Objective: Dolutegravir (DTG) is an integrase inhibitor (INI), nowadays widely used for the treatment of antiretroviral-naive and experienced HIV-affected patients, but there are some concerns about the risk of adverse events, especially regarding neuropsychiatric disorders and central nervous system (CNS) affections. We reviewed the safety of DTG in first- and second-line therapy.
Materials and Methods: MEDLINE and Web-of-Science have been screened from 2013 until November 2017. Data from literature have been reviewed to identify randomized controlled trials, non-randomized controlled trials, cohort studies and observational studies on DTG-use in clinical practice. We focused our attention on the investigation of psychiatric and CNS-affecting drug-related adverse events (AEs).
Results: DTG discontinuations due to AEs resulted to range from 1 and 4% in clinical trials and from 3 to 15% in real-life cohort studies. Among all AEs, CNS symptoms (mostly headache or insomnia) were the most represented, together with gastro-intestinal affections.
Conclusions: CNS AEs can still be considered infrequent in patients submitted to DTG containing regimens, but these events become significantly higher when compared to other anti-retroviral regimens. These discontinuation rates should not discourage health-care providers from prescribing DTG-containing regimens, but they certainly should incite them to take into consideration the patient’s antiretroviral history or any previous CNS event before the prescription.