Charles B. Hicks, MD reviewing Hoffman C et al. HIV Med 2016 Nov 10.

Retrospective data from persons initiating dolutegravir in Germany suggest the rate of neuropsychiatric adverse events and drug discontinuations, particularly in women and older patients, may be higher than what was observed in clinical trials.

Dolutegravir, a highly potent HIV integrase strand transfer inhibitor (INSTI), is a recommended antiretroviral therapy (ART) agent in most HIV treatment guidelines. Its efficacy, favorable pharmacokinetic and drug-interaction profile, resistance characteristics, and ease of use make it a popular choice for initial ART and as a component in management of treatment-experienced patients. A retrospective cohort analysis in two large German HIV clinics assesses adverse event (AE) rates in 1704 HIV-infected patients initiating INSTI-based ART between 2007 and 2016.

Overall, rates of AE-related discontinuation within 12 months of INSTI initiation were comparable for elvitegravir-based (7.6%) and dolutegravir-based (7.6%) treatment regimens; most elvitegravir discontinuations were renal toxicity-related and most dolutegravir discontinuations were attributed to neuropsychiatric AEs (primarily, sleep disturbance, dizziness, headache/paresthesia). Dolutegravir-associated AEs resolved quickly after discontinuation with no reported significant long-term sequelae. Age >60 years, female sex, and abacavir co-administration were associated with higher rates of dolutegravir discontinuation.

CITATION(S):

Hoffman C et al. Higher rates of neuropsychiatric adverse events leading to dolutegravir discontinuation in women and older patients. HIV Med 2016 Nov 10; [e-pub].

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