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E.G. has received honoraria for presentation at workshops, or travel grants from Abbott, Bristol-Myers Squibb, Boheringer Ingelheim; A.G. received honoraria for presentation at workshops, or travel grants from Abbott, Bristol-Myers Squibb, Gilead, Pfizer, GlaxoSmithKline, ViiV Health Care; M.Ar. has received honorarium for expert opinion from Bristol-Myers Squibb and an unrestricted educational grant from Pfizer; M.An. has received honoraria for presentation at workshops, advisory board or research grants from Abbott, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen-Cilag, Merck, Pfizer, ViiV HealthCare; A.d'A.M has received honoraria for presentation at workshops, advisory board or research grants form Abbott, Bristol-Myers Squibb, Janssen-Cilag, Pfizer, Gilead; A.A. has received honoraria for presentation at workshops, consultancy and advisory board, or research grants from Abbott, Bristol-Myers Squibb, Gilead, GlaxoSmithKline, Janssen-Cilag, Merck, Pfizer, ViiV HealthCare. A.C. has received honoraria for presentation at workshops, consultancy and advisory board, or research grants from Abbott, Boehringer-Inghelheim, Bristol Myers Squibb, Gilead Sciences, Glaxo-Smith Kline, Merck, Pfizer, Roche, and Tibotec (Johnson & Johnson). P.S., C.A.,G.M., D.B., G.I. declare that they have no conflict of interest.
EG designed the study and drafted the manuscript. PS participated in the design of the study and drafted the manuscript. CA performed the statistical analysis and contributed with writing the manuscript. AG; DB; MA; GM; AC; A d'AM; AA; GI contributed with national coordination, data collection, and revised critically the manuscript. All authors have read and approved the final manuscript.
Identification of the determinants of access to investigational drugs is important to promote equity and scientific validity in clinical research. We aimed to analyze factors associated with the use of experimental antiretrovirals in Italy.
We studied participants in the Italian Cohort of Antiretroviral-Naive Patients (ICoNA). All patients 18 years or older who had started cART (≥ 3 drugs including at least two NRTI) after their enrolment and during 1997-2007 were included in this analysis. We performed a random effect logistic regression analysis to take into account clustering observations within clinical units. The outcome variable was the use of an experimental antiretroviral, defined as an antiretroviral started before commercial availability, in any episode of therapy initiation/change. Use of an experimental antiretroviral obtained through a clinical trial or an expanded access program (EAP) was also analyzed separately.
A total of 9,441 episodes of therapy initiation/change were analyzed in 3,752 patients. 392 episodes (360 patients) involved an experimental antiretroviral. In multivariable analysis, factors associated with the overall use of experimental antiretrovirals were: number of experienced drugs (≥ 8 drugs versus "naive": adjusted odds ratio [AOR] = 3.71) or failed antiretrovirals(3-4 drugs and ≥ 5 drugs versus 0-2 drugs: AOR = 1.42 and 2.38 respectively); calendar year (AOR = 0.80 per year) and plasma HIV-RNA copies/ml at therapy change (≥ 4 log versus < 2 log: AOR = 1.55). The probability of taking an experimental antiretroviral through a trial was significantly lower for patients suffering from liver co-morbidity(AOR = 0.65) and for those who experienced 3-4 drugs (vs naive) (AOR = 0.55), while it increased for multi-treated patients(AOR = 2.60). The probability to start an experimental antiretroviral trough an EAP progressively increased with the increasing number of experienced and of failed drugs and also increased for patients with liver co-morbidity (AOR = 1.44; p = 0.053). and for male homosexuals (vs heterosexuals: AOR = 1.67). Variability of the random effect associated to clinical units was statistically significant (p < 0.001) although no association was found with specific characteristics of clinical unit examined.
Among patients with HIV infection in Italy, access to experimental antiretrovirals seems to be influenced mainly by exhaustion of treatment options and not by socio-demographic factors.