People diagnosed with HIV and in care in Italy in 2014: results from the second national survey.

We conducted a second National survey in all Italian Infectious Disease clinics to assess the number of people diagnosed and linked to care and, among these, the number of people on antiretroviral therapy and viral load suppressed. In 2014, 100,049 (0.16 per 100 residents) people diagnosed and linked to care were estimated, corresponding to an increase of 6.3% compared to the survey conducted in 2012. Among people diagnosed and linked to care, 91.9% were on antiretroviral therapy (increase of 11.4% compared to 2012), and among these, 87.7% were viral load suppressed. Overall, the majority were males (72.1%), Italians (82.7%), aged 25-49 years (45.6%); the most common HIV mode of transmission was reported to be in heterosexual contact (37.9%) and men who had sex with men (31.3%); 8.8% had less than 350 CD4 cells/µL, 82.4% had VL <50 copies and 22.9% had a CDC stage C. In conclusion, the number of people diagnosed and linked to care was increasing. The vast majority of them was receiving ART but the percentage of people still with a detectable viral load was lower than the 90-90-90 WHO target.

HIV avidity index performance using a modified fourth-generation immunoassay to detect recent HIV infections.

BACKGROUND: Detecting recent HIV infections is important to evaluate incidence and monitor epidemic trends. We aimed to evaluate the diagnostic performance and accuracy of the avidity index (AI) for discriminating for recent HIV infections. METHODS: We collected serum samples from HIV-1 positive individuals: A) with known date of infection (midpoint in time between last HIV-negative and first HIV-positive test); B) infected for >1 year. Samples were divided into two aliquots: one diluted with phosphate buffered saline (PBS) and the other with 1 M guanidine. Both aliquots were assayed by the Architect HIV Ag/Ab Combo 4th generation assay (Abbott). We compared AI found in recent (RI=<6 months from seroconversion) and established (EI) infections. The diagnostic accuracy was evaluated by receiver operating characteristic (ROC) curve analysis. The proportion of samples misclassified as recent (FRR) was calculated. RESULTS: In total, 647 samples were collected: 455 in group A (51.6% RI and 48.4% EI) and 192 in group B. Among these, sixteen samples were from elite controllers, 294 from treated patients, 328 from patients infected with non-B subtypes. Samples before antiretroviral initiation showed a mean AI significantly lower among RI compared to EI (0.66+0.28 vs. 1.00±0.12; p<0.000). The FRR was 0% using a cut-off of ≤0.70. An extremely low FRR was observed among elite controllers, samples with low VL or CD4. HIV subtype had no impact on AI misclassifications. All individuals in group A reached the AI threshold of 0.80 within 24 months after seroconversion. CONCLUSIONS: The AI is an accurate serological marker for discriminating recent from established HIV infections and meets WHO requirements for HIV incidence assays.

A screening method for the quantitative determination of selective androgen receptor modulators (SARMs) in capsules by high resolution 19F- and 1H-NMR spectroscopy.

A new method for rapid determination of the content of selective androgenic receptor modulators (SARMs) andarine, cardarine, ligandrol, ostarine and S-23 in capsules by 1H- and 19F-high resolution nuclear magnetic resonance spectroscopy was described and validated. Specificity, linearity, accuracy, precision, detection and quantification limits were considered as validation parameters. Full 1H-, 13C- and 19F-NMR structural assignment of the SARMs is provided as a tool for self-standing identification without a reference standard. Amounts of 7-15 mg of SARMs/capsule were detected in different products with an intermediate precision of 0.8-1.7% in 4 to 20 minutes of analysis time. The validation results and rapidity of analysis confirm the applicability of the method for large-scale screening. The statistical analysis of the results from 19F- and 1H-quantitative NMR showed that both approaches were equally effective, thus expanding the potential use of the methodology to non-fluorinated SARMs. At present, no SARM has been approved for human consumption; however, SARMs are actually used by bodybuilders and recreational athletes, who purchase them even though the risk-benefit ratio of these molecules has not been definitively established.

Illegal products containing selective androgen receptor modulators purchased online from Italy: health risks for consumers.

Background: Selective androgen receptor modulators (SARMs) are small synthetic drug molecules that are still not approved as medicine in Europe or the United States but are sold on illegal websites to improve sport performance, particularly bodybuilding. Aim: To address the quality issues of illegal SARM products and their increasing diffusion in Italy with their potential health risks for consumers. Methods: Web-based tools were used to investigate retail websites, trending searches, and information exchange via social media. Thirteen SARM products, purchased on retail websites accessible from Italy, were subject to visual inspection and chemical analysis by mass spectrometry and quantitative nuclear magnetic resonance. Outcomes: The primary outcome was demonstration of additional health risks due to the illicit presence of other active ingredients, contamination, and misdosage in SARM products sold on the internet. The secondary outcome was to show the increasing trend of interest in Italy for these products. Results: Most websites reported misleading information; specifically, the statement "for research only" was reported notwithstanding indications on dosage and training phases. The trending search showed that interest toward SARMs increased in Italy in the last years. The use of these products is clearly encouraged by the emerging phenomenon of "broscience" as revealed in socials. Visual inspection evidenced nonconform labeling. Qualitative analysis confirmed the presence of the stated SARM in about 70% of samples. In 23% of samples, the expected SARM was not detected but a different one instead, and in 1 sample, no SARMs were detected. Other undeclared pharmaceutical substances (tamoxifen, clomifene, testosterone, epimethandienone, tadalafil) were measured in 30% of samples. The copresence of >1 active substance was observed in >60% of samples. Quantitative nuclear magnetic resonance data showed nonuniform content ranging from 30% to 90% of the label claim. Clinical Implications: The use of SARMs, in the presence of unexpected life-threatening reactions in persons using the products to increase sport performance, should be assessed. Strengths and Limitations: This investigation involved an integrated approach to study SARM products and related sociologic aspects. The main shortcomings are the limited number of samples and retail websites in the clear web investigated. Conclusion: SARMs sold online as food supplement-like products represent a health hazard due to the presence of unapproved and undeclared active substances. The presence of contaminants clearly indicates the absence of good manufacturing practices in the production, which increases the health risks.

Investigating the Effectiveness of a Carb-Free Oloproteic Diet in Fibromyalgia Treatment.

Fibromyalgia (FM), a chronic disease with a high incidence in women, poses a significant challenge for diagnosis and treatment, especially due to the absence of specific biomarkers and the multifaceted nature of its symptoms, which range from neuromuscular pain to mood disorders and intestinal dysbiosis. While diagnosis currently relies on rheumatological clinical evaluations and treatment options mainly focus on symptom management, FM seems to have possible links with systemic metabolic dysfunctions with a common inflammatory root. In this context, a new therapeutic avenue emerges: could a therapeutic nutritional approach be the missing piece of the puzzle? Indeed, diet therapies employed particularly for metabolic syndromes proved recently to be efficacious for correcting systemic dysmetabolism and a high number of chronic inflammation conditions. In particular, the very-low-calorie ketogenic diet (VLCKD) demonstrated therapeutic benefits in many disorders. In the present study, we aimed to investigate the specific effects of two dietary interventions, namely the oloproteic VLCKD and the low-glycemic insulinemic (LOGI) diet, on two groups of female FM patients (FM1 and FM2) over a 45-day period. Utilizing clinical and laboratory tests, as well as non-invasive NMR metabolomic analysis of serum, urine, and saliva samples, we sought to uncover how these dietary regimens impact the metabolic dysfunctions associated with FM.

Late presenters among persons with a new HIV diagnosis in Italy, 2010-2011.

BACKGROUND: In Western Europe, about 50% of newly diagnosed HIV-positive individuals are diagnosed at a late stage disease and enter in care late (i.e. with a CD4 count ≤350 µL/µL). The aim of the present study is to analyze the characteristics and the factors associated with being diagnosed late or at an advanced stage of disease among persons with a new HIV diagnosis in Italy, in the period 2010-2011. METHODS: We used individual data on new HIV diagnoses reported by the HIV surveillance system in 2010 and in 2011. Persons with CD4 ≤350 cells/µL or diagnosed with AIDS (regardless of the CD4 cell count) were defined as late presenters (LP); persons with CD4 ≤ 200 cells/µL or AIDS (regardless of the CD4 cell count) were defined as presenting with advanced HIV disease (AHD). RESULTS: Of the 7,300 new diagnoses reported in 2010-2011 by the included regions, 55.2% were LP; among these, 37.9% was diagnosed with AIDS. Persons presenting with AHD were 37.8%. The median age of LP was 40 years (IQR 33-48), significantly higher (p < 0.001) than that of non-LP (35 years); 73.9% were males; 30.7% were non-nationals. The median age of AHD was 42 years (IQR 35-50), 74.5% were males; 31.1% were non-nationals. The proportion of LP among IDUs was 59.8%, among heterosexuals (HET) 61.1% and among MSM 44.3%. The proportion of AHD among IDUs was 43.6%, among HET 43.2% and among MSM 27.4%. Factors significantly associated with being LP were: age older than 50 years (OR = 4.6 [95% CI 3.8-5.6]); having been diagnosed in Southern Italy (Southern vs Northern Italy OR = 1.5 [95% CI 1.3-1.7]) having been diagnosed in Central Italy (Central vs Northern Italy OR = 1.3 [95% CI 1.1-1.6]); being HET (HET vs MSM, OR = 1.7 [95% CI 1.5-2.0]), being non-national (Non-national vs Italian, OR 1.7 (95% CI 1.5-2.0); being IDU (IDU vs MSM, OR = 1.6 [95% CI 1.2-2.1]). The same factors were significantly associated with being AHD. CONCLUSIONS: Older people, people diagnosed in Central and Southern Italy, non nationals, and persons who acquired the infection through injecting drug use or heterosexual contact showed a higher risk of being diagnosed late. A more active offer of HIV testing and targeted interventions focussed on these populations are needed to optimize early access to care and treatment.

AIDS patients with tuberculosis: characteristics and trend of cases reported to the National AIDS Registry in Italy--1993-2010.

BACKGROUND: The co-infection of tuberculosis (TB) and human immunodeficiency virus (HIV) continue to be a severe problem in the European region. We estimated the extent of this phenomenon in Italy, describing and analysing the characteristics of persons with acquired immune deficiency syndrome (AIDS) and TB reported to the National AIDS Registry. METHODS: We analysed the cases of TB reported to the National AIDS Registry in Italy since 1993, the year in which TB was introduced as an AIDS-defining disease. RESULTS: From 1993 to 2010, 45,403 cases of AIDS were reported; among these, 4075 (8.9%) had TB (any location). Since 1993, there has been a progressive increase in the proportion of persons with TB, from 6.8% in 1993 to 11.0% in 2010. Men accounted for 76.3%; the median age at diagnosis was 35 years (interquartile range: 31-42 years), and 34.1% were non-nationals. Compared with AIDS cases without TB, AIDS cases with TB were significantly associated with young age (≤33 years), being non-Italian, having heterosexual contacts, living in the south of Italy, being a late tester and being alive at the time of data analysis. The proportion of non-nationals increased from 10.8% in 1993 to 64.6% in 2010. The incidence of AIDS and TB among non-nationals for the whole study period was 2.97 cases per 100,000 non-nationals, compared with 0.11 cases per 100,000 Italians. CONCLUSION: These data suggest that the occurrence of TB among persons with AIDS is also increasing in Italy, with an increasing proportion of non-nationals, and emphasize the need to undergo HIV screening for all persons diagnosed with TB.

A NIR, 1H-NMR, LC-MS and chemometrics pilot study on the origin of carvedilol drug substances: a tool for discovering falsified active pharmaceutical ingredients.

Falsification of drugs, entailing the use of drug substances from unknown unapproved suppliers, is one of the main concerns for the quality of medicines. Therefore, traceability of active ingredients represents an effective tool to fight the illegal trade of medicinal products. In this view, the present pilot study explores the profile of carvedilol active ingredients and possible differences related to the origin. Sixteen samples were examined by near-infrared spectroscopy (NIR), proton nuclear magnetic resonance (1H-NMR spectrometry) and liquid chromatography mass spectrometry (LC-MS) Q-TOF and the data were analysed by principal component analysis (PCA), cluster analysis and PLSDA discriminant analysis. The results evidenced that the combined information from the three techniques gave good classification of the samples neatly distinguishing the APIs from European countries from the APIs manufactured out of Europe. In particular, NIR spectroscopy provided effective separation between European and non-European manufacturers and 1H-NMR or LC-MS added specific information related to the separation. Concerning LC-MS Q-TOF, the analysis of multiple isobaric peaks proved to be highly predictive of the drug substance origin and emerged as a promising tool in the field of medicine traceability.

A multidisciplinary care unit approach for the management of psoriatic arthritis: an Italian experience.

BACKGROUND: Psoriatic arthritis (PsA) is a chronic inflammatory disease that can produce disabling joint symptoms, adding significantly to the physical and psychosocial burden of psoriasis. Early detection is important to allow the development of an appropriate care plan to delay the onset of PsA and maximize the patient's quality of life. Our aim was to present the criteria, based on evidence and expert opinion, for a multidisciplinary approach to the management of PsA in a patient already characterized by skin manifestation. METHODS: An expert panel from the principal psoriatic care units of the Campania region of Italy met to discuss their mutual experience of the multidisciplinary approach to the management of psoriatic disease and to describe an integrated dermatologic/rheumatologic approach focused on the early diagnosis, management, and treatment of PsA. RESULTS: Two types of consultation modalities were considered most relevant to the care of patients with psoriatic disease in Italy: the parallel approach and the face-to-face care unit approach. Screening criteria for multidisciplinary care unit admission were described, with dermatologists, as the primary managers of the majority of patients with psoriasis, playing a critical role in introducing patients early on to therapy. CONCLUSIONS: An integrated management approach may enhance patient care by ensuring early diagnosis and treatment, with the potential to achieve better outcomes for both skin and musculoskeletal manifestations of psoriasis. The multidisciplinary care unit model is an effective and satisfying collaborative approach, not only optimizing outcomes and satisfaction for the patient but strengthening collaboration between the specialties.

Avidity Index for anti-HIV antibodies: comparison between third- and fourth-generation automated immunoassays.

The development of assays for detecting recent HIV infections has become crucial for analyzing trends in infection in different populations, both for surveillance and prevention activities. The anti-HIV avidity index (AI), measured with third-generation immunoassays (which detect anti-HIV antibody), has been shown to be an accurate tool for discriminating recent HIV infections (<6 months) from established infections (≥ 6 months). We compared a third-generation immunoassay (AxSYM HIV 1/2 gO; Abbott Diagnostics) to a fourth-generation immunoassay (Architect HIV Ag/Ab Combo; Abbott Diagnostics; which detects anti-HIV antibody and p24 antigen) in terms of AI performance in distinguishing between recent and established HIV infections. A total of 142 samples from 75 HIV-infected individuals with an estimated date of seroconversion were assayed. The two assays showed the same accuracy in identifying a recent infection (91.5%), using an AI cutoff of 0.80, although Architect HIV Ag/Ab Combo was slightly more sensitive (89.4% versus 84.8%; P > 0.05) and yet less specific (93.4% versus 97.4%; P > 0.05). The correlation between assays was high (r = 0.87). When 20 specimens falling in the gray zone around the cutoff point (0.75 ≤ AI ≤ 0.84) were excluded, the accuracy of AI with Architect HIV Ag/Ab Combo was 94.7%, and the concordance between the two assays was 99.2%. The anti-HIV AI is a serological marker that accurately discriminates recent from established HIV infections. It can be successfully applied on fully automated fourth-generation HIV Ab/Ag immunoassays, which have several advantages, including increased throughput, high reproducibility, no need for specific technical skills, and easy comparability of results obtained in different settings.

Benefits of a Food Supplement Containing Boswellia serrata and Bromelain for Improving the Quality of Life in Patients with Osteoarthritis: A Pilot Study.

Background: Osteoarthritis (OA) is a joint disease involving articular cartilage degeneration causing patients pain, joint stiffness, physical disability, and significantly reducing their quality of life (QoL). Purpose: The aim of this study was to assess whether the daily consumption of a gastroresistant food supplement formulation containing a combination of Boswellia serrata and bromelain could improve the QoL of patients suffering from various forms of OA. Materials and Methods: Forty-nine patients were enrolled in this pilot study conducted from June 2015 to October 2016. Patients took a Boswellia- and bromelain-based supplement for a period between 1 and 6 months. At baseline and at the end of the study, patients completed a self-assessment QoL questionnaire regarding their independence in performing daily activities. QoL scores were compared between baseline and follow-up by means of the Wilcoxon signed-rank test in all patients and in the subgroups of patients with knee, hip, or generalized OA. Results: Forty-nine patients, 6 men and 43 women, aged between 23 and 92 years, (mean age 63.24) participated in the study. At follow-up (3.0 ± 0.7 months), a significant improvement was observed for 7 of 10 QoL questions and, overall, for the total QoL score. The most significant improvements were observed in the joints that were more strongly affected at baseline. A similar trend was observed when separately considering patients with knee, hip, or generalized OA. No patients experienced adverse events and no drug interactions were reported. Conclusions: From this pilot study, it emerges that the use of the gastroresistant formulation containing the combination of Boswellia and bromelain supplements can represent a valuable nonpharmacological tool for improving the QoL of patients suffering from different forms of OA. Further studies should be conducted to confirm this first evidence.

Classification of the ibuprofen active pharmaceutical ingredients by chemical patterns combining HPLC, 1H-NMR spectroscopy and chemometrics: traceability of legal medicines.

INTRODUCTION: Ibuprofen is one of the widespread used non-steroidal anti-inflammatory drugs. Ibuprofen active ingredient is manufactured in many sites located all around the world. The aim of this paper was to classify the geographical source of ibuprofen active pharmaceutical ingredients (APIs) from the legal market, based on chemical characteristics and its impurity pattern and to define a geographical fingerprint. METHODS: To classify ibuprofen in different geographical groups, the chemometrics by principal component analysis (PCA) and Cluster analysis was applied to HPLC, 1H-NMR data of twenty-four samples of APIs from approved manufacturers located in different European and Asian countries. RESULTS: The PCA showed clearly two different geographical groups, based on particular patterns of European or Indian samples; the cluster analysis showed the similarity of group. CONCLUSION: The chemometric analysis is an important tool for tracking the geographical origin of APIs. This could be useful to supplement the quality control ensuring safety of the medicinal products in legal market and dealing with the evolving changes of the illegal market.

HIV-Positive Individuals on Antiretroviral Therapy and with Viral Load Suppressed in 12 Infectious Diseases Clinics in Italy: Successes and Disparities in the HIV Continuum of Care.

The HIV care continuum is a tool that describes the quality of HIV care for people living with HIV and assesses the extent to which the goal of viral suppression has been achieved. In 2014, we conducted a retrospective cross-sectional study to assess the characteristics associated with three steps of the HIV continuum of care in Italy [i.e., most recent diagnoses, people diagnosed and in care who are on therapy, and people with viral load (VL) suppressed among those on therapy]. Among the 10,262 individuals diagnosed and linked to care, 9,810 (95.6%) were on therapy and among these 8,383 (85.7%) had VL suppressed. The comparison between people diagnosed in 2013 to those diagnosed before 2013 shows that they were more likely to be male [adjusted odds ratios (AOR) = 1.46; 95% confidence interval (95% CI): 1.18-1.79], <25 years of age (AOR = 7.59; 95% CI: 4.17-13.79), and born in Italy (AOR = 1.33; 95% CI: 1.09-1.62). Factors significantly associated with not being in therapy were as follows: age <35 years (AOR = 4.03; 95% CI: 2.50-6.51), age 35-55 years (AOR = 1.85; 95% CI: 1.19-2.87), being migrants (AOR = 1.25; 95% CI: 1.13-1.39), being men who have sex with men (MSM) (AOR = 1.54; 95% CI: 1.22-1.95), have been diagnosed in 2010-2012 (AOR = 4.51; 95% CI: 3.03-6.73), or before 2010 (AOR = 3.18; 95% CI: 2.41-4.21), and not had previous clinical AIDS (AOR = 8.24; 95% CI: 3.33-20.23), whereas factors significantly associated with not having VL suppressed were as follows: age <35 years (AOR = 1.56; 95% CI: 1.13-2.13) and age 35-55 years (AOR = 1.23; 95% CI: 1.10-1.38), being migrants (AOR = 1.38; 95% CI: 1.11-1.70), have been diagnosed in 2010-2012 (AOR = 1.34; 95% CI: 1.14-1.57), in 2013 (AOR = 4.35; 95% CI: 2.47-7.68), and not having had previous clinical AIDS (AOR = 0.74; 95% CI: 0.63-0.86). Despite this we observed significant disparities for young people, MSM, and migrants, overall in Italy the vast majority of people diagnosed with HIV and in care in 2013 received therapy and the percentage of people who are VL suppressed is near the Joint United Nations Programme on HIV/AIDS goal.

Estimating minimum adult HIV prevalence: a cross-sectional study to assess the characteristics of people living with HIV in Italy.

In 2012, we conducted a retrospective cross-sectional study to assess the number of people living with HIV linked to care and, among these, the number of people on antiretroviral therapy. The health authority in each of the 20 Italian Regions provided the list of Public Infectious Diseases Clinics providing antiretroviral therapy and monitoring people with HIV infection. We asked every Public Infectious Diseases Clinic to report the number of HIV-positive people diagnosed and linked to care and the number of those on antiretroviral therapy during 2012. In 2012, 94,146 people diagnosed with HIV and linked to care were reported. The majority were males (70.1%), Italians (84.4%), and aged between 25 and 49 years (63.4%); the probable route of transmission was heterosexual contact in 37.5% of cases, injecting drug use in 28.1%, and male-to-male contact in 27.9%. Among people in care, 20.1% had less than 350 CD4 cells/µl, 87.6% received antiretroviral therapy, and among these, 62.4% had a CD4 cell count higher than 350 cells/µl. The overall estimated prevalence of individuals diagnosed and linked to care in 2012 in Italy was 0.16 per 100 residents (all ages). Adding the estimated proportion of undiagnosed people, the estimated HIV prevalence would range between 0.19 and 0.26 per 100 residents. In Italy, the majority of people diagnosed and linked to care receive antiretroviral therapy. A higher prevalence of individuals diagnosed and linked to care was observed in Northern Italy and among males. More information for developing the HIV care continuum is necessary to improve the entire engagement in care, focusing on test-and-treat strategies to substantially reduce the proportion of people still undiagnosed or with a detectable viral load.

The continued ageing of people with AIDS in Italy: recent trend from the national AIDS Registry.

Introduction. In industrialized countries, the availability of highly active antiretroviral therapy (HAART) caused a slow but substantial ageing of the AIDS epidemic mainly due to the longer survival of persons with HIV/AIDS which has turned HIV into a manageable, chronic disease. The number of older people with AIDS is growing in many European countries. We described the impact of AIDS among persons aged 50 years or more in Italy and compared the characteristics of these cases with those of persons diagnosed with AIDS at an age younger than 50. Methods. The source of data was the Italian AIDS Registry, from 1982 to 2011. We defined "older" persons those aged 50 years or more, and younger individuals those aged less than 50 years. We built two multivariate logistic regression models: the first one to identify factors associated with being older, and the second one to identify AIDS-defining diseases correlated with being older. Variables with a P value of <0.05 were entered in the model. Results. Of the total AIDS cases, 10.5% were among persons older than 49 years. This proportion progressively increased from 0.0% in 1983 to 26.4% in 2011. Among older cases, the incidence of AIDS was 2.0 per 100 000 residents in 1996, then decreased to 1.4 per 100 000 in 2000 and levelled off around 1 per 100 000 residents until 2011. Compared to younger cases, older cases were more frequently males, Italians, diagnosed with AIDS in recent years, residing in Northern or Central Italy, non-injecting drug users, and late testers. Discussion. These findings stress the need for physicians to consider carefully the possibility of HIV infection among older individuals not to miss the opportunity to deliver prevention messages, offer HIV testing, and make an early diagnosis.

Estimates of the number of people living with HIV in Italy.

Objective. To estimate the HIV prevalence and the number of people living with HIV (PLHIV) in Italy with a projection for 2020. Methods. Two methods elaborated by Joint United Nations Programme on HIV/AIDS (UNAIDS) were used: Estimate and Projection Package and Spectrum. Results. A total of 123,000 (115,000-145,000) individuals aged 15 or more were estimated to be living with HIV in Italy at the end of 2012 and the estimated HIV prevalence was 0.28 (0.24-0.32) per 100 residents aged 15 or more. In 2012, the estimated number of new HIV infections among adults was 3,000 (2,700-4,000), and the number of adults in need for ART was 93,000 (80,000-110,000). The projection estimates that 130,000 (110,000-150,000) adults will live with HIV/AIDS in 2020 in Italy. Conclusion. Estimates of PLHIV in Italy stress the high number of PLHIV in need of care and treatment, as well as the need for more information and prevention campaigns.

Changing blood donor screening criteria from permanent deferral for men who have sex with men to individual sexual risk assessment: no evidence of a significant impact on the human immunodeficiency virus epidemic in Italy.

BACKGROUND: In 2001, the criteria for blood donor eligibility in Italy were modified by a ministerial decree from a permanent deferral for "men who have sex with men" to an individual risk assessment of sexual behaviours. The aim of this study was to evaluate the impact of this change in donor screening criteria on the human immunodeficiency virus epidemic among blood donors in Italy. MATERIALS AND METHODS: We used the data obtained from the Italian blood donor epidemiological surveillance system. We compared data collected in 2009 and 2010, when the individual risk assessment policy was applied, with data collected in 1999 when permanent deferral was applied for men who have sex with men based on a declaration of sexual orientation. We evaluated the change over time in the relative proportion of HIV antibody-positive donors who likely acquired the infection from men who have sex with men vs heterosexual sexual exposure; the relative risk was calculated using 1999 as the reference year. RESULTS: In all 3 years, the majority of HIV antibody-positive donors reported sexual exposure as a risk factor for HIV infection; this proportion increased over time, although not statistically significantly. Heterosexuals always accounted for at least 40% of all HIV antibody-positive cases. The rate of HIV antibody-positive donors increased similarly in men who have sex with men and heterosexuals; specifically, the rate of HIV antibody-positive cases per 100,000 donors was more than 2-fold higher among men who have sex with men in 2009-2010 than in 1999 (2009-2010 vs 1999, RR =2.8; P =0.06), and that among heterosexuals was 1.5 fold higher (P =0.18). DISCUSSION: When comparing the period before (1999) and after (2009-2010), the implementation of the individual risk assessment policy in 2001, no significant increase in the proportion of men who have sex with men compared to heterosexuals was observed among HIV antibody-positive blood donors, suggesting that the change in donor deferral policy did not lead to a disproportionate increase of HIV-seropositive men who have sex with men.

Low perception of sexual behaviours at risk for human immunodeficiency virus infection among blood donors who call the AIDS/STI Help Line in Italy.

BACKGROUND: In Italy, the circulation of human immunodeficiency virus (HIV) has expanded to include population groups that do not perceive themselves to be "at risk" of HIV infection and who do not even consider undergoing HIV testing. The aim of this study was to describe the socio-demographic and behavioural characteristics, and perceived risk of HIV infection in a sample of blood donors who reported never having been tested for HIV. MATERIALS AND METHODS: A questionnaire was administered to a sample of donors who called the Italian National AIDS/STI Help Line and reported never having been tested for HIV. RESULTS: The study sample consisted of 164 blood donors: 29.3% had given blood in the preceding 2 years. With regards to at-risk behaviours, 39.6% of the donors interviewed were heterosexuals who had sexual contacts with multiple partners, and 5.5% were men who had sex with multiple male partners. Sexual contacts with female sex workers were reported by 11.6% of first-time donors and 25.7% of repeat donors. Of the 164 donors interviewed, 125 (76.2%) said that the main reason that they had never been tested for HIV was that they did not consider themselves at risk. Among these, 56 (44.8%) reported that they would have sexual contacts with a sex worker, 52 (41.6%) reported that they would have sexual contacts with someone having more than one sexual partner, and 36 (28.8%) reported that they would have sexual contacts without using a condom. DISCUSSION: All the donors interviewed reported that they had never been tested for HIV despite the fact that they had been certainly been tested upon blood donation. These results show that some sexual behaviours may not be perceived as behaviours at risk for acquiring HIV infection. These findings suggest that not all blood donors are knowledgeable about HIV risk behaviours and that an explicit pre-donation questionnaire and effective counselling continue to be important for the selection of candidate donors.

HIV virology and pathogenetic mechanisms of infection: a brief overview.

Studies on HIV virology and pathogenesis address the complex mechanisms that result in the HIV infection of the cell and destruction of the immune system. These studies are focused on both the structure and the replication characteristics of HIV and on the interaction of the virus with the host. Continuous updating of knowledge on structure, variability and replication of HIV, as well as the characteristics of the host immune response, are essential to refine virological and immunological mechanisms associated with the viral infection and allow us to identify key molecules in the virus life cycle that can be important for the design of new diagnostic assays and specific antiviral drugs and vaccines. In this article we review the characteristics of molecular structure, replication and pathogenesis of HIV, with a particular focus on those aspects that are important for the design of diagnostic assays.

The epidemic of HIV infection and AIDS, promotion of testing, and innovative strategies.

In Europe, the incidence of new diagnoses of HIV infection in 2008 was 86.7 cases per one million population, and most cases were attributable to sexual transmission. In Italy, in 2007, the incidence was 60.0 cases per one million population (in the areas in which surveillance exists), and 73.7% of the cases were attributable to sexual transmission. At present, there are an estimated 170,000-180,000 persons living with HIV/AIDS in Italy, some of whom are unaware of being infected. Based on available epidemiological data and taking into consideration the level of risk of exposure to HIV, we describe several proposals for promoting access to HIV testing in diverse population groups and contexts, including some innovative approaches. The promotion of HIV testing is fundamental for public health and human rights and must be associated with treatment, care and prevention activities, which must be guaranteed for the entire population.