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Multicenter Study
. 2022 Jan 17;14(1):163.
doi: 10.3390/v14010163.

Real-Life Impact of Drug Toxicity on Dolutegravir Tolerability: Clinical Practice Data from a Multicenter Italian Cohort

Arturo Ciccullo  1 , Gianmaria Baldin  2   3 , Vanni Borghi  4 , Filippo Lagi  5 , Alessandra Latini  6 , Gabriella d'Ettorre  7 , Letizia Oreni  8 , Paolo Fusco  9 , Amedeo Capetti  10 , Massimiliano Fabbiani  11 , Andrea Giacomelli  8 , Alessandro Grimaldi  1 , Giordano Madeddu  12 , Gaetana Sterrantino  5 , Cristina Mussini  4 , Simona Di Giambenedetto  3   13
Affiliations
Multicenter Study

Real-Life Impact of Drug Toxicity on Dolutegravir Tolerability: Clinical Practice Data from a Multicenter Italian Cohort

Arturo Ciccullo et al. Viruses. .

Abstract

Dolutegravir (DTG) is currently one of the most used Integrase inhibitors (INI) in antiretroviral therapies (ARV) in both naïve and experienced people living with HIV (PLWHIV). We analyzed a multicenter cohort of PLWHIV, both naïve and experienced, starting an ARV including DTG. We enrolled 3775 PLWHIV: 2763 (73.2%) were males, with a median age of 50 years. During 9890.7 PYFU, we observed 930 discontinuations (9.4 per 100 PYFU). Estimated probabilities of maintaining DTG at three and five years were 75.1% and 67.2%, respectively. Treatment-naïve pts showed a lower probability of maintaining DTG at three and five years compared to treatment-experienced PLWHIV (log-rank p < 0.001). At a multivariate analysis, a longer time of virological suppression (aHR 0.994, p < 0.001) and having experienced a previous virological failure (aHR 0.788, p = 0.016) resulted protective against DTG discontinuation. Most discontinuations (84.0%) happened within the first 12 months of DTG initiation, in particular, 92.2% of discontinuations due to neuropsychiatric toxicity were observed in the first year. Our data confirm the overall good tolerability of DTG in clinical practice, with a low rate of discontinuations. CNS toxicity resulted the main reason for DTG discontinuation, with most related interruptions happening in the first year from DTG introduction.

Keywords: HAART; HIV; dolutegravir; toxicity.

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Conflict of interest statement

ACi received travel grants and congress’ fees from ViiV Healthcare. ACa has received a personal grant from AB, Gilead and ViiV. GS has received funds for speaking by Gilead, Merk, Janssen, Abbvie, ViiV. CM has participated in advisory boards, received study grants and/or speaker honoraria from: Abbvie, Gilead, Viiv, Janssen, Angelini, BMS, MSD. SDG was a paid consultant or member of advisory boards for Gilead, ViiV Healthcare, Janssen-Cilag, Merck Sharp & Dohme and Bristol-Myers Squibb. All authors declare no conflict of interest.

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