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.
Highlights
Dolutegravir (DTG), a second-generation integrase inhibitor (INI), has shown high efficacy and safety in both naïve and treatment-experienced (TE) people living with HIV (PLWHIV) [1,2], in both three-drug regimens, as well as in two-drug regimens with either lamivudine or rilpivirine [3,4]
Confirming previous findings [9], in our work, we reported less than 10 treatment discontinuation (TD) per 100 PYFU, with over 80% of TD observed in the first year
TDs were due to adverse events: We reported an incidence rate of discontinuations due to all toxicities of 3.2 per 100 PYFU and, in particular, a rate of discontinuations due to neuropsychiatric events incidence rate of 1.30 per 100 PYFU
Summary
Dolutegravir (DTG), a second-generation integrase inhibitor (INI), has shown high efficacy and safety in both naïve and treatment-experienced (TE) people living with HIV (PLWHIV) [1,2], in both three-drug regimens, as well as in two-drug regimens with either lamivudine or rilpivirine [3,4]. Clinical practice studies have shown the optimal tolerability profile of DTG-based strategies [5,6]. Reports from clinical practice about the high rate of neuropsychiatric events in patients treated with DTG leading to treatment discontinuation (TD) [7] have raised questions on the tolerability of DTG-based regimens.
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