title: Effectiveness, safety, durability and immune recovery in a retrospective, multicentre, observational cohort of ART-experienced, HIV-1-infected patients receiving maraviroc.
abstract: The aim of this retrospective, multicentre, observational study was to assess the durability, safety, immune recovery and effectiveness on viral suppression of antiretroviral therapy (ART) in a maraviroc (MVC)-based cohort. We collected clinical, demographical, immunological and virological parameters of adult HIV patients who were infected by CCR5-tropic virus and started an ART regimen containing MVC from 2005 to 2012. We created a longitudinal mixed model to assess the change over time of data. We enrolled 126 drug-experienced patients; the median duration of MVC treatment was 25 months. The probability of stopping ART at one year was 13.3%, and at three years was 27.3%. Statistically significant changes were observed for CD4+ cell count increase ( p < 0.001), HIV-RNA decrease ( p < 0.001) and total cholesterol decrease ( p = 0.005). Ninety-four patients (79.7%) had CD4 ≥ 200 cells/mm3at baseline while nine of them reached this threshold at nine months (7.6%), 17 (13%) after nine months and six (5%) remained below 200 cells/mm3at the end of the study. Overall, 114 patients (90.5%) achieved an HIV-RNA ≤ 50 cp/ml. A majority of patients maintained CD4 cell counts of ≥ 200 cells/mm3and achieved an undetectable HIV viral load within three months. MVC-containing regimens are safe and appear to be a feasible therapeutic option for ART.
authors.affiliation: 1 Infectious Diseases Department, Sanremo Hospital, Sanremo, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Dentone
authors.affiliation: 2 Infectious and Tropical Diseases Department, Careggi Hospital, University of Florence, Florence, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Sterrantino
authors.affiliation: 3 Department of Health Sciences (DISSAL), Section of Biostatistics, University of Genoa, Genoa, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Signori
authors.affiliation: 4 Infectious Diseases Department, Galliera Hospital, Genoa, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Cenderello
authors.affiliation: 5 Infectious Diseases Department, La Spezia Hospital, La Spezia, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Guerra
authors.affiliation: 6 Infectious Diseases Department, San Paolo Hospital, Savona, Italy.
authors.forename: P
authors.initials: P
authors.lastname: De Leo
authors.affiliation: 7 Infectious Diseases Department, Albenga Hospital, Albenga, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Bartolacci
authors.affiliation: 8 Infectious Diseases Department, SS. Antonio, Biagio, Cesare Arrigo Hospital, Alessandria, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Mantia
authors.affiliation: 9 Infectious Diseases Department, Amedeo di Savoia Hospital, Turin, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Orofino
authors.affiliation: 10 Department of Informatics, Bioengineering, Robotic and System Engineering (DIBRIS), University of Genoa, Genoa, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Giacomini
authors.affiliation: 11 DISSAL, Section of Virology, University of Genoa, Genoa, Italy.
authors.forename: B
authors.initials: B
authors.lastname: Bruzzone
authors.affiliation: 12 Infectious Diseases Department, University of Perugia, Perugia, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Francisci
authors.affiliation: 13 Infectious Diseases Department, IRCCS San Martino Hospital, Genoa, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Di Biagio
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000494:pharmacology / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D065100:CCR5 Receptor Antagonists / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D003510:Cyclohexanes / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D015497:HIV-1 / Q000187:drug effects*; D006801:Humans; D008297:Male; D000077592:Maraviroc; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D014230:Triazoles / Q000494:pharmacology / Q000627:therapeutic use*; D019562:Viral Load / Q000187:drug effects*
chemical_list: D019380:Anti-HIV Agents; D065100:CCR5 Receptor Antagonists; D003510:Cyclohexanes; D014230:Triazoles; D000077592:Maraviroc
keywords: AIDS; HIV; Maraviroc; antiretroviral therapy; clinical practice; safety