Blood born viral infections, sexually transmitted diseases and latent tuberculosis in italian prisons: a preliminary report of a large multicenter study.

BACKGROUND: Recent screenings of inmates for Hepatitis C virus (HCV), Hepatitis B virus (HBV), human immunodeficiency virus (HIV), Syphilis and Latent Tuberculosis (LTB) did not provide sufficient information to improve healthcare strategies. AIM: To obtain valuable information on the endemicity of the above mentioned Infections in prisons of Italy. MATERIALS AND METHODS: A screening based on a peer-to-peer communication, followed by a month of blood sampling on a voluntary basis was performed to detect antibody to 4 of the 5 above mentioned infections and detect LTB by PPD (purified protein derivative) Skin Test. The present analysis regards data obtained in 9 of the 20 prisons. RESULTS: The percentage of patients who accepted the screening varied between jails (37.3-95.2%, median 62.2), but it was higher than 10.0-20.5% obtained in the same 9 prisons using traditional methods before our intervention. The participation to the screening reached 65.3% for HBV, 64.6% for HCV, 67.4%for HIV, 55.7% for TPHA (Treponema Pallidum Hemagglutination Assay) and 42.8% for LTB. HBsAg was detected in 4.4% of 2265 subjects, anti-HCV in 22.8% of 2241, anti-HIV in 3.8% of 2339 and TPHA in 2.1% of 1932; PPD Skin Test was positive in 17.2% of 1486 subjects. The screening identified 183 subjects with an unknown infection, 56 italian and 127 foreigners to be evaluated for clinical decisions: 35 with HBV chronic infection, 34 with HCV chronic infection, 3 anti-HIV positive, 14 with syphilis and 97 with LTB. CONCLUSIONS: The new approach to the screening, based on a peer-to-peer communication followed by blood sampling on a voluntary basis provided valuable information to improve the healthcare system in each single prison.

Evaluation of a rapid immunochromatographic test for the serologic diagnosis of tuberculosis in Italy.

OBJECTIVE: To determine specificity, sensitivity and predictive values of a rapid immunochromatographic assay (ICT tuberculosis) for the diagnosis of tuberculosis (TB) in an Italian clinical setting, and to identify tentative new guidance for the interpretation of test results. METHODS: The ICT tuberculosis test is an immunochromatographic test based on the detection of IgG antibodies directed against five highly purified antigens secreted by Mycobacterium tuberculosis during active growth. Sera from 60 patients with active pulmonary (48 sputum smear-positive and six sputum smear-negative cases) and extrapulmonary (six cases) TB were obtained. Personal, anamnestic and clinical data were investigated and recorded for each patient. The control groups comprised 156 subjects: 40 healthy individuals, half of them Mycobacterium bovis BCG-vaccinated, and 116 patients with mycobacterial diseases other than TB (five cases), with nonmycobacterial lung diseases (30 cases), with nonmycobacterial nonlung diseases (30 cases), with nonmycobacterial diseases and rheumatoid factors positivity (30 cases), and with asymptomatic HIV infection (21 cases). For 21 individuals the test was simultaneously performed with both serum and whole blood sample. Each positive result of the ICT test was reported with regard to the number (1-4), position (A, B, C, D) and color intensity (+ to ++++) of the evidenced lines in order to assess the quality of the antibody response. RESULTS: The overall sensitivity and specificity were 56.7% and 90.4%, respectively. The sensitivity for pulmonary TB patients was 61.1% (66.7% for smear-positive and 16.7% for smear-negative cases) and 16.7% for extrapulmonary TB patients. The difference between ICT results in pulmonary TB patients and control subjects was statistically significant (P < 0.0001). The analysis of the positive ICT tests revealed that samples with strong color intensity (>/=++) and specific antibodies bound to antigens immobilized on line D were significantly more frequent in TB patients than in controls (P = 0.001 and P= 0.027, respectively). ICT test results with the presence of at least three visible lines were more often observed in the TB patients than in controls, although not reaching statistical significance (P = 0.052). No difference was observed between the results of the ICT test performed both on serum and whole blood sample. CONCLUSIONS: The ICT tuberculosis test was confirmed to be rapid and easy to perform without requiring special equipment, both on serum and whole blood sample. Our data, in accordance with those obtained in a previous study conducted in extra-European countries, confirmed higher sensitivities for the smear-positive TB patients than for the smear-negative TB patients, and for pulmonary TB patients than for the extrapulmonary TB patients. Data obtained on the quality of antibody response in the ICT positive samples, might be used to improve the performance of the test.

HAART tolerability: post-exposure prophylaxis in healthcare workers versus treatment in HIV-infected patients.

The aim of our study is to compare the tolerability of zidovudine/lamivudine/indinavir when used in post-exposure prophylaxis (PEP) subjects and in HIV-infected patients. HIV-negative patients were enrolled as part of the surveillance protocol for professional exposure at the Luigi Sacco Hospital in Milan. HIV-positive patients were selected among all subjects undergoing treatment with zidovudine/lamivudine/indinavir from the CISAI cohort, an Italian cohort for the evaluation of adverse reactions to HAART. In both studies patients were followed prospectively and the severity of the reactions was evaluated using the AIDS Clinical Trial Group adverse experience grading scales. Up to September 1999, 37 HIV-seronegative subjects had undergone treatment with zidovudine/ lamivudine/indinavir. From a total of 1207 patients belonging to the CISAI cohort, 199 were identified as being treated with the same regimen. The frequency of adverse events in the PEP subjects was 70.3% compared to 11.1% for HIV-infected patients. In the first group, adverse events caused treatment interruption in 21 subjects (56.7%) versus 14 patients (7%) among the HIV-infected group. Only one case of a severe event (grade 3-4) was observed in the prophylaxis group against 12 in the treatment group. Our study shows that treatment interruption is eight times higher in HIV-negative subjects compared to HIV-seropositive patients, and that the incidence of adverse events is approximately six times higher, though such events, are for the most part, not severe.

Incidence of adverse reactions in HIV patients treated with protease inhibitors: a cohort study. Coordinamento Italiano Studio Allergia e Infezione da HIV (CISAI) Group.

OBJECTIVE: To assess the probability that protease inhibitor (PI) therapy might be discontinued because of adverse events (AE) and to evaluate the incidence rate of adverse reactions during PI treatment. DESIGN: A prospective cohort, multicenter study on HIV-positive patients starting treatment with at least one PI. SETTING: Ten departments of infectious diseases in Northern Italy. PATIENTS: A total of 1207 patients who started PI therapy in September 1997 and were consecutively observed up to April 1999. MAIN OUTCOME MEASURES: Adverse reactions following initiation of PI therapy, and time to therapy discontinuation due to AE. RESULTS: During the study period, 35.9% patients presented adverse reactions of any grade, whereas 9.7% presented at least one serious AE. After 12 months of treatment, the percentage of patients who had interrupted treatment was 36% of ritonavir-treated patients, 14.2% of those treated with indinavir, 13.6% of ritonavir-saquinavir hard gel capsules (HGC)-treated patients, and 8.5% and 2.1%, respectively, for those treated with nelfinavir and saquinavir HGC. Women and patients with hepatitis experienced a significantly greater number of adverse events compared with other categories. Gastrointestinal events were more frequently observed in patients treated with either ritonavir alone or in combination with saquinavir HGC, as well as in patients receiving nelfinavir, although in this group serious events were rare. Here again, neurologic, metabolic, and hepatic toxicity occurred more frequently in ritonavir and ritonavir-saquinavir HGC treated patients. Allergic reactions were more often observed in patients receiving nelfinavir. Indinavir-treated patients presented the highest incidence of renal toxicity. CONCLUSION: Ritonavir is the drug associated with the largest number of reactions, which appear during the first few months of treatment. Saquinavir HGC and nelfinavir are the best tolerated drugs in a clinical setting.

[Causality relationship of drug adverse reactions: experience in the use of HIV-protease inhibitors]. / Relazione di causalità delle reazioni avverse a farmaci: un'esperienza nell'utilizzo degli inhibitori della proteasi di HIV.

PURPOSE: To establish the exact cause and effect relationship between protease inhibitors (PIs) and adverse events. MATERIALS AND METHOD: Prospective, cohort, multicenter study on HIV-positive patients who are beginning treatment with a PI. Causal relationships are evaluated using the RUCAM algorithm. RESULTS: Since the beginning of the study 1207 patients have been enrolled. Average time of observation is 10.7 months. To date, 784 adverse events have been observed, distributed as follows: excluded 3.8%, improbable 18.5%, possible 41.3%, probable 30.1%, and highly probable 6.3%. Saquinavir shows a statistically significant difference in the rate of non-correlated events with respect to other groups. CONCLUSIONS: Over 20% of adverse events during PI treatment are shown to be non-correlated to these drugs. Saquinavir shows the highest rate of non-correlated events.