ICONA Cohort

Introduction

The project currently being promoted by the Icona Foundation was born as a direct follow-up of the Icona study. The Icona study began in 1997 as an observational study conducted on a wide cohort of HIVpositive individuals. It is a study that incorporates various innovative elements. The Icona survey consists of more than 20,500 HIV-positive individuals enrolled between April 1, 1997 and December 16, 2006 by the 71 Centres operating throughout Italy and coordinated by 6 University Centres. The only eligibility criterion for participants was that they must never have taken antiretroviral medication. Icona was therefore born as a national cohort of subjects who were “naïve” to antiretroviral therapy.

ICONA, a unique cohort in the world

Today Icona joins other prestigious European and American cohorts, with whom it collaborates on international research projects and represents the first wide-scale, multi-centre study experience based on the use of an IT network fuelled by and accessible to both basic research groups and clinical practices. Icona stands apart as the only cohort in the world capable of supplying reliable data on the impact of initial treatments on epidemiological, clinical, biological, and behavioral parameters:

• For the amount and type of HIV-positive individuals: more than 20,500 antiretroviral naive patients at the beginning of the observation period
• For the length of the observation period: 27 years (1997-2023)
• For considering all aspects of HIV-positive individuals and lifestyles: this cohort is evaluated not only for drug effectiveness and tolerability, but also for issues related to being HIV-positive and the environment with which HIV-positive individuals interact
• For the biological samples bank: 90,000 plasma samples and 25,000 cell samples.

In the end, ICONA is an example of a successful collaboration between private industry and public bodies with the objective of:

• promoting scientific research
• improving clinical practice
• identifying the overall needs of HIV-positive individuals

ICONA, the confirmation of scientific leadership

The results obtained in the first decade of activities in terms of scientific publications, nested studies, communications at international conferences, and collaborations with other international cohorts (Eurosida, D:A:D, ART COHORT, Plato, RDI) confirm the scientific leadership of the project and the potential of Italian infectivology.

Publications

• 171 scientific publications in international journals
• 354 abstracts at international conferences

Principal nested studies

• BEHEPI, coordinator E. Girardi
• AdICoNA, coordinator A. Antinori
• LipoICoNA, coordinator M.Galli
• HepaICoNA, coordinator M. Puoti

Up until today, the Icona project has made it possible to obtain information on:

• Analyses on the progress of the HIV infection from the beginning of treatment with antiretroviral medications prescribed according to Centre indications;
• Frequency and motivation for the withdrawal of the first antiretroviral drug treatment;
• Methods of access to antiretroviral therapies in relation to behavioral and clinical variables;
• Adherence to antiretroviral therapies in relation to demographic, behavioral, and clinical variables;
• The frequency of HIV mutants resistant to antiretroviral drugs in the naïve population that must begin an antiretroviral treatment, and predictability of same on the virological outcome of the treatment.
• The role of ancillary mutations of the pol gene in the modulation of drug-resistance and in influencing the therapeutic response.
• The identification of clinical, therapeutic, and genetic factors that determine the metabolic toxicity of medications and lipodystrophy.
• Collaboration with the D:A:D: study, promoted by the EMEA, together with other international cohorts, with the objective of verifying the risk of cardiovascular events over the course of antiretroviral therapy on more than 15,000 patients.