Stefania Salpietro

San Raffaele Scientific Institute, Milano, Lombardy, Italy

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Publications (40)204.83 Total impact

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    ABSTRACT: This study analyzed the impact of PNPLA3 variants on liver histology of 168 HIV/HCV coinfected patients who were naïve for HCV treatment. A pathologist unaware of the patients’ condition graded liver fibrosis and necroinflammation (Ishak) and steatosis (Kleiner). Patients were tested for PNPLA3 variants and genotyped for the PNPLA3 rs738409 C to G variant underlying the I148M substitution. All were HBsAg-negative and stated no alcohol abuse.
    No preview · Article · Jan 2016 · Clinical Microbiology and Infection

  • No preview · Article · Oct 2015 · Clinical Infectious Diseases
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    Full-text · Article · Apr 2015 · AIDS (London, England)

  • No preview · Article · Apr 2015 · AIDS (London, England)

  • No preview · Article · Apr 2015 · Journal of Hepatology
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    ABSTRACT: Chronic kidney disease (CKD) is a major health issue for HIV-positive individuals, associated with increased morbidity and mortality. Development and implementation of a risk score model for CKD would allow comparison of the risks and benefits of adding potentially nephrotoxic antiretrovirals to a treatment regimen and would identify those at greatest risk of CKD. The aims of this study were to develop a simple, externally validated, and widely applicable long-term risk score model for CKD in HIV-positive individuals that can guide decision making in clinical practice.
    Full-text · Article · Mar 2015 · PLoS Medicine

  • No preview · Article · Feb 2015 · Digestive and Liver Disease
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    ABSTRACT: In this single-centre, retrospective study, we analyzed data of 194 patients receiving antiretroviral therapy with <50 human immunodeficiency virus (HIV) RNA copies/mL in plasma and 318 HIV RNA/DNA paired samples. By kinetic polymerase chain reaction (kPCR) molecular system analysis, 104 (54%) subjects had undetectable HIV RNA and 90 (46%) had residual viraemia. Median (interquartile range) HIV DNA load was 780 (380-1930) copies/10(6) peripheral blood lymphocytes (PBL), and HIV DNA loads were independently associated with residual viraemia (p 0.002). Virological rebound occurred in 29/194 (15%) patients over a median (interquartile range) follow-up of 17.5 (13.5-31.5) months. Residual viraemia (p 0.002), but not HIV DNA load, was independently associated with virological rebound. Copyright © 2014 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.
    No preview · Article · Jan 2015 · Clinical Microbiology and Infection
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    ABSTRACT: Introduction Unboosted atazanavir (ATV) including regimens have been investigated as a ritonavir-sparing simplification strategy. No data are available on removal of one NRTI in subjects effectively treated with unboosted atazanavir+2NRTIs. We present the 48-week virological efficacy and safety of unboosted atazanavir plus lamivudine (3TC) or emtricitabine (FTC) (lamivudine/emtricitabine/Reyataz©, LAREY Study). Materials and Methods Single arm, prospective, pilot study on HIV-treated patients, HBsAg negative, with HIV-RNA<50 cps/mL since at least 2 years, who switched from ATV+2NRTIs to ATV 400 mg QD +3TC or FTC. Virological failure was defined as 2 consecutive values of HIV-RNA>50 cps/ml; viral blip was defined as a single HIV-RNA value>50 cps/ml not subsequently confirmed. Results as median (IQR). Changes between baseline (BL) and week 48 assessed by the Wilcoxon signed rank test. Results Forty patients enrolled: 75% males, 51 (47–54) years, 14% HCV co-infected, infected with HIV since 16 (9–21) years, on antiretroviral therapy since 13 (5–16) years, with a nadir CD4+ of 254 (157–307) cells/mm3, virologically suppressed since 4.2 (2.2–5.4) years; 53 patients switched from a tenofovir (TDF)-based regimens; ATV was associated with 3TC in 83% patients. No virological failures or discontinuations were observed; three patients had a single viral blip in the range 50–250 copies/mL; CD4+ increased from 610 (518–829) cells/mm3 at BL to 697 (579–858) cells/mm3 at week 48 [48-week change: 39 (−63/+160) cells/mm3 p=0.081]. Three clinical events were observed (one herpes zoster, one pneumonia, one syphilis) in absence of renal lithiasis, AIDS-defining or drug-related events or death. Overall, significant 48-week amelioration of ALP [BL: 83 (71–107) mg/dL; 48-week change: −15 (−27/−8) mg/dL p<0.0001] and CKD-EPI [BL: 100 (86–108) ml/min/1.73 m2; 48-week change: 1.5 (−3/+8) ml/min/1.73 m2, p=0.042] were observed. Patients switching from TDF (Table 1) significantly improved CD4+, lymphocytes, hepatic profile, renal profile and ALP; these patients had also a modest but significant decrease in haemoglobin. Conclusions Switch from an unboosted atazanavir-based regimen to ATV+3TC or FTC regimen was effective and safe in this small sample, supporting the hypothesis of a potential two-steps de-intensification (removal of ritonavir and removal of one NRTI) in patients on long-lasting virological suppression.
    Full-text · Article · Nov 2014 · Journal of the International AIDS Society
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    ABSTRACT: Objective: Previous studies have shown that statins use is associated with a lower mortality risk or occurrence of non-Hodgkin's lymphoma or non-AIDS-defining malignancies (NADMs) in HIV-positive patients. We evaluated the effect of statin therapy on the occurrence of all AIDS-defining malignancy (ADM) and NADM among HIV-positive patients. Design: A chart study on HIV-1 infected patients attending the Infectious Diseases Department of the San Raffaele Scientific Institute, Italy. Methods: Incident malignancies diagnosed since antiretroviral treatment (ART) initiation until October 2012 among treated patients not taking statins at ART initiation. Statin therapy had to precede cancer diagnosis, if it occurred. Malignancies that occurred before ART or statin initiation were excluded. Follow-up was calculated since ART initiation until the first cancer diagnosis or loss to follow-up or death or last available visit, whichever occurred first. Results are described as median (interquartile range, IQR). Results: Five thousand, three hundred and fifty-seven HIV-1 treated patients were included. During 52 663 person-years, 740 (14%) patients had a history of statin use; 375 malignancies occurred: 12 (1.6%) malignancies (0 ADM; 12 NADM, crude incidence rate, 1.3/1000 person-years) among statin users and 363 (7.9%) malignancies (194 ADM; 169 NADM, crude incidence rate, 8.4/1000 person-years) among non-statin users. By multivariate Fine-Gray regression, statin use was associated with a lower risk of cancer [adjusted hazard ratio (95% confidence interval) for ever use: 0.45 (0.17-0.71)]. Conclusion: Among HIV-1 treated patients, statin use was associated with a lower risk of cancer; the benefit was mainly related to AIDS-defining malignancies. Confirmatory studies are needed to consider the residual confounding likely present in this study. (C) 2014 Wolters Kluwer Health vertical bar Lippincott Williams & Wilkins
    No preview · Article · Aug 2014 · AIDS (London, England)
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    ABSTRACT: In the study reported here, single-tablet regimen (STR) versus (vs) multi-tablet regimen (MTR) strategies were evaluated through a cost analysis in a large cohort of patients starting their first highly active antiretroviral therapy (HAART). Adult human immunodeficiency virus (HIV) 1-naïve patients, followed at the San Raffaele Hospital, Milan, Italy, starting their first-line regimen from June 2008 to April 2012 were included in the analysis. The most frequently used first-line HAART regimens (>10%) were grouped into two classes: 1) STR of tenofovir disoproxil fumarate (TDF) + emtricitabine (FTC) + efavirenz (EFV) and 2) MTR including TDF + FTC + EFV, TDF + FTC + atazanavir/ritonavir (ATV/r), TDF + FTC + darunavir/ritonavir (DRV/r), and TDF + FTC + lopinavir/ritoavir (LPV/r). Data were analyzed from the point of view of the Lombardy Regional Health Service. HAART, hospitalizations, visits, medical examinations, and other concomitant non-HAART drug costs were evaluated and price variations included. Descriptive statistics were calculated for baseline demographic, clinical, and laboratory characteristics; associations between categorical variables and type of antiretroviral strategy (STR vs MTR) were examined using chi-square or Fisher's exact tests. At multivariate analysis, the generalized linear model was used to identify the predictive factors of the overall costs of the first-line HAART regimens. A total of 474 naïve patients (90% male, mean age 42.2 years, mean baseline HIV-RNA 4.50 log 10 copies/mL, and cluster of differentiation 4 [CD4+] count of 310 cells/μL, with a mean follow-up of 28 months) were included. Patients starting an STR treatment were less frequently antibody-hepatitis C virus positive (4% vs 11%, P=0.040), and had higher mean CD4+ values (351 vs 297 cells/μL, P=0.004) than MTR patients. The mean annual cost per patient in the STR group was €9,213.00 (range: €6,574.71-€33,570.00) and €14,277.00 (range: €5,908.89-€82,310.30) among MTR patients. At multivariate analysis, after adjustment for age, sex, antibody-hepatitis C virus status, HIV risk factors, baseline CD4+, and HIV-RNA, the cost analysis was significantly lower among patients starting an STR treatment than those starting an MTR (adjusted mean: €12,096.00 vs €16,106.00, P=0.0001). STR was associated with a lower annual cost per patient than MTR, thus can be considered a cost-saving strategy in the treatment of HIV patients. This analysis is an important tool for policy makers and health care professionals to make short- and long-term cost projections and thus assess the impact of these on available budgets.
    Full-text · Article · Jan 2014 · Therapeutics and Clinical Risk Management
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    ABSTRACT: Background: The objective of this study was to compare immunologic, virologic, and clinical outcomes between living human immunodeficiency virus (HIV)-infected individuals who had a diagnosis of lymphoma versus outcomes in a control group of cancer-free, HIV-infected patients. Methods: In this matched cohort study, patients in the case group were survivors of incident lymphomas that occurred between 1997 and June 2010. Controls were living, cancer-free, HIV-infected patients who were matched to cases at a 4:1 ratio by age, sex, nadir CD4 cell count, and year of HIV diagnosis. The date of lymphoma diagnosis served as the baseline in cases and in the corresponding controls. Results: In total, 62 patients (cases) who had lymphoma (20 with Hodgkin disease [HD] and 42 with non-Hodgkin lymphoma [NHL]) were compared with 211 controls. The overall median follow-up was 4.8 years (interquartile range, 2.0-7.9 years). The CD4 cell count at baseline was 278 cells/mm³ (interquartile range, 122-419 cells/mm³) in cases versus 421 cells/mm³ (interquartile range, 222-574 cells/mm³) in controls (P = .003). At the last available visit, the CD4 cell count was 412 cells/mm³ (range, 269-694 cells/mm³) in cases versus 518 cells/mm³ (interquartile range, 350-661 cells/mm³) in controls (P = .087). The proportion of patients who achieved virologic success increased from 30% at baseline to 74% at the last available visit in cases (P = .008) and from 51% to 81% in controls (P = .0286). Patients with HD reached higher CD4 cell counts at their last visit than patients with NHL (589 cells/mm³ [range, 400-841 cells/mm³] vs 332 cells/mm³ [interquartile range, 220-530 cells/mm³], respectively; P = .003). Virologic success was similar between patients with HD and patients with NHL at the last visit. Forty cases (65%) and 76 controls (36%) experienced at least 1 clinical event after baseline (P < .0001); cases were associated with a shorter time to occurrence of the first clinical event compared with controls (P < .0001). Conclusions: HIV-infected lymphoma survivors experienced more clinical events than controls, especially during the first year of follow-up, but they reached similar long-term immunologic and virologic outcomes.
    No preview · Article · Aug 2013 · Cancer
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    ABSTRACT: We performed a cross-sectional study on adult HIV-infected patients, on HAART, without calcium or vitamin D supplementation to evaluate if the cardiovascular risk or the presence of osteoporosis may be predictive factors of an optimal daily calcium intake (DCI>1000 mg/day). Patients underwent a dual-energy X-ray absorptiometry, measured biochemical parameters and compiled a validated questionnaire for the assessment of DCI. Osteoporosis (OP) was defined according to the WHO classification at either the vertebral spine or femoral neck. Cardiovascular risk was assessed by the 10-year Framingham cardiovascular risk score. 200 HIV-infected patients evaluated: 171 (86%) males with a median age of 48.1 (42.3-53.8) years and 10.6 (4.3-13.6) years of HAART exposure. DCI was 889 (589-1308) mg/day and 79 (40%) patients had an optimal DCI. Framingham risk>20% was found in 13 (6.7%) patients and femoral OP was diagnosed in 12 (6%) pts. By multivariate analysis, optimal DCI was more likely in patients with a Framingham risk>20% [OR = 5.547, 95% CI:1.337, p = 0.025] and less likely in patients with femoral osteoporosis [OR = 0.159, 95% CI: 0.018-0.790, p = 0.047]. We found that an optimal dietary calcium intake was more likely in patients with high cardiovascular risk and no femoral osteoporosis.
    No preview · Article · Jul 2013 · Clinical nutrition (Edinburgh, Scotland)
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    ABSTRACT: Switches from lopinavir/ritonavir (LPV/r) to either atazanavir/ritonavir (ATV/r) or unboosted ATV (ATV) are increasingly common in clinical practice, but data on outcome comparison between these two simplification strategies are very limited. Methods. Multicenter, observational, retrospective study. Data were collected from five Italian clinics. The objective of the study was to investigate the utcome of LPV/r simplification with ATV/r or ATV and to identify factors predicting virological rebound. Patients who switched from LPV/r to ATV/r or ATV with an HIV-RNA value<50 copies/mL at the time of switch and with at least one follow-up visit were included. We evaluated 468 patients (74.1% males), followed for a median (Q1-Q3) of 547 (305-788) days: 380 (81%) and 88 (19%) switched to ATV/r and to ATV, respectively. Virological rebound was detected in 78/468 (16.7%, 95% CI: 13.6 -20.3) patients [16/88 (18.2%, 95% CI: 11.4 -27.6) switched to ATV and 62/380 (16.3%, 95% CI: 12.9 -20.4) to ATV/r (p=0.638)]. Virological rebound was more frequent in patients who started LPV/r with HIV-RNA >30000 copies/mL (28% vs 6%, p=0.014). Replacing lopinavir/r with ATV or ATV/r yielded similar rates of virological rebound. Viral load at the initiation of lopinavir/r may be useful in driving the choice between ATV/r and ATV. Lopinavir, Atazanavir, Ritonavir, Unboosted, Simplification.
    Full-text · Article · Jul 2013 · The New Microbiologica: official journal of the Italian Society for Medical Virology (SIVIM)
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    ABSTRACT: Human immunodeficiency virus (HIV) -infected patients with HIV RNA loads of < 50 copies/mL were followed-up for a median (interquartile range) of 30.8 (11.7-32.9) months to study the effect of residual viraemia (RV) on virological rebound (VR). At baseline, 446 (60.3%) patients had undetectable HIV RNA (group A) and 293 (39.7%) had RV (1-49 HIV RNA copies/mL, group B) by kinetic PCR. VR occurred in 4 (0.9%) patients in group A and in 12 (4.1%) patients in group B (p 0.007). Time to VR was shorter among patients of group B (Log-rank test: p 0.003). However, the proportion of VR was extremely low also among patients with RV.
    Preview · Article · May 2013 · Clinical Microbiology and Infection
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    ABSTRACT: Background & aims: HIV-monoinfected patients are susceptible to liver injury by different factors and may develop liver fibrosis, which requires adequate clinical management in terms of therapy and disease monitoring. We aimed to evaluate the presence of liver fibrosis identified by transient elastography (TE), its relationships with indirect biochemical markers [the aspartate aminotransferase/platelet ratio index (APRI), the Forns index and FIB-4] and its predictive factors in HIV-monoinfected patients receiving antiretroviral therapy (ART). Methods: Seventy-two HIV-monoinfected patients underwent TE and were evaluated using APRI, Forns and FIB-4. The clinical, immunological, virological and other biochemical characteristics were evaluated at the time of TE, together with their history of ART. Results: Seven patients (10%) had liver stiffness (LS) values predicting cirrhosis, and 12 (17%) had values predicting significant or advanced fibrosis. Higher indirect biochemical scores of liver fibrosis were significantly associated with higher LS values [APRI rs = 0.4296 (P < 0.001); Forns rs = 0.4754 (P < 0.001); FIB-4 rs = 0.285 (P = 0.015)]. At multivariable analysis, APRI (β = 2.7405; P = 0.036), Forns (β = 1.4174; P = 0.029) and triglyceride levels (β = 1.3028; P = 0.007) were independently associated with LS. Conclusions: Indirect fibrosis biomarkers may increase the probability to detect liver injury enhancing a specific diagnostic workup and so contribute to improving the clinical management of HIV-monoinfected patients with clinically suspected liver disease.
    No preview · Article · Mar 2013 · Liver international: official journal of the International Association for the Study of the Liver
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    A Castagna · G Colombo · S Salpietro · L Galli · A Poli · A Lazzarin
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    ABSTRACT: We evaluated the single-tablet regimen (STR) versus multiple-tablet regimen (MTR) strategies through an incremental cost-effectiveness analysis in a large cohort of patients starting their first HAART. Adult HIV-1-naïve patients, followed at the San Raffaele Hospital, starting their first-line regimen from June 2008 to April 2012, were included in the analysis. First-line HAART regimens more frequently used (>10%) were grouped into two classes as follows: a) single-tablet regimen (STR) of TDF + FTC + EFV; b) multiple-tablet regimen (MTR) including TDF + FTC + EFV, TDF + FTC + ATV/r, TDF + FTC + DRV/r TDF + FTC + LPV/r. The incremental cost-effectiveness analysis was carried out by means of a Markov model calculating quality of life and costs for each patient, according to the given regimen (including any subsequent switch if occurred), through 1-year cycles. The outcome measure was quality-adjusted life-years (QALYs). Data were analysed from the point of view of the Lombardy Regional Health Service (RHS): HAART, hospitalisations, visits, examinations and other concomitant non-HAART drugs costs were evaluated, price variations included. 474 naïve patients: 90% males, mean age 42.2 years, mean baseline HIV-RNA 4.50 log10copies/ml and CD4+ count of 310 cells/µL with a mean follow-up of 28 months. Patients starting with an STR treatment were less frequently HCVAb positive (4% vs 11%, P=0.040), had higher mean CD4+ values [351 vs 297, P=0.004] as compared to MTR patients. The mean year cost/patient was €9,213 (range: €6,574.71-€33,570.00) with a mean per patient QALYs of 0.986 (range: 0.878-0.999) among STR patients; the mean year cost/patient was €14,277 (range: €5,908.89-€82,310.30) with a mean QALY of 0.933 (0.830-0.976) among MTR patients. STR dominates (i.e. is more effective and less costly) compared to MTR. (Fig. 1) At multivariable analysis, after adjustment for age, gender, HCVAb status, HIV risk factor, baseline CD4+ and HIV-RNA, the cost-effectiveness ratio was significantly lower among patients starting an STR treatment as compared to a MTR regimen (adjusted mean: €12,096 vs. €16,106; P=0.0001). The incremental cost-effectiveness ratio (ICER) values comparing the two treatment strategies reported in the table. Starting with a first-line STR regimen compared to multiple-tablet regimens resulted cost-effective showing lower costs and better efficacy as measured by QALYs.
    Full-text · Article · Nov 2012 · Journal of the International AIDS Society
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    ABSTRACT: Objectives: The aim of the study was to assess whether pill burden is associated with self-reported adherence to current combination antiretroviral regimens and health status in a large sample of unselected and chronically treated HIV-infected patients. Methods: An adherence and health status questionnaire was offered to all patients collecting their drugs between March and May 2010 at our clinic; both parameters were primarily evaluated using a visual analogue scale. Linear correlations were evaluated using Spearman's correlation coefficient. Wilcoxon's rank-sum test and the χ(2) test were used to compare quantitative and qualitative variables. The generalized linear model was used in multivariable analyses. Results: Among 2763 subjects on treatment during the study period, 2114 (78.8% male; mean age 46.9 ± 8.84 years) were tested for adherence; 1803 (85.3%) had viral loads < 50 HIV-1 RNA copies/mL. After adjusting for age, gender, HIV risk factor, current CD4 count, pill burden and dosing interval, adherence was higher in patients with undetectable HIV RNA (P < 0.0001) and directly associated with current CD4 count (P = 0.029). After adjusting for the same variables, health status was better in patients with undetectable viraemia (P = 0.004) and in men who have sex with men (MSM) and heterosexuals compared with injecting drug users and those with other risk factors (P < 0.0001 for MSM and P = 0.008 for heterosexuals); it was also directly associated with current CD4 count (P < 0.0001) and inversely associated with age (P < 0.0001) and pill burden (P = 0.019). Conclusions: In this highly adherent population, the number of daily pills was related to self-reported health status but not to self-reported adherence, whereas the dosing interval did not influence self-reported adherence or health status.
    No preview · Article · Sep 2012 · HIV Medicine
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    ABSTRACT: It is currently debated whether patients with residual viraemia are at higher risk of virological failure than those attaining <1 HIV RNA copy/mL. We therefore investigated the effect of residual viraemia on virological rebound. We used a prospective, non-interventional, single-centre, study. This analysis was based on HIV-infected patients with two consecutive HIV RNA viral loads (VLs) of <50 copies/mL as tested by Versant bDNA, followed by two HIV RNA VLs of <50 copies/mL as tested using the Versant kinetic PCR molecular system (kPCR; limit of quantification = 1 copy/mL). Virological rebound was defined as two consecutive HIV RNA values of >50 copies/mL after baseline, and the time to virological rebound was calculated using the Kaplan-Meier method. There were 739 eligible patients; 446 (60.4%) had HIV RNA <1 copy/mL (group A) and 293 (39.6%) had residual viraemia (1-49 HIV RNA copies/mL; group B). After a follow-up (median 48.9 weeks), virological rebound occurred in four patients in group A (0.9%) and six patients in group B (2%); the time to virological rebound was similar in the two groups (log-rank test P = 0.231). CD4+ cell recovery (slope) was significantly less in the patients with residual viraemia; +14.3 (-7.7, 43.9) cells/mm(3) per year versus +21.2 (-2.5, 53.2) cells/mm(3) per year; P = 0.036. Residual viraemia assessed by kPCR was not associated with virological rebound during 1 year of follow-up. However, the patients attaining <1 HIV RNA copy/mL showed a small but statistically significant improvement in CD4+ cell recovery.
    Preview · Article · Sep 2012 · Journal of Antimicrobial Chemotherapy

  • No preview · Article · Jul 2012 · JAIDS Journal of Acquired Immune Deficiency Syndromes