Background: There is very less information on the use of antiretroviral (ARV) drugs and viro-immunological outcome over calendar years in Italy. Patients and Methods: We performed an analysis of a prospective observational cohort (MASTER) to assess antiretroviral drug use in first tine HAART and explore whether initial treatment response changed over the years. Results: 3,648 ARV-naive patients with available HIV-RNA and CD4+ T cell count at baseline who started their first HAART between 1997 and 2004 were studied. Mean age was 37.7 years; they were mostly mates (72.3%) and Italians (81.4%). Prescription of non-nucleoside reverse transcriptase inhibitors and protease inhibitors boosted with ritonavir rose from 0.3% in 1997 to 58% in 2004 and from 0.3% in 1997 to 33.4% in 2004, respectively. Virological failures decreased over calendar years: from 42.9% in 1997 to 8.1% in 2004 after 6 months of HAART (p < 0.001); from 42.1% (1997) to 10.7% (2004) after 12 months (p < 0.001) and; from 39.5% (1997) to 8.2% (2004) after 18 months (p < 0.001). The same trend, but less striking, was found for immunological failure rates. Conclusions: In the general Italian population of HIV-positive patients, evolution of treatment prescription correlated with improved viro-immunological outcome.
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