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. 2017 Apr 1;74(4):423-431.
doi: 10.1097/QAI.0000000000001269.

Psychiatric Symptoms in Patients Receiving Dolutegravir

Anna Fettiplace  1 , Chris Stainsby, Alan Winston, Naomi Givens, Sarah Puccini, Vani Vannappagari, Ricky Hsu, Jennifer Fusco, Romina Quercia, Michael Aboud, Lloyd Curtis
Affiliations

Psychiatric Symptoms in Patients Receiving Dolutegravir

Anna Fettiplace et al. J Acquir Immune Defic Syndr. .

Abstract

Introduction: 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.

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Conflict of interest statement

A.F., C.S., N.G., S.P., and L.C. are employees of Glaxo SmithKline. V.V., R.Q., and M.A. are employees of ViiV Healthcare.

Figures

FIGURE 1.
FIGURE 1.
TTO of first (A) psychiatric event, (B) insomnia event, (C) depression event, and (D) anxiety event in patients treated with DTG-, RAL-, EFV-, and DRV-containing regimens in the OPERA cohort with number of subjects at risk January 1, 2013–April 30, 2015. EFV, efavirenz; OPERA, Observational Pharmaco-Epidemiology Research & Analysis.
See this image and copyright information in PMC

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