Viral suppression and immunological response in patients receiving maraviroc with and without concomitant raltegravir. Data at three and six months
R. Bucciardini1, V. Fragola1, L. Weimer1, D. Francisci2, L. Martinelli2, G. Guaraldi3, G. Angarano4, N. Ladisa4, R. Bellagamba5, C. Tommasi5, A. Degli Antoni6, G. Parruti7, A. Giacometti8, V. Vullo9, G. d'Ettorre9, F. Ortu10, M.S. Mura11, N. Petrosillo5, S. Cicalini5, O. Armignacco12, F. Ghinelli13, R. Del Gobbo14, D. Dionisio15, G. Verucchi16, L. Sarmati17, R. Libertone5, M. Floridia1
1Istituto Superiore di Sanità, Rome, Italy, 2Infectious Diseases Clinic - S. Maria della Misericordia, Perugia, Italy, 3University of Modena and Reggio Emilia, Modena, Italy, 4Infectious Diseases Clinic - University of Bari, Bari, Italy, 5Istituto Nazionale Malattie Infettive- Lazzaro- Spallanzani, Rome, Italy, 6Infectious Diseases Clinic - Ospedale Maggiore di Parma, Parma, Italy, 7Infectious Diseases Unit - ASL Pescara, Pescara, Italy, 8University of Ancona, Ancona, Italy, 9Infectious Diseases Unit- Sapienza University of Rome, Rome, Italy, 10Policlinico Universitario Cagliari, Cagliari, Italy, 11University of Sassari, Sassari, Italy, 12Infectious Diseases Unit - ASL Viterbo, Viterbo, Italy, 13Infectious Diseases Unit - Arcispedale S. Anna Ferrara, Ferrara, Italy, 14Infectious Diseases Unit - Ospedali Riuniti Ancona, Ancona, Italy, 15Infectious Diseases Unit - Ospedale Civile di Pistoia, Pistoia, Italy, 16Ospedale Policlinico S. Orsola Bologna, Bologna, Italy, 17Infectious Diseases Tor Vergata University, Rome, Italy
Background: There is currently limited information on the combined use of maraviroc and raltegravir in patients harboring a CCR5 HIV phenotype.
Methods: We here report preliminary data from the ISS-NIA Italian open cohort study, enrolling HIV-infected patients with triple-class (PI, NRTI, NNRTI) experience who start a new-class regimen based on CCR5 antagonists and/or integrase inhibitors. We here considered patients with a CCR5 HIV phenotype who received maraviroc (MAR) with/without concomitant raltegravir (RAL).
Results: As of January 2010, 44 patients had started MAR-RAL and 25 MAR. There were no significant baseline differences between groups with respect to demographic and clinical data. Median previous exposure to antiretroviral treatment was 12 years; most of the patients (MAR 64%, MAR-RAL 82%) carried multiresistant (NRTI, NNRTI and IP) HIV at the start of the new drugs. At baseline, the two groups had similar median CD4 counts (MAR 267, MAR-RAL 236), and similar proportions of undetectable (< = 50 copies/ml) plasma HIV-RNA (17% MAR, 14% MAR-RAL). All patients in the RAL-MAR group and 84% of patients in the MAR group had at least two active drugs in the baseline regimen.Follow-up data indicate a more frequent viral suppression among patients in the MAR-RAL group at both 3 (MAR 9/16 (56%), RAL-MAR 30/32 (94%), p=0.004) and 6 months (MAR 10/15 (67%), RAL-MAR 22/25 (88%), p=0.219). No statistically significant differences between groups in terms of median CD4 change from baseline at three months (MAR: 79, MAR-RAL:105) and at six months (92, in both groups) were observed.
Conclusions: Preliminary results indicate that raltegravir added to maraviroc may produce a more rapid and frequent viral suppression. This finding is likely to be due to the virological benefit (no underlying class-resistance expected) provided by adding an entirely new class to the new regimen. Follow up is ongoing to confirm this finding.
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