Papers by Pietro Colletti
Frontiers in medicine, Mar 11, 2024
Conclusion: The mortality risk reported in our study was lower than that previously reported. Alt... more Conclusion: The mortality risk reported in our study was lower than that previously reported. Although CAS/IMV is no longer used, our score might help in identifying which patients are not likely to benefit from monoclonal antibodies and may require alternative interventions.
Gastroenterology, Aug 1, 2018
Background & Aims: Studies have produced conflicting results of the incidence of hepatocellular c... more Background & Aims: Studies have produced conflicting results of the incidence of hepatocellular carcinoma (HCC) in patients with in hepatitis C virus (HCV)-associated cirrhosis treated with direct-acting antivirals (DAAs). Data from clinics are needed to accurately assess the occurrence rate of HCC in patients with cirrhosis in the real world. Methods: We collected data from a large prospective study of 2249 consecutive patients (mean age, 65.4 years and 56.9% male) with HCV-associated cirrhosis (90.5% Child-Pugh class A, 9.5% Child-Pugh class B) treated with DAAs from March 2015 through July 2016 at 22 academic and community liver centers in Sicily, Italy. HCC occurrence was evaluated by Kaplan-Meier curves. Cox regression analysis was used to identify variables associated with HCC development. Results: A sustained virologic response (SVR) was achieved by 2140 patients (95.2% total; 95.9% of Child Pugh class A and 88.3% of Child Pugh class B patients (P<.001). Seventy-eight patients (3.5%) developed HCC during a mean follow-up of 14 months (range, 6-24 months). At 1 year after DAA exposure, HCC developed in 2.1% of Child-Pugh class A patients with an SVR and 6.6% of patients with no SVR; HCC developed in 7.8% of Child-Pugh class B patients with an SVR and 12.4% of patients with no SVR (P<.001 by log-rank test). Albumin level below 3.5 g/dL (hazard ratio,1.77; 95% CI, 1.12-2.82; P=.015), platelets count below 120x10 9 /L (hazard ratio, 3.89; 95% CI, 2.11-7.15; P<.001), and absence of SVR (hazard ratio, 3.40; 95% CI,1.89-6.12; P<.001) were independently associated increased risk for HCC. The mean interval in time from DAA exposure to an HCC diagnosis was 9.8 months (range, 2-22 months) and did not differ significantly between patients with (n=64, 9.2 months) and without an SVR (n=14, 12.0 months) (P=.11). A higher proportion of patients with an SVR had a single HCC lesion 6 (78% vs 50% without an SVR; P=.009) or HCC lesion less than 3 cm (58% vs 28% without an SVR; P=.07). Conclusions: In an analysis of data from a large prospective study of patients with HCVassociated compensated or decompensated cirrhosis, we found that SVR to DAA treatment to reduce the incidence of HCC over a mean follow-up of 14 months.
PubMed, Oct 1, 1998
A cross-sectional study was carried out on the sera of 88 active intravenous drug users (IVDU) co... more A cross-sectional study was carried out on the sera of 88 active intravenous drug users (IVDU) collected between 1985 and 1986 to evaluate the circulation of HCV genotypes in Western Sicily. The patients were grouped by age and classified by their HIV status. Genotype 3a (48.8% of all cases) was most frequently detected, followed by genotype 1a (20.4%) and type 1b (17.0%). No significant differences in HCV genotype distribution were observed between HIV positive and negative individuals. Next, the HCV genotype distribution found in sera samples of IDVUs drawn between 1985 and 1986 was studied and divided into three age groups. The genotype distribution in the younger group was then compared with samples collected ten years later, between 1995 and 1996, from young HIV negative IVDU individuals. A different distribution between HCV genotypes 3a and 1a was found with a relative, though not significant, increase in the detection of genotype 1a (38%). Finally, sera from six IVDUs obtained at three different times over a ten-year period were genotyped for HCV. None of the subjects showed any change in the genotype found at the first sampling throughout the ten years. The results suggest that a) genotype 1a and 3a are the most common among IVDUs in Western Sicily, b) concurrent HIV infection does not seem to influence HCV genotype and c) infected IVDUs harbor almost exclusively one genotype.
Journal of Hepatology, Apr 1, 2012
Background and Aims: Limited data are available on hepatic steatosis (HS) among human immunodefic... more Background and Aims: Limited data are available on hepatic steatosis (HS) among human immunodeficiency virus (HIV) patients uninfected with hepatitis C virus (HCV). Little is known about the relationship between cardiovascular (CVD) risk and HS in HIV monoand HIV/HCV co-infected patients. Aims of the study were to assess prevalence of HS and its risk factors in HIV-patients and to evaluate whether HS correlated with advanced liver fibrosis (ALF) and/or CVD risk. Methods: Fifty seven HIV monoand 61 HIV/HCV co-infected patients were consecutively enrolled. The “bright liver echopattern” (BL) was used for HS diagnosis. ALF was defined as “liver stiffness” ≥ 9.5 kPa by transient elastography (TE). Main parameters of liver function, glycaemia, total cholesterol (T-Chol), triglycerides (TG), HDL-C, HIV and HCV viral load, duration of highly active antiretroviral therapy (HAART) and CD4+ cell count were recorded. CVD risk was appreciated using the 10-year Framingham risk score (FRS) and the diagnosis of metabolic syndrome (MS) performed according to ATP III criteria. Results: In the whole HIV-population HS prevalence was 52.5% (54.4% in HIV monoand 50.8% in co-infected patients (P = not significant). HS was associated with lipodistrophy, TG values (P < 0.0001), MS (P < 0.0004) and T-Chol levels (P < 0.001) in both HIV-groups (table). In HIV mono-infected patients HS was linked with HAART exposure >1 year (P < 0.01). By multivariate analysis only TG levels (P < 0.02) and FRS (P < 0.05) were indipendently associated with HS in both HIV groups. No correlation was observed between HS and ALF, measured by TE.
Journal of Hepatology, 2017
Infection, Dec 5, 2018
Purpose We aimed to assess the diagnostic reliability of two indirect biomarkers, APRI and FIB-4,... more Purpose We aimed to assess the diagnostic reliability of two indirect biomarkers, APRI and FIB-4, for the staging of liver fibrosis using transient elastography (TE) as reference standard, among HIV/HCV co-infected and HCV mono-infected patients. Methods This is an observational, retrospective study on subjects who had access to the RESIST HCV from October 2013 to December 2016, a regional network encompassing 22 hospitals and academic centers throughout Sicily. Sensitivity, specificity and diagnostic accuracy of indirect biomarkers for liver stiffness measurement (LSM) < 9.5 kPa (significant fibrosis) and LSM ≥ 12.5 kPa (cirrhosis) were determined by receiver operator characteristics (ROC) curves. Results 238 HIV/HCV co-infected and 1937 HCV mono-infected patients were included. Performances of FIB-4 and APRI for the detection of significant fibrosis and cirrhosis proved to be unsatisfactory, with very high false negative and false positive rates among both cohorts. No significant differences were found after stratification of HIV/HCV co-infected patients for BMI < or ≥ 25, ALT < or ≥ 40 IU/L, ALT < or ≥ 80 IU/L, and presence/absence of a bright liver echo pattern on ultrasonography. Conclusions Differently from other studies, we detected the unreliability of APRI and FIB-4 for the assessment of liver fibrosis in both HCV mono-infected and HIV/HCV co-infected patients.
Digestive and Liver Disease, 2017
12 weeks plus RBV (100/107, 93.4%), while was suboptimal in G1b F3 (41/46, 89.1%) and Child-A cir... more 12 weeks plus RBV (100/107, 93.4%), while was suboptimal in G1b F3 (41/46, 89.1%) and Child-A cirrhosis (33/42, 78.5%) treated for 12 weeks without RBV. OBV/PTV/r/DSV for 12 weeks was optimal in G1b F3 (105/109, 96.4%), as well as in G1b Child-A cirrhosis treated with (196/211, 92.8%) or without (82/85, 96.4%) RBV. SOF + DCL was optimal in G1b F3 treated for 12 weeks (10/10, 100%) and in G1b Child-A cirrhosis treated for 12/24 weeks with RBV (49/51, 96.1%), while was sub-optimal in G1b Child-A cirrhosis treated for 24 weeks without RBV (43/52, 82.7%). SOF + DCL was also optimal in G2 Child-A cirrhosis treated for 12 weeks (20/22, 90.2%) and in G3 Child-A cirrhosis treated for 24 weeks with RBV (39/43, 90.6%), while was sub-optimal in G3 Child-A cirrhosis treated for 24 weeks without RBV (27/32, 84.3%). Finally, SOF + SIM was optimal in G1b Child-A cirrhosis treated for 12 weeks with RBV (230/246, 93.5%), while was sub-optimal in G1b F3 (12/16, 75%) and G1b Child-A cirrhosis (34/46, 73.9%) treated for 12 weeks without RBV. Conclusions: Real-life data confirmed the efficacy of DAAs in HCV advanced fibrosis or cirrhosis using carefully therapy time and the addiction of RBV.
Digestive and Liver Disease, 2016
Background and aim: Phase 3 studies of Direct Acting Antivirals (DAAs) in patients with chronic h... more Background and aim: Phase 3 studies of Direct Acting Antivirals (DAAs) in patients with chronic hepatitis C or cirrhosis included few patients over 70 years. To evaluate the safety and efficacy of DAAs in elderly, we used the ongoing dataset from our regional database, RESIST-HCV. Patients and methods: Between March and October 2015, 7340 patients were registered in RESIST-HCV, 3264 (44.5%) met the AIFA criteria for treatment and 2307 (31.5%) started DAAs. Of these 2307 patients, 762 (33%) were elderly (age 70 years). Regimen choice and use of ribavirin were based on viral genotype and stage of disease, according to guidelines. Data on viral response are available at the end of treatment (ETR). SVR 12 data will be presented at the meeting. Results: Elderly cohort had a higher prevalence of women (49% vs 33%, p < 0.001), P/R naïve patients (50% vs 41%, p < 0.001), genotype 1b (84% vs 65%, p < 0.001), F4 fibrosis (78% vs 63%, p < 0.001), arterial hypertension (50% vs 30%, p < 0.001), hearth disease (10% vs 4%, p < 0.001), stage-3 kidney disease (18% vs 3%, p < 0.001) and co-medications (79% vs 68%, p < 0.001) than 1545 patients under 70 years. The prevalence of diabetes was comparable (29% vs 26%, p = 0.1). HIV co-infection (0.01 vs 6%, p < 0.001) and previous OLT (5.5% vs 7.8%, p < 0.03) were less frequent in elderly. In October 2015 390 patients (17%) concluded treatment. By ITT, the rate of ETR was 93.5% (129/138) in elderly and 95.2% (240/252) in under 70. Twenty-one out of 392 (5%, 12 elder and 9 non-elder) stopped treatment due to adverse events. Two patients died (1 elder, liver failure; 1 non-elder, variceal bleeding). Conclusions: DAAs regimens in practice are safe and effective in elderly patients with cirrhosis or severe fibrosis due to HCV as in a younger population. The lifetime utility of HCV eradication in terms of reduction of events and survival needs evaluation in long-term observational cohorts.
Artery Research, 2020
Background: The risk of Cardiovascular (CV) events is higher in HIV-infected patients (HIV+) comp... more Background: The risk of Cardiovascular (CV) events is higher in HIV-infected patients (HIV+) compared to HIV-uninfected persons (HIV−). Large artery stiffness, a well-documented predictor of adverse CV prognosis, may mediate this enhanced risk. It is usually assessed by measuring aortic Pulse Wave Velocity (aPWV). Studies examining arterial stiffness in HIV+ yielded inconsistent results. We performed a meta-analysis with the aim to evaluate the association of HIV infection and its therapy [Antiretroviral Therapy (ART)] with aPWV. Design and Method: The Standardized Mean Difference (SMD) and corresponding 95% confidence intervals were calculated for aPWV in different comparison groups. Statistical heterogeneity, assessed by Q-test and I 2 statistic, was observed in all these comparisons. Therefore, random effects model was implemented. Results: In a total of 12 studies, naive HIV+ (n = 547) showed increased aPWV compared to HIV− (n = 864): SMD = 0.333 (0.125-0.542), p < 0.002. A total of 22 studies were identified comparing HIV+ treated with ART (n = 3348) to HIV− (n = 2547) showing higher values of aPWV in the former than in latter: SMD = 0.391 (0.225-0.556), p < 0.001. In 10 studies, HIV+ treated with ART (n = 761) exhibited greater aPWV values than those of naive HIV+ (n = 457): SMD = 0.262 (0.006-0.518), p = 0.045. Conclusion: Our meta-analysis seems to suggest that HIV infection "per se" and ART may impair aortic distensibility. However, interpretation of our results needs caution due to between-study heterogeneity and some potential publication biases.
Acta Endocrinologica (Bucharest), 2018
Context. Nonalcoholic fatty liver disease is common in type 2 diabetes mellitus patients, being d... more Context. Nonalcoholic fatty liver disease is common in type 2 diabetes mellitus patients, being difficult to diagnose. Objective. To find a correlation between elastographic parameters and lab results, for facilitating the diagnosis of nonalcoholic fatty liver disease. Design. This is a cross sectional study, conducted at the Departments of Diabetes, Nutrition and Metabolic Diseases, and Gastroenterology and Hepatology, of the Clinical Emergency Hospital "Pius Brinzeu" Timisoara. Subjects and Methods. We included 190 type 2 diabetes mellitus patients, collected data regarding medical history, clinical and biological features and applied the Alcohol Use Disorders Identification Test. We excluded patients with other causes of liver disease. Liver steatosis and fibrosis were evaluated through transient elastography, yielding two parameters: liver stiffness as an indicator of liver fibrosis stage, expressed in kPa, and liver steatosis stage, assessed by controlled attenuation parameter, expressed in dB/m. Data were analyzed using SPSS 15. Results. The analyzed group comprised 113 patients. Elastographic measurements showed that 93.8% of the patients had steatosis (controlled attenuation parameter ≥232.5 dB/m) and 70.8% severe steatosis (controlled attenuation parameter ≥290 dB/m). Severe steatosis was more common in women (75.7%) than in men (68.1%) (p<0.0001). From the patients with steatosis, 47.2% had liver stiffness values suggestive for fibrosis and 19.8% for cirrhosis. Most patients with steatosis and severe fibrosis were obese (66.7%). Triglycerides/HDLc ratio >4 correlated with hepatic steatosis (p=0.04), being more common in patients with severe fibrosis/cirrhosis (58.3%) than in those with absent or mild fibrosis (36.2%). Conclusions. Our study found a clear correlation between type 2 diabetes mellitus and the presence of liver steatosis. It correlates with body mass index, waist circumference (in men) and triglycerides/HDLc ratio. Controlled attenuation parameter is a useful noninvasive method for detection and quantification of liver steatosis.
AIDS Research and Human Retroviruses
<p>Completed trials of PrEP.</p
Artery Research, 2020
Background: The risk of Cardiovascular (CV) events is higher in HIV-infected patients (HIV+) comp... more Background: The risk of Cardiovascular (CV) events is higher in HIV-infected patients (HIV+) compared to HIV-uninfected persons (HIV−). Large artery stiffness, a well-documented predictor of adverse CV prognosis, may mediate this enhanced risk. It is usually assessed by measuring aortic Pulse Wave Velocity (aPWV). Studies examining arterial stiffness in HIV+ yielded inconsistent results. We performed a meta-analysis with the aim to evaluate the association of HIV infection and its therapy [Antiretroviral Therapy (ART)] with aPWV. Design and Method: The Standardized Mean Difference (SMD) and corresponding 95% confidence intervals were calculated for aPWV in different comparison groups. Statistical heterogeneity, assessed by Q-test and I 2 statistic, was observed in all these comparisons. Therefore, random effects model was implemented. Results: In a total of 12 studies, naive HIV+ (n = 547) showed increased aPWV compared to HIV− (n = 864): SMD = 0.333 (0.125-0.542), p < 0.002. A total of 22 studies were identified comparing HIV+ treated with ART (n = 3348) to HIV− (n = 2547) showing higher values of aPWV in the former than in latter: SMD = 0.391 (0.225-0.556), p < 0.001. In 10 studies, HIV+ treated with ART (n = 761) exhibited greater aPWV values than those of naive HIV+ (n = 457): SMD = 0.262 (0.006-0.518), p = 0.045. Conclusion: Our meta-analysis seems to suggest that HIV infection "per se" and ART may impair aortic distensibility. However, interpretation of our results needs caution due to between-study heterogeneity and some potential publication biases.
Digestive and Liver Disease, 2019
American Journal of Gastroenterology, 2019
INTRODUCTION: The Baveno VI consensus guidelines and an expanded algorithm suggest that transient... more INTRODUCTION: The Baveno VI consensus guidelines and an expanded algorithm suggest that transient elastography (TE) and platelet (PLT) count can be used to identify patients with cirrhosis who can avoid esophagogastroduodenoscopy (EGD). The primary aims of this study were to assess the ability of a simple algorithm, which uses only laboratory parameters, to predict medium/large esophageal varices (EV) in patients with hepatitis C virus (HCV) and cirrhosis from the Rete Sicilia Selezione Terapia-HCV (RESIST-HCV) cohort and to compare the performance of the algorithm with Baveno VI and Expanded Baveno VI criteria. The secondary aim was to assess the role of TE in ruling out large EV.
Infection, 2018
Purpose We aimed to assess the diagnostic reliability of two indirect biomarkers, APRI and FIB-4,... more Purpose We aimed to assess the diagnostic reliability of two indirect biomarkers, APRI and FIB-4, for the staging of liver fibrosis using transient elastography (TE) as reference standard, among HIV/HCV co-infected and HCV mono-infected patients. Methods This is an observational, retrospective study on subjects who had access to the RESIST HCV from October 2013 to December 2016, a regional network encompassing 22 hospitals and academic centers throughout Sicily. Sensitivity, specificity and diagnostic accuracy of indirect biomarkers for liver stiffness measurement (LSM) < 9.5 kPa (significant fibrosis) and LSM ≥ 12.5 kPa (cirrhosis) were determined by receiver operator characteristics (ROC) curves. Results 238 HIV/HCV co-infected and 1937 HCV mono-infected patients were included. Performances of FIB-4 and APRI for the detection of significant fibrosis and cirrhosis proved to be unsatisfactory, with very high false negative and false positive rates among both cohorts. No significant differences were found after stratification of HIV/HCV co-infected patients for BMI < or ≥ 25, ALT < or ≥ 40 IU/L, ALT < or ≥ 80 IU/L, and presence/absence of a bright liver echo pattern on ultrasonography. Conclusions Differently from other studies, we detected the unreliability of APRI and FIB-4 for the assessment of liver fibrosis in both HCV mono-infected and HIV/HCV co-infected patients.
Patient Preference and Adherence, 2016
in order to identify factors related to the frequency of their visits to the outpatient facility ... more in order to identify factors related to the frequency of their visits to the outpatient facility for health care services. Methods: Two hundred and twenty-four HIV-infected subjects were enrolled in the study. Demographic and HIV disease characteristics were recorded and assessed with the number of days accessed to our outpatients unit in univariate and multivariate analyses. The potential relationship with immunological status was also analyzed stratifying the patients into groups according to their CD4 + T-cell counts ($500 vs ,500/mm 3 , and $200 vs ,200/mm 3). Results: Both univariate and multivariate analyses showed that duration of antiretroviral therapy ,5 years and hypertension were significantly associated with a CD4 + T-cell count of ,500/mm 3 , whereas geographic origin (Africa) was associated with a CD4 + T-cell count of ,200/mm 3. Mean number of days the patients sought access to day-care services for laboratory tests was negatively associated with CD4 + T-cell count. Conclusion: Patients with low CD4 + T-cell counts showed higher use of health care services, demonstrating how early HIV diagnosis can help to reduce health care costs. The CD4 + T-cell cutoff of 200 cells emphasizes the importance of identifying and managing HIV infection among hard-to-reach groups like vulnerable migrants. In our sample, the illegal status of immigrants does not influence the management of their HIV/AIDS condition, but the lack of European health card that documents the current antiretroviral status, could interfere with the efforts to eradicate AIDS. A better understanding of the major determinants of HIV treatment costs has led to appropriate large-scale actions, which in turn has increased resources and expanded intervention programs. Further guidance should be offered to hard-to-reach groups in order to improve early AIDS diagnosis, and procedures for identifying and managing these vulnerable subjects should be made available to care commissioners and service providers.
Le infezioni in medicina : rivista periodica di eziologia, epidemiologia, diagnostica, clinica e terapia delle patologie infettive, 2010
Anthrax is a disease caused by Bacillus anthracis which affects herbivorous animals. Humans acqui... more Anthrax is a disease caused by Bacillus anthracis which affects herbivorous animals. Humans acquire the disease incidentally by exposure to infected animals, animal products or spores on soil. The infection is still endemic in many regions in developing countries. In Italy animal clusters are very rare and human cases are exceptional. Bacillus anthrax is also a potential source for acts of bioterrorism. In the natural human infection, cutaneous anthrax is the most widespread, while the other two, pulmonary and gastrointestinal anthrax, are very rare forms. We describe the first case of human anthrax occurring in western Sicily in the last twenty years. The cutaneous lesion healed without significant scarring after antibiotic treatment with tigecycline, rifampin and ciprofloxacin. Following our diagnosis, a cluster of bovine anthrax was detected in the district of Sciacca, causing the death of 13 animals. A larger outbreak was avoided by the vaccination of over 5000 herbivores.
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Papers by Pietro Colletti