Adverse events of raltegravir and dolutegravir. AIDS
Elzi et al. aimed to compare the frequency and risk factors of toxicity-related treatment discontinuations between raltegravir and dolutegravir.
From 1 April 2006 to 31 December 2015, 4’041 HIV-infected individuals participating in the SHCS started an antiretroviral regimen containing either raltegravir (n=2’091) or dolutegravir (n=1’950). Of them, 568 (14.1%) had modification of their antiretroviral therapy (ART) because of any reason during the first year of treatment, corresponding to 15.5 discontinuations per 100 patient-years. The main reason for treatment modification was convenience (n=302), followed by toxicity or intolerance (n=181). Only 10 patients under raltegravir (0.48%) and two patients under dolutegravir (0.10%) demonstrated virological failure.
Adverse events leading to ART modification within the first year occurred in 4.5% of the patients, corresponding to a discontinuation rate of 4.4 per 100 patient-years for dolutegravir and 5.7 per 100 patient-years for raltegravir, although not reaching statistical significance. Neuropsychiatric complaints, occurring in overall less than 2% of the patients, were the most commonly reported adverse events and more frequently in the dolutegravir group (discontinuation rate of 1.83 per 100 patient-years) compared with the raltegravir group (discontinuation rate of 0.70 per 100 patient-years, P=0.002). In multivariable analysis of the subgroup with neurotoxicity, there was a significantly lower risk of discontinuation for raltegravir compared with dolutegravir.
In conclusion, the study confirms the excellent tolerability of the raltegravir and dolutegravir in the treatment of HIV-infected individuals. Raltegravir or dolutegravir drug toxicity is an infrequent reason for treatment modification. Although neuropsychiatric complaints are indeed observed more frequently in patients on dolutegravir compared with raltegravir, in overall these adverse events remain relatively rare.