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1.
SAGE Open Med ; 10: 20503121221113938, 2022.
Article En | MEDLINE | ID: mdl-35924140

Objectives: Data on HIV/AIDS cases in Italy are collected using a standardised form. Regional epidemiology may vary. We described the epidemiological and clinical characteristics of newly diagnosed persons with HIV in the 'Cotugno' hospital in Naples during 2011-2018 and compared them with national data to identify similarities and differences. Methods: Data source for the Campania region is the data collection forms sent to the national surveillance system. The data source for the national data is from the periodic annual bulletins on HIV/AIDS published by the National Institute of Health. Results: In all, 1149 persons with HIV were diagnosed in 'Cotugno' (69.7% of those diagnosed in Campania). Persons with HIV in Campania showed many similarities with the Italian population: men were in the majority in both groups (about 75%), foreign origin was about 30%, heterosexuals were the most represented risk group, followed by men who have sex with men and injecting drug use in both samples. Some notable differences are also present. Among the risk factors for HIV acquisition, injecting drug use is significantly more common in Campania. Among the reasons for testing, significant differences are evident for almost all reasons, with screening activities (testing for concurrent diseases, for diagnosis of sexually transmitted diseases, screening in hospital during maternity care and screening in drug-addition services or prisons) being more common at the national level. The Campania population has a more severe disease pattern, with a significantly higher proportion of patients diagnosed with less than 200 CD4 cells/µL and AIDS. For each variable, we compared trends in the Campania region and in Italy using Spearman's correlation coefficient. Almost all trends show a weak correlation. Conclusion: In conclusion, the prevalence of injecting drug use is still consistent, and requires specific campaigns. The reasons for testing are different: screening activities work less in Campania than in Italy. This untimely approach contributes to a more severe clinical picture in Campania.

2.
Clin Microbiol Infect ; 27(3): 389-395, 2021 Mar.
Article En | MEDLINE | ID: mdl-33359375

SCOPE: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has become pandemic, reaching almost one million death worldwide. At present standard treatment for coronavirus disease 2019 (COVID-19) is not well defined because the evidence, either from randomized or observational studies, with conflicting results, has led to rapid changes in treatment guidelines. Our aim was to narratively summarize the available literature on the management of COVID-19 in order to combine current evidence and interpretation of the data by experts who are treating patients in the frontline setting. METHODS: The panel conducted a detailed review of the literature and eventual press releases from randomized clinical trials for each possible available treatment. Inductive PubMed search waws performed for publications relevant to the topic, including all clinical trials conducted. The result was a flowchart with treatment indications for patients with COVID-19. IMPLICATIONS: After 6 months of a pandemic situation and before a possible second coronavirus wave descends on Europe, it is important to evaluate which drugs proved to be effective while also considering that results from many randomized clinical trials are still awaited. Indeed, among treatments for COVID-19, only glucocorticoids have resulted in an association with a significant decrease in mortality in published randomized controlled trials. New therapeutic strategies are urgently needed.


COVID-19 Drug Treatment , Practice Guidelines as Topic , Societies, Medical/standards , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/therapy , Humans , Italy/epidemiology , Randomized Controlled Trials as Topic , SARS-CoV-2/isolation & purification , Standard of Care
3.
New Microbiol ; 43(1): 28-33, 2020 Jan.
Article En | MEDLINE | ID: mdl-32118282

In Italy, malaria continues to be one of the most common imported parasitoses; therefore, continuous surveillance of epidemiological data and clinical management is needed. In 2016, the National Institute for Infectious Diseases 'Lazzaro Spallanzani' in Rome promoted a retrospective questionnaire-based survey to assess the clinical management of imported malaria cases in Italy in 2015. The questionnaire was sent to 104 Tropical and/or Infectious Diseases Units in the country, and 37 of them filled out and returned the questionnaires. A total of 399 malaria cases were reported in 2015, mostly caused by Plasmodium falciparum and imported from Africa. Malaria chemoprophylaxis was correctly used by a minority of patients. Most patients presented with uncomplicated malaria and were treated orally. In severe cases, intravenous artesunate or quinine alone or in combination were administered, although one third of these severe cases received oral treatment. This retrospective survey reveals a lack of homogeneity in management of malaria-imported cases in Italy. Improvement of malaria chemoprophylaxis, standardization of clinical management of malaria cases and harmonization of oral and intravenous drug availability are needed throughout the country.


Antimalarials , Malaria , Travel , Antimalarials/therapeutic use , Cross-Sectional Studies , Humans , Italy , Malaria/drug therapy , Malaria/prevention & control , Plasmodium , Retrospective Studies , Surveys and Questionnaires
4.
Infection ; 47(1): 141-168, 2019 Feb.
Article En | MEDLINE | ID: mdl-30255389

Hepatitis C virus (HCV) infection is now considered a systemic disease due to the occurrence of extra-hepatic manifestations. Among these, the renal involvement is frequent. HCV infection, in fact, is strongly associated with proteinuria and chronic kidney disease (CKD) and negatively affects the prognosis of renal patients. In the last few years, availability of more specific and effective drugs against HCV has dramatically changed the clinical course of this disease. These drugs may provide further advantages in the CKD population as a whole by reducing progression of renal disease, mortality rate and by increasing the survival of graft in renal transplant recipients. The strict pathogenetic and prognostic link between HCV infection and CKD requires an ongoing relationship among the healthcare professionals involved in the treatment of both HCV infection and CKD. Therefore, Scientific Societies involved in the care of this high-risk population in Italy have organized a joint expert panel. The aim of the panel is to produce a position statement that can be used in daily clinical practice for the management of HCV infected patients across the whole spectrum of renal disease, from the conservative phase to renal replacement treatments (dialysis and transplantation). Sharing specific evidence-based expertise of different professional healthcare is the first step to obtain a common ground of knowledge on which to instate a model for multidisciplinary management of this high-risk population. Statements cover seven areas including epidemiology of CKD, HCV-induced glomerular damage, HCV-related renal risk, staging of liver disease in patients with CKD, prevention of transmission of HCV in hemodialysis units, treatment of HCV infection and management of HCV in kidney transplantation.


Hepatitis C/therapy , Renal Insufficiency, Chronic/therapy , Hepacivirus/physiology , Hepatitis C/virology , Humans , Italy , Renal Insufficiency, Chronic/virology
5.
J Nephrol ; 31(5): 685-712, 2018 Oct.
Article En | MEDLINE | ID: mdl-30255440

Hepatitis C virus (HCV) infection is now considered a systemic disease due to the occurrence of extra-hepatic manifestations. Among these, the renal involvement is frequent. HCV infection, in fact, is strongly associated with proteinuria and chronic kidney disease (CKD) and negatively affects the prognosis of renal patients. In the last few years, availability of more specific and effective drugs against HCV has dramatically changed the clinical course of this disease. These drugs may provide further advantages in the CKD population as a whole by reducing progression of renal disease, mortality rate and by increasing the survival of graft in renal transplant recipients. The strict pathogenetic and prognostic link between HCV infection and CKD requires an ongoing relationship among the healthcare professionals involved in the treatment of both HCV infection and CKD. Therefore, Scientific Societies involved in the care of this high-risk population in Italy have organized a joint expert panel. The aim of the panel is to produce a position statement that can be used in daily clinical practice for the management of HCV infected patients across the whole spectrum of renal disease, from the conservative phase to renal replacement treatments (dialysis and transplantation). Sharing specific evidence-based expertise of different professional healthcare is the first step to obtain a common ground of knowledge on which to instate a model for multidisciplinary management of this high-risk population. Statements cover seven areas including epidemiology of CKD, HCV-induced glomerular damage, HCV-related renal risk, staging of liver disease in patients with CKD, prevention of transmission of HCV in hemodialysis units, treatment of HCV infection and management of HCV in kidney transplantation.


Antiviral Agents/therapeutic use , Hepacivirus/drug effects , Hepatitis C, Chronic/drug therapy , Kidney Transplantation , Renal Dialysis , Renal Insufficiency, Chronic/therapy , Antiviral Agents/adverse effects , Consensus , Evidence-Based Medicine , Hepacivirus/physiology , Hepatitis C, Chronic/diagnosis , Hepatitis C, Chronic/epidemiology , Hepatitis C, Chronic/transmission , Humans , Kidney Transplantation/adverse effects , Prevalence , Renal Dialysis/adverse effects , Renal Insufficiency, Chronic/diagnosis , Renal Insufficiency, Chronic/epidemiology , Risk Assessment , Risk Factors , Treatment Outcome
6.
Intern Emerg Med ; 13(8): 1139-1166, 2018 Dec.
Article En | MEDLINE | ID: mdl-30255464

Hepatitis C virus (HCV) infection is now considered a systemic disease due to the occurrence of extra-hepatic manifestations. Among these, the renal involvement is frequent. HCV infection, in fact, is strongly associated with proteinuria and chronic kidney disease (CKD) and negatively affects the prognosis of renal patients. In the last few years, availability of more specific and effective drugs against HCV has dramatically changed the clinical course of this disease. These drugs may provide further advantages in the CKD population as a whole by reducing progression of renal disease, mortality rate and by increasing the survival of graft in renal transplant recipients. The strict pathogenetic and prognostic link between HCV infection and CKD requires an ongoing relationship among the healthcare professionals involved in the treatment of both HCV infection and CKD. Therefore, Scientific Societies involved in the care of this high-risk population in Italy have organized a joint expert panel. The aim of the panel is to produce a position statement that can be used in daily clinical practice for the management of HCV infected patients across the whole spectrum of renal disease, from the conservative phase to renal replacement treatments (dialysis and transplantation). Sharing specific evidence-based expertise of different professional healthcare is the first step to obtain a common ground of knowledge on which to instate a model for multidisciplinary management of this high-risk population. Statements cover seven areas including epidemiology of CKD, HCV-induced glomerular damage, HCV-related renal risk, staging of liver disease in patients with CKD, prevention of transmission of HCV in hemodialysis units, treatment of HCV infection and management of HCV in kidney transplantation.


Disease Management , Hepatitis C/complications , Renal Insufficiency, Chronic/complications , Antiviral Agents/therapeutic use , Cooperative Behavior , Expert Testimony , Hepacivirus/classification , Hepacivirus/pathogenicity , Hepatitis C/therapy , Humans , Infectious Disease Medicine/organization & administration , Infectious Disease Medicine/trends , Internal Medicine/organization & administration , Internal Medicine/trends , Italy , Kidney Transplantation/adverse effects , Kidney Transplantation/methods , Kidney Transplantation/trends , Nephrology/organization & administration , Nephrology/trends , Renal Insufficiency, Chronic/classification , Renal Insufficiency, Chronic/therapy , Risk Factors , Severity of Illness Index , Societies/organization & administration , Societies/trends
7.
Dig Liver Dis ; 50(11): 1133-1152, 2018 11.
Article En | MEDLINE | ID: mdl-30266305

Hepatitis C virus (HCV) infection is now considered a systemic disease due to the occurrence of extra-hepatic manifestations. Among these, the renal involvement is frequent. HCV infection, in fact, is strongly associated with proteinuria and chronic kidney disease (CKD) and negatively affects the prognosis of renal patients. In the last few years, availability of more specific and effective drugs against HCV has dramatically changed the clinical course of this disease. These drugs may provide further advantages in the CKD population as a whole by reducing progression of renal disease, mortality rate and by increasing the survival of graft in renal transplant recipients. The strict pathogenetic and prognostic link between HCV infection and CKD requires an ongoing relationship among the healthcare professionals involved in the treatment of both HCV infection and CKD. Therefore, Scientific Societies involved in the care of this high-risk population in Italy have organized a joint expert panel. The aim of the panel is to produce a position statement that can be used in daily clinical practice for the management of HCV infected patients across the whole spectrum of renal disease, from the conservative phase to renal replacement treatments (dialysis and transplantation). Sharing specific evidence-based expertise of different professional healthcare is the first step to obtain a common ground of knowledge on which to instate a model for multidisciplinary management of this high-risk population. Statements cover seven areas including epidemiology of CKD, HCV-induced glomerular damage, HCV-related renal risk, staging of liver disease in patients with CKD, prevention of transmission of HCV in hemodialysis units, treatment of HCV infection and management of HCV in kidney transplantation.


Antiviral Agents/therapeutic use , Hepatitis C/drug therapy , Kidney Transplantation , Renal Insufficiency, Chronic/therapy , Renal Insufficiency, Chronic/virology , Hepatitis C/complications , Humans , Italy , Renal Dialysis , Renal Insufficiency, Chronic/classification , Renal Insufficiency, Chronic/complications , Risk Factors , Societies, Medical
8.
New Microbiol ; 41(2): 112-117, 2018 Apr.
Article En | MEDLINE | ID: mdl-29806690

We propose a multidimensional first-level diagnostic assessment easy to use in routine clinical practice to allow infectious disease specialists to have a general and complete overview of persons living with HIV. Following the Delphi method, articles published from January 1, 2011 on controlled trials, clinical reports and observational studies dealing specifically with HIV and its co-morbidities were selected for review by the authors. Participants in the poll were selected among clinicians and infectious diseases specialists, working in 38 different dedicated HIV centres in Italy. The participants were given access to a website dedicated to the project and received a standardized information package containing a synopsis of the study and a description of the Delphi process and the selected literature. A total of 131 Items were divided into 10 first-level survey areas: anamnesis, objective examination, infectious diseases, osteoporosis diagnosis, metabolic pathologies diagnosis, cardiovascular diagnosis, nephrologic diagnosis, hepatological diagnosis, central nervous system diagnosis, evaluation of quality of life (QoL). This simple and concise first level tool identifies a few areas of multi-organ diagnostic assessment beyond the infectivity area. The identification of these areas will allow us to find shared and validated evaluation procedures with the intent to increase the likelihood of early recognition of patients at risk of comorbidity development, in order to facilitate more effective prevention, thereby reducing the overall impact on the quality of life of patients affected by this chronic illness.


Anti-HIV Agents/therapeutic use , HIV Infections/diagnosis , HIV Infections/drug therapy , Algorithms , Anti-HIV Agents/administration & dosage , Comorbidity , Delphi Technique , Humans , Longevity , Quality of Life
9.
PLoS One ; 13(2): e0192627, 2018.
Article En | MEDLINE | ID: mdl-29462201

The renal function is a key-issue in HIV/HCV co-infected patients, nevertheless, it has not established so far whether HCV treatment with new direct acting agents could impact on estimated glomerular filtration rate (eGFR) variations. In the present work, we examined the real-life data on renal function that have been prospectively collected in the SIMIT compassionate-use program of ombitasvir/paritaprevir/ritonavir plus dasabuvir (OBV/PTV/r + DSV) in 144 HIV/HCV genotype 1 co-infected patients. The population was 74% male, 30.5% in CDC stage C, with median age of 52 years (48.0-56.5) and median liver stiffness of 7.8 kPa (6.7-9.2). Median baseline eGFR was 102.0 (90.8-108.1), changing to 99.8 (83.5-104.8) at the end of treatment (EoT), and 100.0 (87.3-105.6) 12 weeks after the EoT (FU12), p<0.0001. No patient had grade 3-4 increase of creatinine. At EoT 60/144 (41.7%) patients had ≥ 5% reduction in their eGFR, confirmed at FU12 in 39/60 (65.0%) cases. Longer duration of HCV infection (cut-off 12.9 years), lower HCV-RNA viral load (cut-off 1,970,160 IU/ml) and lower platelet count (cut-off 167,000 x106/L) were significantly associated with eGFR decline at logistic analysis (adjOR 2.9, 95%CI 1.0-8.8, p = 0.05; adjOR 3.5, 95%CI 1.2-10.4, p = 0.02; adjOR 2.8, 95%CI 1.1-6.8, p = 0.03, respectively). After repeating the analysis throughout a mixed model, a higher eGFR decline was highlighted in patients concomitantly treated with tenofovir (p = 0.0001), ribavirin (p = 0.0001), or integrase inhibitors (p <0.0001), with longer duration of HIV (p = 0.0002) and HCV infection (p = 0.035), lower baseline HCV RNA (p <0.0001), previous HCV treatment (p<0.0001), and older age (p<0.0001). In conclusion, our study confirms a good renal safety profile of OBV/PTV/r + DSV treatment in HIV/HCV patients, and the median decline of 2 ml/min in eGFR, albeit statistically significant, is of doubtful clinical significance. The role of aging, concomitant therapies and duration of HIV/HCV infection needs to be further investigated.


Antiviral Agents/therapeutic use , Glomerular Filtration Rate , HIV Infections/drug therapy , Hepatitis C/drug therapy , 2-Naphthylamine , Antiviral Agents/administration & dosage , Cyclopropanes , Drug Therapy, Combination , Female , HIV Infections/complications , Hepatitis C/complications , Humans , Lactams, Macrocyclic , Macrocyclic Compounds/administration & dosage , Male , Middle Aged , Proline/analogs & derivatives , Ribavirin/administration & dosage , Ritonavir/administration & dosage , Sulfonamides/administration & dosage , Uracil/administration & dosage , Uracil/analogs & derivatives
10.
Infection ; 46(2): 231-238, 2018 Apr.
Article En | MEDLINE | ID: mdl-29335905

PURPOSE: The aim of this study was to evaluate the effects of antiviral therapy on liver stiffness measurement (LSM). METHODS: Two hundred HBV patients were enrolled from four hospital centers in southern Italy; median age was 50.7 (25-75) males were 68%; 171 patients underwent to liver biopsy and 200 patients had LSM at baseline and 189 at the end of follow-up. One hundred and forty-nine patients were treated with nucleos(t)ide analogs, while 51 patients were untreated. The cutoffs of the LSM, related to the fibrosis stages, were as follows: non-advanced fibrosis ≤ 8.1 kPa and advanced fibrosis ≥ 8.2 Kpa. RESULTS: At baseline, the median value of LSM was 14.1 kPa for advanced fibrosis/cirrhosis and 6.9 kPa for non-advanced fibrosis. LSM was performed at 24 months from the start of therapy. The treated patients (68% received Entecavir and 32% Tenofovir) showed a decrease in liver stiffness measurement of 1.5 kPa (p < 0.001) in non-advanced fibrosis and of 6 kPa (p < 0.001) in advanced fibrosis/cirrhosis. In the patients not undergoing antiviral treatment, no statistically significant change of the LSM was observed (p = 0.26). A logistic binary regression model showed that the only independent factor associated with a significant change in the LSM was the liver stiffness value at baseline (odd ratio 2.855; 95% CI 1.456-5.788; (p = 0.007). CONCLUSION: Long-term antiviral therapy induced a significant reduction of liver stiffness measurement and this result may be related to the reduction of liver fibrosis.


Antiviral Agents/therapeutic use , Hepatitis B, Chronic/drug therapy , Hepatitis B, Chronic/physiopathology , Liver Cirrhosis/drug therapy , Liver Cirrhosis/physiopathology , Adult , Aged , Elasticity Imaging Techniques , Female , Hepatitis B, Chronic/diagnostic imaging , Hepatitis B, Chronic/epidemiology , Humans , Liver Cirrhosis/diagnostic imaging , Liver Cirrhosis/epidemiology , Male , Middle Aged , Prospective Studies
11.
New Microbiol ; 41(4): 247-255, 2018 10.
Article En | MEDLINE | ID: mdl-30604833

The Italian Society for Infectious and Tropical Diseases (SIMIT) in collaboration with the Technical Health Committee (Sections L and M) of the Italian Ministry of Health have supported the renewal of the recommendations for the Italian guidelines for the use of antiretroviral agents and the diagnostic-clinical management of HIV-1 infected persons. This publication summarizes the latest updates to the 2017 version of the Italian Guidelines for the management of HIV-1 infected patients and the use of antiretroviral drugs. New recommendations were released framing the clinical questions the use of antiretrovirals according to the Patient Intervention Comparator Outcome (PICO) methodology and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. Diagnostic tools for immunological and virological monitoring, when to start, what to start, optimization and therapeutic failure were updated in order to include the recommendation obtained with these newly developed methods. For a complete review of clinical and therapeutic relevant topics we refer the reader to the extended version of the Guidelines.


Anti-HIV Agents , HIV Infections , HIV-1 , Anti-HIV Agents/therapeutic use , Evidence-Based Medicine , Guidelines as Topic , HIV Infections/diagnosis , HIV Infections/drug therapy , HIV Seropositivity , Humans , Italy
12.
Infection ; 46(2): 183-188, 2018 Apr.
Article En | MEDLINE | ID: mdl-29238918

AIM: This paper is aimed at providing practical recommendations for the management of acute hepatitis C (AHC). METHODS: This is an expert position paper based on the literature revision. Final recommendations were graded by level of evidence and strength of the recommendations. RESULTS: Treatment of AHC with direct-acting antivirals (DAA) is safe and effective; it overcomes the limitations of INF-based treatments. CONCLUSIONS: Early treatment with DAA should be offered when available.


Antiviral Agents , Hepatitis C/drug therapy , Antiviral Agents/administration & dosage , Antiviral Agents/therapeutic use , Humans , Italy , Practice Guidelines as Topic , Societies, Medical
13.
Atherosclerosis ; 263: 398-404, 2017 08.
Article En | MEDLINE | ID: mdl-28522147

BACKGROUND AND AIMS: PREVALEAT (PREmature VAscular LEsions and Antiretroviral Therapy) II is a multicenter, longitudinal cohort study aimed at the evaluation of cardiovascular risk among advanced HIV-positive, treatment-naïve patients starting their first therapy. We hypothesized that these patients, present a higher cardiovascular (CV) risk. METHODS: The study included all consecutive naïve patients with less than 200 CD4 cells/ml starting antiretroviral therapy. Our primary objective was to evaluate changes in carotid intima- media thickness (IMT). Secondary endpoints included changes in flow mediated vasodilation (FMD), inflammatory markers, triglycerides and cholesterol. Patients were evaluated at time 0, and after 3, 6 and 12 months. RESULTS: We enrolled 119 patients, stratified into three different groups: patients receiving atazanavir/ritonavir boosted (ATV/r) based regimens, efavirenz (EFV) based regimens and darunavir/ritonavir boosted (DRV/r) based regimens. At baseline, advanced naïve patients showed a relevant deterioration of CV conditions in terms of traditional CV risk factors, endothelial dysfunction and serum biomarkers. During the 12-month follow up period, mean blood lipids significantly increased: total cholesterol from 159 to 190 mg/dL, HDL-C from 31 to 41 mg/dL, and LDL-C from 99 to 117 mg/dL. D-dimers steadily decreased (median level 624 at baseline and 214 at T3), whereas ICAM and VCAM consistently raised. DRV/r and ATV/r determined a more marked decrease of D-dimers as compared to EFV. Regarding the epi-aortic changes (IMT >1 mm or presence of atherosclerotic plaques), patients in the DRV/r group were at risk of developing pathological IMT during the study (OR 6.0, 95% CI 0.9-36.9), as compared to EFV ones. CONCLUSIONS: CV risk was elevated in advanced naïve patients and tended to remain high in the first year of therapy.


Anti-HIV Agents/therapeutic use , Cardiovascular Diseases/etiology , HIV Infections/drug therapy , Adult , Alkynes , Anti-HIV Agents/adverse effects , Atazanavir Sulfate/therapeutic use , Benzoxazines/therapeutic use , Biomarkers/blood , Brachial Artery/physiopathology , CD4 Lymphocyte Count , Cardiovascular Diseases/diagnostic imaging , Cardiovascular Diseases/physiopathology , Carotid Intima-Media Thickness , Chi-Square Distribution , Cyclopropanes , Darunavir/therapeutic use , Endothelium, Vascular/physiopathology , Female , HIV Infections/complications , HIV Infections/diagnosis , HIV Infections/virology , Humans , Inflammation Mediators/blood , Italy , Lipids/blood , Longitudinal Studies , Male , Middle Aged , Multivariate Analysis , Odds Ratio , Predictive Value of Tests , Risk Factors , Ritonavir/therapeutic use , Time Factors , Treatment Outcome , Vasodilation
14.
New Microbiol ; 40(2): 86-98, 2017 Apr.
Article En | MEDLINE | ID: mdl-28513816

The Italian Society of Infectious and Tropical Diseases (SIMIT) of the Technical Health Committee, Ministry of Health (Sections L and M) of Italy have supported recommendations for the Italian guidelines for the use of antiretroviral agents and the diagnostic-clinical management of HIV-1 infected persons. This publication summarizes the latest updates to the 2016 version of the Italian Guidelines for the management of HIV-1 infected patients and the use of antiretroviral drugs. In particular, new recommendations were released concerning the following topics: estimate of the HIV continuum of care in Italy, optimal timing and preferred drug combinations for starting antiretroviral therapy, treatment optimization, and pre-exposure prophilaxis (PrEP). For a complete review of clinical and therapeutic relevant topics we refer the reader to the extended version of the Guidelines.


Anti-HIV Agents/therapeutic use , HIV Infections/drug therapy , HIV-1 , Practice Guidelines as Topic , Anti-HIV Agents/administration & dosage , Drug Administration Schedule , Drug Therapy, Combination , HIV Infections/epidemiology , HIV Infections/virology , Health Policy , Italy/epidemiology
15.
Lancet Gastroenterol Hepatol ; 2(6): 427-434, 2017 06.
Article En | MEDLINE | ID: mdl-28497758

BACKGROUND: We ran a compassionate use nationwide programme (ABACUS) to provide access to ombitasvir, paritaprevir, and ritonavir, with dasabuvir, plus ribavirin for hepatitis C virus (HCV) genotype 1 infection and ombitasvir, paritaprevir, and ritonavir, plus ribavirin for HCV genotype 4 infection in patients with cirrhosis at high risk of decompensation while approval of these regimens was pending in Italy. METHODS: In this prospective observational study, we collected data from a compassionate use nationwide programme from March 17, 2014, to May 28, 2015. Patients with HCV genotype 1 infection and cirrhosis at high risk of decompensation were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once daily and dasabuvir (250 mg) twice daily for 12 weeks (patients with HCV genotype 1b infection) or 24 weeks (patients with HCV genotype 1a infection). Patients with HCV genotype 4 infection were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once per day for 24 weeks. All patients were given weight-based ribavirin. The primary efficacy endpoint was sustained virological response at week 12 after the end of treatment (SVR12), analysed by intention-to-treat. Univariate and multivariate logistic regression analyses were used to identify baseline characteristics associated with SVR12. Adverse events were recorded throughout the study. FINDINGS: 728 (96%) of 762 patients with cirrhosis who were given ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin therapy for 12 or 24 weeks achieved SVR12. Logistic regression analyses identified that bilirubin concentrations of less than 2 mg/dL were associated with SVR12 (odds ratio [OR] 4·76 [95% CI 1·83-12·3]; p=0·001). 166 (23%) of 734 patients included in safety analyses had an adverse event. 25 (3%) patients discontinued treatment because of adverse events. Asthenia was the most commonly reported adverse event, occurring in 36 (5%) patients. INTERPRETATION: Our findings suggest that the safety and effectiveness of ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin in patients with HCV genotype 1 or 4 infection and cirrhosis at high risk of decompensation in a real-life setting are similar to those reported in clinical trials. The concordance with clinical trials provides reassurance that the reported efficacy of this treatment in clinical trials will translate to its use in routine clinical practice. FUNDING: Dipartimento Biomedico di Medicina Interna e Specialistica dell'Universita di Palermo.


Antiviral Agents/therapeutic use , Hepatitis C, Chronic/complications , Hepatitis C, Chronic/drug therapy , Liver Cirrhosis/complications , 2-Naphthylamine , Adult , Aged , Anilides/adverse effects , Anilides/therapeutic use , Antiviral Agents/adverse effects , Carbamates/adverse effects , Carbamates/therapeutic use , Compassionate Use Trials , Cyclopropanes , Drug Therapy, Combination , Female , Genotype , Hepatitis C, Chronic/genetics , Humans , Lactams, Macrocyclic , Longitudinal Studies , Macrocyclic Compounds/adverse effects , Macrocyclic Compounds/therapeutic use , Male , Middle Aged , Proline/analogs & derivatives , Prospective Studies , Ribavirin/adverse effects , Ribavirin/therapeutic use , Ritonavir/adverse effects , Ritonavir/therapeutic use , Sulfonamides/adverse effects , Sulfonamides/therapeutic use , Treatment Outcome , Uracil/adverse effects , Uracil/analogs & derivatives , Uracil/therapeutic use , Valine
16.
Clin Infect Dis ; 64(5): 680-683, 2017 03 01.
Article En | MEDLINE | ID: mdl-28011605

Patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) are at high risk of liver disease progression. We report a favorable safety profile and SVR12 rates of 96.7% among HIV/HCV co-infected patients participating in an Italian compassionate-use program of ombitasvir/paritaprevir/ritonavir + dasabuvir (OBV/PTV/r + DSV) ± ribavirin (RBV).

18.
J Cell Biochem ; 116(10): 2188-94, 2015 Oct.
Article En | MEDLINE | ID: mdl-25808410

Recently increasing emphasis is placed on preventive health and management of chronic comorbidities avoiding long-term toxicities of antiretroviral therapy (ART). Drawing from this background we decided to use the Saos-2, osteosarcoma cell line, as a cellular model, to evaluate the effects of some antiretroviral drugs such as abacavir (ABC), tenofovir (TDF), efavirenz (EFV), etravirine (ETR), and darunavir (DRV), on bone differentiation related pathways. According to our observation, treatment with TDF and ABC affects the ability of the cells to produce calcium deposits with a reduced expression of type I collagen gene and p21 mRNA, also increasing the activity of Wnt3a related pathway. On the other hand treatment with EFV and DRV was not related to any significant reduction of calcium deposits but displayed a decrease in the expression of Wnt3a at day 14 and Type I Collagen at day 7 compared with untreated cells, even if this last down regulation was not confirmed at day 14. Instead ETR administration to Saos-2 cells increases the calcium deposits collagen type I production, as a result of Wnt3a mRNA overexpression, and of an upregulation of collagen type I expression, being also the only drug able to increase the expression of p21 cdk inhibitor as further marker of terminal differentiation. In summary these data suggest the potential negative interference of TDF and ABC on bone differentiation. DRV and EFV partially affect collagen type I production, instead ETR facilitates a positive bone balance as a result of an increased osteoblasts terminal differentiation.


Bone Development/drug effects , Cell Differentiation/drug effects , Gene Expression Regulation, Developmental/drug effects , HIV-1/drug effects , Alkynes , Antiretroviral Therapy, Highly Active , Benzoxazines/administration & dosage , Calcium/metabolism , Cell Line, Tumor , Collagen Type I/biosynthesis , Collagen Type I/genetics , Cyclopropanes , Darunavir/administration & dosage , Dideoxynucleosides/administration & dosage , HIV-1/pathogenicity , Humans , Nitriles , Osteosarcoma/drug therapy , Osteosarcoma/genetics , Osteosarcoma/pathology , Pyridazines/administration & dosage , Pyrimidines , RNA, Messenger/biosynthesis , Tenofovir/administration & dosage , Wnt3A Protein/biosynthesis , Wnt3A Protein/genetics , p21-Activated Kinases/biosynthesis , p21-Activated Kinases/genetics
19.
In Vivo ; 29(1): 133-6, 2015.
Article En | MEDLINE | ID: mdl-25600542

BACKGROUND: The incidence of Kaposi's sarcoma (KS), an AIDS-related malignancy, has dramatically decreased in the Highly Active Anti-retroviral Therapy (HAART) era. However, KS remains the second most frequent tumor in HIV-infected patients worldwide and has become the most common cancer in the sub-Saharan Africa. Experimental studies have demonstrated a direct anti-neoplastic effect of HAART, and overall of protease inhibitors (PIs), on KS. CASE REPORT: We describe five cases of KS in HIV-infected patients on HAART regimen, containing PIs as atazanavir/r (ATV/r), darunavir/r (DRV/r), lopinavir/r (LPV/r) and fosamprenavir (fAMP/r). CONCLUSION: Clinical and experimental observations support the hypothesis that PIs may play an important role in prevention and treatment of KS. In our study, the treatment with PIs of recent generation was not protective against the development of KS. Therefore, it could be necessary to re-evaluate the therapeutic effects of PIs and their role in the development and treatment of KS in HIV-infected patients.


HIV Infections/complications , HIV Protease Inhibitors/pharmacology , Sarcoma, Kaposi/etiology , Adult , Antineoplastic Agents/pharmacology , Antineoplastic Agents/therapeutic use , Antiretroviral Therapy, Highly Active , CD4 Lymphocyte Count , HIV Infections/drug therapy , HIV Infections/virology , HIV Protease Inhibitors/therapeutic use , Humans , Male , Middle Aged , Risk Factors , Sarcoma, Kaposi/drug therapy , Sarcoma, Kaposi/pathology , Sarcoma, Kaposi/prevention & control , Treatment Outcome , Viral Load , Young Adult
20.
In Vivo ; 29(1): 137-40, 2015.
Article En | MEDLINE | ID: mdl-25600543

BACKGROUND/AIM: HIV infection is a risk factor for re-activation of latent tubercolosis infection (LTBI). In recent years new blood tests for the detection of TB infection have been developed: Quantiferon TB Gold in Tube and TSPOT TB, which are interferon-γ releasing assays (IGRAs), have improved the identification of LTBI. In our study we have compared IGRAs and TST in HIV-positive patients with different settings of immunodeficiency. PATIENTS AND METHODS: 98 consecutive HIV patients were recruited. They underwent a blood draw, a chest radiography and a tuberculin skin test. The HIV infection setting was detected and IGRAs were carried-out. Five patients showed a complete correspondence of TST, TSPOT-TB and QFT-IT. Discordant results were observed in patients testing positive to IGRAs but negative to TST. Only 2 patients showed positive TST and negative IGRAs. CONCLUSION: Our study showed a poor concordance between tuberculin skin test and IGRAs, mainly in patients with a low CD4 cell count.


HIV Infections , Interferon-gamma Release Tests , Latent Tuberculosis/diagnosis , Tuberculin Test , Adult , Aged , Antiretroviral Therapy, Highly Active , CD4 Lymphocyte Count , Female , HIV Infections/drug therapy , HIV Infections/immunology , HIV Infections/virology , Humans , Interferon-gamma Release Tests/standards , Male , Middle Aged , Reproducibility of Results , Sensitivity and Specificity , Tuberculin Test/standards , Viral Load , Young Adult
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