Objectives: The aim of the present study was to compare the efficacy and durability of treatment switch to two-drug (2DR) vs. three-drug (3DR) integrase inhibitor (InSTI)-based regimens in a real-life setting. Methods: Within the ODOACRE cohort, we selected adult patients with HIV RNA < 50 copies/mL switching to an InSTI-based 2DR or 3DR. Survival analyses were performed to estimate the probability of virological failure (VF, defined as one HIV RNA > 1000 copies/mL or two consecutive HIV RNA > 50 copies/mL) and treatment discontinuation (TD, defined as any modification, intensification or interruption of the regimen), and to evaluate their predictors. Results: Overall, 1666 patients were included, of whom 1334 (80%) were treated with a 3DR (19.9%, 25.0% and 55.1% elvitegravir-, raltegravir- and dolutegravir-based, respectively) and 332 (20%) with a 2DR (79.2% dolutegravir + lamivudine and 20.8% dolutegravir + rilpivirine). Over a median (interquartile range) follow-up of 100 (52–150) weeks, 52 (3.1%) patients experienced VF with an incidence of 1.5/100 person-year of follow-up (PYFU). The estimated 96-week probability of VF was similar for the 2DR and 3DR groups (2.3% vs. 2.8%, P = 0.53), but it was higher for elvitegravir (4.9%) and raltegravir (5.0%) than for dolutegravir (1.5%) (P = 0.04). Four hundred (24%) patients discontinued their InSTI-based regimen, with an incidence of 11.3/100 PYFU. At 96 weeks, 3DRs showed a higher probability of TD for any reason (20.6% vs. 11.2%, P < 0.001) and TD for toxicity (9.0% vs. 6.6%, P = 0.02) when compared with 2DRs. A higher risk of TD for central nervous system toxicity was observed for dolutegravir than for elvitegravir and raltegravir (4.0% vs. 2.5% vs. 0.6%, P = 0.005). Conclusions: In virologically suppressed HIV-infected patients, 2DRs showed an efficacy similar to 3DRs but with better tolerability.

Fabbiani, M., Rossetti, B., Ciccullo, A., Oreni, L., Lagi, F., Celani, L., Colafigli, M., De Vito, A., Mazzitelli, M., Dusina, A., Durante, M., Montagnani, F., Rusconi, S., Capetti, A., Sterrantino, G., D'ettorre, G., Di Giambenedetto, S., Zanelli, G., Baldin, G., Borghetti, A., Latini, A., Mastroianni, C., Borghi, V., Mussini, C., Cossu, M. V., Giacomelli, A., Formenti, T., Trecarichi, E. M., Torti, C., Madeddu, G., Vecchiet, J., Vignale, F., Giacometti, A., Efficacy and durability of two- vs. three-drug integrase inhibitor-based regimens in virologically suppressed HIV-infected patients: Data from real-life ODOACRE cohort, <<HIV MEDICINE>>, 2021; 22 (9): 843-853. [doi:10.1111/hiv.13146] [http://hdl.handle.net/10807/193241]

Efficacy and durability of two- vs. three-drug integrase inhibitor-based regimens in virologically suppressed HIV-infected patients: Data from real-life ODOACRE cohort

Rossetti, B.;Colafigli, M.;De Vito, A.;Dusina, A.;Durante, M.;Di Giambenedetto, S.;Borghetti, A.;Mastroianni, C.;Trecarichi, E. M.;Torti, C.;
2021

Abstract

Objectives: The aim of the present study was to compare the efficacy and durability of treatment switch to two-drug (2DR) vs. three-drug (3DR) integrase inhibitor (InSTI)-based regimens in a real-life setting. Methods: Within the ODOACRE cohort, we selected adult patients with HIV RNA < 50 copies/mL switching to an InSTI-based 2DR or 3DR. Survival analyses were performed to estimate the probability of virological failure (VF, defined as one HIV RNA > 1000 copies/mL or two consecutive HIV RNA > 50 copies/mL) and treatment discontinuation (TD, defined as any modification, intensification or interruption of the regimen), and to evaluate their predictors. Results: Overall, 1666 patients were included, of whom 1334 (80%) were treated with a 3DR (19.9%, 25.0% and 55.1% elvitegravir-, raltegravir- and dolutegravir-based, respectively) and 332 (20%) with a 2DR (79.2% dolutegravir + lamivudine and 20.8% dolutegravir + rilpivirine). Over a median (interquartile range) follow-up of 100 (52–150) weeks, 52 (3.1%) patients experienced VF with an incidence of 1.5/100 person-year of follow-up (PYFU). The estimated 96-week probability of VF was similar for the 2DR and 3DR groups (2.3% vs. 2.8%, P = 0.53), but it was higher for elvitegravir (4.9%) and raltegravir (5.0%) than for dolutegravir (1.5%) (P = 0.04). Four hundred (24%) patients discontinued their InSTI-based regimen, with an incidence of 11.3/100 PYFU. At 96 weeks, 3DRs showed a higher probability of TD for any reason (20.6% vs. 11.2%, P < 0.001) and TD for toxicity (9.0% vs. 6.6%, P = 0.02) when compared with 2DRs. A higher risk of TD for central nervous system toxicity was observed for dolutegravir than for elvitegravir and raltegravir (4.0% vs. 2.5% vs. 0.6%, P = 0.005). Conclusions: In virologically suppressed HIV-infected patients, 2DRs showed an efficacy similar to 3DRs but with better tolerability.
Inglese
Fabbiani, M., Rossetti, B., Ciccullo, A., Oreni, L., Lagi, F., Celani, L., Colafigli, M., De Vito, A., Mazzitelli, M., Dusina, A., Durante, M., Montagnani, F., Rusconi, S., Capetti, A., Sterrantino, G., D'ettorre, G., Di Giambenedetto, S., Zanelli, G., Baldin, G., Borghetti, A., Latini, A., Mastroianni, C., Borghi, V., Mussini, C., Cossu, M. V., Giacomelli, A., Formenti, T., Trecarichi, E. M., Torti, C., Madeddu, G., Vecchiet, J., Vignale, F., Giacometti, A., Efficacy and durability of two- vs. three-drug integrase inhibitor-based regimens in virologically suppressed HIV-infected patients: Data from real-life ODOACRE cohort, <<HIV MEDICINE>>, 2021; 22 (9): 843-853. [doi:10.1111/hiv.13146] [http://hdl.handle.net/10807/193241]
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