Drop in CD4+ Counts Below 200 Cells/μL After Reaching (or Starting From) Values Higher than 350 Cells/μL in HIV-Infected Patients With Virological Suppression

Gianotti, N.; Marchetti, G.; Antinori, A.; Saracino, A.; Gori, A.; Rizzardini, G.; Lichtner, M.; Bandera, A.; Mussini, C.; Girardi, E.; Monforte, A. A.; Cozzi-Lepri, A.; D'Arminio Monforte, 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.; Lo Caputo, S.; Puoti, M.; Ammassari, A.; Balotta, C.; Bonfanti, P.; Bonora, S.; Borderi, M.; Calcagno, A.; Calza, L.; Capobianchi, M. R.; Cingolani, A.; Cinque, P.; De Luca, A.; Di Biagio, A.; Monforte, G.; Guaraldi, G.; Lapadula, G.; Madeddu, G.; Maggiolo, F.; Marcotullio, S.; Monno, L.; Nozza, S.; Quiros Roldan, E.; Rossotti, R.; Rusconi, S.; Santoro, M. M.; 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.; Santoro, C.; Suardi, C.; Donati, V.; Verucchi, G.; Minardi, C.; Quirino, T.; Abeli, C.; Manconi, P. E.; 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.; Ridolfo, A. L.; Piolini, R.; Salpietro, S.; Carenzi, L.; Moioli, M. C.; Tincati, C.; Puzzolante, C.; Lanon, L.; 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.; Vullo, V.; Cristaudo, 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.; Rossetti, B.; Caramello, P.; Orofino, G. C.; Sciandra, M.; Bassetti, M.; Londero, A.; Pellizzer, G.; Manfrin, V.

doi:10.1097/QAI.0000000000001522

Background: The aim of the study was to quantify the risk of a drop in CD4+ counts below 200 cells/mL after reaching values >350 cells/mL on antiretroviral therapy (ART) (or after starting ART with CD4+ count >350 cells/mL) in the absence of virological failure. Setting: Ambulatory care services, Italy. Methods: Prospective cohort study of patients enrolled in the ICONA Foundation Study cohort who started ART with >350 CD4+/μL or with ≤350 CD4+/μL and reached values >350 cells/μL after virological suppression (VS, defined by 2 consecutive viral loads ≤50 copies/mL). The date of CD4 count >350 was the baseline for the analysis and those with ≥1 viral load and CD4+ count after baseline were included. The primary end point was the cumulative risk (estimated using the Kaplan-Meier method) of a CD4+ drop below 200 cells/μL over follow-up, which was censored at the date of virological failure (confirmed HIV-RNA >50 copies/mL), death, or last visit. Results: Six thousand six hundred sixty-three patients were included. A confirmed CD4+ drop below 200 cells/μL was never observed over a median follow-up of 45 (Q1: 21, Q3: 89) months, as long as VS was maintained. Upper limits of the 97.5% confidence interval of rates of confirmed CD4+ drop below 200 cells/μL were 0.28 and 0.38/1000 person-years of follow-up for patients with ≤350 and >350 CD4+ cells/μL at starting ART. Conclusions: In patients who started ART in Italy with >350 CD4+ cells/μL or reached >350 CD4+ cells/μL after VS, the risk of a CD4+ drop below 200 cells/μL in those maintaining VS was negligible.