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All patients signed consent forms to participate to the ICONA, in accordance with the ethical standards of the committee on human experimentation and the Helsinki Declaration (1983 revision).
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.
ICONA Foundation Study (ICONA) is a multicenter prospective observational study of HIV-1–infected patients, which was set up in 1997.
Eligible patients were those starting c ART when they were naive to antiretrovirals, regardless of the reason for which they had never been treated and the stage of the disease.
Kaplan–Meier (KM) curves were drawn using a marginal model approach such as follow-up of patients who discontinued for a reason different from that of interest was truncated at the date of last clinical follow-up (administrative censoring).
Overall cumulative risk of stopping was estimated using the KM method and all curves stratified by reason fore stopping were plotted on the same graph.Predictors of discontinuation were examined separately for all 3 endpoints.Kaplan–Meier analysis was used for the outcome discontinuation of ≥1 drug regardless of the reason.Men were 3197 (78.9%), mean age was 39 years (range: 32–47 years), 796 patients (19.6%) were 18–30 year old, 2562 (63.2%) were 31–50 years old and 694 (17.1%) were more than 50 old. Globally, protease inhibitor (PI)–containing regimens accounted for the 55.6% of the patients (n = 2252), non-nucleoside reverse transcriptase inhibitors–containing regimens were the first-line choice in 39.5% of the patients (n = 1601); in 199 patients (4.9%), integrase inhibitors and/or CCR5 inhibitors were the third drugs of combinations (raltegravir was used as part of 126 regimens).Looking at the NRTI backbone, in 3472 patients (85.7%), TDF/FTC was used; in 375 (9.2%) and 145 (3.6%), the backbone was represented by abacavir/lamivudine and zidovudine/lamivudine respectively.Discontinuation was defined as stop of at least 1 drug of the regimen, regardless of the reason.