IANUA: a regional project for the determination of costs in HIV-infected patients.

HIV treatment is based on combined antiretroviral therapy (cART) which has substantially improved survival, thus resulting in an increase in patient life expectancy as well as in the cost of HIV-related medical care. Therefore, several cost effectiveness studies were implemented worldwide, with one specifically in the Liguria region (Italy), to compare the annual economic expense in this area for HIV services, and the related improvement in patients' health. The IANUA project is intended to implement both cost-effectiveness and cost-utility analysis, therefore data related to clinical indicators and perceived health status were collected, the latter using a questionnaire based on the EQ-5D-3L. Information about the antiretroviral drugs and the relative quantity that a patient withdraws from the hospital pharmacy every month were extracted from the regional "F-file". All data gathered were stored in the Ligurian HIV Network, a web platform developed by the DIBRIS - Medinfo laboratory. More than eight hundred questionnaires were collected, and data will be elaborated by economists and psychologists. The first statistical elaborations showed that, as expected, costs increased as the number of therapeutic lines increased. Moreover, the average annual costs for patients whose last CD4 values were below 200 cells/mmc corresponded to the maximum expense recorded, however, the cost for patients with final CD4 counts above 500 cells/mmc was not, as expected, the lowest found. This can be explained by the fact that stabilized patients, who had CD4 values below 500 cells/mmc, did not need very expensive care, while patients with CD4 counts above 500 cells/mmc improved their health status thanks to cART.

Routine surveillance of adverse events following immunization as an important tool to monitor vaccine safety.

Post licensure surveillance of adverse events following immunization (AEFI) is a fundamental activity to improve safety and maintain public confidence in vaccines.   Since 2011, the Liguria Region has been involved in the inter-regional project of post-marketing surveillance of AEFI, coordinated by the Italian Medicine Agency and the Veneto region. The main objectives of the project are: (1) to coordinate the surveillance activities in the 8 Italian Regions included in the project; (2) to encourage the signal of AEFI by healthcare workers and patients; (3) to organize education activities addressed to health care workers, and, finally; (4) to establish vaccination counseling services in each Region. In particular, the Ligurian multidisciplinary team, composed by physicians expert in the field of vaccination and pharmacists, is involved in the causality assessment between vaccines and all adverse events signaled within the Liguria Region and in the analysis of all adverse events signaled in Italy as possibly related to influenza vaccines. During 2013, the team has organized 4 courses, addressed to healthcare personnel of vaccination outpatient clinics, focused on European and Italian legislation on pharmaco-vigilance and vaccine-vigilance and aimed at promoting signal of AEFI. Since October 2013, the Liguria Region has been participating to the inter-regional project of active surveillance of adverse events aimed at promoting the signal of AEFI by parents of vaccinated infants. After two years of implementation of the project both the number of reported AEFI and the reporting rate per 100 000 administered doses of vaccine increased. The activities need to be consolidated in the next years in order to guarantee high standard of vaccine safety, maintain the confidence in current immunization programs and reach optimal vaccination coverage rate.

Quality of life of people living with HIV, preliminary results from IANUA (Investigation on Antiretroviral Therapy) study.

INTRODUCTION: The introduction of combined antiretroviral treatment (cART) has reduced HIV-associated morbidity and mortality, and changed the patients' perspective of life. As a result, Health Related Quality of Life (HRQOL) has become a crucial clinical issue. OBJECTIVE: Assessment of HRQOL in a sample of Italian patients from IANUA study. Investigate correlation between CD4 cell counts, viral load and changes in HRQOL. MATERIALS AND METHODS: EQ-5D-3L self-reported questionnaire has been used in the evaluation of HRQOL. It assesses five dimensions: "mobility," "self care," "usual activities," "pain/discomfort" and "anxiety/depression." Each dimension has three levels: no problems, some problems and extreme problems. In addition, it includes a Visual Analogue Scale (VAS) where one's own health "today" is rated from 0 "worst imaginable health" to 100 "best imaginable health." The respondents provide information on marital status, education, employment/unemployment, other treatments used in addition to HAART (1,2,3,4,5 or more) and number of hospitalizations due to HIV/AIDS. RESULTS: 684 patients completed the questionnaire: 231 females and 453 males. The mean age of the sample was 51 years (range 21-78). The mean VAS score was 69.9. 558 patients (81.5%) reported no problems in mobility. 642 patients (93.5%) had no problems in self care. 423 patients (61.8%) had no pain/discomfort while 219 had some problems. 326 patients (46.1%) had some problems in anxiety/depression. CONCLUSIONS: The analysis of self-reported questionnaires indicates that HRQOL in our sample group is not deeply affected by HIV/AIDS. The dimensions that are affected in the least are "mobility" and "self care" while the major problem is "anxiety/depression" with half of the sample reporting moderate or high level.