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Correspondence to: Antonio Di Biagio, MD, or Roberta Prinapori, MD, Infectious Diseases Unit, IRCCS A. O San Martino-IST, University of Genoa (DISSAL), Largo R.
ICONA Foundation Study (ICONA) is a multicenter prospective observational study of HIV-1–infected patients, which was set up in 1997.
We used a cause-specific hazard approach as our main analysis and the Fine–Gray approach as an alternative analysis with the objective of prediction (see Table S1, S2, S3, Supplemental Digital Content, Rates and reasons for discontinuation or modifications of the first-line c ART regimens have been investigated in a number of recent studies8–17 in which it has been underlined how discontinuation of initial therapy has decreased over time, but is still quite high even for the latest drug combinations.16 Data updated from the Italian Cohort of Antiretroviral-Naive Patients (ICONA) on 2008 highlighted a 1-year probability of first c ART stopping of 36.1%; moreover, it has been noticed that the incidence of discontinuation because of intolerance/toxicity has declined over time, whereas simplification strategies have become more frequent in recent years.11 The latest advances in refinement of c ART strategies, regarding both new drugs and fixed dose formulations, have led to reconsider and change current guidelines for first antiretroviral regimens in naive patients,18 as has already happened for multiple other drugs in the past years.19Furthermore, evaluations of the prevalence and predictors of initial c ART discontinuation have demonstrated that certain patients are more likely to discontinue treatment.20–22 For this reason, identifying groups at increased risk of c ART discontinuation could support clinicians in the choice and optimization of first-line therapy for the individual patient.The aims of this analysis were (1) to estimate the frequency and causes of discontinuation of treatment regimens initiated in very recent years in HIV-infected patients seen for care in Italy and (2) to evaluate factors associated with treatment discontinuation.Three main discontinuation endpoints have been considered: (1) because of toxicity, (2) intolerance, and (3) simplification.These have been decided a priori as likely to be the 3 main reasons for stopping drugs in the modern era of c ART, as previously shown.11 Potential predictors of the risk of stopping, which have been examined separately for all 3 endpoints, included: sex, mode of HIV transmission, nationality (an immigrant patient was considered a patient born outside Italy), AIDS diagnosis, cardiovascular disease diagnosis, hepatitis B and C diagnosis, calendar year of baseline, age, lymphocyte T CD4 cell count, HIV-RNA plasma level, diabetes, total cholesterol, and high-density lipoproteins cholesterol (categorical variable, above and below 40 mg/d L for men and 50 mg/d L for women), use of statins, use of blood pressure lowering drugs, time from HIV diagnosis to date of starting c ART, estimated glomerular filtration rate, blood glucose, third drug and backbone combined in the regimen, mental health disorders.