Background There are no data comparing the response to PI/r-based regimens in people presenting for care with low CD4 counts or AIDS (LC). Aim To compare the response to LPV/r-, DRV/r- or ATV/r-based cART regimens in LC initiating cART from ART-naive. Methods We included people enrolled in Icona with either CD4 counts ≤350 cells/mm3 (low CD4-LC) or CD4 counts ≤200 cells/mm3 (very low CD4-VLC) and/or AIDS, starting their first PI/rbased regimen after 2008. Initial regimens were compared by intention-to-treat: i) time to viral failure (VF) (first of 2 consecutive VL>200 copies/mL after ≥6 months); II) time to PI/r discontinuation/switching for any cause (TD) and for toxicity (TDT); III) treatment failure (TF) (VF or TD). Kaplan-Meier and Cox analyses were used. Results 1,362 LC patients were included (DRV/r 607; ATV/r 552; LPV/r 203); 813 VLC. In a median of 18 months (IQR:7-35), the 1-year probability of VF and TF were 2.8% (1.9-3.8) and 21.1% (18.7-23.4). In the adjusted analysis, patients initiating ATV/r had a 53% lower chance, and those initiating DRV/r a 61% lower chance of TD, as compared to LPV/r; the risk of TF was more likely in people starting LPV/r. Results were similar among VLC; in this subgroup LPV/r including regimens demonstrated a lower chance of VF. Conclusions We confirmed in LC a low chance of virological failure by 1 year, with small differences according to PI/r. However, larger differences were observed when comparing longer-term endpoints such as treatment failure. These results are important for people presenting late for care.
D'Arminio Monforte, A., Cozzi Lepri, A., Maggiolo, F., Rizzardini, G., Manconi, P. E., Gianotti, N., Quirino, T., Pinnetti, C., Rusconi, S., De Luca, A., Antinori, A., Andreoni, M., Angarano, G., Castelli, F., Cauda, R., Di Perri, G., Galli, M., Iardino, R., Ippolito, G., Lazzarin, A., Perno, C. F., Von Schloesser, F., Viale, P., Castagna, A., Ceccherini Silberstein, F., Girardi, E., Lo Caputo, S., Mussini, C., Puoti, M., Ammassari, A., Balotta, C., Bandera, A., Bonfanti, P., Bonora, S., Borderi, M., Calcagno, A., Calza, L., Capobianchi, M. R., Cingolani, A., Cinque, P., Di Biagio, A., Gori, A., Guaraldi, G., Lapadula, G., Lichtner, M., Madeddu, G., Marchetti, G., Marcotullio, S., Monno, L., Nozza, S., Quiros Roldan, E., Rossotti, R., Santoro, M. M., Saracino, A., Zaccarelli, M., Fanti, I., Galli, L., Lorenzini, P., Rodano, A., Shanyinde, M., Tavelli, A., Carletti, F., Carrara, S., Di Caro, A., Graziano, S., Petrone, F., Prota, G., Quartu, S., Truffa, S., Giacometti, A., Costantini, A., Valeriani, C., Monno, L., Santoro, C., Suardi, C., Donati, V., Verucchi, G., Quiros Roldan, E., Minardi, C., Abeli, C., Piano, P., Cacopardo, B., Celesia, B., Vecchiet, J., Falasca, K., Sighinolfi, L., Segala, D., Mazzotta, F., Vichi, F., Cassola, G., Viscoli, C., Alessandrini, A., Bobbio, N., Mazzarello, G., Mastroianni, C., Belvisi, V., Caramma, I., Chiodera, A., Castelli, A. P., Puoti, M., Ridolfo, A. L., Piolini, R., Salpietro, S., Carenzi, L., Moioli, M. C., Tincati, C., Marchetti, G., Mussini, C., Puzzolante, C., Gori, A., Lapadula, G., Abrescia, N., Chirianni, A., Borgia, G., Di Martino, F., Maddaloni, L., Gentile, I., Orlando, R., Baldelli, F., Francisci, D., Parruti, G., Ursini, T., Magnani, G., Ursitti, M. A., Antinori, A., Vullo, V., Cristaudo, A., Cingolani, A., Baldin, G., Cicalini, S., Gallo, L., Nicastri, E., Acinapura, R., Capozzi, M., Libertone, R., Savinelli, S., Latini, A., Cecchetto, M., Viviani, F., Mura, M. S., Madeddu, G., Rossetti, B., Caramello, P., Orofino, G. C., Bonora, S., Sciandra, M., Bassetti, M., Londero, A., Pellizzer, G., Manfrin, V., Response to first-line ritonavir-boosted protease inhibitors (PI/r)-based regimens in HIV positive patients presenting to care with low CD4 counts: Data from the Icona Foundation Cohort, <<PLOS ONE>>, 2016; 11 (6): N/A-N/A. [doi:10.1371/journal.pone.0156360] [http://hdl.handle.net/10807/94873]
Response to first-line ritonavir-boosted protease inhibitors (PI/r)-based regimens in HIV positive patients presenting to care with low CD4 counts: Data from the Icona Foundation Cohort
De Luca, Andrea;Cauda, Roberto;Cingolani, Antonella;Fanti, Iuri;Baldin, Gianmaria;Rossetti, Barbara;
2016
Abstract
Background There are no data comparing the response to PI/r-based regimens in people presenting for care with low CD4 counts or AIDS (LC). Aim To compare the response to LPV/r-, DRV/r- or ATV/r-based cART regimens in LC initiating cART from ART-naive. Methods We included people enrolled in Icona with either CD4 counts ≤350 cells/mm3 (low CD4-LC) or CD4 counts ≤200 cells/mm3 (very low CD4-VLC) and/or AIDS, starting their first PI/rbased regimen after 2008. Initial regimens were compared by intention-to-treat: i) time to viral failure (VF) (first of 2 consecutive VL>200 copies/mL after ≥6 months); II) time to PI/r discontinuation/switching for any cause (TD) and for toxicity (TDT); III) treatment failure (TF) (VF or TD). Kaplan-Meier and Cox analyses were used. Results 1,362 LC patients were included (DRV/r 607; ATV/r 552; LPV/r 203); 813 VLC. In a median of 18 months (IQR:7-35), the 1-year probability of VF and TF were 2.8% (1.9-3.8) and 21.1% (18.7-23.4). In the adjusted analysis, patients initiating ATV/r had a 53% lower chance, and those initiating DRV/r a 61% lower chance of TD, as compared to LPV/r; the risk of TF was more likely in people starting LPV/r. Results were similar among VLC; in this subgroup LPV/r including regimens demonstrated a lower chance of VF. Conclusions We confirmed in LC a low chance of virological failure by 1 year, with small differences according to PI/r. However, larger differences were observed when comparing longer-term endpoints such as treatment failure. These results are important for people presenting late for care.
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