Impact of sex on hepatitis C virus transmission: conflicting results.
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Female↗
Biomedical subjects
G De Carli
Publications and source records attributed to G De Carli.
[Risk factors for hepatitis C virus transmission to Health Care Workers after occupational exposure: a European case-control study].
BACKGROUND: Factors that influence the risk for HCV infection after occupational exposure to hepatitis C virus (HCV) have not yet been determined. The objective of this study was to assess potential risk factors for Hepatitis C seroconversion after occupational exposure to HCV. METHODS: We conducted a European matched case-control study from 01/01/1991 through 31/12/ 2002. Cases were Health Care Workers (HCWs) who were HCV seronegative at the time of exposure, sustained a documented exposure to HCV, and present documented HCV seroconversion temporally associated with the exposure. Controls-HCWs had a documented exposure to HCV, were HCV seronegative at the time of exposure, and remained so at least 6 months later. Controls were matched to cases for the center and the time period of the exposure occurrence. RESULTS: 60 cases and 204 controls were included. All cases were exposed to HCV-infected materials through percutaneous injuries. Those for whom information was available (61.6%) were exposed to viremic source patients. Multivariate conditional logistic regression analysis, in which HCV viral load was not introduced because of missing values, identified needle placed in the source patient's vein or artery (Odds Ratio [OR]=100.1; 95% Confidence Interval [CI]=7.3-1365.7), deep injury (OR=155.2; 95%CI=7.1-3417.2), and HCW's gender (M vs. F: OR=3.1; 95%CI=1.0-10.0) as risk factors for HCV infection. In univariate unmatched analysis the risk of HCV transmission was increased 11-fold (C195%=1.1-114.1) in HCWs exposed to sources with a viral load>6 log10 copies/mL when compared to sources with a HCV viral load<4 log10 copies/mL. CONCLUSION: The risk of HCV transmission after percutaneous exposure increases with a larger volume of blood, and, a higher titer of HCV in the source patient's blood. The role of HCW's gender need to be further investigated. The results of this study have important implications for counselling and follow-up of HCWs after exposure.
Adult↗
Risk factors for hepatitis C virus transmission to health care workers after occupational exposure: a European case-control study.
BACKGROUND: Additional studies are required to identify risk factors for hepatitis C virus (HCV) transmission to health care workers after occupational exposure to HCV. METHODS: We conducted a matched case-control study in 5 European countries from 1 January 1991 through 31 December 2002. Case patients were health care workers who experienced seroconversion after percutaneous or mucocutaneous exposure to HCV. Control subjects were HCV-exposed health care workers who did not experience seroconversion and were matched with case patients for center and period of exposure. RESULTS: Sixty case patients and 204 control subjects were included in the study. All case patients were exposed to HCV-infected fluids through percutaneous injuries. The 37 case patients for whom information was available were exposed to viremic source patients. As risk factors for HCV infection, multivariate analysis identified needle placement in a source patient's vein or artery (odds ratio [OR], 100.1; 95% confidence interval [CI], 7.3-1365.7), deep injury (OR, 155.2; 95% CI, 7.1-3417.2), and sex of the health care worker (OR for male vs. female, 3.1; 95% CI, 1.0-10.0). Source patient HCV load was not introduced in the multivariate model. In unmatched univariate analysis, the risk of HCV transmission increased 11-fold for health care workers exposed to source patients with a viral load >6 log(10) copies/mL (95% CI, 1.1-114.1), compared with exposures to source patients with a viral load < or =4 log10 copies/mL. CONCLUSION: In this study, HCV occupational transmission was found to occur after percutaneous exposures. The risk of HCV transmission after percutaneous exposure increased with deep injuries and procedures involving hollow-bore needle placement in the source patient's vein or artery. These results highlight the need for widespread adoption of needlestick-prevention devices in health care settings, together with other preventive measures.
Adult↗
Postexposure HIV prophylaxis regimen.
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Anti-HIV Agents↗
HIV infection among low-risk first lifetime testers in Rome, 1990-2000.
BACKGROUND: HIV spread among low-risk populations through heterosexual intercourse is a major public health concern. This study was aimed at describing prevalence and determinants of HIV infection among Italian low-risk subjects seeking their first lifetime HIV test. PATIENTS AND METHODS: Information collected between January 1990 and December 2000 at a major counseling and testing site in Rome, Italy, was analyzed. Multiple logistic regression odds ratios (OR) and 95% confidence intervals (CI) were computed. RESULTS: Among the 14,313 study subjects, 64 (0.4%) were seropositive for HIV infection. HIV seropositivity increased with age (OR = 4.0, 95% CI: 2.1-7.6 for >/= 40 years vs 18-24), and it seemed to be more common among men (OR = 1.6, lower 95% CI:0.9). There was no evidence of temporal variations, whereas motivations for HIV testing were strongly associated with HIV prevalence. Testing for alarming symptoms (OR = 13.8) or for heterosexual intercourse (OR = 11.0) were associated with a more than 10-fold increased HIV risk. CONCLUSION: Our findings are consistent with data from other industrialized countries and they show a strong association between HIV seropositivity and reason for first-time testing. Moreover, they indicate a stable trend of HIV prevalence among low-risk persons in the last decade. Further studies on time trends in low-risk populations would be useful to evaluate current HIV prevention programs.
Adolescent↗
European recommendations for the management of healthcare workers occupationally exposed to hepatitis B virus and hepatitis C virus.
Exposure prevention is the primary strategy to reduce the risk of occupational bloodborne pathogen infections in healthcare workers (HCW). HCWs should be made aware of the medicolegal and clinical relevance of reporting an exposure, and have ready access to expert consultants to receive appropriate counselling, treatment and follow-up. Vaccination against hepatitis B virus (HBV), and demonstration of immunisation before employment are strongly recommended. HCWs with postvaccinal anti-HBs levels, 1-2 months after vaccine completion, >or=10 mIU/mL are considered as responders. Responders are protected against HBV infection: booster doses of vaccine or periodic antibody concentration testing are not recommended. Alternative strategies to overcome non-response should be adopted. Isolated anti-HBc positive HCWs should be tested for anti-HBc IgM and HBV-DNA: if negative, anti-HBs response to vaccination can distinguish between infection (anti-HBs >or=50 mUI/ml 30 days after 1st vaccination: anamnestic response) and false positive results(anti-HBs >or=10 mUI/ml 30 days after 3rd vaccination: primary response); true positive subjects have resistance to re-infection. and do not need vaccination The management of an occupational exposure to HBV differs according to the susceptibility of the exposed HCW and the serostatus of the source. When indicated, post-exposure prophylaxis with HBV vaccine, hepatitis B immunoglobulin or both must be started as soon as possible (within 1-7 days). In the absence of prophylaxis against hepatitis C virus (HCV) infection, follow-up management of HCV exposures depends on whether antiviral treatment during the acute phase is chosen. Test the HCW for HCV-Ab at baseline and after 6 months; up to 12 for HIV-HCV co-infected sources. If treatment is recommended, perform ALT (amino alanine transferase) activity at baseline and monthly for 4 months after exposure, and qualitative HCV-RNA when an increase is detected.
Antiviral Agents↗
Towards a standard HIV post exposure prophylaxis for healthcare workers in Europe.
Antiretroviral prophylaxis (PEP) after occupational exposure to HIV in healthcare workers (HCWs) is used across Europe, but not in a consistent manner. A panel of experts, funded by the European Commission, formulated a set of recommendations. When it has been decided that the characteristics of the exposure indicate the initiation of PEP, PEP should be started as soon as possible; initiation is discouraged after 72 hours. PEP should be initiated routinely with any triple combination of antiretrovirals approved for the treatment of HIV-infected patients; a two class regimen is to be preferred. The source patient's treatment history should be sought. Counselling, psychological support, HIV testing and clinical evaluation should be performed at baseline, at 6-8 weeks, and at least 6 months post exposure. Additional clinical and laboratory monitoring at one and two weeks should be considered, as adherence with and tolerance of the regimen can highlight adverse reactions and potential toxicity. Routine HIV resistance tests in the source patient, and direct virus assays in the exposed HCW are not recommended.
Anti-HIV Agents↗
Risk of hepatitis C virus transmission following percutaneous exposure in healthcare workers.
BACKGROUND: We wanted to determine the incidence of anti-hepatitis C virus (HCV) seroconversion after percutaneous exposure to infectious fluids of an anti-HCV positive source in healthcare workers (HCW) and to investigate related risk factors. PATIENTS AND METHODS: Prospective observation in 55 Italian hospitals of anti-HCV-negative exposed HCW were followed clinically and serologically for at least 6 months. RESULTS: Of 4,403 exposed HCW, 14 seroconverted (0.31%; 95% CI 0.15-0.48) after an injury with a hollow-bore, blood-filled needle (14/1,876=0.74%; 95% CI 0.41-1.25). Deep injuries increased the seroconversion risk (OR 6.53; 95% CI 2.01-20.80). Exposure to an HIV co-infected source was associated with an higher, though not yet statistically significant, risk (OR 2.76, 95% CI 0.49-10.77). Source's HCV viremia was available in 674 cases, 566 of whom tested positive, including the nine seroconversion cases for whom this information was available. CONCLUSION: The risk of acquiring HCV after percutaneous exposure seems to be lower than previously reported. Deep injury, injury with a blood-filled needle and HIV co-infection of source seem to be associated with occupational transmission. Needlestick prevention devices could decrease the risk of infection with HCV and other bloodborne pathogens in HCW.
Female↗
Changing patterns in the etiology of HIV-associated bacterial pneumonia in the era of highly active antiretroviral therapy.
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Adult↗
Risk of exposure to bloodborne infection for Italian healthcare workers, by job category and work area. Studio Italiano Rischio Occupazionale da HIV Group.
OBJECTIVE: To analyze the rate of occupational exposure to blood and body fluids from all sources and specifically from human immunodeficiency virus (HIV)-infected sources among hospital workers, by job category and work area. DESIGN: Multicenter prospective study. Occupational exposure data (numerator) and full-time equivalents ([FTEs] denominator) were collected over a 5-year period (1994-1998) and analyzed. SETTING: 18 Italian urban acute-care hospitals with infectious disease units. RESULTS: A total of 10,988 percutaneous and 3,361 mucocutaneous exposures were reported. The highest rate of percutaneous exposure per 100 FTEs was observed among general surgery (11%) and general medicine (10.6%) nurses, the lowest among infectious diseases (1.1%) and laboratory (1%) physicians. The highest rates of mucocutaneous exposure were observed among midwives (5.3%) and dialysis nurses (4.7%), the lowest among pathologists (0%). Inadequate sharps disposal and the prevalence of sharps in the working unit influence the risk to housekeepers. The highest combined HIV exposure rates were observed among nurses (7.8%) and physicians (1.9%) working in infectious disease units. The highest rates of high-risk percutaneous exposures per 100 FTE were again observed in nurses regardless of work area, but this risk was higher in medical areas than in surgery (odds ratio, 2.1; 95% confidence interval, 1.9-2.5; P<.0001). CONCLUSION: Exposure risk is related to job tasks, as well as to the type and complexity of care provided in different areas, whereas HIV exposure risk mainly relates to the prevalence of HIV-infected patients in a specific area. The number of accident-prone procedures, especially those involving the use of hollow-bore needles, performed by job category influence the rate of exposure with high risk of infection. Job- and area-specific exposure rates permit monitoring of the effectiveness of targeted interventions and control measures over time.
Blood-Borne Pathogens↗
Metabolic and morphologic disorders in patients treated with highly active antiretroviral therapy since primary HIV infection.
UNLABELLED: Our objective was to describe morphologic and metabolic disorders in patients treated with highly active antiretroviral therapy (HAART) since primary HIV infection (PHI). Our method was prospective evaluation of patients with PHI initiating HAART at the time of diagnosis. Outcome measures were: development of hyperglycemia, hypercholesterolemia, hypertriglyceridemia, and of body shape abnormalities indicative of lipodystrophy, assessed through self-reported questionnaires and physical examination. RESULTS: From May 1997 to April 2001, 41 patients (35 males) with PHI presented at the National Institute for Infectious Diseases "Lazzaro Spallanzani" in Rome, Italy. A protease inhibitor-including regimen was started in 30 patients, and a nonnucleoside reverse transcriptase-inhibitor in 11. Median interval between enrollment and treatment initiation was 30 days (mean 39, range 10-150). Median HAART duration was 19 months (mean 21.2, range 3-47). Thirty-eight patients had undetectable (less than 80 cp/mL) HIV RNA after a median of 3 months (mean 4.1, range 1-15). Mean CD4 cells count increased from 632/mmc at baseline to 936/mmc at the last follow up. No cases of hyperglycemia (glucose level greater than 110 mg/dL) were observed. After a median of 6 months on HAART, 10 patients developed beyond grade 2 (greater than 240 mg/dL) hypercholesterolemia, 5 developed beyond grade 2 (greater than 400 mg/dL) hypertrygliceridemia, and two developed both. Body mass index did not change significantly. Five patients (12.2%) developed lipodystrophy after a median of 14.5 months (mean 15.3, range 2-30), with an incidence of 7.3 per 100 patient-years. CONCLUSIONS: Dyslipidemia and lipodystrophy can occur in patients treated with HAART since PHI. This risk of should be taken into account when considering this early antiretroviral treatment of HIV infection.
Adolescent↗
Risk of HIV and other blood-borne infections in the cardiac setting: patient-to-provider and provider-to-patient transmission.
Health care workers (HCWs) face a well-recognized risk of acquiring blood-borne pathogens in their workplace, in particular hepatitis B and C viruses (HBV/HBC) and human immunodeficiency virus (HIV). Additionally, infected HCWs performing invasive exposure-prone procedures, including in the cardiac setting, represent a potential risk for patients. An increasing number of infected persons could need specific cardiac diagnostic procedures and surgical treatment in the future, regardless of their sex or age. The risk of acquiring HIV, HCV, HBV infection after a single at-risk exposure averages 0.5%, and 1-2%, and 4-30%, respectively. The frequency of percutaneous exposure ranges from 1 to 15 per 100 surgical interventions, with cardiothoracic surgery reporting the highest rates of exposures; mucocutaneous contamination by blood-splash occurs in 50% of cardiothoracic operations. In the Italian Surveillance (SIROH), a total of 987 percutaneous and 255 mucocutaneous exposures were reported in the cardiac setting; most occurred in cardiology units (46%), and in cardiovascular surgery (44%). Overall, 257 source patients were anti-HCV+, 54 HBsAg+, and 14 HIV+. No seroconversions were observed. In the literature, 14 outbreaks were reported documenting transmission of HBV from 12 infected HCWs to 107 patients, and 2 cases of HCV to 6 patients, during cardiothoracic surgery, especially related to sternotomy and its suturing. The transmission rate was estimated to be 5% to 13% for HBV, and 0.36% to 2.25% for HCV. Strategies in risk reduction include adequate surveillance, education, effective sharps disposal, personal protective equipment, safety devices, and innovative technology-based intraoperative procedures.
Blood-Borne Pathogens↗
Health-related quality of life (HR-QOL) and regulatory issues. An assessment of the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the use of HR-QOL measures in drug approval.
Interest in measuring qualitative aspects of life that are most closely related to health and healthcare has increased in recent years. Methods of describing patients' subjective health status now incorporate standardised measures, and several psychometric measures are available. Despite the thousands of empirical and conceptual papers in the medical and pharmacological literature on health-related quality of life (HR-QOL), the value of such measures in the regulatory process is still being debated. We conducted an assessment to understand and document the position of the European Agency for the Evaluation of Medicinal Products (EMEA) on the use of HR-QOL measures in studies conducted for regulatory purposes. Official documents produced and circulated by the EMEA containing recommendations on trial design, conduct and analysis for sponsors and scientific experts were independently reviewed by authors to document the position of the Agency on the specific topic of HR-QOL. All documents found in the Agency website on 30 September 1999 were identified and then assessed to: (i) identify diseases or drugs for which formal HR-QOL assessment is recommended; (ii) identify measures and methods recommended; and (iii) evaluate the reliability of recommendations across documents. Of the 189 documents retrieved, none focused directly on health-related quality of life. A few explicit recommendations were identified for 13 specific drugs or conditions. These recommendations were mostly general and vague, and used nonstandard terminology. In addition, terminology and recommendations were not consistent across documents and, in at least one case, were in contrast with the US Food and Drug Administration (FDA) guidelines. EMEA guidelines incorporating quality-of-life outcomes are welcomed but it is obvious that more detailed guidance is required. Closer collaboration between the EMEA and the FDA is also recommended. Experts from different disciplines should be involved in the preparation of such documents to assure the necessary technical expertise and the representativeness of the various counterparts.
Drug Approval↗
Rise and fall of asthma-related mortality in Italy and sales of beta2-agonists, 1980-1994.
We performed this study with the aims of describing the trend of asthma-related mortality in Italy between 1980 and 1994, and to evaluate the relationship between sale estimates of beta2-agonists drugs and mortality from asthma. For asthma mortality we used data provided by National Institute of Statistics, for sale estimates of beta2-agonists we used data provided by IMS HEALTH. We calculated the gender specific age-standardized incidence rates of asthma-related deaths for all ages and for age classes. We found that estimates for asthma-related mortality steadily increased between 1980 and 1987 in both sexes, and thereafter decreased. In people, aged between 34 and 64 and over 64, death rates in males were significantly higher than in females while the rates in those aged less than 34, were mostly similar in both gender. The overall exposure to beta2-agonists (alone and in combination) increased from 1980 to 1990, remained stable between 1990 and 1993, and increased steeply in 1994. We conclude that asthma-related death rates have declined since the mid-1980's. This decline has been more pronounced in males and in the older ages, while the rates in younger patients of both genders have remained nearly unchanged. Our data do not substantiate the hypothesis of an increased risk of asthma-related mortality associated to the use of inhaled beta2-agonists in general nor fenoterol or salbutamol in particular.
Administration, Inhalation↗
Health-related quality of life in asymptomatic patients with HIV. Evaluation of the SF-36 health survey in Italian patients.
OBJECTIVE: To investigate the psychometric performance and clinical validity of the 36-Item Short Form (SF-36) health survey when completed by asymptomatic HIV-positive Italian patients and to compare their health profile with a representative sample of 2031 Italian citizens (the Italian norm). PATIENTS AND METHODS: This was an observational, multicentre, cross-sectional survey. Microbiologists throughout Italy recruited asymptomatic HIV-positive individuals who were aged at least 18 years and aware of their infection. Investigators collected demographic, social, clinical and treatment data. Patients, classified into 2 clinical categories (A1 and A2) according to explicit pre-defined criteria, completed the SF-36 health survey in the context of a medical visit. RESULTS: Between April and July 1996, 46 microbiologists recruited 214 patients (201 evaluable). No inconsistent responses were observed in 96% of the sample. The usually recommended psychometric standards were satisfied, and the internal consistency reliability indices were always greater than 0.70. Weak to moderate associations were found between SF-36 health survey scores and physicians' estimates of patients' physical performance, while no significant associations were found with CD4+ counts. On average, HIV-positive patients reported lower scores than the Italian norm, and patients in category A2 showed lower scores than patients in A1. These differences were more relevant in scales describing role limitations, general health perception, and psychological well-being. CONCLUSION: Our study showed that the SF-36 health survey maintained its psychometric properties in a sample of Italian asymptomatic HIV-positive patients and produced data that showed its validity and robustness in such a setting.
Adolescent↗
[HIV occupational infections in gynecology: risk assessment, post-exposure management, and drug prophylaxis].
The average risk of HIV infection after percutaneous exposure to HIV-infected blood is 0.3%. Higher risk factors of HIV transmission to health care worker after percutaneous exposure are deep injury, visible blood on device, procedure involving needle in artery or vein and terminal: Illness in source patient or high viremia. It has been shown that post-exposure use of zidovudine diminishes risk of transmission. In Italy 5 occupational HIV infections in health care workers have been documented. Although prevention of exposure to blood is the best method to avoid occupational risk of HIV infection, nevertheless an adequate management of blood-borne exposure is essential for achieving a safer health care workplace. In this paper we reviewed the modality and the frequency of blood-borne exposures in Italian health care setting, focusing on in obstetric and gynaecology. Finally, Italian recommendation for the management of blood-born exposure, including post-exposure chemoprophylaxis are discussed.
Gynecology↗
Occupational human immunodeficiency virus infection in health care workers: worldwide cases through September 1997.
The average estimated risk of human immunodeficiency virus (HIV) infection for health care workers following a percutaneous or mucous exposure is <0.5% in incidence studies, although a case-control study suggests it is much higher for highest-risk percutaneous exposure. To characterize exposures resulting in HIV transmission, we reviewed available data on occupational cases reported worldwide, identifying 94 documented and 170 possible cases. The majority of documented infections occurred in nurses, after contact with the blood of a patient with AIDS by means of percutaneous exposure, with a device placed in an artery or vein. High-exposure job categories, e.g., midwives and surgeons, are represented mostly among possible cases. Transmission occurred also through splashes, cuts, and skin contaminations, and in some cases despite postexposure prophylaxis with zidovudine. Health care workers could benefit if these data were incorporated in educational programs designed to prevent occupational bloodborne infections.
Global Health↗
Measuring quality of life in dyspeptic patients: development and validation of a new specific health status questionnaire: final report from the Italian QPD project involving 4000 patients.
OBJECTIVE: Despite the fact that gastrointestinal disorders represent one of the most common reasons for medical consultations, formal assessment of patients' health-related quality of life (HRQOL) has been carried out only in a few studies, and in most cases generic questionnaires have been adopted. Because the specific issue of living with dyspeptic problems has been addressed in very few cases and no questionnaire has been shown to be appropriate for the Italian setting, a prospective project was launched to develop a specific HRQOL questionnaire for dyspepsia sufferers tailored to Italian patients but also appropriate in other cultural settings. METHODS: The project consisted in a 3-yr, three-phase survey, in which different versions of the quality of life in peptic disease questionnaire (QPD) were developed through expert and patient focus groups and empiric field studies and then administered to patients recruited in five multicenter studies. Standard psychometric techniques were used to evaluate the validity, reliability, responsiveness, and patient acceptability of the QPD. RESULTS: Three different versions of the QPD questionnaire were self-administered to more than 4000 patients. The final 30-item version, measuring three health concepts related to dyspeptic disease (anxiety induced by pain, social restriction, symptom perception), fulfilled the recommended psychometric criteria in terms of reliability and validity, correlated with health concepts measured with a well-known independent generic HRQOL instrument (the SF-36 Health Survey questionnaire) and was relatively invariant to diagnosis and sociodemographic variables; it also correlated with a measure of gastric pain frequency and was able to detect meaningful differences over time. CONCLUSIONS: Although further validation studies in different cultural and linguistic settings are mandatory before any firm conclusions can be drawn regarding the cross-cultural validity of the QPD, the data obtained provide evidence of the psychometric validity and robustness of the questionnaire when used in a fairly large, well-characterized population of Italian dyspeptic patients.
Adult↗