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Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (D/C/F/TAF) in Treatment-naïve (AMBER) and Virologically Suppressed (EMERALD) Patients With Neurologic and/or Psychiatric Comorbidities: Week 96 Subgroup Analysis
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IAC 2020 virtual July 6-10
Reported by Jules Levin
IAC2020: Weight/Body Mass Index Gains Following Initiation of Integrase Strand Transfer Inhibitor Versus Protease Inhibitor Among People Living With Human Immunodeficiency Virus in the United States - (07/09/20)
Jennifer Bushen,1,* Donghan Luo,2 Richard Bruce Simonson,1 Ramona Burress,1 Kimberley Brown,1 David Anderson,1 Keith Dunn1
1Janssen Scientific Affairs, LLC, Titusville, NJ, USA; 2Janssen Research & Development, LLC, Titusville, NJ, USA.
*System organ class of Nervous System Disorders.
In AMBER, patients with baseline NPCs experienced the following D/C/F/TAF-related neurologic AEs: headache (n = 1), exertional dizziness (n = 1), postural dizziness (n = 1), disturbance in attention (n = 1), somnolence (n = 1), and dizziness (n = 1); for patients without NPCs, these were: headache (n = 11), dizziness (n = 1), postural dizziness (n = 1), and somnolence (n = 2). In EMERALD, patients with baseline NPCs experienced the following D/C/F/TAF-related neurologic AEs: headache (n = 3), paresthesia (n = 1), somnolence (n = 1), and postural dizziness (n = 2); for patients without NPCs, these were: headache (n = 8), postural dizziness (n = 3), carpal tunnel syndrome (n = 1), hypoesthesia (n = 1), paresthesia (n = 1), syncope (n = 1), and dysgeusia (n = 1).
System organ class of Psychiatric Disorders.
In AMBER, patients with baseline NPCs experienced the following D/C/F/TAF-related psychiatric AEs: listless (n = 1) and restlessness (n = 1); for patients without NPCs, these were: insomnia (n = 5), depression (n = 2), sleep disorder (n = 1), and abnormal dreams (n = 2). In EMERALD, patients with baseline NPCs experienced the following D/C/F/TAF-related psychiatric AEs: insomnia (n = 2), sleep disorder (n = 3), euphoric mood (n = 1), and irritability (n = 1); for patients without NPCs, these were: depression (n = 1), insomnia (n = 1), abnormal dreams (n = 5), sleep disorder (n = 2), suicidal depression (n = 1), and tearfulness (n = 1).
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