in a large prospective cohort
at IAC 2018: Variables Associated With Neuropsychiatric Symptoms in PLWH Receiving Dolutegravir-Based Therapy in Phase III Clinical Trials - (07/25/18) examines patient data from phase 2b/3 dolutegravir studies to identify variables associated with development of neuropsyciatric adverse events. And to determine whether insomnia was a potential precursor to other neruopsychiatric adverse events, neuropsychiatric AEs were categorized according to whether they were predicted by insomnia
Psychiatric Symptoms in Patients Receiving Dolutegravir......http://www.natap.org/2017/HIV/012517_02.htm
from OPERA database: Selected psychiatric symptoms (insomnia, anxiety, depression, and suicidality)occurring in HIV-positive patients during dolutegravir treatment across 5 randomized clinicaltrials (3 double-blind), in the Observational Pharmaco-Epidemiology Research & Analysis(OPERA®) cohort, and among cases spontaneously reported to ViiV Healthcare were analysed......In those patients who developed depression whose psychiatric history was known (34/100), approximately 85% had a history of depression before drug initiation. An absence of past history of depressive symptoms was only identified in 3 cases. Among DTG-treated patients who experienced PSs, few were considered grade 3 to 4 intensity or reported as serious, and most DTG-treated patients (95%) who experienced suicidality had a past history of psychiatric conditions.....History of anxiety, depression, or insomnia was highest in DTG-treated patients and lowest in EFV-treated patients.Despite this, the prevalence of anxiety, depression, and insomnia was similar across all 4 anchor drugs, except for a higher prevalence of anxiety and depression in RAL-treated patients and a lower prevalence of insomnia in DRV-treated patients (Table 2)......In patients without ahistory of these psychiatric conditions at baseline, the incidence of anxiety, depression, and insomnia was similar across all 4 anchor drugs. However, treatment discontinuations for these symptoms were lowest for DTG-treated patients (range 0.1% to 0.3% compared with a range of 0.5% to 1.1% for the other 3 anchor drugs)"....Using OPERA data that included 98% of all DTG data allowed PSs to be assessed inpatients in a real-world setting and allowed all drugs of interest to be compared starting from thesame date and for the same follow-up period. Data for EFV, RAL, and DRV before DTG wasintroduced in 2013 were consistent with the data set used in this study (data not shown). Theseresults support conclusions from the clinical trial data that the frequency of PSs associated withDTG was generally low and similar to that of other anchor drugs, and most similar to DRV. Patients treated with EFV had the lowest prevalence of PSs at baseline (before medication wasinitiated), which suggests that in the real-world setting physicians may be preferentiallyprescribing INSTIs and DRV rather than EFV to treat patients with a history of psychiatricevents. Despite this potential channeling bias, the prevalence, incidence, and withdrawal ratesof PSs with DTG remained low compared with patients treated with the other anchor drugs,including EFV. JAIDS Jan 20 2017. Anna Fettiplace, PhD, MBChB,1 Chris Stainsby, BSc Hons,1 Alan Winston, MD,2 Naomi Givens,MSc,1 Sarah Puccini, BSc Hons,1 Vani Vannappagari, PhD,3Ricky Hsu, MD,4 Jennifer Fusco,BS,5 Romina Quercia, MD, PhD,3 Michael Aboud, MBChB, MRCP,3 Lloyd Curtis, MA, MRCP1. 1GlaxoSmithKline, London, UK; 2Imperial College, London, UK; 3ViiV Healthcare, ResearchTriangle Park, NC, USA; 4NYU Langone Medical Center, New York, NY, USA; 5Epividian Inc.,Research Triangle Park, NC, USA
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Integrase inhibitors and neuropsychiatric adverse events in a large prospective cohort
Reported by Jules Levin
IAC Aug 2018 Amsterdam
L. Cuzin1, Pascal Pugliese2, Christine Katlama3, Isabelle Ravaux4, Firouzé Bani-Sadr5, Tristan Ferry6, David Rey7, Jeremy Lourenco8, Sylvie Bregigeon9, Clotilde Allavena10, Jacques Reynes11, for the Dat'AIDS Study Group*.
1: University Hospital of Martinique and INSERM UMR1027; 2: University Hospital of Nice ,
3: University Hospital of Pitié Salpêtrière, 4: University Hospital of Marseille, 5: University Hospital of Reims, 6: University Hospital of Lyon, 7: University Hospital of Strasbourg, 8: University Hospital of Necker, 9: Aix Marseille University, AP-HM Ste Marguerite, 10: University Hospital of Nantes, 11: University Hospital of Montpellier
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