Background. International guidelines recommend the use of INI-based regimens as first line ARV in both naïve and experienced HIV-infected patients. Materials and Methods. We analyzed a multicenter cohort of HIV-infected patients, both naïve and experienced, starting a ARV including an INI. Chi-square test and non-parametric tests were used to assess differences in categorical and continuous variables, respectively. Kaplan-Meyer survival analysis were performed to estimate the probability of maintaining the study-drug and Cox-regression analysis to evaluate predictors of discontinuation. Results. We enrolled 4343 patients: 3143 (72.4%) were males, with a median age of 49 years (IQR 41-55). Naïve patients were 733 (16.9%), of whom 168 (22.9%) AIDS-presenters. Overall, 2282 patients (52.5%) started DTG, 1426 (32.8%) RAL and 635 (14.7%) EVG. During 10032 PYFU, we observed 1278 discontinuations (13 per 100PYFU); 448 of them (35%) due to simplification and 355 (28%) to toxicities (98 for CNS toxicity). Reasons of discontinuation were different between INIs. Estimated probability of maintaining DTG at 3 and 4 years were 81.5% (95%CI 80.5-82.5) and 76.3% (95%CI 73.9-78.7), respectively; RAL 61.6% (95%CI 60.2-63.0) and 54.1% (95%CI 52.7-55.5); EVG 71.6% (95%CI 69.2-74.0) and 68.3% (95%CI 65.3-71.3) (p<0.001). At a multivariable analysis, being on a RAL-based ARV (vs DTG, aHR 2.9, 95%CI 2.3-3.6, p<0.001), a EVG-based ARV (vs DTG, aHR 1.3 95%CI 1.1-1.7, p=0.049) and a peak HIV-RNA>500k cp/mL (aHR 1.3, 95%CI 1.1-1.6, p=0.006) predicted INI discontinuation. Conclusions. Our data confirm the good tolerability of INIs in clinical practice. Differences emerge between the three drugs in reasons for discontinuation.
Overall tolerability of Integrase Inhibitors in clinical practice: results from a multicenter Italian cohort / A. Ciccullo, G. Baldin, V. Borghi, G. Sterrantino, G. Madeddu, A. Latini, G. d'Ettorre, A. Lanari, M. Mazzitelli, M. Colafigli, A.F. Capetti, L. Oreni, F. Lagi, S. Rusconi, S. Di Giambenedetto. - In: AIDS RESEARCH AND HUMAN RETROVIRUSES. - ISSN 0889-2229. - (2020). [Epub ahead of print]
Overall tolerability of Integrase Inhibitors in clinical practice: results from a multicenter Italian cohort
S. RusconiPenultimo
;
2020
Abstract
Background. International guidelines recommend the use of INI-based regimens as first line ARV in both naïve and experienced HIV-infected patients. Materials and Methods. We analyzed a multicenter cohort of HIV-infected patients, both naïve and experienced, starting a ARV including an INI. Chi-square test and non-parametric tests were used to assess differences in categorical and continuous variables, respectively. Kaplan-Meyer survival analysis were performed to estimate the probability of maintaining the study-drug and Cox-regression analysis to evaluate predictors of discontinuation. Results. We enrolled 4343 patients: 3143 (72.4%) were males, with a median age of 49 years (IQR 41-55). Naïve patients were 733 (16.9%), of whom 168 (22.9%) AIDS-presenters. Overall, 2282 patients (52.5%) started DTG, 1426 (32.8%) RAL and 635 (14.7%) EVG. During 10032 PYFU, we observed 1278 discontinuations (13 per 100PYFU); 448 of them (35%) due to simplification and 355 (28%) to toxicities (98 for CNS toxicity). Reasons of discontinuation were different between INIs. Estimated probability of maintaining DTG at 3 and 4 years were 81.5% (95%CI 80.5-82.5) and 76.3% (95%CI 73.9-78.7), respectively; RAL 61.6% (95%CI 60.2-63.0) and 54.1% (95%CI 52.7-55.5); EVG 71.6% (95%CI 69.2-74.0) and 68.3% (95%CI 65.3-71.3) (p<0.001). At a multivariable analysis, being on a RAL-based ARV (vs DTG, aHR 2.9, 95%CI 2.3-3.6, p<0.001), a EVG-based ARV (vs DTG, aHR 1.3 95%CI 1.1-1.7, p=0.049) and a peak HIV-RNA>500k cp/mL (aHR 1.3, 95%CI 1.1-1.6, p=0.006) predicted INI discontinuation. Conclusions. Our data confirm the good tolerability of INIs in clinical practice. Differences emerge between the three drugs in reasons for discontinuation.File | Dimensione | Formato | |
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