title: Psychiatric Symptoms in Patients Receiving Dolutegravir.
abstract: BACKGROUND
  Psychiatric symptoms (PSs) are reported to occur frequently in people living with HIV and may be associated with specific antiretrovirals. We analyzed PSs observed with dolutegravir (DTG) and other frequently prescribed anchor drugs.
  
  
  METHODS
  Selected PSs (insomnia, anxiety, depression, and suicidality) occurring in HIV-positive patients during DTG treatment across 5 randomized clinical trials (3 double-blind), in the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) cohort, and among cases spontaneously reported to ViiV Healthcare were analyzed.
  
  
  RESULTS
  In clinical trials, PSs were reported at low and similar rates in patients receiving DTG or comparators [atazanavir, darunavir, efavirenz, or raltegravir (RAL)]. Insomnia was most commonly reported. The highest rates were observed in SINGLE (DTG 17%, efavirenz 12%), with consistently lower rates in the other trials (DTG: 3%-8% versus comparator: 3%-7%). More efavirenz-treated patients withdrew because of PSs than patients treated with other anchor drugs. In OPERA, history of PSs at baseline was lowest in efavirenz-treated patients compared with patients treated with DTG, RAL, or darunavir. Despite baseline differences, prevalence and incidence during treatment were similar across the 4 anchor drugs. Withdrawal rates for PSs were lowest for DTG (0%-0.6%) and highest for RAL (0%-2.5%). Spontaneously reported events were similar in nature to clinical trial data.
  
  
  CONCLUSIONS
  Analysis of 3 different data sources shows that, similar to other frequently prescribed anchor drugs to treat HIV infection, PSs are also reported in DTG-treated patients. These events are reported with low frequency and rarely necessitate DTG discontinuation.
authors.affiliation: *GlaxoSmithKline, London, United Kingdom; †Department of medicine, Faculty of medicine Imperial College, London, United Kingdom; ‡ViiV Healthcare, Research Triangle Park, NC; §Department of Medicine, NYU Langone Medical Center, New York, NY; and ‖Epividian Inc., Research Triangle Park, NC.
authors.forename: Anna
authors.initials: A
authors.lastname: Fettiplace
authors.forename: Chris
authors.initials: C
authors.lastname: Stainsby
authors.forename: Alan
authors.initials: A
authors.lastname: Winston
authors.forename: Naomi
authors.initials: N
authors.lastname: Givens
authors.forename: Sarah
authors.initials: S
authors.lastname: Puccini
authors.forename: Vani
authors.initials: V
authors.lastname: Vannappagari
authors.forename: Ricky
authors.initials: R
authors.lastname: Hsu
authors.forename: Jennifer
authors.initials: J
authors.lastname: Fusco
authors.forename: Romina
authors.initials: R
authors.lastname: Quercia
authors.forename: Michael
authors.initials: M
authors.lastname: Aboud
authors.forename: Lloyd
authors.initials: L
authors.lastname: Curtis
mesh_terms: D001007:Anxiety / Q000139:chemically induced* / Q000523:psychology; D017326:Clinical Trials, Phase III as Topic; D003863:Depression / Q000139:chemically induced* / Q000523:psychology; D015658:HIV Infections / Q000188:drug therapy*; D019428:HIV Integrase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects*; D006575:Heterocyclic Compounds, 3-Ring / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D008297:Male; D010078:Oxazines; D010879:Piperazines; D011605:Psychoses, Substance-Induced; D011728:Pyridones; D016032:Randomized Controlled Trials as Topic; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced* / Q000523:psychology; D059020:Suicidal Ideation; D016896:Treatment Outcome; D055815:Young Adult; D000099226:Dolutegravir
chemical_list: D019428:HIV Integrase Inhibitors; D006575:Heterocyclic Compounds, 3-Ring; D010078:Oxazines; D010879:Piperazines; D011728:Pyridones; D000099226:Dolutegravir