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1. Metabolic syndrome and body weight in people living with HIV infection: analysis of differences observed in three different cohort studies over a decade

Author

Taramasso L., Bonfanti P., Ricci E., Maggi P., Orofino G., Squillace N., Menzaghi B., Madeddu G., Molteni C., Vichi F., Riguccini E., Saracino A., Santoro C., Guastavigna M., Francisci D., Di Biagio A., De Socio G. V., Sarchi E., Chichino G., Bolla C., Bellacosa C., Angarano G., Calza L., Farinazzo M., Angioni G., Gussio M., Celesia B. M., Falasca K., Mastroianni A., Guadagnino G., Salomoni E., Martinelli C., Dentone C., Bassetti M., Cenderello G., Pellicano G. F., Nunnari G., Valsecchi L., Cordier L., Parisini S., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G. M., Martini S., Cascio A., Trizzino M., Gulminetti R., Nofri M., Cibelli D., Parruti G., Mameli M. S., Taramasso L., Bonfanti P., Ricci E., Maggi P., Orofino G., Squillace N., Menzaghi B., Madeddu G., Molteni C., Vichi F., Riguccini E., Saracino A., Santoro C., Guastavigna M., Francisci D., Di Biagio A., De Socio G.V., Sarchi E., Chichino G., Bolla C., Bellacosa C., Angarano G., Calza L., Farinazzo M., Angioni G., Gussio M., Celesia B.M., Falasca K., Mastroianni A., Guadagnino G., Salomoni E., Martinelli C., Dentone C., Bassetti M., Cenderello G., Pellicano G.F., Nunnari G., Valsecchi L., Cordier L., Parisini S., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G.M., Martini S., Cascio A., Trizzino M., Gulminetti R., Nofri M., Cibelli D., Parruti G., Mameli M.S., Taramasso, L, Bonfanti, P, Ricci, E, Maggi, P, Orofino, G, Squillace, N, Menzaghi, B, Madeddu, G, Molteni, C, Vichi, F, Riguccini, E, Saracino, A, Santoro, C, Guastavigna, M, Francisci, D, Di Biagio, A, De Socio, G, Taramasso, Lucia, Bonfanti, Paolo, Ricci, Elena, Maggi, Paolo, Orofino, Giancarlo, Squillace, Nicola, Menzaghi, Barbara, Madeddu, Giordano, Molteni, Chiara, Vichi, Francesca, Riguccini, Erika, Saracino, Annalisa, Santoro, Carmen, Guastavigna, Marta, Francisci, Daniela, Di Biagio, Antonio, and De Socio, Giuseppe Vittorio

Subjects
Adult, Male, dyslipidaemia, antiretroviral therapy, HIV Infections, Overweight, Logistic regression, Body Mass Index, Cohort Studies, Prevalence, medicine, overweight, Humans, Pharmacology (medical), Metabolic Syndrome, business.industry, Health Policy, Incidence (epidemiology), Body Weight, HIV, weight gain, Odds ratio, Middle Aged, medicine.disease, Confidence interval, metabolic syndrome, Cross-Sectional Studies, Infectious Diseases, Metabolic syndrome, medicine.symptom, business, Weight gain, Demography, Cohort study
Abstract

Objectives: The aim of this study was to assess the incidence of being overweight and metabolic syndrome (MS) among people living with HIV (PHIV) in three different cross-sectional studies conducted over three different periods: 2005, 2011 and 2015. Methods: This was a multi-centre, nationwide study. Data were collected in three studies from the CISAI group - SIMOne, HIV-HY and STOPSHIV - and included a total of 3014 PHIV. Logistic regression [odds ratio (OR), 95% confidence interval (CI)] was used to account for age and gender difference among three groups when comparing MS prevalence and being overweight; potential confounders were accounted for by including them in the regression equation. Results: Overall, the mean age was 46.9±10.2years, and men comprised 73.3% of participants. Comparing 2005, 2011 and 2015, MS was present in 34.5%, 33.0% and 29.3% of PHIV, respectively. Adjusted OR for MS was 0.64 (95% CI: 0.52-0.78) in 2011 and 0.56 (95% CI: 0.46-0.69) in 2015 compared with 2005, while BMI (kg/m2 ) increased from 23.6 in 2005, 24.5 in 2011 and 24.5 in 2015, with a concomitant increase of being overweight from 29.4% to 39.5% to 39.6% (p&nbsp

Published
2021

2. Smoking habits in HIV-infected people compared with the general population in Italy: a cross-sectional study

Author

De Socio, G. V., Pasqualini, M., Ricci, E., Maggi, P., Orofino, G., Squillace, N., Menzaghi, B., Madeddu, G., Taramasso, L., Francisci, D., Bonfanti, P., Vichi, F., Dell'Omo, M., Pieroni, L., Santoro, C., Quirino, T., Farinazzo, M., Magne, F., Molteni, C., Malincarne, L., Riguccini, E., Nofri, M., Bagella, P., Mameli, M. S., Tiri, B., Guastavigna, M., De Socio, G, Pasqualini, M, Ricci, E, Maggi, P, Orofino, G, Squillace, N, Menzaghi, B, Madeddu, G, Taramasso, L, Francisci, D, Bonfanti, P, Vichi, F, Dell’Omo, M, and Pieroni, L

Subjects
Adult, Male, medicine.medical_specialty, Cross-sectional study, medicine.medical_treatment, Population, HIV Infections, 030312 virology, 03 medical and health sciences, 0302 clinical medicine, Acquired immunodeficiency syndrome (AIDS), Surveys and Questionnaires, Epidemiology, Tobacco, medicine, Odds Ratio, Prevalence, Tobacco Smoking, Humans, 030212 general & internal medicine, education, 0303 health sciences, education.field_of_study, Smokers, business.industry, Public health, lcsh:Public aspects of medicine, Smoking, Public Health, Environmental and Occupational Health, HIV, lcsh:RA1-1270, Middle Aged, medicine.disease, Lifestyle, Cardiovascular disease, Stratified sampling, AIDS, Smoking, Tobacco, Italy, Lifestyle, HIV, AIDS, Cardiovascular disease, Cross-Sectional Studies, Italy, Smoking cessation, Female, Smoking Cessation, Biostatistics, business, Demography, Research Article
Abstract

Background Tobacco use is a leading cause of preventable diseases and death for all individuals, even more so for people living with HIV (PLWH), due to their status of chronic inflammation. To date, in Italy no study was performed to compare smoking habits in PLWH and the general population. We aimed to investigate smoking habits in PLWH, as compared to the general population. Methods Multi-center cross-sectional study. Smoking habits were compared between PLWH and the general population. PLWH were enrolled in the STOPSHIV Study. The comparison group from the general population was derived from a survey performed by the National Statistics Institute (ISTAT), with a stratified random sampling procedure matching 2:1 general population subjects with PLWH by age class, sex, and macro-area of residence. Results The total sample consisted of 1087 PLWH (age 47.9 ± 10.8 years, male 73.5%) and 2218 comparable subjects from the general population. Prevalence of current smokers was 51.6% vs 25.9% (p p p p p 20 cigarettes per day) (aOR = 4.84; 95% CI = 3.74–6.27; p p Conclusion HIV-infected patients showed a higher rate of current smokers, a larger number of cigarettes smoked and a lower quitting rate than the general population. Our findings emphasize the need for smoking cessation strategies targeting HIV persons.

Published
2020

3. Improvement of lipid profile after switching from efavirenz or ritonavir-boosted protease inhibitors to rilpivirine or once-daily integrase inhibitors: results from a large observational cohort study (SCOLTA)

Author

Taramasso, L., Tatarelli, Paola, Ricci, Elena, Madeddu, G., Menzaghi, B., Squillace, Nicola, De Socio, G. V., Martinelli, C., Gulminetti, Roberto, Maggi, P., Orofino, G., Vichi, F., Di Biagio, A., Bonfanti, Paolo, Bellacosa, C., Calza, L., Abeli, C., Celesia, B. M., Grosso, C., Stagno, A., Mazzotta, F., Penco, G., Cassola, G., Nicolini, L. A., Dentone, C., Molteni, C., Palvarini, L., Scalzini, A., Carenzi, L., Rizzardini, G., Valsecchi, L., Cordier, L., Rusconi, S., Colombo, Valeria, Galli, M., Franzetti, M., Sgrelli, A., Mazzotta, E., Parruti, G., Bagella, P., Mura, M. S., Libertone, R., Antinori, A., Di Giambenedetto, S., Guastavigna, M., Caramello, P., Taramasso, L, Tatarelli, P, Ricci, E, Madeddu, G, Menzaghi, B, Squillace, N, De Socio, G, Martinelli, C, Gulminetti, R, Maggi, P, Orofino, G, Vichi, F, Di Biagio, A, Bonfanti, P, Bellacosa, C, Calza, L, Abeli, C, Celesia, B, Grosso, C, Stagno, A, Mazzotta, F, Penco, G, Cassola, G, Nicolini, L, Dentone, C, Molteni, C, Palvarini, L, Scalzini, A, Carenzi, L, Rizzardini, G, Valsecchi, L, Cordier, L, Rusconi, S, Colombo, V, Galli, M, Franzetti, M, Sgrelli, A, Mazzotta, E, Parruti, G, Bagella, P, Mura, M, Libertone, R, Antinori, A, Di Giambenedetto, S, Guastavigna, M, Caramello, P, Taramasso, L., Tatarelli, Paola, Ricci, Elena, Madeddu, G., Menzaghi, B., Squillace, Nicola, De Socio, G. V., Martinelli, C., Gulminetti, Roberto, Maggi, P., Orofino, G., Vichi, F., Di Biagio, A., Bonfanti, Paolo, Bellacosa, C., Calza, L., Abeli, C., Celesia, B. M., Grosso, C., Stagno, A., Mazzotta, F., Penco, G., Cassola, G., Nicolini, L. A., Dentone, C., Molteni, C., Palvarini, L., Scalzini, A., Carenzi, L., Rizzardini, G., Valsecchi, L., Cordier, L., Rusconi, S., Colombo, Valeria, Galli, M., Franzetti, M., Sgrelli, A., Mazzotta, E., Parruti, G., Bagella, P., Mura, M. S., Libertone, R., Antinori, A., Di Giambenedetto, S., Guastavigna, M., and Caramello, P.

Subjects
0301 basic medicine, Cyclopropanes, Male, Protease Inhibitor, Integrase inhibitor, HIV Infections, Gastroenterology, Piperazines, Cohort Studies, chemistry.chemical_compound, 0302 clinical medicine, HIV Infection, 030212 general & internal medicine, medicine.diagnostic_test, Elvitegravir, Drug Substitution, HIV-Associated Lipodystrophy Syndrome, Lipid, Middle Aged, Lipids, Infectious Diseases, Cholesterol, Treatment Outcome, Rilpivirine, Alkynes, Dolutegravir, Drug Therapy, Combination, Female, Heterocyclic Compounds, 3-Ring, Cholesterol, Dyslipidemia,Framingham risk score, Integrase inhibitors, Rilpivirine, Human, medicine.drug, Research Article, Benzoxazine, Adult, medicine.medical_specialty, Efavirenz, Anti-HIV Agents, Pyridones, 030106 microbiology, Integrase Inhibitors, Drug Administration Schedule, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Internal medicine, Oxazines, medicine, Humans, lcsh:RC109-216, Protease Inhibitors, Ritonavir, business.industry, Anti-HIV Agent, Lipid Metabolism, Benzoxazines, Integrase Inhibitor, chemistry, Dyslipidemia, Framingham risk score, Cohort Studie, Lipid profile, business
Abstract

Background: Dyslipidemia represents a significant non-infectious comorbidity among people living with HIV. The aim of this study is to evaluate the impact on lipid profile of switches from an efavirenz (EFV) or protease inhibitor/ritonavir (PI/r)-based regimen to a rilpivirine (RPV) or a once-daily integrase inhibitor-based regimen. Methods: We analyzed data from SCOLTA prospective database. All patients with HIV-RNA < 50 copies/ml in therapy with two NRTI + EFV or PI/r were included if they switched from EFV to dolutegravir (group EFV-DTG), elvitegravir (EFV-EVG), or RPV (EFV-RPV) and from PI/r to DTG (PI/r-DTG), PI/r to EVG (PI/r-EVG), or PI/r to RPV (PI/r-RPV). Total cholesterol (TC), TC/HDL ratio, LDL-cholesterol (LDL) and triglycerides (TG) were compared at baseline, six months and one year. Comparisons among groups were performed by a general linear model. Results: Four hundred and ninety patients were enrolled, 24.9% female, mean age 47.3 years (±10.1). According to ART switch, 11.4% were classified in group EFV-DTG, 3.9% in EFV-EVG, 23.9% in EFV-RPV, 17.6% in PI/r-DTG, 17.8% in PI/r-EVG, and 25.5% in PI/r-RPV. After adjusted analysis, TC significantly decreased in all groups but EFV-EVG, TC/HDL in all but EFV-DTG and EFV-EVG, while the reduction of TG was significant only in switches to RPV (EFV-RPV and PI/r-RPV). The one year decrease of TC, TC/HDL, LDL and TG was higher in patients with higher baseline levels of the same variable (p < .0001 for all). Conclusions: In SCOLTA, all switches from PI/r regimens gave advantages on lipid profile, while stopping EFV had consistently favorable lipid effects only if replaced by RPV.

Published
2018

4. Positioning of darunavir/cobicistat-containing antiretroviral regimens in real life: results from a large multicentre observational prospective cohort (SCOLTA)

Author

Taramasso L., Ricci E., Cascio A., Valsecchi L., Menzaghi B., Squillace N., Maggi P., De Socio G. V., Dentone C., Madeddu G., Pellicano G. F., Calza L., Angioni G., Bonfanti P., Di Biagio A., Sarchi E., Chichino G., Bellacosa C., Angarano G., Farinazzo M., Gussio M., Celesia B. M., Falasca K., Mastroianni A., Guadagnino G., Vichi F., Salomoni E., Martinelli C., Nicolini L., Cenderello G., Molteni C., Nunnari G., Cordier L., Parisini A., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G. M., Martini S., Trizzino M., Gulminetti R., Cibelli D., Parruti G., Mameli M. S., Orofino G., Guastavigna M., Lucia Taramasso, Elena Ricci, Antonio Cascio, Laura Valsecchi, Barbara Menzaghi, Nicola Squillace, Paolo Maggi, Giuseppe Vittorio De Socio, Chiara Dentone, Giordano Madeddu, Giovanni F. Pellicanò, Leonardo Calza, Goffredo Angioni, Paolo Bonfanti, Antonio Di Biagio, CISAI Study Group, Taramasso, L, Ricci, E, Cascio, A, Valsecchi, L, Menzaghi, B, Squillace, N, Maggi, P, De Socio, Gv, Dentone, C, Madeddu, G, Pellicanò, Gf, Calza, L, Angioni, G, Bonfanti, P, Di Biagio, A, Sarchi, E, Chichino, G, Bellacosa, C, Angarano, G, Farinazzo, M, Gussio, M, Celesia, B, Falasca, K, Mastroianni, A, Guadagnino, G, Vichi, F, Salomoni, E, Martinelli, C, Nicolini, L, Cenderello, G, Molteni, C, Pellicanò, G, Nunnari, G, Cordier, L, Parisini, A, Rizzardini, G, Rusconi, S, Conti, F, Bandiera, A, Gori, A, Motta, D, Puoti, M, Migliorino, G, Martini, S, Trizzino, M, Gulminetti, R, De Socio, G, Cibelli, D, Parruti, G, Mameli, M, Orofino, G, Guastavigna, M, Pellicano, G, Bandera, A, Taramasso L., Ricci E., Cascio A., Valsecchi L., Menzaghi B., Squillace N., Maggi P., De Socio G.V., Dentone C., Madeddu G., Pellicano G.F., Calza L., Angioni G., Bonfanti P., Di Biagio A., Sarchi E., Chichino G., Bellacosa C., Angarano G., Farinazzo M., Gussio M., Celesia B.M., Falasca K., Mastroianni A., Guadagnino G., Vichi F., Salomoni E., Martinelli C., Nicolini L., Cenderello G., Molteni C., Nunnari G., Cordier L., Parisini A., Rizzardini G., Rusconi S., Conti F., Bandera A., Gori A., Motta D., Puoti M., Migliorino G.M., Martini S., Trizzino M., Gulminetti R., Cibelli D., Parruti G., Mameli M.S., Orofino G., and Guastavigna M.

Subjects
0301 basic medicine, Male, HIV Infections, 0302 clinical medicine, Dual, Medicine, HIV Infection, Pharmacology (medical), 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Darunavir, Cobicistat, Middle Aged, Viral Load, Tolerability, Anti-Retroviral Agents, Cohort, Molecular Medicine, Drug Therapy, Combination, Female, Darunavir/cobicistat, Human, medicine.drug, Adverse event, Adult, lcsh:Immunologic diseases. Allergy, medicine.medical_specialty, 030106 microbiology, Context (language use), Durability, 03 medical and health sciences, Darunavir/cobicistat, Dual, Durability, Tolerability, CISAI, Adverse events, Virology, Internal medicine, Humans, business.industry, Research, Hypertriglyceridemia, medicine.disease, CISAI, Discontinuation, Prospective Studie, Adverse events, HIV-1, Anti-Retroviral Agent, business, lcsh:RC581-607
Abstract

Background Study aim was to evaluate the safety and durability of darunavir/cobicistat (DRV/c) in a real life setting. Methods Multicentre prospective cohort study performed in the context of SCOLTA (Surveillance Cohort Long-Term Toxicity Antiretrovirals). Patients were evaluated at baseline, week 24 and 48. Changes were evaluated using the paired t test or signed rank test. The multivariable analysis was performed using a general linear model, after ranking of not normally distributed variables. Results A total of 249 patients were included, 72 (29%) were in DRV/c-based dual therapies (DT). Hypercholesterolemia, HC, (total cholesterol (TC) ≥ 200 mg/dL or low density-C (LDL-C) ≥ 130 or statin use) was present in 121 (48.6%) and hypertriglyceridemia, (triglycerides (TG) ≥ 200 mg/dl or fibrate use) in 41 (16.5%) patients. Blood lipid profile did not change significantly in either the global population or patients with HC. After a median observation of 17 months (IQR 13–20), 59 (25.3%) patients discontinued DRV/c, of which 13 were in DT. The durability DT resulted higher than that of triple therapy (log-rank test p = 0.01). Main reasons for stopping DRV/c were simplification (15 patients), adverse events (13 patients), planned discontinuation for treatment initiation with DAA (4 patients), treatment failure (2 patients); death (2 patients), other causes (10 patients). Twenty-six were lost to follow-up. Conclusions DRV/c was safe and well tolerated. Dual therapies showed a better profile of tolerability and a longer durability compared to triple therapies.

Published
2019

5. Weight Gain: A Possible Side Effect of All Antiretrovirals

Author

Taramasso, L., Ricci, E., Menzaghi, B., Orofino, G., Passerini, S., Madeddu, G., Martinelli, C. V., De Socio, G. V., Squillace, N., Rusconi, S., Bonfanti, P., Biagio, A. D., Quirino, T., Bellacosa, C., Maggi, P., Calza, L., Abeli, C., Celesia, B. M., Grosso, C., Stagno, A., Vichi, F., Mazzotta, F., Penco, G., Cassola, G., Nicolini, L. A., Dentone, C., Molteni, C., Palvarini, L., Scalzini, A., Carenzi, L., Rizzardini, G., Valsecchi, L., Cordier, L., Colombo, Virginia, Galli, M., Franzetti, M., Mazzotta, Eleonora, Parruti, G., Bagella, P., Mura, M. S., Libertone, R., Antinori, A., Di Giambenedetto, S., Guastavigna, M., Taramasso, L, Ricci, E, Menzaghi, B, Orofino, G, Passerini, S, Madeddu, G, Martinelli, C, De Socio, G, Squillace, N, Rusconi, S, Bonfanti, P, Biagio, A, Quirino, T, Bellacosa, C, Maggi, P, Calza, L, Abeli, C, Celesia, B, Grosso, C, Stagno, A, Vichi, F, Mazzotta, F, Penco, G, Cassola, G, Nicolini, L, Dentone, C, Molteni, C, Palvarini, L, Scalzini, A, Carenzi, L, Rizzardini, G, Valsecchi, L, Cordier, L, Colombo, V, Galli, M, Franzetti, M, Mazzotta, E, Parruti, G, Bagella, P, Mura, M, Libertone, R, Antinori, A, Di Giambenedetto, S, and Guastavigna, M

Subjects
0301 basic medicine, cardiovascular risk, medicine.medical_specialty, 030106 microbiology, darunavir, INSTI, ART, BMI, Cardiovascular risk, Darunavir, Rilpivirine, Weight, rilpivirine, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, medicine, 030212 general & internal medicine, Elvitegravir, business.industry, Brief Report, nutritional and metabolic diseases, weight, Raltegravir, Infectious Diseases, Oncology, chemistry, Dolutegravir, Cohort, medicine.symptom, business, Body mass index, Weight gain, medicine.drug
Abstract

Weight gain and body mass index (BMI) increase are central issues in patients living with HIV who need to minimize the risk of metabolic disease. Information collected through the SCOLTA cohort revealed significant 1-year BMI increase in patients treated with dolutegravir (P = .004), raltegravir (P = .0004), elvitegravir (P = .004), darunavir (P = .0006), and rilpivirine (P = .029). BMI gain correlated with low baseline BMI (P = .002) and older age (P = .0007) in Centers for Disease Control and Prevention stages A/B, with lower BMI (P = .005) and CD4+ T-cell count (P = .007) at enrollment in stage C.

Published
2017

6. Muscle symptoms and creatine phosphokinase elevations in patients receiving raltegravir in clinical practice: Results from the SCOLTA project long-term surveillance

Author

Madeddu, G., De Socio, G. V. L., Ricci, E., Quirino, T., Orofino, G., Carenzi, L., Franzetti, M., Parruti, G., Martinelli, C., Vichi, F., Penco, G., Dentone, C., Celesia, B. M., Maggi, P., Libertone, R., Bagella, P., Di Biagio, A., Quirino T, Bonfanti P., Bonfanti, P, Ricci, E, Bellacosa, C, Maggi, P, Abeli, C, Menzaghi, B, Celesia, Bm, Cosentino, S, Grosso, C, Stagno, A, Cappelletti, A, Santoro, D, Car-radori, S, Ghinelli, F, Vichi, F, Mazzotta, F, Maria Annunziata, S, Martinelli, C, Giustini, R, Leoncini, F, Penco, G, Cassola, G, Di Biagio, A, Viscoli, C, Molteni, C, Farinazzo, M, Miccolis, S, Scalzini, A, Landonio, S, Melzi, S, Rizzardini, G, Valsecchi, L, Cordier, L, Rusconi, S, Franzetti, M, Galli, M, Rosella, E, Fioni, G, De Socio GV, Sgrelli, A, Baldelli, F, Mazzotta, E, Parruti, G, Adri-ani, B, Paladini, A, Bagella, P, Madeddu, G, Mura, Ms, Marconi, P, Libertone, R, Antinori, A, Den-tone, C, Ferrea, G, Guastavigna, M, Orofino, G, Cristina, G, Carcò, F, Migliorini, D, Armignacco, O., Madeddu, G, De Socio, G, Ricci, E, Quirino, T, Orofino, G, Carenzi, L, Franzetti, M, Parruti, G, Martinelli, C, Vichi, F, Penco, G, Dentone, C, Celesia, B, Maggi, P, Libertone, R, Bagella, P, Di Biagio, A, Bonfanti, P, Madeddu, G., De Socio, G. V. L., Ricci, E., Quirino, T., Orofino, G., Carenzi, L., Franzetti, M., Parruti, G., Martinelli, C., Vichi, F., Penco, G., Dentone, C., Celesia, B. M., Maggi, P., Libertone, R., Bagella, P., Di Biagio, A., and Bonfanti, P.

Subjects
myalgia, Male, Pyridines, Pyridine, Muscle symptoms, HIV Infections, Creatine phosphokinase elevations, Raltegravir Potassium, Medicine, HIV Infection, Pharmacology (medical), Prospective Studies, Creatine phosphokinase elevation, Pyrrolidinone, Creatine Kinase, Muscle Weakness, biology, Incidence, General Medicine, Middle Aged, Pyrrolidinones, Infectious Diseases, Oligopeptide, Female, medicine.symptom, Raltegravir, Adult, Anti-HIV Agents, Atazanavir Sulfate, Drug-Related Side Effects and Adverse Reactions, Humans, Myalgia, Oligopeptides, Rhabdomyolysis, Human, Muscle Weakne, medicine.drug, Microbiology (medical), medicine.medical_specialty, Muscle symptom, Asymptomatic, Internal medicine, business.industry, Anti-HIV Agent, Muscle weakness, medicine.disease, Surgery, Atazanavir, Prospective Studie, biology.protein, Creatine kinase, Drug-Related Side Effects and Adverse Reaction, business
Abstract

Muscle alterations ranging from asymptomatic creatine phosphokinase (CPK) increases to rhabdomyolysis and central nervous system (CNS) symptoms have been reported in patients receiving raltegravir. Muscle symptoms and CPK increases were investigated in a cohort of HIV-infected patients receiving raltegravir-based antiretroviral therapy, and possible associated predictors were evaluated. The SCOLTA Project is a prospective, observational, multicentre study created to assess the incidence of adverse events in patients receiving new antiretroviral drugs in clinical practice. In total, 496 HIV-infected patients were enrolled [333 (67.1%) male]. CDC stage was C in 196 patients (39.5%). Mean age at enrolment was 45.9 ± 9.3 years. Median follow-up was 21 months. Twenty-six patients (5.2%) reported muscle symptoms (16 muscle pain and 17 weakness; 7 had both). Of 342 patients with normal baseline CPK values, 72 (21.1%) had a CPK increase. Seven patients (1.4%) discontinued raltegravir because of muscular events (three for muscle pain/weakness and four CPK increases). No cases of rhabdomyolysis were observed. Patients with muscle symptoms were more frequently receiving in their regimen than those not receiving atazanavir (P = 0.04) and were more likely to also report CNS symptoms (P < 0.0001). Significant predictors of muscle symptoms were CNS symptoms and use of atazanavir. Female sex was associated with a reduced risk of CPK increase. In conclusion, muscle symptoms and CPK elevations occurred frequently and caused most discontinuations due to adverse events. Their monitoring in patients receiving raltegravir should be considered, especially when co-administered with atazanavir or when CNS symptoms are also present.

Published
2015

7. Durability of Dolutegravir-Based Regimens: A 5-Year Prospective Observational Study

Author

Lucia, Taramasso, Andrea, De Vito, Elena Delfina, Ricci, Giancarlo, Orofino, Nicola, Squillace, Barbara, Menzaghi, Chiara, Molteni, Roberto, Gulminetti, Giuseppe Vittorio, De Socio, Giovanni Francesco, Pellicanò, Eleonora, Sarchi, Benedetto Maurizio, Celesia, Leonardo, Calza, Stefano, Rusconi, Laura, Valsecchi, Canio Vito, Martinelli, Antonio, Cascio, Paolo, Maggi, Francesca, Vichi, Goffredo, Angioni, Giuliana, Guadagnino, Giovanni, Cenderello, Chiara, Dentone, Alessandra, Bandera, Katia, Falasca, Paolo, Bonfanti, Antonio, Di Biagio, Giordano, Madeddu, M, Guastavigna, Taramasso, L., De Vito, A., Ricci, E. D., Orofino, G., Squillace, N., Menzaghi, B., Molteni, C., Gulminetti, R., De Socio, G. V., Pellicano, G. F., Sarchi, E., Celesia, B. M., Calza, L., Rusconi, S., Valsecchi, L., Martinelli, C. V., Cascio, A., Maggi, P., Vichi, F., Angioni, G., Guadagnino, G., Cenderello, G., Dentone, C., Bandera, A., Falasca, K., Bonfanti, P., Di Biagio, A., Madeddu, G., Taramasso L, De Vito A, Ricci ED, Orofino G, Squillace N, Menzaghi B, Molteni C, Gulminetti R, De Socio GV, Pellicanò GF, Sarchi E, Celesia BM, Calza L, Rusconi S, Valsecchi L, Martinelli CV, Cascio A, Maggi P, Vichi F, Angioni G, Guadagnino G, Cenderello G, Dentone C, Bandera A, Falasca K, Bonfanti P, Di Biagio A, Madeddu G, Taramasso L., De Vito A., Ricci E.D., Orofino G., Squillace N., Menzaghi B., Molteni C., Gulminetti R., De Socio G.V., Pellicano G.F., Sarchi E., Celesia B.M., Calza L., Rusconi S., Valsecchi L., Martinelli C.V., Cascio A., Maggi P., Vichi F., Angioni G., Guadagnino G., Cenderello G., Dentone C., Bandera A., Falasca K., Bonfanti P., Di Biagio A., Madeddu G., Taramasso, L, De Vito, A, Ricci, E, Orofino, G, Squillace, N, Menzaghi, B, Molteni, C, Gulminetti, R, De Socio, G, Pellicanò, G, Sarchi, E, Celesia, B, Calza, L, Rusconi, S, Valsecchi, L, Martinelli, C, Cascio, A, Maggi, P, Vichi, F, Angioni, G, Guadagnino, G, Cenderello, G, Dentone, C, Bandera, A, Falasca, K, Bonfanti, P, Di Biagio, A, and Madeddu, G

Subjects
adverse events, dolutegravir, durability, HIV, safety, toxicity, virolgical failure, Cohort Studies, Female, Heterocyclic Compounds, 3-Ring, Humans, Middle Aged, Oxazines, Piperazines, Prospective Studies, Pyridones, Anti-HIV Agents, HIV Infections, Pediatrics, medicine.medical_specialty, Settore MED/17 - Malattie Infettive, Oxazine, Human immunodeficiency virus (HIV), adverse event, Pyridone, medicine.disease_cause, 3-Ring, chemistry.chemical_compound, Heterocyclic Compounds, Antiretroviral treatment, Medicine, Adverse effect, Piperazine, business.industry, Public Health, Environmental and Occupational Health, Anti-HIV Agent, Discontinuation, Prospective Studie, Infectious Diseases, chemistry, Dolutegravir, Observational study, Cohort Studie, business, Human
Abstract

This study evaluates the frequency and causes of dolutegravir (DTG) discontinuation along 5 years of follow-up, in both antiretroviral treatment (ART)-naive and experienced people living with HIV (PLWH). This is a prospective multi-center cohort study enrolling PLWH on DTG from July 2014 until November 2020. DTG-durability was investigated using the Kaplan-Meier survival curve. The Cox proportional-hazards model was used for estimating the hazard ratio (HR) of DTG discontinuation for any cause, and for adverse events (AEs). Nine hundred sixty-three PLWH were included, 25.3% were women and 28.0% were ART-naive. Discontinuations for any causes were 10.1 [95% confidence interval (95% CI) 8.9-11.5] per 100 person-years, similar in most regimens, with the apparent exception of tenofovir alafenamide/emtricitabine+DTG (p

Published
2021

8. Effect of High-Titer Convalescent Plasma on Progression to Severe Respiratory Failure or Death in Hospitalized Patients with COVID-19 Pneumonia: A Randomized Clinical Trial

Author

Menichetti, F., Popoli, P., Puopolo, M., Alegiani, S. S., Tiseo, G., Bartoloni, A., De Socio, G., Luchi, S., Blanc, P., Puoti, M., Toschi, E., Massari, M., Palmisano, L., Marano, G., Chiamenti, M., Martinelli, L., Franchi, S., Pallotto, C., Suardi, L. R., Pasqua, B. L., Merli, M., Fabiani, P., Bertolucci, L., Borchi, B., Modica, S., Moneta, S., Marchetti, G., d'Arminio Monforte, A., Stoppini, L., Ferracchiato, N., Piconi, S., Fabbri, C., Beccastrini, E., Saccardi, R., Giacometti, A., Esperti, S., Pierotti, P., Bernini, L., Bianco, C., Benedetti, S., Lanzi, A., Bonfanti, P., Sani, S., Saracino, A., Castagna, A., Trabace, L., Lanza, M., Focosi, D., Mazzoni, A., Pistello, M., Falcone, M., Locatelli, F., Ippolito, G., Magrini, N., Bernardini, R., Brusaferro, S., De Angelis, V., Perotti, C., Remuzzi, G., De Silvestro, G., Costantini, M., Bocchino, M., De Donno, G., Francisci, D., Menichetti, F., Popoli, P., Puopolo, M., Spila Alegiani, S., Tiseo, G., Bartoloni, A., De Socio, G. V., Luchi, S., Blanc, P., Puoti, M., Toschi, E., Massari, M., Palmisano, L., Marano, G., Chiamenti, M., Martinelli, L., Franchi, S., Pallotto, C., Suardi, L. R., Luciani Pasqua, B., Merli, M., Fabiani, P., Bertolucci, L., Borchi, B., Modica, S., Moneta, S., Marchetti, G., D'Arminio Monforte, A., Stoppini, L., Ferracchiato, N., Piconi, S., Fabbri, C., Beccastrini, E., Saccardi, R., Giacometti, A., Esperti, S., Pierotti, P., Bernini, L., Bianco, C., Benedetti, S., Lanzi, A., Bonfanti, P., Sani, S., Saracino, A., Castagna, A., Trabace, L., Lanza, M., Focosi, D., Mazzoni, A., Pistello, M., Falcone, M., Menichetti, F, Popoli, P, Puopolo, M, Spila Alegiani, S, Tiseo, G, Bartoloni, A, De Socio, G, Luchi, S, Blanc, P, Puoti, M, Toschi, E, Massari, M, Palmisano, L, Marano, G, Chiamenti, M, Martinelli, L, Franchi, S, Pallotto, C, Suardi, L, Luciani Pasqua, B, Merli, M, Fabiani, P, Bertolucci, L, Borchi, B, Modica, S, Moneta, S, Marchetti, G, d'Arminio Monforte, A, Stoppini, L, Ferracchiato, N, Piconi, S, Fabbri, C, Beccastrini, E, Saccardi, R, Giacometti, A, Esperti, S, Pierotti, P, Bernini, L, Bianco, C, Benedetti, S, Lanzi, A, Bonfanti, P, Sani, S, Saracino, A, Castagna, A, Trabace, L, Lanza, M, Focosi, D, Mazzoni, A, Pistello, M, and Falcone, M

Subjects
Male, medicine.medical_specialty, Randomization, Settore MED/17 - Malattie Infettive, Population, Aged, COVID-19, Disease Progression, Female, Humans, Italy, Middle Aged, Prospective Studies, SARS-CoV-2, Severity of Illness Index, Standard of Care, Hospital Mortality, Hospitalization, Immunization, Passive, Plasma, Respiratory Insufficiency, Passive, law.invention, Randomized controlled trial, law, Internal medicine, Clinical endpoint, medicine, education, Adverse effect, education.field_of_study, business.industry, General Medicine, Odds ratio, medicine.disease, Pneumonia, Respiratory failure, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Immunization, business
Abstract

Importance: Convalescent plasma (CP) has been generally unsuccessful in preventing worsening of respiratory failure or death in hospitalized patients with COVID-19 pneumonia. Objective: To evaluate the efficacy of CP plus standard therapy (ST) vs ST alone in preventing worsening respiratory failure or death in patients with COVID-19 pneumonia. Design, setting, and participants: This prospective, open-label, randomized clinical trial enrolled (1:1 ratio) hospitalized patients with COVID-19 pneumonia to receive CP plus ST or ST alone between July 15 and December 8, 2020, at 27 clinical sites in Italy. Hospitalized adults with COVID-19 pneumonia and a partial pressure of oxygen-to-fraction of inspired oxygen (Pao2/Fio2) ratio between 350 and 200 mm Hg were eligible. Interventions: Patients in the experimental group received intravenous high-titer CP (≥1:160, by microneutralization test) plus ST. The volume of infused CP was 200 mL given from 1 to a maximum of 3 infusions. Patients in the control group received ST, represented by remdesivir, glucocorticoids, and low-molecular weight heparin, according to the Agenzia Italiana del Farmaco recommendations. Main outcomes and measures: The primary outcome was a composite of worsening respiratory failure (Pao2/Fio2 ratio

Published
2021

9. Switch to dolutegravir and unboosted atazanavir in HIV-1 infected patients with undetectable viral load and long exposure to antiretroviral therapy

Author

Andrea Poli, Agostino Riva, Simona Di Giambenedetto, Roberto Gulminetti, Antonella Castagna, Sinibaldo Carosella, Giovanni Mazzola, Stefano Bonora, Anna Maria Cattelan, Stefano Rusconi, Laura Galli, Maria Eugenia Quiros-Roldan, Giuseppe Vittorio De Socio, Maurizio Mena, Nicoletta Ladisa, Castagna, A., Rusconi, S., Gulminetti, R., Bonora, S., Mazzola, G., Quiros-Roldan, M. E., De Socio, G. V., Ladisa, N., Carosella, S., Cattelan, A., Di Giambenedetto, S., Mena, M., Poli, A., Galli, L., and Riva, A.

Subjects
0301 basic medicine, Male, HIV Infections, Kaplan-Meier Estimate, Piperazines, chemistry.chemical_compound, 0302 clinical medicine, Antiretroviral Therapy, Highly Active, Immunology and Allergy, Medicine, Pharmacology (medical), 030212 general & internal medicine, Drug Substitution, Health Policy, virus diseases, Middle Aged, Viral Load, dolutegravir, Treatment Outcome, Infectious Diseases, Dolutegravir, RNA, Viral, Drug Therapy, Combination, Female, Viral load, Heterocyclic Compounds, 3-Ring, medicine.drug, medicine.medical_specialty, Pyridones, Immunology, Atazanavir Sulfate, antiretroviral therapy, switch strategy, Settore MED/17 - MALATTIE INFETTIVE, 03 medical and health sciences, Pharmacotherapy, Internal medicine, Oxazines, Humans, HIV Integrase Inhibitors, dual therapy, business.industry, Antiretroviral therapy, Discontinuation, Atazanavir, CD4 Lymphocyte Count, Regimen, 030104 developmental biology, chemistry, HIV-1, business
Abstract

We evaluated the efficacy and safety of a two-drug regimen including dolutegravir (DTG) and unboosted atazanavir (uATV) in 151 HIV-1 infected patients with HIV-RNA of more than 50 copies/ml. During a median follow-up of 62 (42-97) weeks, two virological failures (1%) and 13 treatment discontinuations (9%) occurred; the 48-week probability of virological failure was 0.8% (95% confidence interval 0.2-5.6%). Switch to DTG + uATV may represent a boosting and transcriptase reverse inhibitors sparing otion in individuals with long exposure to antiretroviral therapy and risk of cardiovascular disease.

Published
2019

10. Statins and aspirin in the prevention of cardiovascular disease among HIV-positive patients between controversies and unmet needs: Review of the literature and suggestions for a friendly use

Author

A. Di Biagio, Vincenzo Spagnuolo, M. D’Abbraccio, Laura Sighinolfi, Gabriella d'Ettorre, Nicola Squillace, Paolo Maggi, Stefano Rusconi, G. V. De Socio, Giuseppe Nunnari, Stefania Cicalini, Canio Martinelli, Maggi, P., De Socio, G. V., Cicalini, S., D'Abbraccio, M., Dettorre, G., Di Biagio, A., Martinelli, C., Nunnari, G., Rusconi, S., Sighinolfi, L., Spagnuolo, V., Squillace, N., Maggi, P, De Socio, Gv, Cicalini, S, D'Abbraccio, M, Dettorre, G, Di Biagio, A, Martinelli, C, Nunnari, G, Rusconi, S, Sighinolfi, L, and Spagnuolo, V

Subjects
lcsh:Immunologic diseases. Allergy, 0301 basic medicine, Drug, Adult, medicine.medical_specialty, Statin, medicine.drug_class, media_common.quotation_subject, Atorvastatin, 030106 microbiology, Population, HIV Infections, Disease, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Virology, medicine, Humans, Pharmacology (medical), Rosuvastatin, 030212 general & internal medicine, Intensive care medicine, education, media_common, Aged, education.field_of_study, Aspirin, business.industry, Methodology, Antiplatelet agents, Statins, HIV, Middle Aged, Cardiovascular disease, Oral anticoagulants, United States, Primary Prevention, Cardiovascular Diseases, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Practice Guidelines as Topic, Molecular Medicine, Position paper, lcsh:RC581-607, business, medicine.drug
Abstract

Background As in non-infected subjects, statins and aspirin have a pivotal preventive role in reducing the cardiovascular related morbidity and mortality in HIV infected patients. The persistence of immune activation in these subjects, could contribute to accelerate atherosclerosis, therefore, these treatments that reduce inflammation could provide additional cardiovascular protection. However the current guidelines for the use of these drugs in general population are dissimilar, with important differences between American and European ones. Aim of the present position paper is to provide recommendations aimed to overcome the actual differences and limitations among the current ones and to adapt them to the needs of HIV infected patients. Results We propose to adopt the new ACC/AHA guidelines, simple to use and cost effective, to use the ASCVD score that seems to estimate more accurately the cardiovascular risk among these patients. We suggest to start statin therapy in all patients with a calculated 10-year risk of a cardiovascular event of 10% or greater. Rosuvastatin and atorvastatin should be preferred. LDL-C target may be adopted. Aspirin should be always associated with a statin, in secondary prevention, while in primary prevention it should be reserved only to patients with ≥ 20% 10-year risk particularly adherent to treatments, and with low risk of bleeding. We suggest to start with a dose of 100 mg/day. Finally, management of antiplatelet agents or novel oral anticoagulants may include selecting antiretrovirals with a lower potential for drug interactions or choosing agents least likely to interact with antiretrovirals. Conclusions As demonstrated in surveys, HIV physicians are generally highly committed regarding CVD and autonomous in prescribing statins and ASA. Consequently, in the light of the previously discussed discrepancies among the different guidelines and of the incomplete indications regarding HIV-positive persons, the present suggestions could overcome the actual differences and limitations among the current ones.

Published
2019

11. Elderly HIV-positive women: A gender-based analysis from the Multicenter Italian 'GEPPO' Cohort

Author

Emanuele Focà, Paola Magro, Giovanni Guaraldi, Agostino Riva, Anna Maria Cattelan, Giuseppe Vittorio De Socio, Cecilia Costa, Stefania Piconi, Benedetto Maurizio Celesia, Silvia Nozza, Giancarlo Orofino, Antonella Castagna, Giovanni Di Perri, Francesco Castelli, Andrea Calcagno, GEPPO (GEriatric Patients living with HIV/AIDS: a Prospective Multidimensional cOhort) Study Group, Foca, E., Magro, P., Guaraldi, G., Riva, A., Cattelan, A. M., de Socio, G. V., Costa, C., Piconi, S., Celesia, B. M., Nozza, S., Orofino, G., Castagna, A., Perri, G. D., Castelli, F., and Calcagno, A.

Subjects
RNA viruses, 0301 basic medicine, CD4-Positive T-Lymphocytes, Male, Multivariate analysis, Bone disease, Psychological intervention, Human immunodeficiency virus (HIV), Integrase inhibitor, HIV Infections, Cardiovascular Medicine, Pathology and Laboratory Medicine, medicine.disease_cause, Cohort Studies, White Blood Cells, Elderly, 0302 clinical medicine, Immunodeficiency Viruses, Animal Cells, HIV Seropositivity, Medicine and Health Sciences, Public and Occupational Health, 030212 general & internal medicine, Aged, 80 and over, education.field_of_study, Sex Characteristics, Multidisciplinary, T Cells, HIV diagnosis and management, Viral Load, Vaccination and Immunization, Medical Microbiology, Cardiovascular Diseases, Viral Pathogens, Viruses, Cohort, Infectious diseases, RNA, Viral, Medicine, Drug Therapy, Combination, Female, Pathogens, Cellular Types, Bone Diseases, Research Article, Cart, medicine.medical_specialty, Anti-HIV Agents, Immune Cells, Science, Immunology, Population, Antiretroviral Therapy, Viral diseases, Microbiology, 03 medical and health sciences, Antiviral Therapy, Internal medicine, Retroviruses, medicine, Humans, education, Microbial Pathogens, Aged, Blood Cells, business.industry, Lentivirus, Organisms, Biology and Life Sciences, HIV, Cell Biology, medicine.disease, 030112 virology, Diagnostic medicine, Geriatrics, Age Groups, People and Places, HIV-1, Population Groupings, Preventive Medicine, business
Abstract

BackgroundHIV-positive patients are facing age-and disease-related comorbidities. Since gender differences in viro-immunological, clinical and therapeutic features have been described, aim of this analysis was to explore such differences in elderly HIV-positive females compared to males coming from the same cohort.DesignCross-sectional study.SettingTen Infectious Diseases Center participating to a new multicenter Italian geriatric Cohort aiming at describing health transition over time in HIV-positive individuals.ParticipantsHIV-positive patients aged ≥65 years old.MeasurementsWe recorded clinical, viro-immunological and therapeutical data.ResultsWe included 210 women (17%) out of 1237 patients. Compared to males, elderly females were less likely to present a HIV-RNA 0.05), although women were less likely to be treated with protease Inhibitors (PIs) (p = 0.05); specifically, in triple-drug regimens females received less PIs (28% vs 38% p = 0.022) and more integrase inhibitors (30% vs. 20% p = 0.012). Bone disease was more common in females (p0.05). A higher use of lipid-lowering drugs (20.5% vs. 14.8%, p = 0.04) was observed in females and yet they were less likely to receive anti-thrombotic agents (18.6% vs. 26.3%, p = 0.019) even when CVD was recorded (57.1% vs. 83.1%, p = 0.018). In multivariate analysis, we found that female gender was independently associated with a higher CD4+/CD8+ ratio but not with virological suppression.ConclusionsElderly HIV-positive women display a worse virologic response despite a better immune reconstitution compared to males. The burden of comorbidities as well as the medications received (including cART) may slightly differ according to gender. Our data suggest that more efforts and focused interventions are needed in this population.

Published
2019

12. Raltegravir-based therapy in a cohort of HIV/HCV co-infected individuals

Author

Paolo Maggi, M. Franzetti, G. V. De Socio, Tiziana Quirino, Giovanni Penco, A. Di Biagio, Chiara Dentone, Elena Ricci, G. Orofino, Paolo Bonfanti, Lucia Taramasso, Simone Passerini, Barbara Menzaghi, Canio Martinelli, Raffaella Libertone, Benedetto Maurizio Celesia, Giordano Madeddu, Taramasso, L, Madeddu, G, Ricci, E, De Socio, G, Menzaghi, B, Orofino, G, Passerini, S, Franzetti, M, Maggi, P, Dentone, C, Martinelli, C, Celesia, B, Penco, G, Libertone, R, Quirino, T, Bonfanti, P, Di Biagio, A, De Socio, G V, and Celesia, B M

Subjects
Male, HIV Infections, medicine.disease_cause, Hepatitis, Cohort Studies, HIV Infection, Viral, Pyrrolidinone, Univariate analysis, Coinfection, Hazard ratio, virus diseases, Alanine Transaminase, General Medicine, Middle Aged, Tolerability, Hepatitis C, Pyrrolidinones, Liver, HCV, Cohort, RNA, Viral, Female, Safety, Human, medicine.drug, medicine.medical_specialty, Efficacy, Hepatitis C virus, Hepatiti, Follow-Up Studie, Raltegravir Potassium, Internal medicine, medicine, Humans, Aspartate Aminotransferases, Adverse effect, Demography, Pharmacology, business.industry, Aspartate Aminotransferase, medicine.disease, Raltegravir, Immunology, RNA, Cohort Studie, Follow-Up Studies, business
Abstract

The relationship between hepatic tolerance and hepatitis C virus (HCV) co-infection has not been extensively studied in clinical practice. We assessed the efficacy and safety of raltegravir-based therapy in an Italian cohort of HIV/HCV co-infected patients. One hundred and forty patients with HIV/HCV co-infection initiating raltegravir from SCOLTA project (Surveillance Cohort Long-Term Toxicity Antiretrovirals) were examined. Of them, 43 were women, with mean age of 45.4. ±. 6.4. years; 65 (46%) had undetectable HIV-RNA. < 50. copies/mL and 75 (54%) HIV-RNA. ≥. 50. copies/mL. According to CDC classification, 49 (35%) were in stage C. Based on Fib4 score at the time of starting raltegravir, patients were classified in class I in 41 cases, class II in 68 and in class III in 31 cases. Globally, the Fib4 score slightly decreased during 24. months follow-up, from 2.2 to a value of 1.8. Hepatic adverse events of any grade were observed in 67 patients, of which only 2 cases (3%) had severe liver toxicity (grade 3-4). Only one patient had to discontinue the therapy because of adverse events. According to univariate analysis, being in CDC stage C represented a risk for the development of liver toxicity, with a hazard ratio (HR) of 2.27 (95% CI 1.06-4.84, P= 0.033). None of the other variables considered (age, sex, years since detection of HIV and HCV-RNA detectable, years of previous HIV therapy, concomitant therapy with PI or NRTI, CD4+ cell count, Fib4, and transaminases level at baseline) resulted statistically correlated to the outcome. In conclusion, raltegravir-based regimens can be safely used in HCV infected patients; in this study, the hepatic toxicity has been found to be more frequent in patients with an advanced HIV disease (CDC stage C), independently of HIV-RNA suppression at raltegravir initiation.

Published
2015

13. Co-administration of tenofovir plus protease inhibitor based antiretroviral therapy during sofosbuvir/ledipasvir treatment for HCV infection: Much Ado About Nothing?

Author

Nicola Squillace, Paolo Bonfanti, Tiziana Quirino, Giuseppe Vittorio De Socio, Lucia Taramasso, Elena Ricci, Antonio Di Biagio, Canio Martinelli, Benedetto Maurizio Celesia, Laura Ambra Nicolini, Paolo Maggi, Taramasso, L., Ricci, E., Celesia, B. M., Bonfanti, P., Quirino, T., Squillace, N., Nicolini, L. A., Maggi, P., Martinelli, C., De Socio, G. V., Di Biagio, A., Taramasso, L, Ricci, E, Celesia, B, Bonfanti, P, Quirino, T, Squillace, N, Nicolini, L, Maggi, P, Martinelli, C, De Socio, G, Di Biagio, A, Celesia, Bm, Nicolini, La, and De Socio, Gv

Subjects
0301 basic medicine, Ledipasvir, Sofosbuvir, Tenofovir, Hepatitis C virus, medicine.disease_cause, Antiviral Agents, Benzimidazole, Drug Administration Schedule, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Pharmacotherapy, medicine, Humans, Protease inhibitor (pharmacology), 030212 general & internal medicine, Antiviral Agent, Fluorenes, Evidence-Based Medicine, Hepatology, business.industry, Gastroenterology, Hepatitis C, Antiretroviral therapy, Virology, Fluorene, Treatment Outcome, 030104 developmental biology, chemistry, Sofosbuvir/ledipasvir, Benzimidazoles, Drug Therapy, Combination, Hepatitis C viru, business, Human, Co administration, medicine.drug
Published
2017

14. Safety and tolerability of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil fumarate in a real life setting: Data from surveillance cohort long-term toxicity antiretrovirals/antivirals (SCOLTA) project

Author

Nicola Squillace, Elena Ricci, Tiziana Quirino, Andrea Gori, Alessandra Bandera, Laura Carenzi, Giuseppe Vittorio De Socio, Giancarlo Orofino, Canio Martinelli, Giordano Madeddu, Stefano Rusconi, Paolo Maggi, Benedetto Maurizio Celesia, Laura Cordier, Francesca Vichi, Leonardo Calza, Katia Falasca, Antonio Di Biagio, Giovanni Francesco Pellicanò, Paolo Bonfanti, CISAI Study Group, Squillace N, Ricci E, Quirino T, Gori A, Bandera A, Carenzi L, De Socio GV, Orofino G, Martinelli C, Madeddu G, Rusconi S, Maggi P, Celesia BM, Cordier L, Vichi F, Calza L, Falasca K, Di Biagio A, Pellicanò GF, Bonfanti P, Squillace, N, Ricci, E, Quirino, T, Gori, A, Bandera, A, Carenzi, L, De Socio, G, Orofino, G, Martinelli, C, Madeddu, G, Rusconi, S, Maggi, P, Celesia, B, Cordier, L, Vichi, F, Calza, L, Falasca, K, Di Biagio, A, Pellicano, G, Bonfanti, P, Squillace, N., Ricci, E., Quirino, T., Gori, A., Bandera, A., Carenzi, L., De Socio, G. V., Orofino, G., Martinelli, C., Madeddu, G., Rusconi, S., Maggi, P., Celesia, B. M., Cordier, L., Vichi, F., Calza, L., Falasca, K., Di Biagio, A., Pellicano, G. F., and Bonfanti, P.

Subjects
RNA viruses, Male, 0301 basic medicine, HIV, AIDS, Quinolone, Physiology, Cancer Treatment, lcsh:Medicine, HIV Infections, Hepacivirus, Quinolones, Toxicology, Biochemistry, MED/17 Malattie infettive, 0302 clinical medicine, Drug Combination, Medicine and Health Sciences, Emtricitabine, Public and Occupational Health, HIV Infection, 030212 general & internal medicine, lcsh:Science, Pathology and laboratory medicine, Multidisciplinary, Elvitegravir/cobicistat/emtricitabine/tenofovir, biology, Hepatitis C virus, Elvitegravir, Cobicistat, Medical microbiology, Middle Aged, Vaccination and Immunization, AIDS, Drug Combinations, Oncology, Tolerability, Research Design, Creatinine, Viruses, elvitegravir, Female, Pathogens, Anatomy, Adult, Anti-HIV Agents, HIV-1, Humans, Maximum Tolerated Dose, Safety, Tenofovir, Research Article, Glomerular Filtration Rate, Human, medicine.drug, medicine.medical_specialty, Clinical Research Design, Immunology, Antiretroviral Therapy, Research and Analysis Methods, Microbiology, 03 medical and health sciences, Antiviral Therapy, Internal medicine, medicine, Adverse effect, Renal Physiology, Flaviviruses, Toxicity, business.industry, lcsh:R, Organisms, Viral pathogens, Biology and Life Sciences, Anti-HIV Agent, HIV, Kidneys, Renal System, cobicistat, 030112 virology, Hepatitis viruses, Microbial pathogens, Surgery, Alanine transaminase, biology.protein, Abnormal Liver Function Test, lcsh:Q, Preventive Medicine, Adverse Events, business, Biomarkers
Abstract

Objectives: The study aim was to evaluate the impact on Liver and Kidney toxicity of the single tablet regimen Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (EVG/COBI/FTC/TDF) on Antiretroviral Therapy (ART) experienced or naïve patients. Methods: Patients initiating EVG/COBI/FTC/TDF were enrolled in the SCOLTA project, a multicenter observational study reporting grade 3–4 Adverse Events in subjects beginning new antiretroviral drug regimens. In this analysis, patients were evaluated at T0 (baseline), T1 (six months) and at T2 (twelve months). Results: A total of 329 patients were enrolled, and 280 (85.1%) of these had at least one follow-up visit. Median observation time was 11 months (IQR 7.0–15.5). Two hundred and two patients (72.1%) were ART experienced and 78 (27.9%) ART naive. Prevalence of HCV-co-infection was 21.4%. At T1, we observed a significant decline in estimated glomerular filtration rate (eGFR), both in experienced and naive patients (mean change from T0–7.5 ± 12.8 ml/min, -15.5 ± 17.8 ml/min, respectively, p = 0.0005), which was confirmed at T2 (mean change from T0–8.2 ± 15.8 ml/min, -17.6 ± 19.4 ml/min, respectively, p = 0.001). Regarding aspartate aminotransferase (AST) and alanine transaminase (ALT) grade 1–2 modifications, no significant differences were observed between experienced and naïve subjects, but an increased prevalence of abnormal liver function test was observed in patients with chronic HCV infection (p Conclusions: A significant decline in eGFR was observed in patients initiating EVG/COBI/FTC/TDF in the first 6 months, with no significant worsening occurring at 12 months vs. 6 months of therapy. Patients with chronic HCV infection were at higher risk to develop abnormal liver tests.

Published
2017

15. Effectiveness of first-generation HCV protease inhibitors: Does HIV coinfection still play a role?

Author

Elena Ricci, Carlo Alberto Magni, Barbara Menzaghi, Tiziana Quirino, Elena Salomoni, Paolo Maggi, Francesca Vichi, Canio Martinelli, Katia Falasca, Laura Ambra Nicolini, Sergio Babudieri, Benedetto Maurizio Celesia, Giuseppe Vittorio De Socio, Paolo Bonfanti, Giustino Parruti, Antonio Di Biagio, Nicolini, L. A., Menzaghi, B., Ricci, E., Martinelli, C., Magni, C., Maggi, P., Celesia, B. M., Parruti, G., Babudieri, S., Bonfanti, P., Falasca, K., Vichi, F., De Socio, G. V., Salomoni, E., Di Biagio, A., Quirino, T., Nicolini, L, Menzaghi, B, Ricci, E, Martinelli, C, Magni, C, Maggi, P, Celesia, B, Parruti, G, Babudieri, S, Bonfanti, P, Falasca, K, Vichi, F, De Socio, G, Salomoni, E, Di Biagio, A, and Quirino, T

Subjects
0301 basic medicine, Male, Protease Inhibitor, HIV Infections, Hepacivirus, Polyethylene Glycol, Polyethylene Glycols, Telaprevir, chemistry.chemical_compound, 0302 clinical medicine, HIV Infection, Prospective Studies, 030212 general & internal medicine, education.field_of_study, Boceprevir, Sustained virologic response, Coinfection, Gastroenterology, Effectivene, virus diseases, Middle Aged, Viral Load, Interferon, Oligopeptide, RNA, Viral, Drug Therapy, Combination, Female, Oligopeptides, Viral load, medicine.drug, Human, Adult, medicine.medical_specialty, Proline, Population, Direct active agent, Antiviral Agents, 03 medical and health sciences, Internal medicine, Ribavirin, medicine, Humans, Protease Inhibitors, Adverse effect, education, Antiviral Agent, Hepaciviru, Hepatology, business.industry, HIV, Odds ratio, Hepatitis C, Chronic, medicine.disease, 030112 virology, Virology, Prospective Studie, chemistry, Interferons, business, Hepatitis C viru
Abstract

Objective HIV/hepatitis C virus (HCV) coinfected patients are usually considered a difficult-to-treat population. The aim of this study was to assess the effectiveness of telaprevir-based and boceprevir-based treatments with respect to the HIV status. Methods A prospective multicentre study was conducted among 22 Infectious Disease centres in Italy. Demographic, HIV and HCV related variables were collected, as well as data on HCV viral decay, sustained virologic response (SVR12) and grade 3-4 adverse events. Results Overall, 162 patients (24.7% HIV/HCV coinfected) received HCV treatment. Out of 145 evaluable patients, 57.2% achieved SVR12 (49.5% monoinfected, 78.9% coinfected). HIV coinfection was associated with a slight increase in the probability of SVR12 (adjusted odds ratio 1.66, 95% confidence interval 0.59-4.64, P =0.33). Premature discontinuation rates and adverse events were similar irrespective of HIV status, with the exception of skin reactions, which were more frequently in the HIV group. Conclusion In a real-life setting, with a high proportion of cirrhotic and treatment-experienced patients, the overall SVR12 rate was 57.2%. HIV coinfection was not associated with impaired outcome. Eur J Gastroenterol Hepatol 28:37-41.

Published
2016

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