nt was 18 and the oldest 75 years old. Median CD4+ T-cell count at the time of HAART initiation was 77 cells/l and 56% of the patients had already experienced one or more AIDS-defining illnesses before study baseline. After 1 year of treatment, median CD4+ counts had increased to 286 cells/ l, but 319 patients had a CD4+ count below 200 cells/l and were, therefore, classified as INR. Characteristics of the patients, overall and stratified by immunological response after 1 year of treatment, are shown in Predictors of immunological non-response Applying a logistic regression model adjusted for age and gender, the following factors were associated with a higher risk of INR after 1 year of treatment: older age, intravenous drug use as HIV route of infection, hepatitis C co-infection, previous AIDS event and use of single PI-based HAART. Conversely, initiating HAART in latest years and higher pre-HAART CD4+ T-cell counts were associated with lower risk of INR. In multivariable logistic regression models, older age, IVDU route of infection and pre-HAART CD4+ T-cell count were significantly associated with INR after 1 year of treatment, after adjustment for each other and for gender, history of previous AIDS-defining events, calendar year at treatment initiation and type of HAART initiated. The association between hepatitis C seroreactivity and a higher risk of INR was confirmed in a separate multivariable logistic regression model not including risk factor for HIV acquisition. Events description Overall 1620 clinical events were observed since 1 year before HAART initiation: 983 before HAART, 399 INK-128 during the first year of treatment and 238 during the subsequent follow-up. Full description of all observed events is included in S1 5 / 15 Risk of PubMed ID:http://www.ncbi.nlm.nih.gov/pubmed/19776696 Severe Non-AIDS Events among Immunological Non-Responders List of abbreviations: AIDS, acquired immunodeficiency syndrome; HAART, highly-active antiretroviral treatment; HBsAg, hepatitis B surface antigen; HCV-Ab, hepatitis C virus PubMed ID:http://www.ncbi.nlm.nih.gov/pubmed/19777456 antibodies; HIV, human immunodeficiency virus; INR, immunological non-responders; IQR, interquartile range; IR, Immunological responders; NNRTI, non-nucleoside reverse transcriptase inhibitor; PI, protease inhibitor. List of abbreviations: AIDS, acquired immunodeficiency syndrome; HAART, Highly-active antiretroviral therapy. Due to high correlation between IVDU and hepatitis C serostatus, only IVDU was included in a second multivariate Cox model, where adjustments for all factors significantly associated with the outcome in the previous model and those considered to be clinically significant were included. In this analysis, the following factors were significantly and independently associated with a higher risk of nADE: immunological response at year 1, older age, previous serious nADE and occurrence of AIDS defining event during the follow-up. The association between hepatitis C serostatus and increasing risk of severe nADE was confirmed in a separate multivariable model, not including risk factor for HIV acquisition. When CD4+ percentage change after 1 year of HAART was considered in a model including immunological response at year 1, higher CD4+ increases were only marginally associated with lower risk of nADE. Results of Cox proportional hazard models are shown in 8 / 15 Risk of Severe Non-AIDS Events among Immunological Non-Responders List of abbreviations: AIDS, acquired immunodeficiency syndrome; CI, confidence interval; HAART, highlyactive antiretroviral treatment; H
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